22nd Guide to German Biotech Companies 2021

22nd Guide to German Biotech Companies 2021

22 Guide to German Biotech Companies nd

2021

In cooperation with: BIO Deutschland – German Biotech Industry Organisation European Biotechnology Network ISBN 978-3-928383-76-9

VBU Association of German Biotechnology Companies

22nd Guide to German Biotech Companies 2021 In cooperation with: BIO Deutschland – German Biotech Industry Organisation European Biotechnology Network VBU Association of German Biotechnology Companies

© BIOCOM AG, Berlin 2020 22nd Guide to German Biotech Companies Published by:

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ISBN: 978-3-928383-76-9

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Editorial

Corona kicks our butts No doubt, 2020 is an exceptional year. The corona pandemic has hit the entire planet, causing great suffering and disrupting structures everywhere. The 22nd Guide to German Biotech Companies is also affected: For the first time in decades, no OECD survey of biotechnology companies was conducted here. For this reason, this issue also lacks an overview of the industry‘s structural data. However, the list of companies at the end of the book has been updated and shows the current state of findings with 883 companies.

However, the Corona crisis did not only produce losers – think of airlines, gastronomes, cinemas or cultural workers – but also winners. These clearly include many biotechnology companies. German vaccine developers such as Biontech or Curevac, are worth billions on the international stock markets, and numerous diagnostics companies, suppliers, and equipment manufacturers are also experiencing a boom.

Even the word “biotechnology”, long frowned upon in many parts of Europe, has become respectable again. All within a year – and it‘s going so fast.

Andreas Mietzsch Publisher

In addition to climate change, the pandemic is now a second booster for the biotechnology industry. These major crises on the planet call for solutions that make use of nature‘s own tools. They are now forcing the long-needed paradigm shift away from the technologies of past centuries – fossil fuels, cars, nuclear power plants – towards gentle, biological solutions that will lead mankind onto a path of sustainability. Otherwise, the human species will not be able to survive – especially in the billions – on a planet that is limited.

It is now important to transform the rapid progress in knowledge of the past decades faster and more strongly into attractive, biotechnological products that can disruptively conquer global markets. A refocusing on what really counts is underway and must continue: Health, food, clean environment, and freedom. Clogging the roads with SUVs weighing tons, flying into boozy, all-inclusive, large size hotels four times a year, even the constant travelling of managers – we no longer need all that.

How difficult it is to let go of old habits is something we experience daily in coronarelated discussions. And the cheap price of oil undermines any sustainable innovation, which also has a strong impact on the bioeconomy. But let us rather look ahead: The 22nd Guide to German Biotech Companies presents an abundance of ideas, products and solutions for today and tomorrow.

Browse and find out more, dear readers!

22 nd Guide to german biotech companies 2021

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Content

Editorial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

The German Biotech Sector 2020 . .

6

Prefaces of Biotech Associations . . 11 Oliver Schacht, PhD, BIO Deutschland – German Biotech Industry Organisation. . . . . . . . 11 Dr Kathrin Rübberdt, Dr Sebastian Hiessl, DECHEMA e.V. and VBU Association of German Biotechnology Companies. . . . . . . . . . . . . . . . . . 13 Profiles of German Biotech Companies. . . . . . . .

4HF Biotec GmbH. . . . . . . . . . . . . . . . . . . . . . . . . acromion GmbH . . . . . . . . . . . . . . . . . . . . . . . . . .

Aeterna Zentaris GmbH. . . . . . . . . . . . . . . . . . . . .

Affimed GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . .

AGC Biologics. . . . . . . . . . . . . . . . . . . . . . . . . . . .

AGCT GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

AiCuris Anti-infective Cures GmbH. . . . . . . . . . . .

AmpTec GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . .

Apogenix AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Axolabs GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . .

BAG Health Care GmbH. . . . . . . . . . . . . . . . . . . .

Bioassay GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . .

Biofrontera AG. . . . . . . . . . . . . . . . . . . . . . . . . . . .

BioMed X GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . biosyn Arzneimittel GmbH. . . . . . . . . . . . . . . . . . .

Boehringer Ingelheim Biopharmaceuticals GmbH. BRAIN AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . c-LEcta GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cardior Pharmaceuticals GmbH. . . . . . . . . . . . . .

Cellex CMT GmbH . . . . . . . . . . . . . . . . . . . . . . . .

CellGenix GmbH. . . . . . . . . . . . . . . . . . . . . . . . . .

Co.don AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Coriolis Pharma Research GmbH. . . . . . . . . . . . .

CRS Clinical Research Services Andernach GmbH. CTI Clinical Trial & Consulting Services Europe GmbH. CureVac AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CYBERTRON GmbH. . . . . . . . . . . . . . . . . . . . . . .

DyNAbind GmbH . . . . . . . . . . . . . . . . . . . . . . . . . eleva GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Eurofins BioPharma Product Testing Munich GmbH. Evotec SE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fassisi GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 54 56 58 60 62 64 66 68 70 72 74 76 78

FGK Clinical Research GmbH. . . . . . . . . . . . . . . . 80 FILTROX AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Formycon AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84 Fraunhofer ITEM. . . . . . . . . . . . . . . . . . . . . . . . . . 86 GEMoaB Monoclonals GmbH. . . . . . . . . . . . . . . . 88 Glycotope GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . 90 glyXera GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . 92 HS Diagnomics GmbH . . . . . . . . . . . . . . . . . . . . . 94 IBA GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 IDT Biologika GmbH. . . . . . . . . . . . . . . . . . . . . . . 98 Immunic AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 in.vent Diagnostica GmbH. . . . . . . . . . . . . . . . . . . 102 INCYTO GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . 104 Indivumed GmbH . . . . . . . . . . . . . . . . . . . . . . . . . 106 InVivo BioTech Services GmbH. . . . . . . . . . . . . . . 108 iOmx Therapeutics AG . . . . . . . . . . . . . . . . . . . . . 110 ITM Isotopen Technologien München AG. . . . . . . 112 Labor Dr. Merk & Kollegen GmbH. . . . . . . . . . . . . 114 LenioBio GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . 116 LIFE & BRAIN GmbH. . . . . . . . . . . . . . . . . . . . . . . 118 Metronomia Clinical Research GmbH. . . . . . . . . . 120 Mettler-Toledo GmbH . . . . . . . . . . . . . . . . . . . . . . 122 Microcoat Biotechnologie GmbH . . . . . . . . . . . . . 124 Microsynth Seqlab. . . . . . . . . . . . . . . . . . . . . . . . . 126 MLM Medical Labs GmbH. . . . . . . . . . . . . . . . . . . 128 Molecular Health GmbH . . . . . . . . . . . . . . . . . . . . 130 Molzym GmbH & Co. KG. . . . . . . . . . . . . . . . . . . . 132 MorphoSys AG . . . . . . . . . . . . . . . . . . . . . . . . . . . 134 MYR GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136 Neovii Biotech GmbH. . . . . . . . . . . . . . . . . . . . . . 138 New England Biolabs GmbH. . . . . . . . . . . . . . . . . 140 Nordmark Arzneimittel GmbH & Co. KG. . . . . . . . 142 PeproTech GmbH . . . . . . . . . . . . . . . . . . . . . . . . . 144 Pharma Waldhoff GmbH. . . . . . . . . . . . . . . . . . . . 146 Pharmaplan GmbH. . . . . . . . . . . . . . . . . . . . . . . . 148 Phyton Biotech GmbH. . . . . . . . . . . . . . . . . . . . . . 150 Pieris Pharmaceuticals, Inc. . . . . . . . . . . . . . . . . . 152 PlasmidFactory GmbH & Co. KG . . . . . . . . . . . . . 154 ProBioGen AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . 156 PROGEN Biotechnik GmbH . . . . . . . . . . . . . . . . . 158 ProJect Pharmaceutics GmbH. . . . . . . . . . . . . . . 160 Protagen Protein Services GmbH. . . . . . . . . . . . . 162 PSL Peptide Specialty Laboratories GmbH . . . . . 164 Rentschler Biopharma SE. . . . . . . . . . . . . . . . . . . 166 RheinCell Therapeutics GmbH . . . . . . . . . . . . . . . 168 Richter-Helm BioLogics GmbH & Co. KG. . . . . . . 170 Roche Diagnostics GmbH. . . . . . . . . . . . . . . . . . . 172 ScheBo® · Biotech AG. . . . . . . . . . . . . . . . . . . . . . 174

SERVA Electrophoresis GmbH . . . . . . . . . . . . . . . 176 Sino Biological Europe GmbH. . . . . . . . . . . . . . . . 178 Sirius Fine Chemicals SiChem GmbH. . . . . . . . . . 180 SphingoTec GmbH . . . . . . . . . . . . . . . . . . . . . . . . 182 SSS International Clinical Research GmbH . . . . . 184 Taconic Biosciences GmbH . . . . . . . . . . . . . . . . . 186 TETEC AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188 Thermo Fisher Scientific . . . . . . . . . . . . . . . . . . . . 190 Therycell GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . 192 Tosoh Bioscience . . . . . . . . . . . . . . . . . . . . . . . . . 194 TRIGA-S Scientific Solutions. . . . . . . . . . . . . . . . . 196 UGA Biopharma GmbH. . . . . . . . . . . . . . . . . . . . . 198 VAXIMM GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . 200 Velabs Therapeutics GmbH. . . . . . . . . . . . . . . . . . 202 Vetter Pharma-Fertigung GmbH & Co. KG . . . . . . 204 Vibalogics GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . 206 Vivoryon Therapeutics AG. . . . . . . . . . . . . . . . . . . 208 X-act Cologne Clinical Research GmbH. . . . . . . . 210 Xell AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212 YUMAB GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . . 214

Profiles of Service Providers . . . . . . . 217 BIO.NRW. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218 BioM Biotech Cluster Development GmbH. . . . . 220 BIOPRO Baden-Württemberg GmbH. . . . . . . . . . 222 btS e.V. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224 Central BioHub GmbH. . . . . . . . . . . . . . . . . . . . . . 226 Fördergesellschaft IZB. . . . . . . . . . . . . . . . . . . . . 228 HealthCapital Berlin Brandenburg. . . . . . . . . . . . 230 L&R Kältetechnik Ges.m.b.H. & Co. KG . . . . . . . . 232 Life Science Nord Management GmbH. . . . . . . . 234 Maiwald Patentanwalts- und Rechtsanwaltsgesellschaft mbH . . . . . . . . . . . . . 236 NEUWERK Rechtsanwälte. . . . . . . . . . . . . . . . . . 238 RauCon GmbH & Co. KG . . . . . . . . . . . . . . . . . . . 240 Technologiepark Heidelberg. . . . . . . . . . . . . . . . . 242 TVM Life Science Management. . . . . . . . . . . . . . 244 Woll Maschinenbau GmbH. . . . . . . . . . . . . . . . . . 246 Wuesthoff & Wuesthoff Patentanwälte PartG mbB. 248 Xlife Sciences AG. . . . . . . . . . . . . . . . . . . . . . . . . 250

German Biotech Companies . . . . . . . . . 252

22 nd Guide to german biotech companies 2021

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COVID-19 and the German Biotechnology Sector The year 2020 was not a normal one, neither for the international nor the German biotechnology sector. Triggered by the COVID-19 pandemic, which emerged in Wuhan, China, in December 2019 and was declared a pandemic by the World Health Organisation (WHO) in March 2020, medical biotechnology is experiencing unprecedented public attention and reporting in leading media.

The majority of economic sectors suffered losses as a result of the lockdown that went far beyond those stemming from the global economic and financial crisis 2008/2009. In contrast, it was small and medium-sized biotech companies upon which the hopes of political decision makers rested in order to return to a halfway normal social and economic life. Accordingly, the financial support provided by the Federal Government and the German EU Council Presidency in H2/2020 for medical biotechnology was significantly higher than in the years before, exceeding the €1bn mark for COVID-19 vaccines alone.

Due to the pandemic, the focus of attention shifted from Germany’s planned focus on the bioeconomy – a new action plan was presented in January 2020 – to pharma biotech but with an almost unmitigated focus on the COVID-19 pandemic. Until mid-October 2020, large amounts of public money were invested into three priority areas:

· COVID-19 vaccines · SARS-CoV-2 diagnostics (RT-PCR, antigen tests) · Protection/Social distancing (masks etc.)

Vaccines There is high hope for the rapid availability of vaccines that can protect at least 50% of non-infected people or ameliorate severity of an infection with the new corona virus. Most vaccine candidates recognise parts of the spike protein that SARS-CoV-2 uses to enter human cells by binding to its ACE2 and TMPRSS2 receptors. As of mid-October, 45 SARS-CoV-2 experimental vaccines were in clinical development globally, 11 of which were in Phase III pivotal testing.

As part of a €750million “Special Programme of the Federal Government to Accelerate R&D of Urgently Needed Vaccines against SARS-CoV-2”, the world-leading mRNA vaccine developers Curevac AG (Tübingen) and Biontech SE (Mainz) were selected to receive up to €375million and €252 million, respectively, from Germany’s Federal Government. A third vaccine maker, IDT Biologika (Dessau), which produces a COVID-19 vaccine based on the viral MVA vector receive €114 million to complete clinical trials and submit a Market Authorisation Application (MAA) for MVA-SARS-2-S by the end of 2021.

Virus proliferation Antibody production

Incubation period

Week 1

Symptoms

Week 2

Limit of detection

Week 3

Source: ECDC

RT-PCR and antigen-based diagnostics are suitable for virus detection up to 14 days after infection with SARS-CoV-2. All test results must be confirmed by RT-PCR.

Lead Discovery Center (Dortmund)

Evotec (Hamburg)

AiCuris (Wuppertal)

Vibalogics (Cuxhafen)

Taconic Biosciences (Leverkusen) ARTES Biotechnology (Langenfeld)

moloX (Berlin)

Richter-Helm BioLogics (Hamburg)

Glycotope (Berlin)

Yumab (Braunschweig)

Cyano Biotech (Berlin)

Miltenyi Biotec (Teterow)

Berlin Cures (Berlin) Belyntic (Berlin)

CEVEC Pharmaceuticals (Köln)

Adrenomed (Hennigsdorf)

syntab therapeutics (Würselen) Siegfried (Hameln) Biotest (Dreieich)

IDT Biologika (Dessau)

BioNTech / Pfizer

InflaRx (Jena)

Boehringer Ingelheim (Ingelheim) Merck (Darmstadt) AbbVie (Ludwigshafen) NEC Laboratories Europe (Heidelberg)

Bayer (Leverkusen)

Vakzine Projekt Management (Hannover)

Miltenyi Biotec (Bergisch Gladbach)

Novartis (Nürnberg)

Sanofi (Frankfurt)

Thermo Fisher Scientific GENEART (Regensburg)

Apogenix (Heidelberg) CureVac (Tübingen)

2bind (Regensburg)

INTAVIS Peptide Services (Tübingen)

R-PHARM (Illertissen)

PRIME Vector (Tübingen) Atriva Therapeutics (Tübingen) develops a vaccine

Daiichi Sankyo (Pfaffenhofen)

ethris (Planegg) Eleva (Freiburg)

Secarna (Planegg)

Boehringer Ingelheim (Biberach)

Eisbach (Planegg)

Rentschler Bipharma (Laupheim)

Leukocare (Planegg)

develops a new therapeutic clinically tests repurposed drug S upports development of drugs or vaccines Source: taken from vfa, BIO Deutschland, PHARMIG and Interpharma; as of 08-10-2020

Immunic Therapeutics (Planegg) Dermapharm (Gründwald)

Sirion Biotech (Planegg)

Isar Bioscience (Planegg)

Proteros biostructures (Planegg) baseclick (Neuried) Formycon (Planegg)

Origenis (Planegg)

Lead Discovery Center (Planegg) Icanomab (Polling)

© BIOCOM

Corporate projects for COVID-19 vaccines and therapeutics in Germany

As part of a pre-IPO financing of €560million at the end of July 2020, the federal government also contributed €300million through the federal bank KfW (Kreditanstalt für Wiederaufbau) to prevent Tübingen-based Curevac AG from moving abroad. Media reports in March suggesting an offer by the US government to get exclusive access to Curevac’s mRNA vaccine candidate CVnCoV, however, were denied by Curevac’s majority shareholder Dietmar Hopp and the US Ambassy. Additionally, the European investment bank provided loans to allow ramping up mRNA vaccine production, with €75million for Curevac and a €100million debt financing for Biontech.

While IDT Biologika just begun enrolment for Phase I testing of its MVA-based vaccine in September, Curevac will complete Phase II testing this year and Biontech and its ex-China global marketing partner Pfizer are in “rolling submission” of Phase III data on BNT162-b2 to the European Medicines Agency (EMA).

The international bidding race for COVID-19 vaccines boosted the market capitalisations of Biontech, which went public in an US$150 million Nasdaq-IPO in October 2019. Since then, the company’s market capitalisation increased from US$3,5 billion (€3,2 billion) to US$21.526 billion by mid-October 2020.

Under marketing agreements with Chinese Fosun Pharma Co. Ltd., Biontech could gain up to US$120m and a portion of 50% of Chinese sales. Pfizer Inc. will pay a total consideration of US$748 million and 100% development costsuntil marketing authorisation in the US and the EU, which might be possible in 2020, while Biontech will repay 50% of the development costs from sales. Rentschler Biotechnology will contribute to Biontech’s and Pfizer’s global GMP manufacturing network. The company signed prepurchase agreements with the US government on 100 million doses worth US$1.95 billion in April, and with the European Commission on initial 200 million and further 22 nd Guide to german Biotech Companies 2021

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optional 100 million doses of BNT162-b2 in September 2020. Following a US$213m Nasdaq IPO in mid-August, Curevac’s share value more than tripled from US$16 to US$53 by mid-October; market capitalisation rose to US$9.254billion. The company has prepurchase agreements with the US government on 100 million doses worth US$1.95 billion, and with the European Commission on 225 million doses of CVnCoV. According to analysts from the US financial services firm Cowen Inc., the addressable market of COVID-19 vaccines is potentially US$20bn globally from 2021 to 2033.

However, according to experts, it is still unclear if any of the more than 200 vaccine candidates have an protective effect and for how long protection would last. Efficacy results will give some information on immunogenicity and safety of the candidates, but solid data on its protective will become available only through mass vaccination programmes.

Diagnostics As infection numbers were looming in Germany to a record high of 7.830 positively diagnosed people per day in midOctober (March peak value: 6,294/d) together with a rising positive rate, a new testing strategy of the German government came into force. It is aimed at complementing RT-

Model of the spike protein structure of SARS-CoV-2

PCR diagnostic testing by cheap antigen lateral flow tests to increase SARS-CoV-2 testing capacity in Germany.

However, real-time RT-PCR testing remains the golden testing standard from nasopharyngeal swabs because it is currently the most sensitive (the ability of the test to correctly identify those patients with the disease) and specific (the ability of the test to correctly identify those patients without the disease) method to detect SARSCoV-2.

Specifically, within the new strategy, cheap antigen tests will be used in mobile mass screening applications in population groups that had no previous contact with positively tested persons. However positive results must be confirmed by real time RT-PCR. Concomitantly, Roche Diagnostics and Siemens Healthineers launched antigen tests, and Qiagen NV announced to launch a test shortly.

On the other hand, developers of ultrafast, innovative RTPCR diagnostic approaches such as altona Diagnostics, GNA Biosolutions, Microgen, Centogene etc. launched highly sensitive rapid tests even for mobile testing.

For companies such as Qiagen, which provide SARSCoV-2 diagnostics and equipment for RNA sample preparation, the pandemics significantly improved sales. After Qiagen’s shareholders rejected an US$11.5billion takeover bid from Thermo Fisher Scientific in mid-August, the company’s net sales grew by 26%. However, non-COVID-19 revenue suffered a mid-single-digit decline. Figures provided by the diagnostics industry association VDGH in October demonstrate that a similar pattern appears to be representative for the whole German diagnostics sector. While overall growth saw a decline of 0.4% to €2.16 billion in 2019, the in-vitro diagnostics market saw a 12.5% increase in sales in H1/2020. However, according to a survey carried out in September 2020, only 34% of VDGH member companies faced growth on the back of increased COVID-19 related sales, 51% of them reported no significant changes or sales declines.

While figures of the Robert-Koch Institute’s (RKI) Epidemiological Bulletin 38 suggested that the weekly testing capacity had been increased in Germany from more than 128,000 RT-PCR tests in week 11 to 1.5 million

Number of tests in million

weekly testing capacity based on working days/week in million

in million

Positive rates in per cent in %

1,50

10

1,35

9

1,20

8

1,05

7

0,90

6

0,75

5

0,60

4

0,45

3

0,30

2

0,15

1

0

11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38

0

Development of PCR test capacity, tests actually performed and positive rate in Germany from calendar week 11 to 38 (mid-March to end of September 2020).

Source: RKI

tests in week 38, the German diagnostics industry association VDGH spoke of an 18-fold increase in testing capacity plus associated products from February to June 2020. Initial ideas of an immunity pass for people that have anti-SARS-CoV-2 antibodies in their blood have been stalled as it is not known what antibody titer is required to protect humans from an infection with the new coronavirus or how long such protection would last. The same is true for vaccine-induced antibody titers.

Protection & Prevention COVID-19 is inextricably linked to the only non-medical concept that has been demonstrated to slow down the spread of SARS-CoV-2: protection through social distancing, masks, hygiene, and individual documentation of contacts and potential sources of infection. However, vaccines for protection of non-infected as well as therapeutics for infected people will be needed to significantly reduce the number of severe courses of the COVID-19 syndrome and its still mysterious long-term effects.

Latest developments In order to assure that EU citizens are sufficiently protected and can be supplied with necessary medicines and medical products, European Commission President Ursula von der Leyen in March 2020 published guidelines how to include medical biotechnology companies in the EU FDI screening regulation. The transposition into German law in the summer and the introduction of a monthlong case-by-case examination of ex-EU investments and follow-up investments is viewed critically by equity capital managers. The 10% verification threshold for each individual participation of an investor in a fund or financing round which has its headquarters legally outside Europe would lead to the grotesque situation that the sector would most likely be cut off from its current main source of funding. Thus existing biotech innovations, which could help to effectively contain the pandemic, could not be developed to market maturity. The establishment of the biotech company Dewpoint Therapeutics, a spin-off from German research institutes in the USA, which recently supplemented its US$60 million Series A financing with a US$77 22 nd Guide to german Biotech Companies 2021

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million Series B round, might point to what could happen if either the development of an effective capital market in Germany or an EU umbrella fund is blocked.

Since systematic international clinical trials such as RECOVERY showed that repurposed drugs – with the exception of Dexa­m ethasone – such as Remdesivir, Hydroxychloroquine and Lopinavir/Ritonavir did not significantly reduce 28-day mortality in hospitalised COVID19 patients, the German government’s investment in such COVID-19 therapeutics was negligible. Some of the most advanced clinical projects of German biotech companies that might end Phase III development by 2021/2012,

New rules for investment On 25 March, the European Commission published the Guidance to the Member States concerning foreign direct investment and free movement of capital from third countries, and the protection of Europe’s strategic assets, ahead of the application of Regulation (EU) 2019/452 (FDI Screening Regulation). Three months later, the 15th amendment to Germany’s Foreign Trade and Payments Act (AWV) was adopted by the parliament and entered into force in July.

According to the new rule, any investment of 10% or more by a non-EU buyer in a German company, which develops, produces or markets medicinal products essential for the “… provision of health care to the population... including their starting materials and active substances …” is subject to the consent of the Federal Ministry of Economics and Energy (BMWi) (AWV §55(1)9.). Due to the broad phrasing, the majority of all German biotechnology companies will be affected. According to AWV §55(1)10. and 11., this obligation to obtain approval also applies to developers of diagnostics and medical devices used in the field of serious infectious diseases.

however, include repurposed drugs with antiviral (AIC649, Aicuris GmbH, Phase I/II) or anti-inflammatory effect (Inflarx N.V., IFX-1, Phase II/III) or both (Immunic Inc., Phase II). Furthermore, just a small part of a €45m funding programme for novel COVID-19 countermeasures launched in March 2020 was invested in clinical testing of new COVID-19 biologicals. Projects that might reach conditional market approval by 2021/2022 include antiviral antibodies (Corat GmbH, IND), inflammation blockers (Icanomab GmbH), or both (ATR-002, Atriva Therapeutics GmbH). The biotech industry association BIO Deutschland thus has urged talks on a fund for mid-to-late-stage COVID-19 therapeutics.

Background An acquirer resident in the EU is also deemed to be non-EU if a non-EU investor holds a stake of 10% or more in it (AWV §56(3)). This also applies to the vast majority of private venture capital investors with head office on the channel islands, e.g. Jersey or Guernsey, who are active in the EU, whose holdings in German biotechnology companies are now subject to the approval of the BMWi. Follow-on financing of existing portfolio companies is also subject to this approval. An application for approval can only be submitted to the BMWi by the investor if the structure of the investment has already been clarified. The examination by the BMWi takes up to two months from the date of submission of the application, and four months or longer if the BMWi takes the initiative. During this period, the investor may no longer receive any confidential information from the target company, i.e. it may not carry out any due diligence, for example. It is not possible for a biotechnology company to apply for a clearance certificate in accordance with the AWV before the start of a financing round. Similarly, VC funds cannot apply for a general clearance certificate for their investment activities in Germany.

Prefaces

A transformative year

When we started our work in the New Year, nobody could have foreseen that a pandemic would change our health, our economy, our daily lives, and societies worldwide so dramatically. The disruption caused by the corona pandemic has also had a dramatic impact on the German biotechnology sector, both good and bad.

What was the picture before the pandemic? The industry figures that we always collect at the beginning of the year showed a solid overall picture for 2019 with positive trends. The German biotechnology industry was growing dynamically. Spending on research and development (R&D) increased by 21 per cent last year and turnover rose by ten per cent. The number of people employed in the industry also grew at doubledigit rates. Only in the case of company figures was there a small increase of just three per cent to a total of 668.

In 2019, private biotechnology companies raised around EUR 525 million in venture capital. Another 333 million euros were raised via the stock exchange. More than EUR 186 million of this was raised through two IPOs, both on the Nasdaq. BioNTech, an immunotherapy specialist and vaccine developer, and Centogene, a diagnostics expert for rare diseases that is now heavily involved in corona testing, took the step onto the stock exchange floor. Thus, with a total of EUR 858 million, the industry was not able to reach the financing record of EUR 1.27 billion set in 2018, and more than half of the amount was raised by just one company, BioNTech from Mainz.

In our annual trend survey, which we carried out at the turn of the year, around 90 per ent of the entrepreneurs surveyed assessed their current and also future business situation as good or more favourable, satisfactory, or the same as the year before. 60 per cent stated that they wanted to build up staff in Germany, while only around seven per cent intended to cut back. Half of those surveyed plan to increase investment in research and development (R&D). Only 20 per cent expected the political climate in Germany to improve in 2020 and a mere 28 per cent considered the current political climate to be good. A clear trend could be observed in the assessment of the future business situation. Here the index has been falling continuously over the years.

Oliver Schacht, PhD President of the BiotechnologyIndustry-Organisation Deutschland (BIO Deutschland e. V.)

The fight against corona With the beginning of the pandemic, the framework conditions for our sector have changed significantly. It starts with overall public perception of the biotechnology industry. The whole world is eagerly awaiting a vaccine or effective therapies developed by our companies. Molecular diagnostic tests, whether for acute or past infections, have almost become part of everyday life and daily 24-hour news cycles keep reporting on progress in the science and product development. This change has helped with funding, at least for the many companies that develop vaccines, tests, and diagnostics 22 nd Guide to german Biotech Companies 2021

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to contain the pandemic. More than 70 of our member companies are currently working on SARS-CoV-2 and COVID-19, respectively. The two vaccine developers BioNTech and CureVac as well as diagnostics leader QIAGEN are amongst the best-known examples worldwide. Both CureVac and BioNTech started as university spin-offs and are now considered beacons of the German biotech industry. The German government has so far earmarked well over one billion euros for vaccine research, whether for funding programmes or even a direct investment in CureVac. In contrast, however, only about 45 million euros have been provided to fund early-stage therapy developments.

Other areas of research Although the number of German companies active in the fight against corona is remarkable, the majority are active in other therapeutic areas or in other sectors, such as industrial biotechnology. For some of them their business operations have suffered considerably during the pandemic. The supply of reagents and laboratory equipment has become difficult, hygiene plans need to be adhered to, employees had to go into home office, and clinical trials were delayed or postponed. It is not yet clear how the crisis will affect the availability of venture capital or other forms of financing for our industry overall and the chances of successfully founding and financing a company at the moment. The concern is that start-ups in particular will have more problems successfully raising capital. According to a survey by the Bavarian biotech cluster BioM on the impact of the pandemic on resident biotech companies, 55 per cent of those surveyed said they were concerned about the corona pandemic for their company. Half of the companies reported a decline in turnover, while 17 per cent even said that the decline was threatening their existence or very significant. A quarter of the companies had applied for financial support, and around six per cent urgently needed financial assistance.

Our role in the pandemic

BIO Deutschland Office Schützenstr. 6a 10117 Berlin Germany www.biodeutschland.org

BIO Deutschland has assumed several important roles in the current situation. Early on, we identified those of our members that are actively involved in research and development to fight the corona virus and COVID-19. With this information we built a dedicated resource on our website (https://www.biodeutschland.org/en/coronaspecial.html). We have taken up the needs of the companies, not only of those that do corona research, but also of those who work in other areas, and communicated the issues to the administration at all levels. We keep track of corona-specific funding initiatives and have also asked the federal government to significantly increase the financial resources in this regard. The unprecedented focus on research and developments and appreciation of the biotech industry triggered by this crisis is long overdue.

It is of course a shame that it would take such a drastic crisis to make clear just how important biotechnology is for each and every one of us as individuals and our societies at large. We remain committed to ensuring that this awareness continues well beyond this pandemic and that it becomes ever clearer that it is indeed biotechnology that provides solutions to the major challenges of our time and we simply cannot successfully address these pressing issues without biotechnology at all.

Prefaces

A time of transformation and innovation The last six months have been a challenge for everyone: businesses asked their employees to work from home within a few days, production chains were disrupted as international trade slowed or stopped altogether, and priorities changed dramatically as, it seemed, fighting the pandemic dominated every research and development agenda worldwide.

Since March 2020, a lot of things have changed, and although we certainly hope some of them will never be regarded as the “new normal”, many of the initial challenges have been tackled successfully. Enterprises have adapted their internal processes to a more digital way of working. Industry representatives report that although travel is still very much reduced, they have explored novel ways to reach out to prospective customers that are as – or sometimes even more – effective than traditional client visits. New supply chains have been established, sometimes involving new local or national partnerships that also offer new perspectives for companies.

Nonetheless, the pandemic is still under way, and at the time of writing, infection numbers are on the rise all over Europe. And other challenges that have temporarily been overshadowed remain as urgent as ever. Climate change is showing its effects, in Europe maybe less dramatically than in California, but nonetheless with severe consequences for agriculture and forestry, changing the face of entire landscapes where trees are being damaged irrevocably by drought. Preserving Europe as a competitive industrial location in the face of increasing global competition is also a prerequisite to ensuring the wealth and well-being of coming generations.

Dr Kathrin Rübberdt, Head of Biotechnology, DECHEMA e.V.

The answer is innovation The answer to many if not all of these challenges is: innovation. And at a time of – albeit enforced – transformation, new windows of opportunity have opened that would have remained firmly shut in a “business as usual” scenario. Company executives have become aware that what would have been inconceivable only weeks ago is, in fact, working well. This new openness extends beyond internal processes; it also encourages many organisations to try new ways of doing business. Start-ups and SMEs are, in general, more flexible and adaptable than larger global players, and many of them are pushing forward in new business sectors. They can also benefit from the shift from on-site meetings to virtual events, lowering the threshold for getting in touch with important potential cooperation partners, but also extending the range of the audience that can be reached with a webinar or online presentation.

Dr Sebastian Hiessl, VBU Vereinigung Deutscher Biotechnologie-Unternehmen

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Striving for quality However, as everybody “goes virtual”, the need to identify the right networks becomes even more important. The surge in online events may well lead to oversaturation – virtual trade shows, supplier presentations, and many others are vying for the attention of speakers and participants, and one could easily spend the whole working week following one online presentation after another. To achieve one’s goals, one should therefore always determine the perfect environment for one’s pitch or presentation.

Is the event more sales-oriented or more focused on networking? Who will attend – marketing experts and buying agents, researchers, or corporate representatives?

For DECHEMA and VBU, the step into cyberspace is not new. VBU has successfully been running online events for many years, always with networking as the foremost aim. Over the last months, we have intensified our efforts together with partners such as the Forum Startup Chemie. Larger conferences by DECHEMA have also been moved to the virtual sphere, maintaining the high standards we set ourselves for any workshop or conference. We provide support to speakers and the audience and strive to achieve the best possible quality both in planning the agenda and executing the events.

The voice of application-oriented research

Dr Sebastian Hiessl Theodor-Heuss-Allee 25 60486 Frankfurt am Main Germany +49(0)-69-7564-301 hiessl@dechema.de

Your personal contact: VBU – Association of German Biotechnology Companies in DECHEMA e. V. Find out more about VBU and DECHEMA at: www.v-b-u.org www.dechema.de

DECHEMA is a neutral platform where SMEs, start-ups, industry, and academia can meet, discuss, and develop new ideas and cooperations. We are independent and dedicated to promoting scientific progress regardless of the particular technology.

And we represent application-oriented research in the political sphere and the public, formulating recommendations for policy-makers and funding agencies based on the identification of scientific gaps and needs for technological developments.

VBU – the Association of German Biotech Companies – is an integral part of DECHEMA. In addition to the topical working groups hosted by DECHEMA and covering everything from synthetic biology to cell culture and single-use technologies, VBU addresses the specific needs of younger and smaller companies with events and information on topics such as business development, IP handling, and financing. We are always open to requests and suggestions from our members.

Combining the best of both worlds Virtual events can achieve a lot, but there are some things that cannot be transferred to the internet: a deep conversation over a cup of coffee during a break; a moment of silence in a brainstorming session when all participants are running ideas through their minds; a seemingly unfocused chat that results in a completely new line of thought. These are our best moments, and we are looking forward to reviving them at on-site meetings in the months to come. Bringing the best of two worlds together has always been at the core of DECHEMA: research and application, academia and industry, engineering and biotechnology – and virtual and “real” meetings.

Profiles of German Biotech Companies

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4 H F Biotec

Cancer Data Mining Name · 4HF Biotec GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · ·

Am Flughafen 14 79108 Freiburg im Breisgau Baden-Wuerttemberg Prof. Dr Heinz-Herbert Fiebig (CEO) Dr Vincent Vuaroqueaux (CSO) +49-761-7088-93-10 +49-761-7088-93-99 Fiebig@4HF.eu www.4hfbiotec.com

· · · · · I · 5–10 · 2015 · Bioinformatics platform/Dry Lab

Areas of Activity · Oncology-Bioinformatics-Data MiningCancer treatment discovery-preclinical drug profiling

4HF Biotec GmbH was founded by Prof. Dr. Fiebig in Freiburg in 2015 after he had sold his former company Oncotest GmbH to Charles River Laboratories. 4HF Biotec is a multidisciplinary team including scientists and network with more than 20 years of experience in various areas of cancer research notably in in vitro and in vivo human tumour models, in anti-cancer agent testing’s, bioinformatics and OMICS data analyses, and software development.

4HF Biotec is dedicated to the discovery of novel anticancer targets and therapies by means of in silico cancer data mining. We have developed a platform aggregating different databases, which are consisting of >2,000 model tumours (cell lines and patient derived xenograft models), about 10,000 patient tumours, and 12,000 normal tissues being annotated for gene expression, exome mutations, copy number variations, and gene fusions.

The platform also integrates in vitro testing’s data for >800 compounds with defined mechanisms of action.

Biological Patents · 1 External · several Collaborations Request for · 4HF Biotec is interested in strategic Further Collaborations collaborations in the fields of antibodies and targeting therapies development, bioinformatics-based projects involving cancer data, and preclinical drug profiling and evaluation.

After 4 years of R&D, these data have been selected, curated, reanalysed and connected. We developed a specific in-house software for OMICS and Drug sensitivity data statistical analysis, visualisation and interpretation.

We propose an extensive portfolio of analyses answering to key questions in Oncology. For example, we created specific processes to select gene candidates for antibody drug conjugate (ADCs) development, pipelines enabling early identification of predictive biomarkers, as well as tools to identify putative new cancer targets.

Based on these analyses, we are establishing lists of candidates that are reviewed and prioritised by our scientists for next steps of drug development.

Importance of OMICS and pharmacogenomics studies has been demonstrated over the recent years by identification of innovative treatments to treat cancers. Beside immune-oncology treatments, which are efficient only in certain subset of tumours, identifying solutions to better target cancer cells remains strongly needed. In this latest field 4HF Biotec strongly emphasises developing rational way to translate cancer data into new solutions to better treat cancers.

4hf biotec

4HF Biotec’s goals Discovery of novel targeted anti-cancer drugs ·· Drug profiling with available or newly generated testing data in vitro ·· Identification of sensitive tumour types in relation to the target and mode of action ·· Drug target interaction via pharmacogenomics ·· Biomarker discovery and pathway interaction predicting drug sensitivity or resistance Molecular analyses of all targets used in oncology ·· for antibody drug conjugates (ADCs) ·· targeted therapies Discovery of novel tumour associated genes, antibodies, and antibody drug conjugates ·· Selection of membrane bound tumour selective genes (completed) ·· Generation of antibodies against these genes and their characterisation for binding and internalisation ·· With collaborations, development of ADCs. This work can be offered as a fee for service for pharma and biotech industry generating revenues. Furthermore, we envision to profile very specific ADCs and targeted agents until clinical Phase I studies with collaboration partners or investors.

4HF Biotec cooperates with many academic institutes, pharma and biotech companies and the PAMM group of the EORTC.

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Name · acromion GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media

· · · · · · · · ·

Europaallee 27–29 50226 Frechen North Rhine-Westphalia Oana Braun, MD +49-2234-203737-0 +49-2234-203737-9 info@acromion-gmbh.com www.acromion-gmbh.com

IQ

Areas of Activity · Full-service clinical CRO: biostatistical medical operational regulatory

Special Service at its best acromion GmbH is a German headquartered, privatelyowned, full-ser vice, clinical Contract Research Organisation. Operating throughout Europe, we provide the full range of clinical research services for biotech, pharmaceutical, medical device and diagnostics companies. acromion is the right sized clinical research partner that integrates professional expertise, as well as consultancy aiming at the most suitable trial design and development programme for new drug candidates.

Founded in Germany in 2002, our company is offering almost two decades of successful clinical research across all stages of drug development, starting at Firstin-Man. Our work has been successfully audited by numerous clients and inspected by the competent authorities.

Clinical Trial Experience Our team has supported early phase development of various biotherapeutics and has conducted clinical trials across a wide range of indications: ·· cardiovascular diseases ·· dermatology, endocrine disorders and metabolism ·· gastroenterology, gynaecology, immunology incl. mABs ·· infectious diseases, musculoskeletal diseases ·· neurology & psychiatry ·· oncology & haemato-oncology incl. mABs ·· respiratory diseases , ENT, urology ·· orphan diseases and ATMPs

Acromion

Clinical Trial Services ·· ·· ·· ·· ·· ·· ··

consultancy in design and concept development of efficient trial conduct strategies medical writing project management trial feasibility assessment budget and contract management clinical trial design and conduct ·· clinical monitoring ·· regulatory management ·· data management, EDC, coding ·· biostatistics, analysis and reporting ·· pharmacovigilance ·· quality management ·· management of auxiliary parties i.e. EDC, clinical supplies, expert boards, etc.

A highly professional and experienced team Our specific corporate know-how in medicine and clinical research, the international background plus our experience in early phase trials, particularly with innovative biologics, translates into a quality expertise for supporting your activities.

Our specialisation provides our customers with: ·· access to a team with extensive experience in clinical research ·· a single contract partner with expanded geographical reach ·· team members with true clinical understanding of diseases and investigational agents ·· experience in managing early phase trials ·· close working relationships with expert investigators The fluctuation rate is minuscule providing sponsors and investigative sites with stable and well-practiced study teams. Experience and knowledge gained over years in various therapeutic indications, with many different agents, with our customers and investigators remain within the company and conduce to the success of future trials and projects.

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Name · Aeterna Zentaris GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Weismuellerstr. 50 60314 Frankfurt am Main Hesse Dr Eckhard Guenther +49-69-42602-0 +49-69-42602 -3413 info@aezsinc.com www.zentaris.com

FL I 10 2001

Areas of Activity · l Endocrinology l Cancer l Rare and orphan diseases l Growth hormone deficiency l Pediatric indications Biological Patents · Several patents and patent applications covering our products and projects External · Big and medium-sized pharmaceutical Collaborations companies together with academic institutions Request for · We are interested in in-licensing Further Collaborations preclinical or early stage clinical opportunities in our areas of activity.

In Pursuit of Medical Innovations Aeterna Zentaris (NASDAQ: AEZS) is a publicly listed, specialty biopharmaceutical company commercialising and developing therapeutics and diagnostic tests.

Zentaris was founded in 2001 as a spin-off from ASTA Medica, the pharmaceutical division of Degussa AG, later acquired by Laboratoires AEterna in Quebec, Canada, which led to the foundation of Aeterna Zentaris Inc. Aeterna Zentaris GmbH is the German entity located in Frankfurt am Main. The GmbH is the R&D centre of the group, whereas the legal headquarters is in Toronto, Canada.

In the past, Aeterna Zentaris successfully developed Cetrotide ® for in-vitro fertilisation, Impavido ® for the treatment of leishmaniasis, and Lobaplatin for the treatment of solid tumours. All three products have been commercially available through global and local pharmaceutical companies for many years and have improved the lives of patients around the world.

At present, our lead product macimorelin, a ghrelin receptor agonist, is the first and only approved oral drug indicated for the diagnosis of adult growth hormone deficiency (AGHD) in the US and EU. Macimorelin stimulates the secretion of growth hormone from the pituitary gland into the circulatory system. Macimorelin has the potential to displace current tests as the standard diagnosis.

Our commercial and development partner for Macrilen™ for the US and Canada, is Novo Nordisk, a global leader in endocrinology. In 2020 we entered into a distribution agreement with Megapharm Ltd., to commercialise macimorelin in Israel and the Palestine Authority. Our business development efforts are ongoing to secure commercialisation partners for macimorelin in Europe and ROW. We are leveraging the clinical success of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD) to expand the existing indication. In April 2020, we announced positive results of the dose finding study and expect to start the multinational pivotal Phase 3 efficacy study in early 2021 jointly with Novo Nordisk.

aeterna zentaris

Our expertise AEZS has strong scientific R&D expertise in endocrinology and cancer, with a focus on small molecules, natural products, phospholipids, and peptides. In addition, AEZS has profound experience in clinical development, manufacturing, supply chain and regulatory affairs.

Pipeline expansion opportunities We are seeking growth opportunities as part of our efforts to re-establish a diversified, yet focused, development pipeline to leverage our expertise and experience. We are focused on opportunistically utilising our well-established and extensive network of universities in Europe and the US to identify innovative development candidates in different indications, with a focus on rare or orphan indications and the potential for pediatric use.

CEO, Dr Klaus Paulini: “Aeterna Zentaris was established with strong expertise in research and development, which I believe is an incredible asset to the company and one that we plan to leverage moving forward. Apart from investigating opportunities for new therapeutic usages of macimorelin, we are assessing whether development candidates from our previous programmes may be re-purposed for alternative indications based on prior key findings from data already available to us. With our capabilities and specific know-how, we believe we are well-positioned as we explore these opportunities and consider potential co-development strategies that could be synergistic for the company moving forward.�

Management Dr Klaus Paulini President & CEO Aeterna Zentaris Inc. Managing Director Aeterna Zentaris GmbH Leslie Auld Senior Vice President, CFO Dr Nicola Ammer Chief Medical Officer Dr Eckhard GĂźnther Managing Director Aeterna Zentaris GmbH 22 nd guide to german biotech companies 2021

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Name · Affimed

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Im Neuenheimer Feld 582 68120 Heidelberg Baden-Wuerttemberg Dr Angela Sickmann +49-6221-6743672 +49-6221-6743649 a.sickmann@affimed.com www.affimed.com

LI 115 2000

Areas of Activity · Immuno-Oncology External · l Genentech Collaborations l Leukemia and Lymphoma Society l MSD (Merck & Co.) l The University of Texas, MD Anderson Cancer Center

Affimed – engaging immune cells to fight cancer Affimed (Nasdaq: AFMD) engineers target immunotherapies, seeking to cure patients by giving them back their innate ability to fight cancer. We are developing single and combination therapies to treat hematologic and solid tumours.

Our approach Although the human immune system is normally capable of recognising foreign or aberrant cells, cancer cells have acquired highly effective ways to escape immune surveillance. As a result, immune cells such as NK cells and macrophages, which are part of the innate immune system (the first line of defence) cannot recognise tumour cells as foreign or aberrant and therefore cannot fight them.

To overcome these limitations, we develop antibodies that activate innate immune cells and redirect them to the tumour, thereby disabling the tumour’s evasion mechanisms. They establish a bridge between either NK cells or macrophages and cancer cells, triggering an immune response that leads to the destruction of tumour cells.

Our ROCK® platform Leveraging our modular and versatile ROCK® (Redirected Optimised Cell Killing) platform, we generate proprietary, next-generation multi-specific antibodies. Our tetravalent (four binding sites), bispecific (two targets) innate cell engagers (ICE® formats) have the ability to bring NK cells or macrophages into proximity to cancer cells and trigger a signal cascade that leads to the destruction of these cancer cells. A number of clinical and preclinical programmes are in development based on the ROCK® platform and our ICE® molecules have already shown a favourable safety profile and promising signs of therapeutic efficacy.

Our modular ROCK® platform with its versatile features enables the generation of multi-specific antibodies with appropriate properties for tailored treatment including half-life, tissue distribution, and optimal tumour and immune cell targeting. This allows us to tailor our immune cell engagers to specific indications and patient settings.

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Targeted !"#"$%& tumour cell killing !"#"$%&via immune cell engagement !""#$%&'%((&%$)*)%+& Innate cell engager & & !""#$%&,*+)%,& & & -#".#+&,*+)%,&

innate cell

!""#$%&'%((&%$)*)%+& & & !""#$%&,*+)%,& Innate cell target & & -#".#+&,*+)%,&

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Engager Therapy

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Affimed

Our product candidates AFM13 Innate cell target: CD16A Tumour target: CD30 AFM13 is our lead product candidate and engages NK cells and macrophages. It is designed to treat CD30-positive malignancies including cutaneous and peripheral T-cell lymphoma (CTCL, PTCL) and Hodgkin lymphoma (HL). A registration-directed Phase 2 study (REDIRECT) with AFM13 as monotherapy in relapsed or refractory patients with CD30-positive T-cell lymphoma or transformed mycosis is ongoing.

In addition, AFM13 is being investigated in combination studies, e.g. with Merck’s checkpoint inhibitor KEYTRUDA® and with adoptive NK cells.

AFM24 Innate cell target: CD16A Tumour target: EGFR AFM24 binds to the EGFR, which is constitutively active in some solid tumors. AFM24 has demonstrated the killing of tumour cells independent of their mutational status (e.g. Ras) and is currently investigated in a Phase 1 study.

Release of Perforins and Granzymes

RO7297089 (formerly AFM26, partnered programme) NK cell target: CD16A Tumour target: BCMA RO7297089 binds to B-cell maturation antigen (BCMA), an attractive target due to its limited expression on healthy tissues and almost universal expression on multiple myeloma cells in the majority of patients. A Phase 1 study with RO7297089 is ongoing.

AFM28 and AFM32 AFM28 and AFM32 are our new product candidates in the pipeline and are currently in preclinical development.

The tumor targets have not yet been disclosed.

Tumour Cell Lysis

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Name · AGC Biologics GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax

· · · · · ·

Czernyring 22 69115 Heidelberg Baden-Wuerttemberg Dieter Kramer (Site Head) +49-6221-90260 +49-6221-902690

Name Address/P.O. Box Postal Code/City Address/P.O. Box Postal Code/City Country Contact Person

· · · · · · ·

Affiliate: MolMed, now part of AGC Biologics Via Olgettina 58 20132 Milan Via Meucci 3 20091 Bresso, Milan Italy Luca Alberici (Site Head)

Name · AGC Biologics A/S Address/P.O. Box · Vandtaarnsvej 83B Postal Code/City · 2860 Soeborg Country · Denmark Contact Person · Andrea Porchia (Site Head) Email Address Internet Website Number of Employees Type of Laboratory

· · · ·

contact@agcbio.com www.agcbio.com >1,300 S1, GMP

Areas of Activity · | Contract manufacturing of biopharmaceuticals | Process development | Microbial fermentation and mammalian cell culture | Plasmid DNA production (pDNA services) | Microbial cell banking | Bioanalytical services | Viral Vector | Cell Therapy External · AGC Biologics clinical and commercial Collaborations manufacturing sites in Japan (Chiba), USA (Seattle), and Denmark (Copenhagen)

AGC Biologics is a leading global Contract Development and Manufacturing Organisation (CDMO), with a strong commitment to delivering the highest standard of service to our clients and partners. AGC Biologics is the product of the convergence and integration of AGC Bioscience, Biomeva GmbH, CMC Biologics, and Molmed. The company currently employs more than 1,300 employees worldwide. Our extensive network spans three continents, with cGMP-compliant facilities in Heidelberg, Germany; Milano and Bresso, Italy; and Chiba, Japan. AGC Biologics offers deep industry expertise and unique customised services for the scale-up and cGMP manufacture of biologics and protein-based therapeutics: from preclinical to commercial production with both mammalian and microbial platforms. Our integrated service offerings include cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage, and protein expression — including our proprietary CHEF1® Expression System for mammalian production.

Milan & Bresso facilities Cell & gene therapy manufacturing capacity AGC Biologics brings technical expertise to develop and optimize every aspect of cell & gene therapy. Our services range from production of plasmid DNA necessary for the transfection of producing cells to engineering of cells through the use of produced viral vectors. Our technical know-how allows us to bring small-scale process to scalable industrial manufacturing, ensuring process robustness and commercial viability. AGC Biologics has the experience to develop and manufacture Lenti and Retro viral vector, as well as diverse cell therapies including CD34+ hematopoietic stem cells, autologous and allogenic T-cells, and NK cells. For viral vector, our ready-to-use platform capabilities are built on Cell Factories (up to 48L) and Bioreactor (up to 200L) using adherent process, designed entirely in-house.

Our cell therapy capabilities cover numerous technologies, ranging from closed to open systems at different scales depending on client needs. Our quality system, cGMP manufacturing scale, facility layout, as well as regulatory qualification, allow us to meet both clinical and commercial demand. As we perform more than 100 analytical tests

agc biologics

in-house, AGC Biologics reduces turnaround time. With experience manufacturing two commercial products, we are the only C&GT CDMO, which has brought its own product to the market (Zalmoxis®).

Microbial Facility Equipment Microbial cell banking and storage ·· Master cell banks and working cell banks ·· Production, characterisation, and storage Process development ·· Upstream development ·· Downstream development ·· Analytical development Microbial manufacturing capabilities ·· Production of therapeutic proteins and DNA plasmids (pDNA) ·· Stainless steel fermenters with working volumes of 10L, 100L, and 1000L ·· Continuous centrifugation harvest ·· Experience with E. coli, P. pastoris, and other microbial expression systems ·· Quality control release and stability testing

Mammalian Facility Equipment Mammalian cell banking and storage ·· Master cell banks and working cell banks ·· Production, characterisation, and storage Process development ·· Upstream development ·· Downstream development ·· Analytical development Mammalian manufacturing capabilities ·· Production of therapeutic proteins, monoclonal antibodies, fragments, and other biologics ·· Single Use Bioreactors with working volumes of 100L, 500L, 2,000L and up to 6x2,000 L (6-Pack®) ·· Experience with several mammalian expression systems; facility approved commercially by EMA, FDA, HCA, PMDA ·· Quality control release and stability testing 22 nd guide to german biotech companies 2021

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Name · AGCT GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · ·

Emil-von-Behring-Str. 76 35041 Marburg Hesse Dr Hans-Joerg Hess +49-6421-395535 agct-contact@agctechnologies.com www.agctechnologies.com

Company overview AGCT GmbH is an innovative molecular testing company driven by cutting-edge R&D in molecular engineering and backed by an experienced team of researchers, laboratory physicians, and entrepreneurs. Founded in early 2016, the company is privately held and funded and has a growing team of currently 13 employees. The laboratories are located in Marburg within the Behringwerke Biotech-Center.

I 13 2016

Areas of Activity · Molecular diagnostics and testing

Cancer diagnostic and research market The company focuses on the cancer diagnostic and research market where earlier detection of cancer malignancies and personalized treatments based on companion diagnostics are key trends. PCR is the gold standard for most tissue and blood based (liquid biopsy) sampling methods. However, detection of rare molecules for cancer diagnostics by PCR remains challenging as DNA from tumor and healthy wildtype cells are simultaneously amplified. Today’s solutions for increasing the Limit-of-Detection (LOD) for tumor DNA come from combining various technologies thus creating cumbersome detection methods and complex laboratory workflows.

AGCT

cyberPCR technology AGCT has developed a robust, proprietary PCR-like technology with dramatically improved Limit-ofDetection (LOD) in a simple-to-use assay format. The patented assay platform aims to replace complex PCR workflows and can be applied on any common realtime PCR cycler in any research or diagnostics laboratory. The cost-competitive method is called cyberPCR and provides a controlled amplification process that selectively amplifies mutant target DNA such as tumor DNA only. Together with cancer and clinical research laboratories the technology performance has been fully demonstrated.

Products and broad range of applications AGCT is currently developing first oncology kits for research use only to be released in 2021. At the same time the company’s development team is starting to evaluate the applicability of cyberPCR on NGS platforms. Overall, the technology has a potential for a broad range of applications beyond cancer diagnostics and AGCT sees the potential not only in bringing forward own testing products, but also to collaborate with international partners via licensing agreements for a faster penetration of the assay technology into various market segments.

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Name · AiCuris Anti-infective Cures GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Friedrich-Ebert-Str. 475 / Building 302 42117 Wuppertal North Rhine-Westphalia Katja Woestenhemke +49-202-317-63-0 +49-202-317-63-11-77 info@aicuris.com www.aicuris.com

LI 70 2006 Biological, pharmacokinetic and formulation labs

Areas of Activity · Anti-Infectives 1. Antivirals against: Human Cytomegalovirus (HCMV), Herpes Simplex Virus (HSV), Hepatitis B Virus (HBV), Adenovirus, SARS-CoV-2 2. Antibacterials against multiresistant Gram-negative and Grampositive hospital infections (AMR) External · Merck & Co. (MSD): Licensee of Collaborations AiCuris’s HCMV drug PREVYMIS™ (letermovir) Request for · AiCuris is interested in collaborations Further Collaborations with academic and industrial partners and pursues an active in- and outlicensing strategy

Company overview AiCuris was founded in 2006 as a spin-off from Bayer and focuses on the discovery and development of drugs targeting infectious diseases; such as human cytomegalovirus (HCMV), herpes simplex virus (HSV), hepatitis B virus (HBV), adenoviruses, and SARS-CoV-2. In the field of AMR, AiCuris seeks to develop innovative treatment options for life-threatening, multidrug-resistant hospital-treated pathogens.

The head office and laboratories of AiCuris are located at the Life Science Park in Wuppertal, Germany.

The SANTO Holding is the company’s majority investor.

AiCuris’s experts and management team with Dr. Holger Zimmermann as CEO combine international drug development experience from both small and large pharma companies with scientific expertise in anti-infectives, enabling the company to discover novel therapies and move these drugs through clinical development.

In 2012, AiCuris licensed its HCMV portfolio to Merck & Co., USA (MSD) and granted MSD worldwide rights to develop and commercialise it. Under the terms of the agreement with MSD, AiCuris receives milestone payments as well as royalties on net sales. This was one of the largest agreements of this kind in the European biotech industry. So far, AiCuris has received 260 million Euros as upfront and milestone payments plus a regular royalty stream since the launch of Prevymis™.

Corporate strategy AiCuris is dedicated to developing innovative drugs in the field of anti-infectives that target severe and potentially life-threatening infectious diseases. Recently AiCuris added the topic “Pandemic and resistance emergency preparedness” to the portfolio, focussing on solutions for future pandemics and antimicrobial resistance (AMR). AiCuris follows a proof-of-concept strategy before out-licensing its development projects.

aicuris

Commited to making the difference Currently, the company is running multiple clinical development programmes: PREVYMIS™ (letermovir), the first-in-class non-nucleoside cytomegalovirus (CMV) inhibitor acting via a novel mechanism of action (out-licensed to MSD), received market approval in the U.S., Europe, and Japan for the prevention of CMV infections in adult recipients of an allogeneic hematopoietic stem cell transplant (HSCT). A phase III trial in solid organ transplant recipients is ongoing.

Pritelivir, a helicase-primase inhibitor, is being developed to treat herpes simplex virus Type 1 (HSV-1) and Type 2 (HSV-2) infections. Pritelivir is currently in a phase II/III clinical trial for immunocompromised patients with acyclovir-resistant infections.

AIC649 is a novel biological immunomodulator in the clinical stage as a Hepatitis B cure and as a potential SARS-CoV-2 and other future pandemics.

Several preclinical approaches are being followed up in the field of AMR and antivirals (HBV, adenovirus).

With “PREP – Pandemic and Resistance Emergency Preparedness” AiCuris is strongly focusing on both unmet medical needs and protection against future threats from viral and bacterial pandemics, developing new effective solutions in-house and in close collaboration with partners.

AiCuris is actively in-licensing preclinical and early clinical projects that are helping to make a real difference in the anti-infectives field.

A company incubator “AiCubator” for early projects was initated in 2020.

AiCuris’s key areas of interest are viral indications (in particular HBV, adenovirus) and life-threatening nosocomial bacterial infections, especially caused by Gramnegative pathogens.

Partners: Merck & Co. (MSD): licensee of Letermovir, Lysando, Max-Planck-Institute, ICIQ, Cyclenium, and others.

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Name · AmpTec GmbH an ISO 13485:2007 Company Address/P.O. Box Postal Code/City State Contact Persons

· · · ·

Telephone Fax Email Address Internet Website

· · · ·

Koenigstr. 4A 22767 Hamburg Hamburg Dr Peter Scheinert (CEO), Dr Guido Krupp (CEO) +49-40-636-747-22 +49-40-636-747-19 info@amp-tec.com www.amp-tec.com

Areas of Activity · l Contract development and manufacturing of synthetic nucleic acids (RNA & DNA) for diagnostic and therapeutic applications l cGMP manufacturing of messenger RNA (mRNA) therapeutics for preclinical-and clinical studies l Process Development l Development and establishment of cGMP compliant customer specific QC-tests

AmpTec GmbH, is a Hamburg, Germany based international active contract manufacturing company (CMO) with comprehensive services for cGMP manufacturing of synthetic nucleic acids for biotech and pharma companies. The company was founded in May 2005

by Dr Guido Krupp and Dr Peter Scheinert and has a proven trackrecord of 15 years right now.

Key products are synthetic RNAs and DNAs for in vitro diagnostics as well as fully functional mRNAs as drug substance or active pharmaceutical ingredient (API) for the pharmaceutical industry using mRNAs to develop a new category of medicines.

Regulatory history ·· Manufacturer in compliance with ISO 9001 since 2008 ·· Manufacturer in compliance with ISO 13485 since 2010 ·· Compliance with cGMP since 2012 (regulations of FDA 21 CFR Part 820) ·· Implementation of cGMP FDA 21 CFR Part 211 and ICH Q7 (section 19: APIs for use in clinical trials) requirements in advanced state ·· In 2018: IND submission for clinical trials. FDA Clearance in 2019

cGMP biomanufacturing AmpTec provides customized solutions for each client and offers guaranteed product quality according to international cGMP guidelines. All AmpTec products are produced in a highly regulated state-of-the art GMP environment.

Products and services Customized Long single stranded RNAs (ssRNA) and DNAs from any sequence at at any length and scale Key applications: ·· Reference material for the development of in vitro diagnostic assays ·· Therapy-accompanying diagnostics (companion diagnostics) ·· Internal controls for real time-PCR diagnostic kits

amptec

Customized Long RNA Oligos fully enzymatically produced at at any length and scale Key applications: ·· Guide RNAs for CRISPR ·· RNA therapeutics ·· RNAi applications ·· Short RNA controls Customized Long double-stranded RNAs (dsRNA) at any length and scale Key applications: ·· dsRNA as tool for gene-specific silencing of gene expression ·· Long dsRNA is substantially more effective than short dsRNA Customized fully functional messenger RNAs (mRNA) from any sequence at at any length and scale Key applications: ·· Highly specific vaccination ·· Individualized tumor therapy with patient-specific tumor neo-antigens ·· Cellular reprogramming ·· Genome editing ·· Protein replacement

Capabilities AmpTec has a highly motivated team of currently 41 employees with outstanding experience in GMP-compliant manufacturing of synthetic nucleic acids.

Experience AmpTec offers complete customized solutions for its customers worldwide since 15 years and is a highly reliable partner for the biotechnology & pharmaceutical industry. mRNA batches manufactured at AmpTec are already used by our customers for Clinical Trials (ex vivo), PreClinical Trials (in vivo) and Clinical Trials (in patient).

AmpTec offers excellent customer contact and flexibility to make our customer projects successful.

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Name · Apogenix AG

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · ·

Im Neuenheimer Feld 584 69120 Heidelberg Baden-Wuerttemberg Juergen Gamer, PhD +49-6221-58608-0 +49-6221-58608-10 contact@apogenix.com www.apogenix.com 50 2005 S1

Areas of Activity · Drug development Biological Patents · Comprehensive international patent portfolio External · Strong network with numerous Collaborations academic and industrial partners Request for · Apogenix is exploring partnerships Further Collaborations with pharmaceutical and biotechnology companies as well as collaborations with leading academic institutions in order to advance the preclinical and clinical development and commercialisation of its proprietary drug candidates targeting members of the TNF superfamily and the TNF receptor superfamily.

Company overview Apogenix develops innovative immunotherapeutics for the treatment of cancer and viral infections, such as COVID-19. The company has built a promising pipeline of drug candidates that target different tumour necrosis factor superfamily (TNFSF)-dependent signaling pathways, thereby restoring the anti-tumour immune response in cancer patients and reducing lymphopenia and inflammatory cell death in patients with viral infections.

Lead immuno-oncology candidate asunercept Apogenix’s lead immunotherapy candidate asunercept is a fully human fusion protein that consists of the extracellular domain of the CD95 receptor and the Fc domain of an IgG antibody. It is in clinical development for the treatment of solid tumours, malignant hematological diseases, and COVID-19. Published data indicate that the CD95 ligand (CD95L) – the target of asunercept – plays a role in the induction of life-threatening lymphopenia, lung epithelial damage, and inflammatory cell death in COVID-19 patients. By blocking CD95L, asunercept could reduce these complications reported in COVID-19 patients. Asunercept is currently being evaluated in an Apogenix-sponsored clinical phase II trial in patients with severe COVID-19 disease in Spain and Russia.

In a randomised, controlled phase II efficacy trial in recurrent glioblastoma – the most frequent and aggressive brain tumour – treatment with asunercept in combination with radiotherapy has shown statistically significant improvements in progression-free survival and quality of life as well as a positive trend in overall survival compared to treatment with radiotherapy alone. Glioblastoma patients expressing a certain biomarker associated with the CD95 ligand experienced the greatest benefit from treatment with asunercept. The median overall survival rate in biomarker-positive patients treated with asunercept more than doubled to 16 months compared to patients treated with radiotherapy alone. Apogenix is developing a companion diagnostic test based on this biomarker, so that asunercept can be used as a personalised therapy.

Asunercept was granted PRIME (PRIority MEdicines) designation by the European Medicines Agency for the treatment of glioblastoma, which will greatly facilitate the

Apogenix

further clinical development toward approval in the EU. In patients with myelodysplastic syndromes (MDS) – a stem cell disorder that can lead to severe anaemia – the CD95 ligand inhibits the differentiation and development of red blood cells. Asunercept blocks the CD95 ligand, thereby enabling the maturation of erythrocyte precursor cells to functional erythrocytes. Final results of a phase I trial with asunercept in low and intermediate-I-risk MDS patients demonstrated an increase in erythrocyte precursor cells and a strong trend toward reduction in transfusion frequency after treatment with asunercept.

In addition, an investigation of parameters involved in erythropoiesis revealed how asunercept stimulates the production of red blood cells in these patients.

The CD95 system, which is inhibited by asunercept, plays an important role in the progression of other solid tumors, hematological diseases, and viral infections, underlining the tremendous potential of this compound for the treatment of malignant diseases beyond glioblastoma, MDS, and COVID-19.

HERA-ligand technology platform Apogenix’s highly qualified scientific team has developed the proprietary HERA-ligand technology platform for the construction of novel fusion proteins that target different TNFSF-dependent signaling pathways. Due to their specific molecular structure, Apogenix’s fusion proteins offer clear advantages over other biotherapeutics such as antibodies and have the potential for broad application in oncology.

Apogenix’s HERA-ligands have shown strong antitumour efficacy in vitro and in vivo, with a benign safety profile. The company has successfully out-licensed its first programme based on this technology platform – TRAIL receptor agonist APG880 and derivatives – to AbbVie. AbbVie has initiated clinical trials with TRAIL receptor agonist ABBV-621 in patients suffering from solid tumours, non-Hodgkin lymphoma, or acute myeloid leukaemia. Apogenix is currently utilising its technology platform to develop CD40, CD27, GITR, HVEM, and 4-1BB receptor agonists for cancer immunotherapy.

Management Thomas Hoeger, PhD (CEO) Peter Willinger (CFO) 22 nd guide to german biotech companies 2021

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Name · Axolabs GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Number of Employees Founded (year)

· · · · · · · · · ·

Fritz-Hornschuch-Str. 9 95326 Kulmbach Bavaria Dr Roland Kreutzer +49-9221-82762-0 +49-9221-82762-99 info@axolabs.com www.axolabs.com 120 2000 (under the name of Ribopharma; acquired by LGC in 2017) Type of Laboratory · S1, S2 Areas of Activity · Preclinical research solutions with focus on oligonucleotide therapeutics and other nucleic acid medicines, including high-quality oligonucleotide manufacturing, analytics, bioanalytics, lead molecule identification, in vitro and in vivo pharmacology, GMP release Biological Patents · Proprietary bioanalytics assay for the detection and quantification of oligonucleotides in blood and tissue; proprietary lipid platform for the cellular delivery of nucleic acids External · Axolabs collaborates with the majority Collaborations of research groups in the field of oligonucleotide therapeutics worldwide, including >10 Big Pharma enterprises, >160 biotech companies and >30 academic research institutes

Expertise and scientific excellence Axolabs is the leading custom research organisation focused on the discovery and preclinical drug development of oligonucleotide therapeutics and other nucleic acid medicines. Based on our world-leading know-how and 20+ years of experience we provide high-end preclinical solutions tailored to our clients’ specific needs.

Services and products Manufacturing ·· High-quality oligonucleotide synthesis ·· Custom-tailored process optimisation ·· Long RNA/DNA ·· Wide range of chemically modified oligonucleotides and conjugates ·· Potency and stability improvement ·· Impurity markers and reference standards ·· Lipid synthesis Oligonucleotide and nucleic acid analytics ·· Physicochemical and thermodynamic characterisation ·· Stability determination in biological matrices ·· Identification of metabolites by LC/MS ·· Analysis of nucleic acid-protein interactions Bioanalytical services ·· Unique and proprietary assay system for the sensitive detection of oligonucleotides from biological matrices ·· GLP-and GCP-certified test site Oligonucleotide lead identification ·· Bioinformatics assessment for sequence pre-selection ·· Drug design and synthesis ·· High-throughput in vitro screening ·· Lead characterisation and optimisation ·· In vivo efficacy and early safety assessment Biological and pharmacological tests and analyses ·· Safety and toxicology ·· Cell-based assays for cell function, proliferation, and toxicity ·· Ligand-receptor interaction and uptake studies/ histology ·· Flow cytometry

axolabs

Platform for functional cell type-specific delivery of oligonucleotides and mRNAs ·· In vitro functional analysis and in vivo models ·· Rational oligonucleotide design tailored for specific delivery systems ·· Proprietary lipid nanoparticle formulations CMC analytical services ·· GMP-compliant ·· Broad analytical capabilities ·· Materials science GMP-compliant oligonucleotide and mRNA release and stability analysis ·· Analysis of oligonucleotides and mRNA drug substance and drug product: ·· Purity and identity by UHPLC with UV and HR-ESIMS detection ·· Temperature-controlled UV spectroscopy ·· Lipid characterisation by UHPLC with CAD detection ·· LNP characterisation ·· Moisture, pH, osmolarity, etc. ·· ICH-compliant stability studies mRNA therapeutics ·· mRNA fingerprinting ·· Capping efficacy by HPLC/MS ·· Characterisation of mRNA drug product (LNP) ·· mRNA and mRNA-LNP bioanalysis ·· Quantification of mRNA from biological matrices (GLP) Gene-editing therapeutics ·· Unprecedented purity of therapeutic sgRNAs ·· Superior biological editing efficiency

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Name · BAG Health Care GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Email Address Internet Website Number of Employees Founded (year)

· · · · · · · · ·

Amtsgerichtsstrasse 1–5 35423 Lich Hesse Nico-Tobias Paulus +49-6404-925-0 contact@bag-healthcare.com www.bag-healthcare.com 135 1947

Areas of Activity · l Contract manufacturing organisation (CMO) for biopharmaceuticals and small molecules l Aseptic filling and lyophilisation in vials and ampoules in small to mid-size batches l Analytical services for API, drug product and stability programme l Packaging, labelling, and serialisation l QP-release

BAG Health Care.

Safety in Medical Treatment.

BAG Health Care GmbH is a pharmaceutical contract manufacturer specialised in aseptic filling and lyophilisation of parenterals, benefitting from over 40 years of experience in lyophilisation. We are focused on small to mid-size batches for market supply or clinical trials. In addition to manufacturing pharmaceuticals, we offer our customers many other services, such as analytical services, packaging, and serialisation, as well as the release of the drug product for the market or clinical trial.

Who are we?

BAG is 100% family-owned, independent, and proud to be part of the German “Mittelstand”. Located in Lich, close to Frankfurt, we are very easy to reach. We meet our customers on equal terms and are convinced that a long-term business relationship grows through personal contact and performance. It doesn’t matter whether our clients are a 5-person start-up or a successfully established group – we listen, analyse your needs, and tailor a personal solution for you.

What services do we offer?

Our manufacturing services for clinical Phase I–IlI and commercial supply include: ·· bulk compounding ·· sterile filtration ·· preparation of primary packaging materials ·· aseptic filling and/or lyophilisation ·· visual inspection ·· stability testing ·· labelling & packaging ·· QP release BAG has strong experience in fill& finishing of sterile lyophilised and liquid dosage forms for small molecules and biologicals including: ·· monoclonal antibodies ·· peptides ·· fusion proteins ·· interferons ·· oligonucleotides ·· vaccines (non-living)

bag health care

·· enzymes ·· human growth hormones ·· interleukins

Do you have some case studies available?

Sure! Learn more about our competence by reading the following case study. Of course, we are not limited to what is written here; it is just a small excerpt from our larger portfolio.

1. Fill & finish of very small bulk volumes (<2.5L) Problem: Line losses become onerous when working with very small bulk volumes.

Solution: The substance was delivered by the client in bottles and was subsequently pooled into a small-scale pressure vessel in our compounding area. By using nitrogen pressure, <30mL of substance remained in the vessel. Small-size sterile filters and flexible tubing minimised further losses. Finally, a filling machine with a single pump was used, further reducing losses in tubes and pumps compared to regular machines with multiple dosage-stations. By using the flushing volume to adjust the filling weight, the saved volumes meant significant additional product units. Losses between compounding and filling amounted to only 4%, meaning that 96% was available for the clinical trial.

What is BAG’s greatest strength?

At BAG we believe in empowering the client through the project manager. Our project managers are strong problem solvers and consummate multi-taskers. Personable and with strong leadership skills for managing both the internal and the client’s teams, our project managers ensure that everyone is working together to meet the project timeline and budget.

The project managers coordinate all activities and are the interface between the client and BAG, holding the individual team members and different functional areas responsible for meeting deadlines, providing action item updates, and advising of any potential timeline delays.

Depending on the status and complexity of the project, regularly scheduled phone conferences are held, with specialists from the individual areas attending as required. The dedicated project manager is at your disposal throughout the process.

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Name · Bioassay GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Email Website Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · ·

Im Neuenheimer Feld 515 69120 Heidelberg Baden-Wuerttemberg Dr Sven-Michael Cords +49-6221-433 88-911 cords@bioassay-online.de www.bioassay-online.de 25 2002 Bioanalytical contract laboratory

Areas of Activity · l GMP-potency assays l BioPharma efficacy l Biopharma safety

Bioassay – bioanalytical contract laboratory Bioassay GmbH is an independent bioanaly tical contract laboratory, specialising in the development, validation, and routine performance of bioanalytical assays in the area of Pharmacology and Toxicology.

We carry out qualified analytical services on the sound basis of our GMP & GLP certification, which provides an excellent framework for successful projects and routine bioanalysis. Key global players as well as startup companies in the pharmaceutical and chemical industries trust in the experience and dedication of our bioanalytical experts.

Bioassay – portfolio Bioassay GmbH is specialised in the development, validation, and execution of biological assays within the framework of Development & Quality Control of pharmaceutical and chemical products. Our portfolio contains 4 focus areas: BioPharma Potency, BioPharma Efficacy, BioPharma Safety, & Chemicals/Cosmetics Safety. In our in-vivo and in-vitro facilities we are running state-of-the-art-equipment and our analytical experts will welcome you to visit us in our laboratories located directly in the Heidelberg Technology Park (Germany).

Potency assays Bioassay GmbH offers the execution and assessment of potency assays within quality control of active pharmaceutical ingredients and drug products. Furthermore we have extended experience in the development and validation of new assays accordingly to ICH-Guidelines, as well as in optimisation of existing assay formats and transference into routine applications.

Established potency assays of therapeutic antibodies are run under GMP at Bioassay GmbH. Further, the development of assays regarding antibody dependent cell mediated cytotoxicity (ADCC), attributed to the mode of action of several therapeutic antibodies, in particular tumour cell targeting, is one our focus areas. Bioassay GmbH offers ADCC assays for development and quality control for the biopharmaceutical industry.

bioassay

Hormones and growth factors are widely used within the biopharmaceutical industry. Our portfolio includes most of them and potency assays based on monographs of EP and USP are run under GMP in a daily quality control routine for stability testing and batch release of active pharmaceutical ingredients and drug products.

BioPharma efficacy Bioassay GmbH has established efficacy models to address the demand for the characterisation of new drugs, especially in the field of biopharmaceuticals like monoclonal antibodies, hormones or cytokines, including FACS-based receptor binding assays, specific cell line development, or neutralising antibody assays.

Bioassay GmbH has extended experience in the field of characterisation of biosimilars or modified biologics (e.g. pegylated products).

Bioassay â&#x20AC;&#x201C; your bioanalytical contract laboratory Located in Heidelberg (Germany) Bioassay GmbH has specialised since 2002 in biological assays within the framework of the development & quality control of pharmaceutical and chemical products. We combine standardised processes with flexible organisation to fulfill the demands of our customers. Experienced project managers will work with you from the beginning until the end of your project.

Please test us!

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Name · Biofrontera AG

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Number of Employees Founded (year)

· · · · · · · · · ·

Hemmelrather Weg 201 51377 Leverkusen North-Rhine Westphalia Pamela Keck (Head of IR) +49-214-876-32-92 +49-214-876-32-90 ir@biofrontera.com www.biofrontera.com 154 (as of June 30, 2020) 1997

Areas of Activity · Dermatology Annual Turnover · €31.3m (2019)

Biofrontera AG (Frankfurt Stock Exchange: B8F; NASDAQ: BFRA) is a biopharmaceutical company specializing in the development and sale of dermatological drugs and medical cosmetics.

The Germany-based company, with over 150 employees worldwide, develops and markets innovative products for the care, protection, and treatment of the skin.

The company is uniquely positioned to exploit the growing global market of photodynamic therapy (PDT) for non-melanoma skin cancer and other dermatological conditions as well as to revolutionise the topical antibiotics market in the U.S. The company’s lead product is the combination of Ameluz®, a topical prescription drug, and medical device BF-RhodoLED ® for the photodynamic therapy of certain superficial skin cancers and their precursors.

Ameluz® has been marketed in the EU since 2012 and in the United States since May 2016.

In addition, the company markets the licensed product XepiTM, a prescription medication for the treatment of impetigo in the United States. Xepi TM is the first new topical antibiotic to enter the US market in ten years. No antibiotic resistance against XepiTM is known and it has been specifically approved by the FDA for the treatment of antibiotic-resistant bacteria.

biofrontera

In the EU, the company also sells the dermocosmetics series Belixos®, which offers specialised care for damaged or diseased skin.

Biofrontera’s goal is to optimise the positioning and market potentials of Ameluz® and XepiTM to become a leading specialty pharmaceutical company in dermatology.

Biofrontera is the first German founder-led pharmaceutical company to receive a centralised European and US approval for a drug developed in-house. The Biofrontera Group was founded in 1997 by the current CEO Prof. Dr. Hermann Lübbert and is listed on the Frankfurt Stock Exchange (Prime Standard) with the ticker symbol B8F and on the US NASDAQ with the ticker symbol BFRA. www.biofrontera.com

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Name · BioMed X Institute

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Im Neuenheimer Feld 515 69120 Heidelberg Baden-Wuerttemberg Dr Christian Tidona +49-6221-426-11-0 +49-6221-426-11-22 info@bio.mx https://bio.mx

LI 60 2013 Molecular and cell biology laboratory, S1/S2

Areas of Activity · l Biomedicine l Molecular biology l Cell biology l Oncology l Immunology l Neuroscience l Respiratory l Diagnostics External · l AbbVie Collaborations l Boehringer Ingelheim l Johnson & Johnson l Merck l Roche Request for · l Pharmaceutical companies Further Collaborations l Biotechnology companies l Foundations

Two Worlds · One Institute BioMed X is an independent research institute tackling the unmet needs in biomedical research & development.

Located at the campus environment of the University of Heidelberg, BioMed X operates at the interface between academia and industry and performs biomedical preclinical research projects in the fields of biomedicine, molecular biology, cell biology, and diagnostics.

Together with renowned industry partners, such as AbbVie, Boehringer Ingelheim, Johnson & Johnson, Merck, and Roche, the research institute provides creative solutions by combining global crowdsourcing with local incubation of the brightest early-career research talents from all over the world.

Scouting the best of the best Each research project at BioMed X starts with an ambitious R&D challenge that adds significant value to the industry partner’s product development pipeline. In a next step, BioMed X publishes the challenge world-wide on its crowdsourcing platform where interested candidates can apply with an outstanding project proposal.

On average, BioMed X gets 200–400 project proposals from 60–80 countries per challenge. The best 15 candidates will be invited to a 5-day boot camp in Heidelberg for interdisciplinary team building, mentorship, and conversion of outstanding ideas into well-designed project proposals. The scouting process ends with the selection and relocation of two or three winning candidates for a three- to five-year fellowship at the BioMed X Institute to run the industry partner’s research project.

biomed x institute

Serving a large purpose in advancing translational medicine BioMed Xâ&#x20AC;&#x2122;s innovation model leverages synergies and fosters cross-pollination in biomedical preclinical research. The highly diverse research teams at BioMed X are continuously guided by experienced mentors from academia and industry and work in a free, creative, and curiosity-driven environment which, at the same time, fosters a solid validation of results, timelines, and deliverables. Each team member has access to a stateof-the-art research infrastructure: 1,600 sqm laboratory and office space at the Technology Park on the campus of the University of Heidelberg, Germany, surrounded by renowned research institutes such as University of Heidelberg, German Cancer Research Center (DKFZ), National Center for Tumor Diseases (NCT), European Molecular Biology Laboratory (EMBL), Center for Molecular Biology (ZMBH), Heidelberg University Hospital with 44 specialised clinical departments, and approximately 100 large and small life sciences companies.

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we are research

Name · biosyn Arzneimittel GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Websites

· · · · · · · ·

Schorndorfer Str. 32 70734 Fellbach Baden-Wuerttemberg Dr Thomas Stiefel +49-711-57532-413 +49-711-57532-99 pia_buerger@biosyn.de www.biosyn.de www.biosynpharma.com Number of Employees · 70 Founded (year) · 1984 Areas of Activity · Research and sales of drugs and food supplements

The pharmaceutical and biotech company biosyn Arzneimittel GmbH is a hidden champion in its field: a family business with an eye for the big picture. This approach drives the innovative medium-sized company.

What is so special about biosyn Arzneimittel GmbH? biosyn Arzneimittel GmbH is a pharmaceutical and biotech company based in Fellbach, Germany. It is specialised in dietary supplements and trace elements, is a world market leader in high-dose selenium injections, and is the developer and operator of two globally unique GMP active ingredient manufacturing facilities. For example, the company has developed its own process to manufacture sodium selenite pentahydrate – the active ingredient in all of the company’s selenium products – in Germany in the internationally prescribed cGMP quality. Further cGMP manufacturing processes for active pharmaceutical ingredients of the trace elements chromium, iron, copper, manganese, and molybdenum have been developed for partners. Large international pharmaceutical companies rely on the company’s decades of experience in this field. CEPs (Certificate of suitability to the Monographs of the European Pharmacopoeia) have been issued for three active pharmaceutical ingredients (anhydrous sodium selenite, sodium selenite pentahydrate, and sodium molybdate dihydrate).

And the hidden champion is also active in the biotech field with a glycoprotein isolated from Megathura crenulata, a marine snail found in California.

What is behind this special glycoprotein?

The glycoprotein keyhole limpet hemocyanin (KLH) is obtained from the hemolymph of the marine snail, obtained by the non-lethal puncture of these snails in California at the American subsidiary, where it is also prepurified. The substance is then highly purified and processed at the company headquarters in Fellbach. The immunocyanin obtained from one snail is roughly sufficient to treat a patient with bladder carcinoma for one year. This substance has a high therapeutic potential. Marketed as IMMUCOTHEL®, KLH is approved in various countries,

biosyn

including Austria and the Netherlands, for the recurrence prophylaxis of superficial bladder carcinoma.

What does the future look like?

In the meantime, the gene sequence of the protein has been clarified and a patent application filed. This means that the genetic engineering production of the recombinant protein is also conceivable in the future. On the other hand, this high-molecular glycoprotein serves as a carrier molecule for various antigens in new generations of vaccines.

International vaccine manufacturers use it under the brand name VACMUNÂŽ for novel vaccine generations.

The first success of such a vaccine was shown in a phase III study conducted by Biovest International, Inc. (Worcester, MA, a subsidiary of Accentia Biopharmaceuticals, Inc.) in patients with non-Hodgkin lymphoma.

This development has also stimulated the search to treat Alzheimerâ&#x20AC;&#x2122;s disease. The phase II clinical trial of a potential vaccine has been successfully completed and significant indications of improvement in Alzheimerâ&#x20AC;&#x2122;s patients have been obtained, leaving biosyn Arzneimittel GmbH is optimistic: there is a good chance that the phase III study, which is expected to start soon, will also be successfully completed.

What drives the people at biosyn Arzneimittel GmbH? The name biosyn stands for research and progress in medicine. However, the focus of the biotechnology company, founded in 1984, is not on basic research, but on the production processes of active pharmaceutical ingredients and clinical research.

More than half of the sales of biosyn Arzneimittel GmbH are generated outside of Germany, in over 20 countries around the world. Active in the fields of intensive care medicine, oncology, and endocrinology, biosyn and its products are a partner for hospitals and general practitioners, as well as for naturopathic physicians and holistic health practitioners.

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Name · Boehringer Ingelheim Biopharmaceuticals GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · ·

Binger Strasse 173 55216 Ingelheim Rhineland-Palatinate Matthias Reinig +49-6132-77-0 +49-6132-72-0 bioxcellence@boehringer-ingelheim.com www.bioxcellence.com around 51,000 in 2019 1885 in Ingelheim, Germany S1

Areas of Activity · Focus on human pharmaceuticals, animal health and biopharmaceutical contract manufacturing Net Sales · €19,000 million in 2019 Relevant R&D Budget · €3,500 million in 2019 Request for · Boehringer Ingelheim BioXcellence™ Further Collaborations seeks companies in need of biopharma development and GMP manufacturing services and helps customers to get their products to market on time.

Company profile The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 175 affiliates and around 51,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing, and marketing novel medications of high therapeutic value for human and veterinary medicine.

In 2019, Boehringer Ingelheim achieved net sales of about 19 billion euros.

Boehringer Ingelheim BioXcellence™ is a leading biopharmaceutical contract manufacturer — a preferred partner providing the entire production chain from DNA to Fill & Finish. With over 35 years of biotechnology experience, more than 4,600 dedicated and highly trained employees, and a global network we have helped our customers to bring more than 35 biologics to the market.

We have also transferred and optimised more than 150 development and manufacturing projects at all stages from our customers to our facilities, as well as within our network. We work with 70% of the world’s Top 20 pharma and many innovative biotech companies in getting the right treatments and therapies to patients.

Wherever you are, we are by your side.

Our network of manufacturing facilities spans the globe, from Fremont, California in the United States to Biberach in Germany, Vienna in Austria and Shanghai in China.

From these sites, we offer our customers first class biopharmaceutical medicines anywhere in the world and the best suited business model and production site for their needs: Global capacity for cell culture: > 290 kL commercial Global capacity for microbials and yeast fermentation: > 12 kL commercial

Boehringer Ingelheim

We deliver progress. And it’s our pleasure.

For many of our customers we are the preferred partner or even the single supplier for the production of biopharmaceutical medicines, ranging from mammalian cell cultures to microbial and yeast fermentations. We have comprehensive experience with a variety of different host cells, producing an equally broad variety of molecules according to cGMP manufacturing guidelines and covering all stages of development including Fill & Finish. Our focus is on producing value for our customers with robust processes, optimal preparation for launch, and global commercial supplies.

We treat your products as if they were our own.

Aside from our extensive experience and technical expertise, there are several other good reasons to choose us as your trusted contract manufacturing partner: ·· Pharma mindset and traditional values ·· Long-term view on customer partnerships ·· Independent contract manufacturing organisation within a large corporation ·· Constantly expanding global capacities and capabilities ·· Excellent global regulatory track record

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Name · BRAIN AG Biotechnology Research And Information Network AG Address/P.O. Box Postal Code/City State Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · ·

Darmstädter Str. 34–36 64673 Zwingenberg Hesse +49-6251-9331-0 +49-6251-9331-11 public@brain-biotech.com www.brain-biotech.com

Advanced bio-based products for industry BRAIN is one of Europe’s leading companies in the field of industrial (white) biotechnology. As such, BRAIN identifies previously untapped efficient enzymes, microbial producer organisms, and natural substances from complex biological systems for industrial applications and products. The innovative solutions and products are successfully applied in the feed, food, health, and chemical industries, many of them serving to make products and processes more sustainable.

LI 130 1993 S1, S2, L1, L2

Areas of Activity · White biotechnology: bio-based products and solutions for industrial applications in nutrition, health, and the environment; discovery and development of novel and customised enzymes, bioactive natural compounds, and high-performance microorganisms; strain development; synthetic biology; metabolomics; cell-based screening systems; process engineering; precise fermentation.

Biological Patents · 175 active country patents in 42 patent families: metagenome technologies, enzymes, enzyme libraries, bioactives, technical proteins, microorganisms, processes.

External · BASF, Bayer, Evonik, Henkel, Nutrinova, Collaborations RWE, Sandoz, Schering, Südzucker, Symrise (D), CIBA (CH), Clariant (CH), Diana (F), DSM (NL), Roquette (F), Genencor (USA), and others; global academic R&D network.

Request for · Looking for industry partners for joint Further Collaborations development of Salt-E and FRESCO programs.

Resources The BRAIN Group’s proprietary collection “BRAIN Bioarchive” offers access to an immense variety of new biological solutions for sustainable industrial processes and ingredients. It encompasses microorganisms, natural compounds, fractions obtained from edible plant material, metagenome and enzyme libraries, as well as complete metabolic pathways including previously uncultivable organisms.

Products and services based on the BRAIN Bioarchive BRAIN AG provides first-class R&D work for innovative solutions that support the development towards a bio-economy. We use synergies within the BRAIN Group for R&D as well as for specialised production of biomass, enzymes, or bioactives. As BRAIN Group we offer advanced bio-based products and solutions from small-scale to large-scale approaches. ·· Enzymes: Discovery, analysis, optimization, sampling, formulation, and production in a variety of hosts. ·· Microorganisms: Identification and strain development (non-GMO and GMO); supply of functional biomass to optimise industrial production processes. ·· Bioactives and performance biologicals: Discovery (high-throughput isolation; extraction and purification of natural products from variable biological resources); structure elucidation and characterisation; activity- and sequence-based screenings incl. biochemical and human cell-based assays; production.

brain

Bioengineering services ·· Bio-process development at lab-scale ·· Scale-up to 200L scale for process validation and sample generation ·· Process transfer & production scale Applied technologies Our R&D activities are driven by a solution-focused creative mindset, which overcomes the limitations of a single technology approach. State-of-the-art technologies such as next generation sequencing (NGS), digital 3D modelling, and experiment simulation, as well as protein engineering, genome editing, and big data analysis are applied. Examples of how we combine resources and technologies: ·· Microbial expression: Large set of pro- and eukaryotic expression strains (“chassis”) for the economic production of enzymes and biocatalysts. ·· Microbial strain development: Tailor-made designer strains based on conventional methodologies, plus engineering novel synthetic pathways and artificial operons for high-value industrial production. ·· Gene and protein engineering: Expression of genes and gene clusters for rationally re-designed production strains, including synthetic biology application, for customised enzymes and biocatalysts with optimised properties. ·· Data Analysis: Cutting edge bioinformatic technologies enabling the read-out of next-generation sequencing (NGS) results, Design Of Experiments (DOE), big data analysis.

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Name · c-LEcta GmbH

Address/P.O. Box Postal Code/City State Contact Person

· · · ·

Perlickstraße 5 04103 Leipzig Saxony Kristina Richter (Communications Manager) Telephone · +49-341-355-214 0 Email Address · contact@c-lecta.com Internet Website · www.c-lecta.com Social Media · L I Number of Employees · 86 (by Aug/2020) Founded (year) · 2004 Areas of Activity · l Enzyme engineering l Product development l Strategic partnerships with industry External · l DSM Collaborations l BASF l Novozymes l Roche l Symrise

High-value biotech products as a growth driver c-LEcta is an international fast growing biotech company that is leading in enzyme engineering and bioprocess development and distribution. c-LEcta is developing innovative enzymes and ingredients mainly for customers from the pharmaceutical and food industries. The products produced by the Leipzig-based company are delivered to more than 200 customers in 40 countries. c-LEcta is leveraging a unique technology platform to develop new innovative biotechnology products.

Tailor-made enzymes for use in industrial production processes are generated using a bioinformatics-driven enzyme engineering platform that is efficient and flexible. Proprietary microbial high-performance production strains are used to deliver high-value biotech products.

Experienced research teams come up with scalable and robust bioprocesses that satisfy the most stringent regulatory requirements. These processes are then implemented in industrial production.

The enzymes and ingredients of c-LEcta are used in numerous fields. They enable the production of life-saving drugs and foods for current consumers needs and help make products safer or allow them to be produced in a more sustainable manner.

c-lecta

Products meet growth markets The market development for enzymes by c-LEcta is supported by long-term trends, such as the need for more healthy and functional foods. One example is enzymes to improve a plant-based sweetener with a sugar-like taste that has been marketed since 2018. Other products can only be produced using the specialised enzymes from c-LEcta. For example, undesirable DNA components are removed by the enzyme DENARASE during the production of viral vaccines. Other enzyme products from c-LEcta are used to produce pharmaceutical agents, such as for use in cancer therapy.

Further growth is envisioned particularly in its already well-stocked product pipeline: several launches are planned for the coming years. For example, the portfolio of enzymes for use as biocatalysts in producing active pharmaceutical ingredients will be expanded. Several food ingredient products are also in the development pipeline, including an already well-established functional sugar that is created using a new groundbreaking production process. In its next major planned step, c-LEcta intends to step into an additional market, the cosmetics industry, with an active ingredient for body care products.

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Name · Cardior Pharmaceuticals GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · ·

Feodor-Lynen-Str. 15 30625 Hannover Lower Saxony Dr Claudia Ulbrich, CEO +49-511-338599-30 +49-511-338599-39 info@cardior.de www.cardior.de 17 2016 S1

Areas of Activity · Research & development of RNA-based therapeutics and diagnostics External · l MHH Collaborations l IMTTS l Fraunhofer ITEM l CRC

Cardior is a privately held clinical stage biopharmaceutical company founded in 2016 by Prof. Thomas Thum (CSO) and Dr. Claudia Ulbrich (CEO and co-founder) as a spin-off from Hannover Medical School.

A Series A financing round of € 15m was closed in May 2017 with five international leading venture capital funds including LSP, BioMedPartners, Boehringer Ingelheim Venture Fund, Bristol-Myers Squibb, and High-Tech Gründerfonds.

Technology The company is dedicated to becoming a world leader in design, research, and development of non-coding RNAbased therapeutics and diagnostics for cardiovascular diseases. These non-coding RNAs are a novel class of regulatory RNAs and have huge therapeutic potential.

As its lead compound, CDR132L, Cardior is developing an anti-sense oligonucleotide as a therapeutic to inhibit a specific non-coding RNA in the heart that controls cardiac growth, autophagy, and contractility. Its inhibition reverses cardiac remodelling, restores normal cardiac function, and can revolutionise the treatment of patients with myocardial infarction-induced as well as chronical heart failure.

In addition to the patent-protected lead compound, Cardior has access to a large patent portfolio consisting of several candidates for heart failure therapy and other indications, e.g. kidney fibrosis.

cardior

Unmet medical need New innovative treatments for heart failure are scarce, even among those that are in early phases of development. But with this novel approach Cardior’s clear advantage is having a well-characterised target with convincing preclinical efficacy and safety data leading to a superior approach for the treatment of patients with heart failure.

Indeed, and in contrast to standard of care or other therapeutics in development, which are mainly symptomatic or disease-halting, Cardior’s innovative strategy is designed as the first real curative approach to heart failure.

Development of lead compound Within only two years Cardior has advanced from research to clinical stage. The company’s lead compound, CDR132L, has shown preclinical proof-of-concept and successfully completed a clinical phase 1b trial in Q3 2020. After proof-of-concept (POC) data and clinical validation Cardior seeks to market its lead compound in collaboration with a Big Pharma partner.

Furthermore, Cardior is working on innovative cardiac delivery technologies that enable a safe cardiac-specific long-term treatment for patients with chronic heart failure.

This tool offers the possibility to acquire precise data on the patient’s disease-specific status and to tailor an individual treatment plan.

Beyond that, Cardior is developing a companion diagnostic to provide a tool to predict the future outcome of patients with myocardial infarction.

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Name · Cellex CMT Manufacturing, Transport and Logistics GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Founded (year)

· · · · · · · · ·

Mathias-Brüggen Str. 140 50829 Cologne North-Rhine Westphalia Ingrid Seidel +49-221-4545702 +49-221-4545809 i.seidel@cellex.me www.cellex.me Company founded in 2001 Active in ATMP manufacturing since 2016 2018 opening of the Cellex Cell Manufacturing Plant in Cologne Ossendorf Type of Laboratory · l Grade C and D cleanrooms l Isolators used for open manipulation steps under clean room class A conditions – S2 l Quality control laboratories l Cryo storage area l Additional special training facility Areas of Activity · Full service provider with regard to innovative cell therapies: l Manufacturing and storage l Logistics and scheduling l Transports Specialised in transfer of activities from academic invention to GMPcompliant manufacturing and in contract manufacturing of Advanced Therapy Medicinal Products (ATMPs) External · Large international pharmaceutical Collaborations companies and academia.

Request for · Cellex is interested in collaborations Further Collaborations with academic and industrial partners.

The CMT Cellex Manufacturing Transports and Logistics GmbH, founded in 2018, belongs to the Cellex group of companies.

The Cellex group offers a broad spectrum of services for pharma, biotech, clinical, and research institutions in the field of cellular therapies.

Our apheresis centres have all the techniques for collection of hematopoietic blood stem cells and lymphocytes from patients and healthy donors for clinical use and research purposes.

Our state-of-the art Cellex Cell Manufacturing Plant (CCMP), based in Cologne, is the heart of CMT services and offers GMP-compliant contract ATMP manufacturing. Cellular subsets are separated, genetically modified, and frozen.

CCMP staff has expertise in cryopreservation and storage of cryopreserved products. Storage can take place at temperatures ≤ 140 °C in vapor phase over liquid nitrogen in tanks with vacuum super insulation or at - 80 °C in freezers. An alarm system monitors the constant adherence to storage temperatures.

Intermediates and final products are analysed. The quality control, including flow cytometry, cell count, viability, blood count, etc., complies with the requirements of the current EU and US regulations, ICH recommendations, and GMP guidelines.

We import cell therapy products into the European Union, perform EU QP release, and distribute ATMPs in member states.

cellex

The Cellex range of services also includes scheduling and coordination as well as AEO-certified worldwide transportation of all cellular subsets including all related GxP documentation.

Cellex has obtained manufacturing licences for multiple cell therapy products for clinical applications.

All employees are highly qualified and have extensive experience in the GMP-regulated environment. Their training, performed on a regular basis in all GMP-relevant areas, ensures the high standard of services and product quality to our customers.

Our company has experience in GMP manufacturing of autologous and allogeneic cell types, which are genetically modified with retroviral and lentiviral vectors. The primary knowledge is for CAR-T technologies.

With a growing team of over 60 employees, we cover project management, manufacturing, and quality control and ensure the maintenance of our quality management system.

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Name · CellGenix GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Am Flughafen 16 79108 Freiburg Baden-Wuerttemberg Prof. Dr Felicia Rosenthal +49-761-888 89-0 +49-761-888 89-800 info@cellgenix.com cellgenix.com

I 70 1994 GMP Clean Room facilities A/B/C/D S1/S2

Areas of Activity · l E x vivo raw materials for Cell & Gene Therapy l Regenerative Medicine External · Distribution in Europe of Saint Gobain Collaborations FEP cell culture and cryopreservation bags Request for · l T cells Further Collaborations l MSCs l iPSCs, ESCs l NK cells

High-quality GMP reagents for cell and gene therapy manufacturing CellGenix is a leading global supplier of high-quality raw and ancillary materials for the expanding market of cell and gene therapy as well as regenerative medicine.

We develop, manufacture, and market human cytokines, growth factors, and other recombinant cell culture components in preclinical and GMP quality, as well as proprietary serum-free media for further manufacturing of Advanced Therapy Medicinal Products (ATMPs). Our products are used by academia and industry partners in clinical trials and commercial manufacturing throughout the world. As an ATMP developer and manufacturer we have acquired in-depth cell culture knowledge and superior regulatory expertise. With this unique background we understand the high requirements our customers face during product development and the regulatory approval process.

CellGenix is headquartered in Freiburg, Germany and operates a subsidiary near Boston in Portsmouth, NH, USA.

Our mission & vision Our mission is to enable and accelerate safe and efficient transition of cell, gene, and tissue-engineered products from preclinical to post-approval clinical applications for the benefit of patients worldwide. We foster this by providing premium ancillary products, reagents, tools, and expert regulatory support to our academic and industry partners worldwide.

We aim to be a key provider in the fight against disease, the preferred supplier of raw materials and tools, and a trusted partner for large-scale manufacturing in cell and gene therapy as well as regenerative medicine.

Our history CellGenix has more than two decades of in-house expertise in GMP manufacturing and the development of products (for dendritic cells, HSC, cord blood cells, and

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chondrocytes) in the field of cell and gene therapy and regenerative medicine. The company was founded in 1994 as a spin-off of Freiburg University Medical Center and was the first European company to obtain a GMP manufacturing authorisation for cell processing in 1995.

CellGenix’s current Quality Management (QM) system was established for the manufacture of recombinant protein investigational products (patient-specific idiotype vaccines and recombinant tumour vaccines) in compliance with GMP under manufacturing authorisation from German regulatory authorities. The QM system has been adapted for the manufacture of recombinant raw materials and has been ISO certified since 2012 (currently DIN EN ISO 9001:2015).

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With many years of experience in the field of cell and gene therapy, CellGenix has always taken active interest in supporting the advancement of the regulatory framework in this evolving environment. We filed the first FDA DMF for a cytokine as ancillary reagent in 2002 and co-authored chapter <92> with the USP in 2010.

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CellGenix GMP products are based on three major quality standards: ·· Safety Safe and qualified raw materials in compliance with our animal-derived, component-free, and serum-free policy. ·· GMP Compliance Manufacturing and quality control following all applicable GMP guidelines to provide documented evidence of purity, potency, consistency, and stability. ·· Regulatory Compliance & Support GMP products are manufactured, tested, released, and distributed under an ISO 9001:2015 certified Quality Management System and allow for safe use in accordance with USP Chapter <1043>, Ph. Eur. General Chapter 5.2.12 and ISO TS 20399. GMP cytokines are tested and released according to USP Chapter <92> as applicable.

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Name · CO.DON AG

Address/P.O. Box · Warthestr. 21 (Headquarters) Postal Code/City · 14513 Teltow State · Brandenburg Subsidiary: Address/P.O. Box · Deutscher Platz 5d Postal Code/City · 04103 Leipzig State · Saxony Contact Person · Matthias Meißner, M.A. (Director Corporate Communications / IR / PR) Telephone · +49-30-240352 330 Fax · +49-30-240352 309 Email Address · info@codon.de Internet Website · www.codon.de Number of Employees · 123 (2019) Founded (year) · 1993 Type of Laboratory · GMP/Integrated Isolator Technology (IIT) Areas of Activity · Tissue Engineering Biological Patents · For cell-based human tissue engineering therapeutics External · Various ongoing projects with several Collaborations well-renowned hospitals, universities, and university hospitals in Europe in the field of product distribution, product development, clinical evaluation, and research Request for · CO.DON AG is seeking national and Further Collaborations international corporate partners who have substantial resources in the field of tissue engineering and regeneration for distribution and marketing of the company’s products (international) as well as for the development of product lines.

The company CO.DON AG develops, produces, and markets autologous cell therapies for the minimally invasive repair of knee cartilage defects following trauma or degeneration. The medicinal product is a cell therapy product that uses only the patient’s own cartilage cells (“autologous chondrocytes”). CO.DON’s method is currently used in over 200 clinics in Germany and more than 15,000 patients have already been treated. In July 2017 CO.DON received EU-wide marketing authorisation for its product, with approval for Switzerland following in March 2019. The shares in CO.DON AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227).

Chief Executive Officer: Tilmann Bur. CO.DON AG manufactures cell-based therapies of the highest purity and to the highest quality standards.

Its products represent a revolutionary process in the biological regenerative treatment of articular cartilage defects.

The products are 100% autologous and free of additives, setting the stage for the highest level of personalised treatment. Because no exogenous materials are used, the risks of rejection, inflammation, and infection are low. Due to a minimally invasive or arthroscopic application of the product, surgery and rehabilitation time can be reduced.

CO.DON AG has been certified in accordance with European Guidelines for Good Manufacturing Practice (EU-GMP) since 1997. In 1997 CO.DON AG was the first biopharmaceutical company in Europe to be granted a permit for the manufacture of autologous chondrocyte transplants under section 13 of the German Drugs Law (AMG).

CO.DON has also developed a proprietary platform technology: The Integrated Isolator Technology (IIT).

co.don

Integrated Isolator Technology (IIT) CO.DON has an established tissue engineering programme for the development, production, and distribution of biotechnological products for the treatment of articular cartilage defects. For the manufacturing process and quality control of autologous cell therapies the company has developed its own clean room production plant, the Integrated Isolator Technology (IIT) (a cleanroom in a cleanroom). In 2018, the company initiated the setup of a second production site in Leipzig. With this, CO.DON is entering a new dimension: the production site is one of the largest plants for the industrial-scale cultivation of human cells. It will enable the company to ensure the supply of the highest quality cell therapy products to their customers in Germany and Europe going forward.

CO.DONâ&#x20AC;&#x2122;s technological, production, and regulatory expertise makes the company a first mover in the market for biological cartilage regeneration and a provider of highly effective, safe treatment options from pain therapy to endoprosthetics with the aim to become market leader in arthrosis prophylaxis. Moreover, the product is currently the only cell-based medicinal product for the regenerative treatment of knee cartilage defects that is authorised EU-wide. With that, CO.DON has the chance to open up a market that is worth millions and to raise its company value. CO.DON founded subsidiaries in the UK (2017) and the Netherlands (2018) to develop this promising market in line with the companyâ&#x20AC;&#x2122;s strategy Currently, the products are distributed in Germany, the Netherlands, UK, Switzerland, and Austria.

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Name · Coriolis Pharma Research GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Fraunhoferstr. 18B 82152 Martinsried Bavaria Dr Jörg Müller +49-89-417760-111 +49-89-417760-222 Joerg.Mueller@coriolis-pharma.com www.coriolis-pharma.com

I 130+ 2008 Contract research and development

Areas of Activity · Formulation excellence for biopharmaceuticals, incl.: l Liquid and lyophilised formulations l Lyophilisation process development l Analytical services for biologics l Aggregate analysis l Particle characterisation l Higher-order structure analysis l Forced-degradation studies l Long-term and in-use stability l Pre-formulation screening l Developability assessment Level: R&D, GMP, S1 (BSL1), S2 (BSL2) External · Experience with 650+ different Collaborations molecules gained in 1,500+ projects Request for · Worldwide customers in all stages of Further Collaborations product development (early R&D to and beyond market approval). We collaborate with small virtual biotech firms, mid-size pharma-biotech, as well as TOP20 pharma-biotech companies.

Approach our experts with your formulation, stability, and analytical challenges. We provide tailor-made, science-driven solutions that align with your development strategy.

Your partner with scientific excellence Coriolis is a globally operating service provider and one of the world leaders in formulation research and development of (bio)pharmaceutical drugs including proteins, peptides, monoclonal antibodies, RNA/DNA, virus-like particles, vaccines, ATMPs, and GMOs (up to Biosafety Level S2).

More than 700 customers – from start-ups to Big Pharma – trust the expertise of Coriolis. We develop liquid and lyophilised formulations entirely in-house: no subcontracting to third parties. For each individual project, our highly skilled scientists develop tailor-made study designs that align with our customers’ drug development strategies. Our formulation services support all phases of drug development from early R&D to and beyond market approval.

Coriolis is specialised in the provision of: ·· Formulation development services for liquid and lyophilised products including BSL1 and BSL2 · Pre-formulation and candidate selection · Early stage formulation development · Late phase formulation development · Lyophilisation process development · Lyophilisation cycle optimisation · Scale-up and transfer studies ·· Developability / manufacturability assessment ·· Support in container closure system selection ·· In-use stability studies ·· Stability testing including forced degradation studies ·· R&D and cGMP-compliant contract analytical services ·· Orthogonal analysis of subvisible aggregates and particles ·· Testing of BSL1 and BSL2 GMO material ·· Polysorbate analytics ·· Biosimilarity studies ·· Outstanding scientific expertise

coriolis pharma research

Formulating innovation By following our mission of “Formulating Innovation”, we combine technologies, knowledge, and experience to add substantial financial value to our customers projects by generating IP for your pharmaceutical compound and supporting patent life cycle management in later phases. Coriolis will seek no financial participation in generated IP.

Impressive analytical portfolio Coriolis can draw from a unique analytical portfolio of more than 100 different techniques – performed entirely in-house – to obtain orthogonal and meaningful data. With the in-house lyophilisation development centre, our scientists can obtain time-saving and robust lyophilisation cycles at lab, pilot and production scale. Dedicated GMP facilities enable us to conduct lot-release analysis and generate supportive data for market approval and allow for tailored “enhanced R&D” level studies. Coriolis – as a trendsetter – provides state-of-the-art as well as promising new and emerging technologies in the field of: ·· Particle characterisation (from nanometre to visible) ·· Aggregate analytics ·· Physico-chemical characterisation of lyophilisates ·· Surfactant characterisation ·· Higher order structure analysis ·· Chemical changes

Our benefits are yours Our scientific advisory board contains some of the most renowned specialists in biopharmaceutical formulation development and particle characterisation: Prof. Wim Jiskoot, Prof. Gerhard Winter, Prof. Wolfgang Friess, and Prof. Christian Schöneich. They are actively involved throughout each customer project – if desired – and contribute with independent advice to a successful outcome. Our team consists of more than 20 different nationalities, with English as our business language. The scientific expertise of our project teams is driven by our internal research unit – composed of post-docs, PhD candidates, and students – who continuously publish exciting articles in high-impact journals.

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Name · CRS Clinical Research Services Andernach GmbH Address/P.O. Box Postal Code/City State Subsidiaries

· · · ·

Contact Person · Telephone Mobile Fax Email Address Internet Website Social Media Number of Employees Founded (year)

Friedrich-König-Str. 3–5 68167 Mannheim Baden-Wuerttemberg | Kiel | Berlin | Wuppertal | Mannheim Dr Volker Menschik (Chief Business Officer) +49-30-859-949-401 +49-151-526-416-33 +49-30-859-949-222 volker.menschik@crs-group.de www.crs-group.de

· · · · · · IQ · 250 · Merger 2006, Foundation of Legacy up to 1977 Type of Company · Full-Service CRO Areas of Activity · | Consultancy | Project Management | Clinical Conduct | Quality Assurance | Clinical Trial Supply Management | Medical Writing | Clinical Data Management | Statistics by external partners | Laboratory/Bioanalytical Services by external partners

In-house Capacity · 250 beds Request for · Our Business Development team is Further Collaborations happy to discuss your project and to propose tailor-made solutions for the clinical development of your product.

Please do not hesitate to contact us: WWW.CRS-GROUP.DE/CONTACT

CRS. Experts. Early Phase.

CRS is a leading European full-service CRO in early clinical development and has more than 40 years of experience in the performance of clinical trials in healthy volunteers and dedicated patient segments.

The excellent quality of CRS’s services is demonstrated by an outstanding track record of more than 2,000 successfully completed trials and numerous publications in prominent international scientific trade journals.

All research units of CRS are located in the most important German metropolitan regions. CRS maintains a database covering more than 50,000 entries with healthy subjects or certain patient populations all over Germany. In addition, CRS has built up close collaborations with numerous academic and clinical sites to extend access to patients in dedicated indications, such as cardiometabolic diseases, renal and hepatic impairment as well as women’s health.

Especially for settings of patient trials or complex designs, CRS provides a specific supersite concept, i. e. up to four sites under one project and quality management following the same SOP regulations. Due to the standardised and centralised project management, subject recruitment and quality control, CRS is able to handle multi-centre settings at highest standards.

CRS maintains close relationships to numerous opinion leaders and several outstanding academic institutions.

Well established collaborations with specialised care providers allows CRS to provide a wide range of diagnostic tools like metabolic staging, PDFF-MRI, tissue biopsies, or catheter investigations and many more.

CRS Kiel is situated close to the University Hospital Schleswig-Holstein (UKSH); the one in Berlin is close to the famous Charité and the Federal Military Hospital.

CRS Mannheim is located in a region that is home to established research institutes as well as the renowned University Hospital Heidelberg and University Medical Centre Mannheim (UMM).

CRS is regularly audited by sponsors and inspected by the authorities (FDA, EMA, BfArM, AFSSAPS, etc.).

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CRS. Extensive Expertise.

Prof. Dr Thomas Forst Chief Medical Officer Speaker of the Management

Ekkehard Herrmann Chief Financial Officer

Dr Atef Halabi Partner, Managing & Medical Director

Dr Volker Menschik Chief Business Officer

CRS is one of the leading experts in the performance of all kind of first in human and early phase pharmacokinetic and pharmacodynamic studies in healthy volunteers to Proof of Concept in special indications like: ·· ·· ·· ·· ·· ·· ·· ·· ·· ··

Renal & hepatic impairment Cardiometabolic diseases NASH Diabetes Obesity Men’s & women’s health Dermatology Medical devices Respiratory/inhalative devices Vaccines

CRS. Your CRO. Full-service. A complete service solution out of one hand, under one contract.

Customer-focused. Your needs and your satisfaction are our motivation to deliver maximum performance.

Tailor-made. Our solution is individually customised to your specific requirements. No one-size fits all approach.

Shared expertise. Take advantages of more than 40 years of experience.

Small enough to be customer-centric and highly flexible to act according to your needs.

Big enough to manage even complex and challenging trials out of one hand.

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Name · CTI Clinical Trial and Consulting Services Europe GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Schillerstr. 1/15 89077 Ulm Bavaria Dr Christiane Alexander +49-160-43-56834 +49-731-4000-8429 calexander@ctifacts.com www.ctifacts.com

FL I  I 800 1999

Areas of Activity · l Regulatory Development & Strategy l Clinical Services l Research Centre (Phase I–IV Site Capabilities) l Real World Evidence & Late Phase

CTI Clinical Trial & Consulting Where life-changing therapies turn first® CTI Clinical Trial and Consulting Services is a global, privately held, full-service CRO, delivering a complete spectrum of services throughout the lifecycle of development. In its third decade, CTI is one of the 20 largest CROs in the world, with associates in more than 60 countries across six continents.

The company was recently named the #1 CRO in the world for quality at the 2020 CRO Leadership Awards, outperforming nearly 30 other recognised global CROs. Additionally, we were a winner in 5 of the 6 categories, including Capabilities, Compatibility, Expertise, Quality, and Reliability.

CTI has kept its initial focus on chronically and critically ill patients and contributed to more than 120 new drug and device approvals through global regulatory agencies such as the FDA and EMA, and has led more than 6000 successful, innovative, and cost-effective projects.

CTI’s excellent relations with our strong network of sites, patient organisations, and the European Reference Networks for rare diseases help our clients to succeed in their clinical studies. CTI’s experts in regulatory, real world evidence, and trial management bring lifechanging therapies to patients in need.

CTI is currently managing more than twenty active COVID-19 trials for treatment and prevention, in addition to work in regenerative medicine, rare diseases, immunooncology, and other critical illness indications.

Therapeutic Areas CTI’s focused approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in: ·· Rare Diseases ·· Regenerative Medicine / Gene Therapy ·· Immunology ·· Transplantation ·· Nephrology ·· Hematology / Oncology

cti

·· ·· ·· ·· ·· ··

Neurology/Sleep Research Infectious Diseases Hepatology Cardiopulmonary Pediatric/Neonate Populations Devices

Global Locations Since 1999, CTI has grown consistently and has become a multi-national organisation with nearly 1,000 associates in more than 60 countries across the world. ·· Global headquarters are located in Covington, Kentucky, USA ·· European headquarters are located in Ulm, Germany since 2009. CTI has additional European offices located in the United Kingdom, France, Portugal, Spain, Italy, Belgium, Sweden, Poland, and the Czech Republic ·· Latin American headquarters are located in São Paulo, Brazil ·· Asia-Pacific headquarters are located in Sydney, Australia ·· Middle Eastern Northern Africa (MENA) headquarters are located in Dubai

Consistency in the Changing Landscape of the CRO Industry How CTI is different: ·· Continued therapeutic focus that maintains the academic relationships important to our sponsors’ programmes ·· A highly experienced global medical affairs team ·· Manageable workloads ·· Strategic consulting support to provide full-service coverage spanning the development spectrum ·· Consistent leadership vision ·· High level of executive involvement ·· Positive/conservative corporate culture – no layoffs, no debt ·· Significantly higher employee retention compared to industry standards ·· Flexibility to make quick adjustments as needed ·· Excellent repeat business award rate For more information, please visit www.ctifacts.com.

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Name · CureVac

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Friedrich-Miescher-Straße 15 72076 Tübingen Baden-Wuerttemberg Thorsten Schüller +49-7071-9883-0 +49-7071-9883-1101 communications@curevac.com www.curevac.com

FL I Q  500 2000

Areas of Activity · Research, development, and manufacturing of transformative medicines based on messenger RNA (mRNA) External · CureVac collaborates with: Collaborations l Boehringer Ingelheim l Bill & Melinda Gates Foundation l Coalition for Epidemic Preparedness Innovations (CEPI) l CRISPR Therapeutics & Casebia Therapeutics l Harvard Medical School l Yale University School of Medicine l Genmab l GlaxoSmithKline (GSK) Current technology partnerships: l Acuitas Therapeutics l Arcturus Therapeutics

CureVac – revolutionising RNA for life CureVac is a global clinical-stage biopharmaceutical company in the field of messenger RNA (mRNA) technology with expertise in developing and optimising this molecule for medical purposes. The principle of CureVac’s proprietary technology is the use of mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a wide range of diseases. The company applies its technologies for the development of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases.

CureVac’s RNA technology – inspired by nature The natural molecule mRNA offers enormous potential for use as a data carrier for “healthy messages”. In the body, mRNA translates the genetic message encoded in DNA into a corresponding protein. CureVac has adapted from nature a way to utilise mRNA to communicate with the body: we add the medically desired message to synthetically produced mRNA, so that the body can read it as it does with its own mRNA and, consequently, produce the targeted protein itself.

mRNA prophylactic vaccines RNActive ® prophylactic vaccines represent a novel technology for the production of safe, efficacious, and cost-effective vaccines for infectious diseases. CureVac is currently testing both COVID-19 and rabies vaccine candidates in clinical trials. In 2019, CureVac received 34m USD from CEPI to advance the development of The RNA Printer® – a disruptive, transportable mRNA manufacturing platform that can rapidly combat diseases in outbreak situations. In 2020, the company was granted significant funding by the German Federal Ministry of Education and Research to accelerate the development of the COVID-19 vaccine and to expand production.

Furthermore, CureVac is developing vaccines against infectious diseases in collaboration with the Bill & Melinda Gates Foundation and GlaxoSmithKline.

curevac

mRNA cancer therapeutics RNActive® cancer immunotherapies mobilise the patient’s own immune system to fight tumour(s) with a specific immune response. CureVac’s products typically consist of several mRNA molecules that encode for specific tumour-associated or shared neo-antigens. In initial clinical trials, CureVac demonstrated clinical safety and activity in generating target-specific immune responses against all anti-tumour antigens.

Protein-based therapies

©picture alliance/dpa

CureVac’s technologies RNArt® and RNAntibody® are being developed as molecular therapy to trigger the body’s own production of therapeutic proteins including antibodies. This therapy can be used for protein replacement or passive immunisation. Together with the Schepens Eye Institute of Harvard Medical School, CureVac is working on mRNA-based treatment of eye indications. Furthermore, CureVac has entered into a collaboration with Yale University on mRNA-based pulmonary therapeutic candidates as well as with Genmab on mRNA-based antibody products.

mRNA manufacturing Since 2006, CureVac has been operating its own GMP facility to allow for the rapid production of all RNA drug products. Based on this standardised process, CureVac has successfully produced huge numbers of mRNA constructs. CureVac’s multi-product facility has been audited by regulatory authorities, and has received several manufacturing approvals for GMP-supply for clinical trials (PEI, FDA, Swissmedic). Currently CureVac has three GMP-certified production facilities in operation.

A further facility for industrial scale is scheduled to start operations in 2022.

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Name · Cybertron GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Number of Employees Founded (year)

· · · · · · · · · ·

Am Borsigturm 100 13507 Berlin Berlin Dr C. Rogge +49-30-8303093-50 +49-30-8303093-51 info@cybertron.berlin www.cybertron.berlin 10–50 2012

Areas of Activity · l Development of laboratory equipment l Laboratory automation l Liquid handling l Kinematic systems

Cybertron is a dynamic team of engineers, technicians, and scientists develop, produce, and distribute ISO-certified devices, modular components, and kinematic systems in the field of medical and laboratory technology as well as industrial automation. Our developments range from classic instruments for laboratory routines (e. g. dosing, dispensing, and detection units) to complex automation systems developed specifically for our customers. Each and every one of us contributes to the success of our products with our many years of experience, comprehensive technical knowledge, and corresponding core competencies.

You work in the field of diagnostics, medical technology, biotechnology, or pharmaceuticals? Then Cybertron GmbH offers you a competent, efficient, and serviceoriented environment in which medical and laboratory technology can be implemented in the shortest possible time. Together we determine the sustainable success of our company and our customers. We work together with a wide variety of research institutions, medical technology, and biotech industries as well as life science-oriented industrial companies and can rely on an important network of specialists and service providers.

MiniDevice Platform (MDP) The MiniDevice Platform is an OEM product for medical technology and laboratory automation for handling liquids and samples. The MDPs are equipped with fast, low-friction axis systems and high-end control units.

The dispensing heads can be equipped with Teflon/ steel dispensing needles (1μl, 10μl, 100μl), disposable tips suitable for automation (20μl, 50μl, 200μl, 1000μl) or dosing systems for the sub-microlitre range (>100 nl). For sample preparation of comminuted/powdered solids we also provide individually developed powder dosing heads. Depending on the application, the working deck or MDP tray can be individually configured with the desired number of 96/384/1536 MTP slots (SBS) and with various holders and adapters for deep well blocks,

cybertron

tubes (5â&#x20AC;&#x201C;50 ml), and microtubes (0.5, 1, 2 ml). For the automation process in sample preparation we offer the following options: washing stations, external pump systems, cooling/heating adapter, temp. MTP orbital shaker, Magnetic Bead Station, SPE vacuum station, etc. Optional integration of UV-VIS-, FL- detection units (bottom read), biosensor technology, microfluidics, and other analytical measuring techniques.

T-Move Sampler The compact OEM system has been specially developed for large-scale pipetting platforms, fraction collectors, and various autosampler systems. All laboratory standard tasks in the field of liquid handling can be achieved cleanly, quickly, and precisely. For example, the filling, distribution, dilution, mixing, or removal of samples and reagents in and out of microtitre plates, HPLC vials, and other vessels. The xy drive is provided by toothed belts with stationary encoder-based servomotors, and is therefore mass-optimised, which enables speeds of up to 600 mm/s. The freely programmable column Z-stroke has a 4 mm through-hole, through which the dosing device can be guided. The combination with a steel needle as the dosing device enables the optional integration of an automatic liquid level detection.

Certification Our company is certified according to DIN EN ISO 13485 and ISO 9001.

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Name · DyNAbind GmbH

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Tatzberg 47 01307 Dresden Saxony Dr Michael Thompson +49-351-7999-2921 +49-351-7999-2929 info@dynabind.com www.dynabind.com

I <10 2017 S1

Areas of Activity · Drug discovery External · l Big Pharma Collaborations l Biotech SMEs l Academic research groups Request for · l Big pharma Further Collaborations l Biotech SMEs l Academic research groups

DyNAbind is a biotechnology company based in Dresden/Germany offering drug discovery partnerships which leverage its proprietary platform of DNA-Encoded Dynamic Library technologies. Our libraries are designed with meaningful drug development in mind, offering only quality-controlled hit compounds across a massive amount of fragment and small molecule chemical space, all favourable for medicinal chemistry development. Combined with our patented suite of technologies to improve data quality, reliability, and speed of downstream analysis and triage, DyNAbind is uniquely positioned to be your partner for rapid discovery of higher-quality hits.

DNA-encoded libraries (DEL) DEL technology is a drug discovery method based on tagging molecules with unique DNA barcodes and then interrogating them in an affinity screen. In a single afternoon, up to billions of compounds can be tested against a target protein.

Library Composition DyNAbind’s full library collection was designed to provide only pharmaceutically relevant hits with physicochemical properties that provide ideal starting points for further medicinal chemistry development across both traditionally druglike and fragment chemical space.

dynabind

Path Coding Our proprietary Path-Coding system allows smart encoding and decoding of the DNA barcodes of our libraries, reducing signal-to-noise ratio and generating up to 40% more usable reads.

Binding Profiler Our unique Binding Profiler technology lets us rapidly triage hit compounds for smarter allocation of medicinal chemistry efforts. Using a customised biosensor platform, we perform a kinetic assay with the DNA-tagged compounds to reveal dissociation constants as well as on- and off-rates for the hits identified during the selection process, skipping the classical need for macroscale resynthesis of hundreds of different compounds.

Working with us DyNAbind is proud to deploy our suite of technologies to solve unmet drug discovery needs. Depending on your goals, our campaigns can go from pre-selection optimization all the way through to hit follow-up and fragment linking. With a global track record of dealmaking with pharmas, biotechs, and academic groups, we are confident in our ability to design the right project for any partner and any target.

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Name · eleva GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Number of Employees Founded (year)

· · · · · · · · · ·

Hans-Bunte-Str. 19 79108 Freiburg im Breisgau Baden-Wuerttemberg Jana Gross +49-761-470-99-0 +49-761-470-99-191 hello@elevabiologics.com www.elevabiologics.com 30 1999

Areas of Activity · Developing complex proteins, such as antibodies, enzymes, fusion toxins for clinical therapies Request for · Advancing drug candidates into the Further Collaborations clinic with pharmaceutical partners

Corporate strategy Eleva utilises its moss-based technology platform to develop complex proteins for future therapies, elevating the current level of potential molecules to greater heights. Individual drug candidates are led through the clinic and into industrial stages in partnerships with pharmaceutical companies.

The platform is based on an entire organism – moss (Bryophyta) – rather than cell cultures. It offers all the benefits of standard cell line development, but without the problems. Thanks to the advantages of this technology, the most demanding proteins can be created. They can be utilised in innovative therapies that operate on a whole new level, with the potential of fulfilling as yet unmet medical needs.

Pipeline & business model ·· We develop complex proteins into tomorrow’s drugs in partnership with pharmaceutical companies ·· We unlock the potential of difficult compounds that have so far failed to be expressed ·· We explore unusual opportunities in other promising fields We have successfully developed enzymes and other proteins into clinical stages and continue to scout for promising compounds. This results in a plethora of opportunities. Whilst our technology platform remains the property of Eleva, individual assets will be developed with pharmaceutical partners. Each of those partnerships will be taken into a newly formed subsidiary, allowing the partners to focus on the respective indication.

Our team has an extensive network in the medical field and prime experience in developing compounds all the way to the clinic.

We are looking for pharmaceutical partners to take all current and future candidates to clinical success.

eleva

BryoTechnology Tailored glycosylation Moss has no core α-1,6 fucose to begin with. Any other glycans can be modified to the desired effect, be it by knocking certain genes out or inserting the necessary transferases. No allergens mean more power. We are experts in moss glycodesign, “humanising” the molecules’ glycostructure. We have demonstrated excellent organ uptake, even in clinical studies.

Flexible genetic engineering Moss is haploid by nature and boasts its very own pair of DNA scissors. It virtually invites easy genome editing. Make any changes you like, wherever you need them: change one nucleotide or a thousand, one site or many. We don’t even need markers to check the correct modifications, just PCR. The moss production system is based on an intact organism, not artificial cell cultures. This guarantees exceptionally reliable and stable modifications.

Therapies for complement disorders Research

Preclinical

Compleva FH/CPV-101

Phase I

Phase II

(natural complement regulator)

Compleva MFHR1/CPV-102 Compleva FHL/CPV-103

(novel multi-level complement regulator)

(natural complement regulator)

Integrated fusion toxin production Moss can produce any desired toxin or toxin fusion protein. Moss cells hardly leak any toxins into the cytosol but secrete them. This is impossible in any other cells.

Enzyme replacement therapies Research

Preclinical

Repleva AGAL/ RPV-001 Repleva GAA/ RPV-002

Phase I

Pathogen-free processing The lack of animal pathogens means antibiotics are not necessary. Not only does this ensure a constant supply with no threat of contamination. It also eliminates the time and cost-consuming process of removing pathogens in the first place and ticks another box for regulatory approval.

Phase II

(glyco-improved Fabry-ERT)

(glyco-improved Pompe-ERT)

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Name · Eurofins BioPharma Product Testing Munich GmbH Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Founded (year) Type of Laboratory

· · · · · · · · · ·

Behringstraße 6–8 82152 Planegg near Munich Bavaria Dr Bettina Katterle +49-89-899-650-0 +49-89-899-650-11 info-munich@eurofins.com www.eurofins.com/pharma-services 1984 GMP/GLP Facilities

Areas of Activity · Testing services for bio-/ pharmaceutical and medical device companies External · BSL BIOSERVICE Collaborations Scientific Laboratories Munich GmbH

Global BioPharma Product Testing within your reach As the largest international network of harmonised GMP product testing labs, Eurofins BioPharma Product Testing delivers a true local service experience.

Eurofins BioPharma Product Testing offers the most complete range of testing services, harmonised quality systems, and LIMS to more than 2,000 pharmaceutical and biopharmaceutical companies worldwide.

In our world, global is local Our local presence ensures personal service backed by a unique global breadth of harmonised capabilities that support all functional areas of bio/pharmaceutical drug development and manufacturing, including method development, microbiology, process validation, and quality control.

With a global capacity of more than 150,000 square metres and 35 facilities located in Australia, Belgium, Canada, Denmark, France, Germany, India, Ireland, Italy, Japan, Netherlands, New Zealand, Spain, Sweden, Switzerland, UK, and the US, our network of GMP laboratories and vast experience allow us to support projects of any size from conception to market. Furthermore, we have teams of scientists placed at more than 70 client facilities worldwide through our award-winning Professional Scientific Services® (PSS) insourcing programme.

Experience our expertise Eurofins BioPharma Product Testing offers complete testing services for the pharma and biopharma industries, including all starting materials, process intermediates, drug substances, drug products, and manufacturing support, as well as broad technical expertise in Biochemistry, Molecular & Cell Biology, Virology, Chemistry, and Microbiology.

Our focus in Germany lies on bioassays/Biacore, microbiology, in vitro toxicology, and immuno- and bioana-

Eurofins Biopharma Product testing

lytical studies. Additionally we work in close cooperation with BSL BIOSERVICE Munich, an internationaly active contract research organisation, to assess biological safety and activity of bio-/pharmaceuticals and medical devices.

Our services at a glance ·· ·· ·· ··

Toxicology/Pharmacology/Biocompatibility Bioanalytics Immunoanalytics Bio-/Pharmaceutical Lot Release and Stability Testing (GMP) ·· Microbiology ·· Bioassays/Biacore In addition we offer the flexibility to manage your testing programmes more efficiently with a choice of three unique service models, including our award-winning Professional Scientific Services ® (PSS), Full Time Equivalent (FTE), or traditional fee-for-service. You can choose the best, most cost-effective service solution for your project goals.

International presence means global regulatory compliance Operating under the same strict quality procedures, our worldwide laboratories offer a broad range of methodologies under GMP authorisation, ISO 17025 accreditation, and ISO 9000 certification, and all analyses are performed according to European and British Pharmacopeia (EP), United States Pharmacopeia (USP), and Japanese Pharmacopeia (JP), as well as specific customer methods.

Our philosophy Our fundamental philosophy is to help clients efficiently allocate their research and manufacturing expenditures by strategically engaging with them to meet their unique outsourcing needs.

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Name · Evotec SE

Address/P.O. Box · Manfred Eigen Campus Essener Bogen 7 Code/City · 22419 Hamburg State · Hamburg Contact Person · Gabriele Hansen (SVP Head of Global Corporate Communications & Marketing) Telephone · +49-40-56081-255 Fax · +49-40-56081-222 Email Address · info@evotec.com Internet Website · www.evotec.com Social Media · L I Number of Employees · >3,300 Founded (year) · 1993 Type of Laboratory · Chemical, biological, cell culture S1, S2, S3 Areas of Activity · Partnered drug discovery and development solutions as well as proprietary R&D on a multimodality platform offering a unique set of technologies and services comprising iPSC, cell & gene therapy, PanOmics, artificial intelli-

Annual Turnover · Relevant R&D Budget · Biological Patents ·

External · Collaborations

Request for · Further Collaborations

gence, integrated biologics design, manufacturing, CMC, compound management, IND-enabling studies (INDiGO) €446.4m (2019) €37.5m (2019) A broad portfolio of patent families relating to compounds, targets, and assays.

Evotec is working with more than 700 pharma and biotech companies, notfor-profit organisations, academia, and foundations on a global basis.

Our team of business development managers are happy to discuss our R&D solutions, in- and out-licensing opportunities, and how we can assist you in meeting your drug discovery and development needs.

For more information, please contact us at info@evotec.com.

Evotec is a globally operating drug discovery alliance and development partnership company headquartered in Hamburg, Germany. The publicly listed stock corporation provides comprehensive one-stop drug discovery solutions with a large pool of highly experienced scientists, state-of-the-art technology platforms, and first-class scientific operations. The company has key therapeutic expertise in the areas of neuronal diseases, diabetes (including complications), pain and inflammation, oncology, infectious diseases, respiratory diseases, fibrosis, rare diseases, and women’s health.

Evotec aims to identify and develop first-in-class and best-in-class differentiated therapeutics for collaborators or for its own pipeline development. With sites in France, Germany, Italy, the UK, the USA, and Austria, Evotec drives research and development projects in numerous alliances and partnerships with pharma and biotech companies as well as academia and foundations. Its strategy follows a clear goal: to become the leading drug discovery solutions provider by building a partnered product pipeline based on both scientific and operational excellence.

Evotec has set out to contribute innovation efficiency to the drug discovery and development process. Building on its expertise in the field of drug discovery services, Evotec has evolved into a drug discovery engine in its own right with its two business segments: EVT Execute and EVT Innovate. Both segments operate from Evotec’s unique drug discovery and development platform, which aims to achieve multimodality by providing the right set of technologies and services for any given discovery or development project.

EVT Execute – speed, expertise, and new technologies Evotec’s drug discovery platform and development services deliver an industrialised, cutting-edge, comprehensive, and unbiased infrastructure to meet the industry’s needs for innovation in drug discovery and accelerated population of its drug development pipelines. The EVT Execute segment provides stand-alone or integrated drug

evotec

discovery and development solutions on a typical fee-forservice basis or through a variety of commercial structures including research fees, milestones, and/or royalties. EVT Execute contributes efficiency, project management, and speed to the drug discovery and development process – agnostic of therapeutic modality. The Seattle-based subsidiary Just – Evotec Biologics designs and applies innovative technologies to dramatically expand global access to biotherapeutics. Its integrated technology platform includes “J.POD®”, the biologics manufacturing facility of the future, which is currently being constructed in the Seattle area. Evotec continuously upgrades its platforms and has recently extended its offerings with a dedicated gene therapy site in Austria.

EVT Innovate – source of new pipeline entries The EVT Innovate segment focuses on building a long-term co-owned pharmaceutical pipeline. Evotec’s programmes focus on first-in-class and best-in-class projects based on innovative biology or chemistry. Through its EVT Innovate segment, Evotec builds BRIDGEs with academia, which identify and translate promising projects out of academia through access to Evotec’s industrial-scale discovery platforms and expertise. Evotec is expanding its EVT Innovate segment through equity participation in selected companies.

Paradigm shift in drug discovery To continue operating at the forefront of drug discovery and development, and to be prepared to deliver precision medicine from patient to patient, Evotec invests in technologies with game-changing potential, such as induced pluripotent stem cells (iPSCs), PanOmics data-driven approaches, as well as artificial intelligence and machine learning. The company aims to facilitate the industry’s transformation to a shared economy by providing a comprehensive, easily accessible platform across all modalities, small molecules, biologics, as well as cell & gene therapies, thus meeting the needs of the most ambitious discovery and development goals and increasing innovation efficiency.

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Name · Fassisi GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Email Address Internet Website Number of Employees Founded (year)

· · · · · · · · ·

Marie-Curie-Strasse 7 37077 Göttingen Lower Saxony Stephan Sander +49-551-5008840 info@fassisi.de www.fassisi.de 15 2006

Areas of Activity · l On-site rapid test systems with a focus on veterinary sector l Lateral-flow test systems l Manufacturing and development l OEM contract manufacturing l Contract development Request for · l Partnership for innovative Further Collaborations development of on-site rapid test systems and LFA l Partners for cooperation to establish new technologies in LFA systems l Partners to digitise LFA systems

Fassisi Fassisi GmbH is a manufacturer and developer of onsite rapid test systems, with a focus on the veterinary sector. The quality of our IVD products results from our more than 10 years of experience in the development and production of rapid test systems, especially for field applications. We also work as a contract manufacturer and realise individual OEM productions for various international partners with a high customisation level as a full service provider. Our production is “Made in Germany”. We work according to the international guidelines of GMP and we are also certified according to ISO 9001:2015.

A special focus at Fassisi is the contract development of on-site rapid test system solutions for field application, where we can bring in our entire experience in handling sample materials of various species and the detection of various parameters, such as e.g. antigens, antibodies, or hormones.

Who are we?

Fassisi GmbH is a 100% privately owned, independent company located in the middle of Germany. We were founded as a spin-off of a human diagnostics company and since 2010 we have been active as an independent company in the field of veterinary diagnostics. We work in a close network with other biotech companies, research institutes, and universities to realise even more complex developments. Our customers are international, ranging from small start-ups to internationally operating groups, among others in the fields of diagnostics, retail, agriculture, and pharmaceuticals. In addition to the supply and development of products, we support them with a tailor-made service.

What do we offer?

Fassisi IVD test kits for the veterinary sector ·· Fassisi brand “Made in Germany” ·· Production under certified quality standards ·· Technical support as part of our customer service

fassisi

OEM production and contract manufacturing ·· Customised tests and ready-packed kits ·· Production under certified quality standards “Made in Germany” ·· Technical support and training Contract development ·· Tailor-made tests and kits for special customer specific parameters ·· Many years of experience with various species and sample materials ·· Various projects already successfully brought to market

Examples of product developments The first internationally established product of Fassisi in 2008 was the Fassisi BoDia, a multi-parameter test for calf diarrhoea, which is easy to use in the barn. With this test, Fassisi was the first company to launch a multiple cassette for this field application. Further examples are i.a. the Fassisi PAG Test (bovine cow-side pregnancy rapid test as international innovation) or the Fassisi GiarDia for the detection of Giardia in dogs and cats with the help of latex particles.

Currently Fassisi is working on the establishment of new platforms for on-site rapid test systems using multiplex methods or e.g. the use of aptamers and peptide technology.

The greatest strengths of Fassisi We have many years of experience in the handling of sample materials of various species in field applications, and through numerous successful implemented projects we have built up a large knowledge base for the realisation of appropriate test systems for our customers. We work as an agile company with pragmatic problem solutions and rapid decision-making processes as well as with a focus on the pragmatic implementation of projects.

Our primary goal is to strengthen our customers, using our products to solve their problems.

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Name · FGK Clinical Research GmbH

Address/P.O. Box Postal Code/City State Contact Persons Telephone Email Addresses

· · · · · ·

Heimeranstr. 35 80339 Munich Bavaria Martin Krauss, Dr Edgar Fenzl +49-89-893-119-0 martin.krauss@fgk-cro.com edgar.fenzl@fgk-cro.com Internet Websites · www.fgk-cro.com www.fgk-pv.com www.fgk-rs.com Number of Employees · 150 Founded (year) · 2002 Areas of Activity · Full service CRO (contract research organisation) offering a complete range of clinical development and consulting services: l Regulatory Affairs l Project Management and Monitoring l Medical Safety l Data Management / Biostatistics l Medical Writing l eSolutions for Clinical Trials l Quality Assurance FGK Clinical Research has two daughter companies: “FGK Pharmacovigilance” and “FGK Representative Service”, enabling us to offer our clients pharmacovigilance services including services of QPPV and PMSF management as well as legal representation for non-European customers conducting clinical studies or seeking marketing authorisation within the EU/EEA.

Company overview FGK Clinical Research is a Europe-based CRO of an ideal size for cooperation with smaller and mid-sized biotech, pharmaceutical, or medical device companies. FGK was founded in 2002 and currently has 150 employees – most of them located in our headquarters in Munich, Germany. Covering all phases and areas of clinical development, our focus is on phase II and III trials. We have experience in all important medical indications, including in particular in oncology, cardiology, neurology, dermatology, and gastroenterology.

Broad knowledge in alternative therapies completes our expertise. Besides our services for drug development, we also help to guide all kinds of innovative medical devices through the increasingly demanding framework of clinical investigations.

Locations We directly supervise international projects and operate Europe-wide, with staff located in our headquarters in Munich, in our new branch office in Berlin, and in our subsidiaries in the Czech Republic, Hungary, and Poland. Our in-house CRAs monitor many European study sites themselves. For additional countries and sites in the US/Canada, we have suitable long-term partners.

Our approach to a project The main philosophy for FGK is to prepare and conduct studies in close cooperation with the sponsor. Thus, we not only closely interact with our clients throughout the project but long beyond it, as maintaining a good relationship forms the basis for long-term cooperation. FGK is a full-service CRO and can conduct a study from the planning to the final report and beyond. Our operational team works hand in hand with all other departments involved. Distances for internal information flows are very short since most staff is in-house and located in the Munich HQ. This also applies for the project manager, who is the central contact person delivering all required information to the sponsor. Timely approvals and efficient trouble-shooting are achieved through a combination of centralised project management and local monitoring, as well as local expertise in regulatory submissions within the country of study conduct.

fgk clinical research

Services Consulting ·· Advice for drug and device development ·· Biostatistical support Regulatory Affairs ·· Submission ·· All communication with competent authorities and ethics committees Project Management and Monitoring ·· Development of study documents ·· Study set-up and feasibility ·· Investigator meetings ·· Site management & monitoring ·· TMF handling Medical Safety ·· Adverse Event Management and assessment/reporting ·· Drug Safety, medical monitoring and adverse event coding Data Management / Biostatistics ·· CRF design ·· Data collection, review, and analysis Medical Writing ·· Generation and review of entire spectrum of regulatory documents eSolutions for Clinical Trials ·· eCRF with integrated IWRS, eTMF Quality Assurance ·· Regularly reviewed and updated set of SOPs ·· Quality system audited on a regular basis ·· Audits on behalf of sponsors ·· Assistance during inspections Since 2017, we have been participating in an independent “GCP Qualification Programme”, offering our clients the possibility to obtain an all-encompassing audit report from a third party. Visit our website www.fgk-cro.com to learn details about our complete portfolio.

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Name · FILTROX

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Address Internet Website Number of Employees Founded (year)

· · · · · · · · · ·

Moosmühlestr. 6 9001 St. Gallen Switzerland Ralph Daumke +41-71-272-9236 +41-71-272-9100 r.daumke@filtrox.ch www.filtrox.com 300 1938

Areas of Activity · Microfiltration and treatment of high value liquids, Depth filtration, Single-use cell removal, Activated carbon filter External · l ZHAW Wädenswil, Switzerland Collaborations l FH Trier, Bioverfahrenstechnik Prof. Kampeis, Germany l HES-SO, Institut of Lifetechnology, Switzerland Request for · Partners for business and product Further Collaborations development

Company profile As the global leader in depth filtration, the FILTROX Group offers complete solutions for filtration of valuable liquids by using depth filter systems. We are experts in the development, manufacturing, production and delivery of Swiss quality products for a wide range of applications in the pharmaceutical, biotechnology, chemicals and cosmetics industry. Since 1938, filter media and filter systems are developed and manufactured at our corporate headquarter in St. Gallen. Based on this experience, we offer a complete range of products and solutions.

With the FILTROX Academy we also offer filtration trainings, seminars, audits and customized trainings.

It is our pleasure, to share our expertise in the area of application and filtration technology, to optimize your processes.

The FILTROX Group has a worldwide distribution network, which provides comprehensive technical support and will help you in improving your filtration process. Our well trained sales teams provide you with on-site assistance and ensure a worldwide rapid product availability.

For more information, please visit our website.

Products FILTRODICS™ BIO SD FILTRODISC™ BIO SD is the first depth filter using the advantages of the well-established method of alluvial (cake or precoat) filtration technology in a disposable format. FILTRODISC™ BIO SD is used e.g. for singleuse cell separation, as the system is fully scalable and disposable, fulfilling all validation requirements.

Depth filter sheets and lenticular filter modules: PURAFIX® depth filter sheets have been specifically developed for the use in critical applications in the pharmaceutical or biological industries. They are characterized by their extremely low levels of ions and pyrogens.

The new PURAFIX® PF P media has been developed specifically for the high requirements of the plasma fractionation industry. With his very high stability, easy handling and efficient filtration properties it is ideal for the paste harvesting process.

filtrox

SYNTHAFIX™ filter sheets, reinforced with synthetic fibers and typically used when a very high wet strength or stability against cellulase enzymes is required.

CARBOFIL™ sheets allow the user to handle immobilized activated carbon in a much cleaner way than with loose carbon powders. It offers a lot of potential for API manufactures around the world to optimize their process.

DISCSTARTM H

CARBOFILTM

NOVOX® CPPT

Plate and frame filters and module housings: NOVOX® systems are high precision stainless steel plate and frame filters for heavy duty use. The NOVOX® CP filter is designed and built for pharmaceutical and other critical applications. The plates are available in stainless steel, polypropylene or PVDF (other materials on request). The NOVOX® CP is an enclosed filtration system completely sealed for CIP without filter sheets.

It eliminates any drip loss and prevents the liquid from having contact with the outside environment.

DISCSTAR™ is a highly precise stainless steel filter housing for filter modules for everyday use. The enclosed system allows for depth filtration to be carried out without drip loss. The new DISCSTAR™ H is the ideal housing for everyday use. With his horizontal position, this housing is much safer to operate and easier to handle due to the economic chest working height.

Locations FILTROX AG Switzerland All depth filter sheets and modules for pharmaceutical applications manufactured here.

FILTROX France s.a.r.l., Sales office FILTROX North America USA, Sales office FILTROX Latinoamerica S.A. de C.V., Sales office FILTROX (Shanghai) Filtration System Co., Ltd. China, Sales office FILTROX UK & Northern Europe UK, Sales office FILTROX Southern Europe Spain, Sales office FILTROX Asia-Pacific Pte Ltd. Singapore, Sales office FILTRODISCTM BIO SD SKID 16D

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Name · Formycon AG

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Fraunhoferstr. 15 82152 Martinsried/Planegg Bavaria Sabrina Müller +49-89-864-667-149 +49-89-864-667-110 sabrina.mueller@formycon.com www.formycon.com

Who we are Formycon is a leading and independent developer of Biosimilars Medicines.

We focus on Biosimilar Medicines in ophthalmology and immunology as well as for other key chronic diseases.

In addition, in response to the world-wide corona virus pandemic, Formycon has launched efforts to develop a new and innovative antibody-based COVID-19 drug.

LI ~120 2012

Areas of Activity · Biosimilar Development

What is a Biosimilar Medicines?

A Biosimilar Medicine is a biologic drug that is highly similar to an approved biologic drug (or reference product) that is already used to treat patients.

Biosimilars Medicines have the same quality, efficacy, and safety as their reference products.

What we do Formycon develops Biosimilars Medicines for the rapidly growing disease areas of ophthalmology and immunology as well as for other key chronic diseases and is able to cover all technical stages of the biopharmaceutical development chain from analytics and cell line development to preclinical studies and clinical trials, all the way through to the preparation and submission of regulatory approval documents.

We develop Biosimilar Medicines to meet the high standards of the world’s most stringently regulated markets: the European Union, the United States, Canada, Japan, and Australia. Formycon has signed numerous licensing agreements with renowned pharmaceutical partners.

formycon

Our expertise Our unique advantage lies in the vast expertise of our scientists, our management, and our board members.

Through their long and distinguished careers, these scientific and business professionals have already, in their past work, successfully brought the world’s first Biosimilar Medicinces to market and bring comprehensive experience and expertise spanning all stages of development – from market analysis and protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.

Based on the specialized expertise and long experience of our team, as well as our successful established track record in biosimilar development, we will continuously develop our pipeline of Biosimilar Medicines.

Medicines for the future Biosimilar Medicines are the drugs of the future. Through their proven efficacy, cost efficiency, and high standard of quality, Biosimilar Medicines are already making a major contribution towards improving patient access to essential medical treatments. Thereby Biosimilar Medicines help patients around the world and also contribute to ease the financial strains on the world’s healthcare systems.

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Name · Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Division of Pharmaceutical Biotechnology Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email

· · · · · · ·

Inhoffenstr. 7 38124 Braunschweig Lower Saxony Prof. Dr Holger Ziehr +49-531-6181-6000 +49-531-6181-6099 biopharmaceutical-services@item. fraunhofer.de Number of Employees · Institute: 384 Pharmaceutical Biotechnology: 59 Founded (year) · 1981 Type of Laboratory · S1, S2, clean rooms of grades D, C, and B Areas of Activity · Biopharmaceutical consultancy, cell line development, GMP-contract manufacture of cell banks and investigational biopharmaceuticals, bioprocess development, analytical development and bioanalytical service, aseptic fill and finish of investigational medicinal products

Company overview As a service to clients, Fraunhofer ITEM develops biopharmaceutical manufacturing processes, performs investigations into cause-and-effect processes, develops methods and concepts for disease diagnosis and therapy, and conducts preclinical and clinical studies.

All studies with drug regulatory status are performed in compliance with current GXP regulations: preclinical development is performed in compliance with GLP, clinical studies are conducted in compliance with GCP and biopharmaceutical active ingredients (APIs) and final dosage forms are manufactured in compliance with GMP requirements.

Division of pharmaceutical biotechnology The service portfolio of the Fraunhofer ITEM Division of Pharmaceutical Biotechnology covers the development of manufacturing processes for biopharmaceutical APIs such as proteins, antibodies and nucleic acids, as well as manufacture of technical batches for preclinical research. Additionally, the division transforms API manufacturing processes into compliance with current Good Manufacturing Practice (GMP) requirements. For its pharmaceutical clients the division performs pilotmanufacture of APIs and sterile investigational medicinal products (IMPs) for use in early-phase clinical trials.

Annual Turnover · €31 million (2019) Request for · l C ollaborations concerning GMP Further Collaborations manufacture of biological active pharmaceutical ingredients for clinical trials and analytical development l Manufacture of investigational medicinal products

The division has been licensed since 1997. They are equipped with stirred-tank bioreactors of up to 400 litres volume, with process scale chromatography systems and process filtration systems, enabling GMP-compliant manufacture of investigational biopharmaceutical APIs in 0.5–200 gramme quantities. Process equipment is located in grade-D, grade-C, and grade-B clean rooms that have been EU-licensed by the regulatory agencies but meet US regulatory standards (FDA) as well.

Fraunhofer ITEM

Core elements of the GMP clean-room facilities are clean-room grade-B (class-1000) suites housing laminar flow hoods that represent class-100 work environments (clean-room grade A) for manual aseptic fill and finish operations or as restricted-access barrier system (RABS) equipped with an automatic filling line for vials and ampoules of volumes between 1 and 20 millilitres and batch sizes up to 9000 units.

Services ·· D evelopment of cell lines based on insect cells, CHOcell lines and microorganisms (e.g. E. coli) for manufacture of biopharmaceutical APIs ·· GMP manufacture of master and working cell banks ·· N2 gas-phase storage and shipment of cell banks ·· D evelopment of manufacturing processes for biopharmaceutical active ingredients such as proteins, glycoproteins/antibodies, nucleic acids/plasmids, virus-like particles, and bacteriophages ·· Validation of cultivation (USP) and purification (DSP) unit operations and complete processes ·· Development and validation (ICHQ2) of bioanalytical methods ·· ICH stability testing of drug substances and IMPs ·· N on-GMP and GMP contract manufacture of biopharmaceutical active ingredients ·· Aseptic manufacture of final dosage forms as IMPs for clinical trials ·· GCP

labelling and release of IMPs for clinical trials

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Name · GEMoaB GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address

· · · · · · ·

Internet Website Number of Employees Founded (year) Type of Laboratory

· · · ·

Tatzberg 47 01307 Dresden Saxony Michael Pehl, Jana Fiebiger +49-351-4466450-12 +49-351-4466450-99 m.pehl@gemoab.com; j.fiebiger@gemoab.com www.gemoab.com 56 2011 Biotec

Areas of Activity · Immunotherapy, oncology

Company overview GEMoaB, a privately owned clinical-stage biopharmaceutical company based in Dresden, Germany, is working on next-generation immunotherapies to treat cancer patients with high unmet medical needs.

GEMoaB was formed in 2011 and today has a deep pipeline of immunotherapies, three of which are being trialled in a range of cancer indications, and a significant number of preclinical candidates for solid tumours and hematological malignancies. GEMoaB’s immunotherapies are built around three proprietary platforms: two based on chimeric antigen receptor T cells (CAR-T cells) named UniCAR and RevCAR, and another employing GEMoaB’s Affinity-Tailored Adaptors for T cells (ATACs), all of which promise to offer significant advantages over existing immunotherapies.

Proprietary immunotherapy platforms UniCAR is a universal CAR-T platform that can be rapidly turned on and off with a switch consisting of two components. The first is a genetically modified T cell with a chimeric antigen receptor that by itself does not recognise tumour antigens and is therefore not directly activated by them. The second component is a targeting module (TM), a soluble adaptor that comprises a motif recognised by the UniCAR receptor and a highly flexible antigen-binding moiety directed against a cancer antigen.

TMs efficiently penetrate and accumulate in bone marrow and solid tumour tissue. When TMs simultaneously bind to the UniCAR receptor and the target antigen on a cancer cell, the UniCAR effector T cells become activated and expanded, and then lyse the cancer cells.

Crucially, TMs have a short half-life and are rapidly internalised, so UniCAR cells rapidly revert to an “off” state in less than 4 hours, which avoids acute and long-term toxicity usually associated with continuous activation of CAR-T cells.

RevCAR, GEMoaB’s second cellular immunotherapy platform, is similar to UniCAR in featuring a rapid switch system, but with a different design. Whereas

gemoab

the UniCAR receptor consists of an scFV domain that binds to a TM, RevCAR employs a CAR with an inert peptide attached.

GEMoaBâ&#x20AC;&#x2122;s ATACs are fully humanised bi-specific antibodies that combine a domain with high affinity for tumour antigens with a domain that binds with lower affinity to the CD3 antigen on effector T cells. In preclinical models, ATACs, were shown to activate effector cells without T cell auto-activation, promising a best-in-class safety profile.

Clinical progress UniCAR-T-CD123, GEMoaBâ&#x20AC;&#x2122;s lead asset based on the UniCAR platform, is directed against the CD123 antigen and is being developed for the treatment of relapsed/ refractory AML. UniCAR-T-CD123 is currently being investigated in a phase I study. GEMoaB is also developing UniCAR-T-PSMA, which targets prostate-specific membrane antigen (PSMA) for the treatment of several PSMA-expressing advanced solid tumours. A phase I trial of UniCAR-T-PSMA is planned to begin enrolment in the second half of 2020.

In addition, two ATAC assets are currently in clinical trials: GEM333, which binds to the CD33 cancer antigen, is in a phase I study for the treatment of CD33-positive rrAML; and GEM3PSCA, which binds to the prostate stem cell antigen (PSCA), is being tested in a phase I study for a range of PSCA-expressing metastatic solid cancer indications. Both GEM333 and GEM3PSCA are being developed under a global partnership agreement with Bristol Myers Squibb.

GEMoaB: next-generation immunotherapies for hardto-treat cancers

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Name · Glycotope GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Number of Employees Founded (year)

· · · · · · · · · ·

Robert-Roessle-Str. 10 13125 Berlin Berlin Henner Kollenberg +49-30-9489-2600 +49-30-9489-2630 contact@glycotope.com www.glycotope.com ~50 2000

Areas of Activity · l Immuno-oncology l Oncology

Glycotope – Driving Medical Innovation Glycotope is a clinical stage biotechnology company applying world-leading glyco-biology expertise to develop highly innovative mAb-based therapeutics in immuno-oncology and oncology.

The Company’s GlycoBodies target specific glycoepitopes to generate first-in-class products including bi-specifics and conventional antibodies. Glycotope’s technology provides a platform for the development of additional clinical and pre-clinical programmes with an array of modes of action, providing a unique and cluster-risk free offering in the immuno-oncology and oncology space.

Immuno-oncology or cancer immunotherapy is completely different from untargeted chemotherapy or “classic” tumour-targeting cytotoxic antibodies. It targets the problem, that cancer cells utilise clever mechanisms to protect themselves from the immune system by pretending to be normal cells that must be protected, e.g. by inhibiting immune cells from recognition and attack. Immunomodulatory iOnc drugs, e.g. checkpoint antibodies, T-cell engagers, or immuno-cytokines, aim to re-enable the patient’s immune system to recognise and attack the tumour. We are applying our unique glyco-biology expertise to further improve this therapeutic field, e.g. by applying different iOnc approaches to a new class of highly specific antibodies (“GlycoBodies”).

GlycoBodies Glycosylation plays an important role in oncology and is therefore intensively addressed in immunotherapy. Glycans are involved in different steps of tumour progression, e.g. tumour cell proliferation, invasiveness, metastasis, and angiogenesis. Cancer cells show altered glycosylation patterns, which emphasises glycans as interesting therapeutic targets that can be addressed by a new class of highly specific antibodies, our so-called “GlycoBodies”, applicable to a wide range of cancers.

glycotope

GlycoTargets are broadly expressed on tumours of different origin including cancer stem cells & metastases but are virtually absent from normal cells. They typically have an important biological function in tumour development and progression. Targeting by GlycoBodies provides the advantages of broad indication range, long-term treatment potential, and reduced on-target/off tumour toxicities, which is key for highly potent therapies. Thereby GlycoBodies are highly suitable for a multi-function platform approach with independent MoAs to provide a tailored therapy format for as many patients as possible.

Schematic illustration of the TA-MUC1 carbohydrate-protein mix epitope

The pioneer of this concept is our lead antibody Gatipotuzumab (historically PankoMab-GEX®), which is being developed as a naked antibody in a combination trial with anti-EGFR antibodies (GATTO), as ADC (worldwide licensing agreement with Daiichi Sankyo), as well as in multiple additional formats including immuno-modulatory bi-specifics, e.g. our TA-MUC1 targeted T-cell engager and immuno-cytokine in preclinical development.

Using our unique know-how in GlycoTarget identification and GlycoBody generation in combination with our proven track record in pre-clinical and clinical platform exploitation, we address additional high-potential glycoepitope targets using novel GlycoBodies.

With Glycotope’s platform technology and our experienced team, we believe our promising pipeline will deliver more effective treatments to improve outcomes for patients.

Carbohydrate part: Human tumour-specific carbohydrate epitopes Tn (GalNAα1-O-) or TF (Galβ1-3GalNAcα1-O-) on Thr of PDTRP-sequence of tandem repeats

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Name · glyXera GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Founded (year) Type of Laboratory

· · · · · · · · · ·

Brenneckestraße 20 – ZENIT 39120 Magdeburg Saxony-Anhalt Dr Erdmann Rapp (CEO & CSO) +49-391-6117-251 +49-391-6117-255 info@glyxera.com www.glyxera.com 2011 | Glycomics | Glycoproteomics | Proteomics

Areas of Activity · High Performance Glycoanalytical & (Glyco)Proteinanalytical Services & Products

glyXera GmbH is a Max Planck Society spin-off, specialised in high performance glycoanalysis. We are utilising separation- and mass-spectrometry-based glycoanalytical tools and have substantial experience in providing glycoanalytical products & services tailored to the specific needs of our customers. Worldwide exclusively glyXera provides the high-performance glycoanalysis system glyXboxTM. Our clients include leading pharmaceutical, biotechnology and food companies throughout the world. We offer you our sophisticated technology platforms and our expertise with respect to glycoanalytical services, tailored to your specific needs. We guide you for better decisions and help you to perform better and faster during discovery phase, R&D, (clinical) trials and approval of your innovative products (biopharmaceuticals (originators & biosimilars), vaccines, food additives, functional food, etc.), and QA/QC in your production stages.

Expertise & pace glyXera GmbH is specialised in glycoanalysis, utilising state-of-the-art separation- and mass-spectrometrybased glycoanalytical tools and has a strong background in providing glycoanalytical services. We run modern analytical and synthesis labs, equipped with state-of-the-art instrumentation. glyXera offers high performance glycoanalysis to its clients, providing sophisticated technology platforms and expertise with respect to glycoanalytical services, tailored to the specific needs of the variety of its customers from academia, clinics, pharmaceutical and food industries.

We have substantial experience in glycomics, glycoproteomics and proteomics of biotechnological (e.g. recombinant glycoproteins (mAbs, fusion proteins, factors, hormones, etc) or viral membrane glycoproteins) and clinical (blood, milk and other body fluids) samples.

High-performance glycoanalysis glyXera provides exclusively worldwide fast and reliable glycoanalysis utilising a “real” high-throughput system (method/software/database) with superior performance and capacity compared to other glycoanalysis tools available on the market.

Glyxera

Our patented system glyXboxTM, based on multiplexed capillary gelelectrophoresis with laser induced fluorescence detection (xCGE-LIF) enables generation and comparison of glyco-fingerprints from large sets of samples and structural analysis of glycans within these samples.

High throughput, high resolution, high sensitivity, high reproducibility, high reliability: ·· Up to 96 capillaries in parallel enable “real” high throughput ·· Up to 3500x more sensitive and 450x faster, compared to LC ·· An order of magnitude higher separation power, compared to LC High-performance glycoanalysis on 3 levels: ·· Glycofingerprinting: Glycosylationpattern analysis & comparison ·· Standard Glycoprofiling: Identification of glycans in complex mixtures via database matching ·· Extended Glycoprofiling: Extended structural analysis of glycans in complex mixtures using exoglycosidase sequencing in combination with repeated glycoprofiling.

Our services ·· Glycofingerprinting & Glycoprofiling by xCGE-LIF & HILIC-FLR ·· MALDI-MS based Glycoprofiling ·· LC-MS based profiling of N- and/or O-glycans ·· Monosaccharide (Composition) Analysis ·· Site Occupancy Analysis ·· Proteomics ·· N- & O-Glycopeptide Mapping ·· Intact Mass Protein Analysis (Glycoform Determination) ·· General (Glyco)-Protein Characterisation by Protein Gel Electrophoresis Pattern Analysis

Our products ·· glyXboxCE: High performance glycoanalysis system based on xCGE-LIF (incl. glyXtoolCE software) ·· glyXboxLC: Standard glycoanalysis system based on HILIC-FLR (incl. glyXtoolLC software) ·· Tailored standards & kits for glycoanalysis 22 nd Guide to german biotech companies 2021

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Name · HS Diagnomics GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · ·

Schlossstrasse 110 12163 Berlin Berlin Dr Steffen Hennig +49-30-70014-5330 +49-30-54611-698 hennig@hsdiagnomics.de www.hsdiagnomics.de 6 2012 Molecular Biology Lab

Areas of Activity · l Cancer immunology l T cell profiling l Immune system l Tumour-reactive T-cells Biological Patents · EP2746405 ‘Methods and primer sets for high throughput PCR sequencing’ EP3180433 ‘Method for providing tumour-specific T-cells’ External · l Vivantes Clinics Berlin Collaborations l Charité Berlin l UMC Mainz l University Hospital Kiel Request for · l Pharmacompanies R&D Further Collaborations l Immunotherapies

Background T-cells are among the most promising candidates for novel and effective therapies against cancer. Deep knowledge about the T-cell receptor repertoire of an individual patient is essential for finding the best therapy.

With its patented TCRsafe method, HSDiagnomics delivers ultra-deep sequence profiles of T-cell receptors from blood and tissue samples within days – a key to unraveling the details of adaptive immune responses to disease and treatment conditions. We are partners with pharma industries in contract research projects.

HS Diagnomics is a Berlin-based company founded in 2012. We are specialists in T-cell receptor profiling by ultra-deep sequencing. With our proprietary technology, tested and optimised in hundreds of samples, we can display the T-cell beta repertoire in blood and tissue samples at maximal resolution, up to the single cell level and up to every single nucleotide and translated peptide of the TCR. Within days our customers will receive an atomic view of TCRbeta profiles, a key to understanding of the adaptive immune system. Moreover, our TCRsafe procedure allows the simultaneous analysis of cohorts of samples, with detailed overlap analysis – a cuttingedge tool for systematic studies of the adaptive immune system.

Our mission and our offer to the market is a robust and integrated service to explore TCRbeta profiles in yet unprecedented resolution. Our customers send us the samples, the rest of the procedure is with us. Our experienced team of molecular biologists, technicians, and bioinformaticians will deliver TCRbeta profiles comprising thousands of clonotypes, which are characterised base by base in their CDR3 regions. All results are displayed in compact tables which can be easily managed by customers.

hs diagnomics

The T-cell first contacts the tumour antigen via its TCR. Only if it fits the T-cell will destroy the tumor cell.

With TCRsafe we sequence hundreds of thousands of T-cell receptors in parallel by nothing but genomic T-cell DNA.

Our patented technologies 1. TCRsafe is based on a multistep PCR-amplification with proprietary primer systems, which amplify TCRbetaspecific regions directly from genomic DNA. With an inbuilt 2-fold contamination protection our TCRsafe protocol is superior to other technologies, since it eliminates spurious intake of alien samples very efficiently. Following state-of-the-art deep-sequencing HSDiagnomics uses in-house developed bioinformatics tools to condense millions of raw sequence reads into clusters (clonotypes).

2. In contract research projects we employ our patented method to identify tumour-specific T-cells from tumour samples â&#x20AC;&#x201C; without knowledge of tumour antigens. The method has been tested in lung and colon cancers successfully. Tumour-specific T-cells are ideal starting points for identification of tumour antigens or development of cellular tumour therapies. Our sister company TheryCell is developing T-cell based cancer therapies based on this technology.

The T-cell with its hundreds of receptors on the surface.

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Name · IBA GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Rudolf-Wissell-Str. 28 37079 Göttingen Lower Saxony Dr Mike Rothe +49-551-50672-0 +49-551-50672-181 info@iba-lifesciences.com www.iba-lifesciences.com

FL I  ~50 1996 S1

Areas of Activity · l Cell Selection & Expansion l Protein Production & Assays Biological Patents · l Strep-Tactin®XT l Twin-Strep-tag® l Streptamer ® External · Numerous in- and out-licensing Collaborations contracts

High performance research tools for cell and protein isolation IBA GmbH is a biotechnology company providing products for life science research in academia and industry. We develop high performance research tools for cell and protein isolation based on our proprietary Strep-tag® technology. Headquartered in Göttingen, Germany, we have built a network of worldwide distributors, making our products available in over 40 countries across 5 continents.

Strep-tag® technology The Strep-tag® technology exploits on one of the strongest non-covalent interactions in nature: the interaction of biotin and streptavidin. Strep-tag® II and its tandem equivalent Twin-Strep-tag ® are peptide sequences exhibiting intrinsic affinity towards the biotin-binding pocket of two specifically engineered streptavidin variants, Strep-Tactin® and its high affinity version StrepTactin®XT. The range of selectable affinities as well as the reversibility of the binding interaction makes the Strep-tag® system a universal tool for isolation of proteins, cells, and exosomes.

Strep-tag® technology in protein purification and analysis The Strep-tag® system enables cloning, expression, detection, purification, and immobilisation of recombinant proteins. The highly specific interaction of the Strep-tag® with Strep-Tactin® ensures efficient one-step purification of the protein of interest and isolation of Strep-tagged targets even from crude cell lysate in unparalleled purity.

The mild and physiological conditions promote the yield of fully functional proteins, making the system particularly suitable for purification of enzymes as well as structural investigations, protein-protein interaction studies, ligand-receptor investigations, or even separation of living cells for re-culturing processes. The Strep-tag ® technology is compatible with a large number of protein classes, e.g. metalloproteins, membrane proteins, and fragile protein complexes with multiple subunits. Simultaneously, a high tolerance towards different buffers and additives promotes its universal applicability. The

iba

near covalent affinity (pM range) of Twin-Strep-tag® to Strep-Tactin®XT expands the range of applications of the Strep-tag® system towards protein analysis e. g. SPR analysis or bio-layer interferometry (BLI).

Strep-tag® technology for cell isolation, expansion and staining Our Strep-tag® technology is also applicable to various cellular research approaches. Cell isolations should aim at keeping the cells in their natural state. Due to the reversible binding properties of the Strep-tag® technology, it is an ideal tool to capture and release cells with minimal impact. The technology is applicable to selecting cells by their surface markers or by their antigen-specificity.

The selection reagents bind loosely to the cells and are therefore easily removable. This principle is very similar between our Fab-TACS ®, Fab-Streptamer ® and MHC I-Streptamer ® approaches, covering different stages in cell research from cell isolation to cell expansion and cell staining.

For different analyses and further experiments it is necessary to expand cells in numbers. Our CD3/CD28 Streptamer ® approach addresses this requirement and offers full removability from the cells after initial activation and stimulation. All Strep-tag® products available for cell research aim at preserving the authentic properties, full effector function as well as viability of the target cells.

Strep-tag® technology for exosome isolation The Strep-tag® technology is also applicable for isolation of exosomes. Targeting exosomes surface markers with low affinity Fab fragments allows quick, simple, and highly pure isolation of these small particles from different sources such as cell culture media, serum, or plasma.

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Name · IDT Biologika

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Am Pharmapark 06861 Dessau-Rosslau Saxony-Anhalt Antje Seidler +49-34901-8850 +49-34901-885-5313 info@idt-biologika.com www.idt-biologika.com

FL I  1,400 1921

Areas of Activity · Contract Development and Manufacturing of Live Viral Vaccines and Viral Vectors Annual Turnover · €221m (2019)

About IDT Biologika IDT Biologika is a global biopharmaceutical contract development and manufacturing organisation (CDMO) that specialises in the production of innovative live viral vaccines, viral vectors for gene and immune therapeutics, as well as fill/finish of sterile liquid and lyophilised biologics to improve human health worldwide. The family-run company of the Klocke Group combines an almost 100-year-old tradition in vaccine research and production with maximum expertise and state-of-theart technology.

Our services We offer clients in B2B business a single source CDMO partner at our sites in Germany and the USA, with seamless end-to-end solutions and the ability to nimbly scale projects from development through to commercialisation. This includes process development, API production, Fill&Finish, secondary packaging, quality control/analytics, and storage. IDT Biologika handles every step in the manufacturing and packaging of small clinical batches as well as of products on a large commercial scale.

Our sites At its headquarters in Germany, IDT Biologika operates one of Europe’s premiere integrated facilities for end-toend services from process development through clinical phases I–III to commercial contract manufacturing. In Rockville, MA, USA we utilise broad capabilities and a depth of technologies for process development and manufacturing of clinical trial material for phases I–II. On request of our clients we supply their products in vials, pre-filled syringes (with and without safety devices), autoinjectors, or as combination products.

idt biologika

Our expertise Our fully integrated services are underscored by our commitment to quality and operational excellence that flows through our best-in-class process and cGMP (up to BSL2) manufacturing capabilities, meeting FDA, EMA and ANVISA standards.

Many human vaccines developed by IDT Biologika, together with international partners, are already in use, fighting infectious diseases such as tuberculosis, AIDS, malaria, cancer, dengue, and ebola.

Particularly noteworthy recent collaborations include with the Biomedical Advanced Research and Development Authority (BARDA), an office of the U.S. Department of Health and Human Services, the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services, and the Coalition for Epidemic Preparedness Innovations (CEPI).

Shortly after the outbreak of the corona epidemic, IDT Biologika started collaboration with the German Center for Infection Research (DZIF) and the universities of Munich and Marburg for the development of a SARSCoV-2 vector vaccine.

Our most important assets are our employees, whose expertise and collaborative nature complement our innovative technologies, resulting in high-quality customer service and satisfaction.

Š all pictures by IDT Biologika/Hartmut BÜsener

Please contact us for further information.

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Name · Immunic Therapeutics

Address/P.O. Box Postal Code/City State Contact Person

· · · ·

Lochhamer Schlag 21 82166 Gräfelfing Bavaria Jessica Breu (Head of IR and Communications) Telephone · +49-89-2080477-61 Email Address · info@imux.com Internet Website · www.imux.com Social Media · FL I Number of Employees · 25 Founded (year) · 2016 Areas of Activity · l Immunology l Chronic inflammatory and autoimmune diseases External · l Daiichi Sankyo: in November 2018, Collaborations the Japanese pharma company granted Immunic the exclusive global rights to IMU-856 through a global option and licence agreement. l Japanese pharma company, University of Kyoto, quattro research: in support of the InnoMuNiCH project, funded by the German Ministry of Education and Research, Immunic together with its partners initiated a three-year research project running from August 2019 to July 2022.

Immunic is a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, including relapsing-remitting multiple sclerosis, ulcerative colitis, Crohn’s disease, and psoriasis. The company’s development pipeline consists of three small molecule products: IMU-838 is a selective immune modulator that inhibits the intracellular metabolism of hyperactivated immune cells by blocking the enzyme DHODH; IMU-935 is an inverse agonist of the transcription factor RORγt; and IMU-856 targets the restoration of intestinal barrier function by inhibiting a new and yet undisclosed target. In November 2018, Japanese pharma company Daiichi Sankyo granted Immunic an exclusive global license to IMU-856 and related molecules.

Lead programme IMU-838 Immunic’s lead development programme, IMU-838, is an orally available, next-generation selective immune modulator that inhibits the intracellular metabolism of hyperactivated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH). IMU-838 acts on activated T and B cells while leaving other immune cells largely unaffected and allows the immune system to stay functioning, e.g. in fighting infections. In previous trials, IMU-838 did not show an increased rate of infections compared to a placebo. In addition, DHODH inhibitors such as IMU-838 are known to possess a direct antiviral effect, which is independent of specific virus proteins and their structure. Therefore, DHODH inhibition may be broadly applicable against multiple viruses.

IMU-838 was successfully tested in two phase 1 clinical trials in 2017 and is currently being tested in phase 2 clinical trials in patients with ulcerative colitis and COVID-19. Immunic reported strong results from its phase 2 trial of IMU-838 in relapsing-remitting multiple sclerosis, achieving both primary and key secondary endpoints with high statistical significance, in August 2020. Furthermore, Immunic’s collaboration partner, Mayo Clinic, has started an investigator-sponsored proof-of-concept clinical trial testing IMU-838 activity in patients with primary sclerosing cholangitis (PSC).

immunic therapeutics

Phase 1 programmes of IMU-935 and IMU-856 IMU-935 is a highly potent and selective inverse agonist of RORγt with additional activity on DHODH. The nuclear receptor RORγt is believed to be the main driver for the differentiation of Th17 cells and the expression of cytokines involved in various inflammatory and autoimmune diseases. This target is believed to be an attractive alternative to approved antibodies for targets such as IL-23, IL-17 receptor and IL-17, itself. IMU-935 is currently in a phase 1 single and multiple ascending dose trial in healthy volunteers. Immunic plans to extend these studies to assess safety and mechanism-related biomarkers in patients with psoriasis.

IMU-856 is an orally available, small molecule modulator that targets a yet undisclosed protein. Based on preclinical data, Immunic believes this compound appears to represent a novel and potentially paradigm-shifting treatment approach, as the mechanism of action targets the restoration of the intestinal barrier function. A phase 1 trial is currently ongoing. The single and multiple ascending dose parts in healthy volunteers are planned to be followed by a third part in patients with IBS-D, UC and CD.

From inception to Nasdaq in only 3 years Immunic AG was founded in 2016 with headquarters in Planegg-Martinsried, Germany. Since April 2019, the company has been operating under the name Immunic, Inc. with its registered office in the United States and has been trading on the Nasdaq Stock Market under the ticker symbol “IMUX”. The listing followed a reverse takeover transaction with US-based Vital Therapies, Inc.. The company’s research and development activities continue to be conducted in Germany.

Concurrently with the closing of the reverse takeover, Immunic raised EUR 26.7 million from existing investors.

Contrary to the general market trend, the company successfully raised about USD 150 million in three followon offerings in 2020, which extended the cash reach substantially and will cover all upcoming milestones. In September 2016, Immunic completed a series A financing round of EUR 31.7 million.

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Name · in.vent Diagnostica GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Emails

· · · · · · ·

Neuendorfstraße 17 16761 Hennigsdorf Brandenburg Dr Jörg-M. Hollidt +49-3302-55199-0 +49-3302-55199-999 info@inventdiagnostica.de jm.hollidt@inventdiagnostica.de Website · www.inventdiagnostica.de Number of Employees · 51 Founded (year) · 1999 Areas of Activity · l Supply of Human Bio-Materials l Performance Evaluation Studies according to IVDR 2017/746 l Standards & Controls l Enhanced Biobanking l Biomarker Screening External · in.vent maintains contact to more than Collaborations 350 international IVD-, pharma- and biotech- companies and organisations on a global basis.

Company profile We are proud to be one of the world’s leading suppliers of Human Bio-Materials and Bioanalytics for Development of IVDs. Our products are intended for non-therapeutical use and are applicable for research, development, production, quality control, and marketing purposes in pharmaceutical companies as well as in in vitro diagnostic companies. The company was founded 1999 and located in Hennigsdorf, nearby Berlin. With our highly qualified and well trained team we guarantee excellent quality, ethically impeccable conduct of all our operations, and highest customer satisfaction.

Core competences ICS – in.vent Clinical Services ICS is the newest expansion of in.vent’s service portfolio. We offer a one-stop service covering every step of IVDR-compliant IVD development, from Performance Evaluation all the way to Post-Market Surveillance.

Analytical & Clinical Performance Studies Ethical & Legal Considerations Sample Procurement | Study Protocols Data Management | Reports Post-Market Performance Follow-Up All according to IVDR 2017/746. in.vent Study Site in.vent ICS runs an own study site in Hennigsdorf, nearby Berlin. Our fully equipped Study Site allows donations of all kinds. Depending on customer’s projects, we recruit for both healthy and diseased donors according to your specifications: ·· Processing specifications (e.g. time, speed) ·· Blood Drawing Specifications (e.g. circadian rhythm, food intake, blood drawing systems) ·· Donor Specification (e.g. BMI, gender, age) Standards and Controls pre-manufactured | individually produced lyophilised | fresh frozen native | spiked | depleted kit-internal controls | kit-external controls routine laboratory surveillance applicable for proficiency testing

in.vent diagnostica

Enhanced Biobanking ·· project-focused procurement of Human Bio-Material Samples ·· all kind of quality, numbers and volumes of samples single donations | consecutive donations panels | pools throughout the whole value chain of IVDs.

Dr Jörg-M. Hollidt Founder & CEO

Human Bio-Materials – Disease State and Normal Whole Blood | Blood Products Sera | Plasma | Other Matrices Human Tissues Faeces | Lavage Fluids | Swabs Single Donations | Consecutive Donations Sample Collections | Cohorts Bulks | Pools Small Volumes | Large Volumes | Very Large Volumes Autoimmunity | Allergy | Infectious Diseases Alcohol Abuse | Liver Diseases | Hormones Oncology | and more Biomarker Screening Cooperation with engine GmbH ·· Customised Arrays | Antibody Validation ·· Biomarker Discovery | Screening Procedure

Quality management system in.vent has established and operates an quality management system according to the standards of ISO 9001 and ISO 13485 from the very beginning. Numerous audits performed and certified by official auditing organisations and as well by our customers followed up by consequent staff training led to a deep understanding and exceptional performance of our quality system.

Strategic outlook in.vent is already one of the major affiliates in the field of Human Bio-Materials. We are constantly adopting to market needs and to front end techniques in biobanking, sample storage and biomarker.

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Name · INCYTO

®

About our company

GmbH

INCYTO ® GmbH is a privately financed company which automises and optimises cell-based assays by combining precise sensorics for key cellular parameters with subsequent attuned actuator technology.

Address/P.O. Box Postal Code/City State Contact Person Telephone Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · ·

Am Klopferspitz 19a 82152 Planegg/Martinsried (Munich) Bavaria Dr Martin Strehle +49-89-203-241-42-71 info@incyton.com www.incyton.com

INCYTO ® sees the cell as a whole functional unit that can be understood by considering key global parameters. Our multi-sensor systems monitor different key parameters simultaneously, in real time and labelfree. Thanks to our technology every event is recorded, giving the user full control at every time-point without being constantly present. A high automation of the whole testing process dramatically reduces the time the customer must personally spend to carry out even the most complex assays. All this without affecting the quality of the research results.

I 7 2018

Areas of Activity · l Lab equipment l Cell-based assays l Toxicology l Metabolic research l Oncology l Drug screening l Basic cellular research l Hypoxia research

Also, INCYTO ® smart technology is combined in one housing, creating a global environmental control (humidity, temperature, gas atmosphere) for all processes and reducing variations due to human influence. Having an incubator together with the measuring devices and treatment station reduces the risk of contamination and increases safety for lab workers who deal with dangerous substances and pathogens. Thus, the results of your assays will be more reliable and accurate.

External · l Helmholtz Zentrum München Collaborations l LMU l TUM l HP Medizintechnik GmbH Request for · Pharmaceutical cooperation: INCYTO Further Collaborations is eager to support research projects in a wide range of applications in the field of cellular research

®

Our mission We at INCYTO ® constantly strive for new horizons in the field of cell-based analysis. Experience and innovation help us to continuously increase the achievable information content in each experiment.

Customers and employees are our top priority. By working together, and through the development of suitable measuring systems and software solutions, we aim for a comprehensive and complete understanding of global cellular reactions. Thus, we focus on label-free in vitro monitoring with microfluidic flow and fully controllable ambient conditions.

incyto

We engage in future-oriented research through our entirely “made in Germany” solutions. Thanks to the smart combination of actuators and life-science sensor technology, we increase the efficiency of our customer’s experiments. Our intent is to improve the prediction of the effects of active substances, drugs, and drug candidates in various cell lines already in the less cost-intensive preclinical phase as well as in regulatory validation studies.

Our products INCYTO ’s CYRIS® analyser platforms perform automated assays with multiple real-time data acquisition in research areas such as drug discovery and screening, oncology, toxicology, and mitochondrial profiling. With CYRIS® platforms a researcher can measure dissolved oxygen, cellular oxygen consumption rate (OCR), pH, extracellular acidification rate (ECAR), and morphological parameters by cellular impedance (magnitude and phase) and fully automated microscopic imaging.

INCYTO ’s technology can currently be used by university laboratories and pharmaceutical companies.

Moreover, an application in the field of personalised medicine will soon be developed.

Additional services Our devices and laboratories are also available for rent for short research projects: the perfect solution, for example, for PhD and post-doc researchers who can use our facilities, instruments, and consumables, while benefitting from the advice and supervision of our scientific staff.

We also offer collaboration with pharmaceutical companies and contract research organisations conducting research in preclinical phases as well as validation studies prior to regulatory investigations.

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Name · Indivumed GmbH

Address/P.O. Box Postal Code/City State Contact Persons Telephone Fax Email Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · · ·

Falkenried 88 – Bldg. D 20251 Hamburg Hamburg Prof. Dr med Hartmut Juhl (CEO) +49-40-4133-83-0 +49-40-4133-83-14 info@indivumed.com www.indivumed.com

LI >200 2002 L2, S1 Service and partnering in the field of personalized cancer medicine; international standardisation of tissue, blood and clinical data collection in >50 cancer clinics in Europe, NorthAmerica and Asia; multiomics analysis of cancer tissue combining WGS with proteomics, phosphoproteomics, and immunophenotyping; Data analysis using bioinformatics, artificial

intelligence, and other tools. Various kinds of laboratory services for target and biomarker development Biological Patents · INDIVUMED has been granted several patents relating to cancer biomarkers.

External · INDIVUMED has developed a unique Collaborations collaborative network with leading cancer clinics in Europe, Asia, Northand South America, as well as with biopharmaceutical companies and academic institutions worldwide, including the Salk Institute, Georgetown University, University of Rochester Medical Center in the US, and the Astar Institute for Molecular and Cell Biology in Singapore.

Request for · INDIVUMED intends to enter into Further Collaborations strategic collaborations with industry partners for the joint development of cancer diagnostics and therapeutics.

Company overview Indivumed, founded in 2002, is one of the first companies in the field of personalised cancer therapy focused on the phenoytypic characterisation of cancer in individual patients. A major challenge for researchers is that cancer cells change expression profiles such as RNA, proteins, and phosphoproteins within minutes when tissue is removed from the body.

As a physician-led company with a deep understanding of the clinical environment and challenges involved implementing science-guided structures, Indivumed has resolutely addressed this problem. Since 2002, Indivumed has developed and implemented >130 SOPs in a collaborative network of more than 50 cancer clinics in Europe, North America, and Asia. Indivumed guarantees identical collection and processing standards for tissue and clinical data from all kinds of solid tumours from tens of thousands of patients annually. There are no variances in biospecimen quality and clinical data regardless of the hospital and region where patients are treated.

Besides this unique resource for R&D, Indivumed is collaborating with pathology institutes worldwide to obain “Routine Pathology Samples” representing tissue and data used for routine diagnostics nowadays. This resource enables us to translate findings and assays from the routine world of current pathology practice.

Service & partnering Two business units offer customers individualised services and collaborative partnerships, respectively.

IndivuServ At IndivuServ we provide a wide range of ISO-certified and GCP-compliant services based on our biobank and state-of-the-art laboratory. These services include: ·· access to biospecimens from our “Indivumed Standard” surgical biobank, routine pathology biobank, and our special longitudinal plasma biobank collected from medically treated cancer patients in oncology to perform nucleic acid testing (e.g. free circulating tumour DNA)

Indivumed

路路 immunohistochemistry assay development including multiplex assays, digital pathology, and tissue analysis for target validation and companion diagnostics development 路路 research services of various kinds including immunooncology phenotyping of tumours and drug testing in viable organoid tissue cultures (e.g., immunooncology compound testing) IndivuType Understanding the full complexity of cancer biology requires a comprehensive approach that goes beyond genomics. Genes are transcribed and expressed in different ways and only a multiomics view (integrating whole genome sequencing, transcriptomics, proteomics, phosphoproteomics, and immuno-phenotyping) can provide the full picture. IndivuType is a global database providing all this biological information and related clinical data from thousands of cases across multiple cancer entities worldwide. The high standardisation in sample and data collection, growing number of cases, depth of information, quality of bioinformatics, and supporting analytical tools make IndivuType a unique resource for cancer researchers and drug and diagnostic developers. Broad access to IndivuType and its tools is mainly provided as part of collaborative partnership projects, although limited datasets are available to cancer researchers worldwide based on specific license agreements.

Executive management team Prof. Dr med Hartmut Juhl (CEO) Fernando Andreu (CBO) Dr med Susanne Arbogast (CMO) Dr med Nils Clausnitzer (COO) Nils Schumacher (CLO)

Financing INDIVUMED generates revenue through the commercialisation of its products and services. To build IndivuType, the first multiomics cancer database, it has received funds from private investors and the European Investment Bank.

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Name · InVivo BioTech Services GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Neuendorfstr. 24a 16761 Hennigsdorf Brandenburg Dr Susanne Wolfenstetter +49-3302-86693-0 +49-3302-86693-62 info.invivo@invivo.de www.invivo.de

I 70 1998 S1, ISO 9001:2015, ISO 13485:2016

Areas of Activity · l Contract manufacturing l Production and development of immunoassays l Cell line development for pre-clinical and research use External · Collaborations with research Collaborations institutions and industrial partners

Company profile InVivo is one of the leading contract manufacturing organizations in Europe, with more 20 years of experience in mammalian cell culture and protein production.

Rely on our experience!

As a trusted provider of cost-effective outsourcing solutions, InVivo has worked with a large number of satisfied clients worldwide. Companies of all sizes, including small university spin-offs, major research institutes-, and biopharmaceutical companies, have taken advantage of our expertise as an independent contract manufacturer.

Our goal is to create lasting relationships by providing outstanding services and highly customised solutions for every client’s needs.

We value quality!

As an ISO 9001 and ISO 13485 certified company, we always aim for the highest quality standard. Our experience in downstream processing and protein purification, together with thorough quality control, ensures that you get exactly the product you’re looking for.

Service Portfolio InVivo’s service portfolio covers the full range of methods and techniques commonly used in modern biochemistry, cell culture, and large-scale protein expression.

Monoclonal antibody production InVivo provides custom monoclonal antibody production from your hybridoma line. Our facilities allow the production of up to 1kg monoclonal antibodies for use in research or preclinical development, human in vitro diagnostics, veterinary diagnostics, as well as food and feed safety. Proprietary serum-free media and optimised processes like high cell-density fermentation guarantee the highest cost-effectiveness in production.

Challenging clones and antibodies receive expert attention and all our processes can be adapted to your specific needs.

invivo biotech services

Recombinant protein production InVivo offers various different expression systems. Our protein experts are happy to assist you in choosing the right one for your application.

Mammalian expression systems Bypassing the time-consuming and costly generation of stable cell lines, InVivo’s optimised system for largescale transient gene expression, InVEST, facilitates the rapid production of mammalian-derived recombinant proteins in only a few weeks.

InVEST combines an optimised host cell line, customised media, large-scale plasmid preparation, sophisticated vector design, and a novel polycationic transfection reagent. This allows an increase in production up to 80 fold compared to other commercially available systems. ·· Complex proteins with post-translational modifications such as antigens, recombinant antibodies, antibody fragments, proteases, tumour markers, or proteohormones ·· Yield: milligram to gram amounts ·· Timeline: 8–12 weeks Bacterial expression systems: The E. coli expression system for production of recombinant proteins offers several advantages: a shorter timeline for the entire procedure from cloning to protein recovery, inexpensive production process, and high protein yields. InVivo offers large flexibility in scale, from 2L shake flask to 50L bioreactor, so you can choose depending on your needs. ·· Smaller peptides and proteins without posttranslational modifications, such as antigens, bacterial proteins, hormones, pro-hormones, tumour markers, or cytokines ·· High yield up to 5g/ batch ·· Timeline: 4–6 weeks

Additional services ·· Hybridoma development ·· Stable CHO cell line development ·· Immunoassay development and production 22 nd guide to german biotech companies 2021

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Name · iOmx Therapeutics AG

Address/P.O. Box Postal Code/City State Contact Person Telephone Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · ·

Fraunhoferstr. 13 82152 Martinsried Bavaria Dr Apollon Papadimitriou +49-89-8999-7090-0 info@iomx.com www.iomx.com

I 30 2016

Areas of Activity · l Next-generation cancer immunotherapies l Drug development l Immuno-oncology

First-in-class immune-oncology drugs targeting cancer immune evasion iOmx Therapeutics AG was founded in 2016 and focuses on the development of first-in-class, next-generation cancer immune therapy drugs that are designed to neutralise the inhibitory function of novel tumour cellexpressed immune checkpoint modulators.

While the currently approved immune-checkpoint inhibitory drugs targeting CTLA-4, PD-1, or PD-L1 pathways have emerged as the standard of care in many tumour indications, they still do not meet the needs of a majority of cancer patients, primarily due to inherent, non-redundant resistance mechanisms of tumours against immune cell attack.

Platform overview In order to discover and to understand alternative druggable vulnerabilities in such immunosuppressive tumours, iOmx Therapeutics efficiently applies its proprietary iOTarg™ target discovery platform, a systematic high-throughput genetic screening approach, to identify and validate novel immune checkpoint targets in cancer models that fail to respond to PD-L1 inhibition.

To date, this screening technology has been applied to several pairs of clinical tumour samples and tumourinfiltrating lymphocytes (TILs), resulting in the identification of a number of novel targets, many of which exhibit stronger inhibition of T cell killing than PD-L1 in classical assays.

Overall, the iOTarg™ platform points the way to nextgeneration immunotherapy approaches which are designed to increase the clinical impact of immunecheckpoint therapies.

iomx

Pipeline iOmx Therapeutics has identified a number of proprietary tumour-associated next-generation immune checkpoints and is advancing a preclinical stage pipeline of promising drug candidates that have the potential to address cancers that are resistant to current immunotherapies, including PD-1/PD-L1 checkpoint inhibitors.

Two highlights of the companyâ&#x20AC;&#x2122;s pipeline are IMT-18, a first-in-class IGSF11-targeting antibody designed to eliminate tumour-induced immune suppression, and IMT-07, a small molecule sensitizing tumor cells to the effect of immune-derived tumor necrosis factor (TNF) in the tumor micro-environment. For both programmes proprietary drug candidates with monotherapy potential have been developed. The companyâ&#x20AC;&#x2122;s lead antibodies and kinase inhibitors have shown very promising single agent anti-tumor effects in multiple preclinical animal models.

Outlook iOmx Therapeutics is in the process of a series B financing round, in order to rapidly advance their promising pipeline through IND-enabling activities to clinical proofof-concept for selected drug candidates.

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Name · ITM Isotopen Technologien München AG

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · ·

Lichtenbergstrasse 1 85748 Garching Bavaria Nicola Scharrer (Head of Marketing & Communications) +49-89-329-8986-600 +49-89-329-8986-650 info@itm.ag www.itm.ag

· · · · · LI · 250 · 2004 · Biotechnology and radiopharmaceutical company

Areas of Activity · l Oncology l Precision Medicine l Targeted Radionuclide Therapy l Nuclear Medicine

Targeted cancer diagnostics and therapies ITM Isotopen Technologien München AG is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment.

Since its foundation in 2004, ITM and its subsidiaries have established GMP manufacturing and a robust global supply network of innovative, first-in-class medical radioisotopes and generator platforms for a new generation of targeted cancer diagnostics and therapies.

Targeted Radionuclide Therapy (TRT) or Peptide Receptor Radionuclide Therapy (PRRT) is a medical specialty using very small amounts of radiopharmaceuticals to precisely diagnose and treat various diseases, such as cancer. Once injected into the patient, the radiopharmaceutical finds its way to the tumour through the bloodstream and binds to the tumour-specific receptor according to the lock and key principle. Radiopharmaceuticals contain a targeting molecule (e.g. peptide or antibody) and a medical radioisotope, conjugated by a chelating agent. In most cases the targeting molecule can be used for both diagnosis and therapy – only the radioisotope has to be changed. This opens up the way for the application of theranostics in the field of precision oncology. For diagnostic applications radioisotopes with short half-lives are used; those with longer halflives are applied for treatment. To destroy the tumour, minimal cytotoxic doses of ionising radiation have to be applied to the tumour site before decay.

ITM is developing a proprietary portfolio and growing precision oncology pipeline of targeted treatments in various stages of clinical development, which address a range of cancers such as neuroendocrine tumors, glioblastoma, osteosarcoma, and bone metastases, as well as folate receptor α positive tumours like lung, ovarian, or breast cancer.

ITM

ITM’s lead candidate no-carrier-added Lutetium-177Edotreotide (n.c.a. 177Lu-Edotreotide) is currently in the international phase III clinical trial COMPETE. COMPETE is evaluating the efficacy and safety of targeted radionuclide therapy with n.c.a. 177Lu-Edotreotide compared to standard therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+) neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NETs). N.c.a. 177Lu-Edotreotide consists of ITM’s highly pure EndolucinBeta ® (nocarrier-added Lutetium-177) and the targeting molecule Edotreotide.

By adding TOCscan® (Gallium-68-Edotreotide) to the product platform in 2018, ITM took a further important step in leading the way towards a new generation of theranostic agents for GEP-NETs. TOCscan ® is the diagnostic companion to n.c.a. 177Lu-Edotreotide and a ready-to-use radiopharmaceutical that ensures highquality PET images. Marketing authorisation is held in Germany, Austria, and France.

ITM is pursuing a strong growth strategy including signing several large-scale radioisotope production and supply agreements as well as opening new production sites.

ITM’s main objectives, together with its scientific, medical, and industrial collaboration partners worldwide, are to significantly improve treatment outcomes and quality of life for cancer patients while at the same time reducing side effects and improving health economics through a new generation of targeted radionuclide therapies in precision oncology.

For more information about ITM, please visit: www.itm.ag

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Name · Labor Dr. Merk & Kollegen GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Founded (year) Type of Laboratory

· · · · · · · · · ·

Beim Braunland 1 88416 Ochsenhausen Baden-Wuerttemberg Dr Ingrid Rapp +49-7352-911930 +49-7352-911940 info@labormerk.de www.labormerk.de 1971 S2

Areas of Activity · l Process development l GMP manufacturing of viral therapeutics l Biosafety testing in virology and microbiology l Cell-based assays l Analytics

Excellence in virology Labor Dr. Merk & Kollegen GmbH (LMK), GMP and GLP certified, is a centre of excellence for virology, pioneering viral characterisation, MVB and WVB establishment, raw material testing, microbial and viral disinfectants testing, vaccine release testing, and viral clearance studies, with more than 40 different high titre purified viruses from animal and human origin available.

History Founded in 1971, LMK is a family-owned company based in Ochsenhausen, Germany with more than 90 employees with outstanding expertise, training, and specialisation in virology, with EMA approval for release testing of vaccines produced outside of Europe, serving the health and welfare of our global population.

Viral therapeutics LMK offers process development and GMP manufacturing of viral gene therapeutics and oncolytic viral therapeutics as well as vaccines. LMK operates as a full CDMO with end-to-end process development, manufacturing of drug substances and drug products with analytical characterisation, and regulatory support.

Upstream processing For manufacturing of a broad range of viral therapeutics such as adenoviruses, adeno-associated viruses, lentiviruses, VSV, and parapox viruses, LMK has established adherent cell technologies in T-flasks, cell factories, and iCELLis, and suspension cell culture technologies with chemically defined media, and feeding systems in SUB. LMK also has the expertise to convert adherent processes to safer and simpler scalable suspension processes up to BSL-2.

LMK performs MCB and WCB of a broad range of cell lines suitable for viral propagation and has an extended media screening programme for cell line growth and virus titre performance.

Harvest systems by depth filtration are available, as well as cell disruption for release of viruses, if required.

labor dr. merk & Kollegen

Downstream processing In downstream processes LMK operates AIEX and CIEX chromatography as well as adsorber membranes, allowing separation of full and empty capsids as well as affinity chromatography for capturing viruses from cell culture fluid in high purity, low HCP content, high titre, and high yield. For formulation LMK offers thermo-stable formulations for viral therapeutics as well as fill & finish in liquid or lyophilised form up to BSL-2. Stability testing is performed according to ICH guidelines. All processes are scalable for industrial manufacturing for clinical supply by LMK.

Analytics LMK offers a broad spectrum of analytical methods for determining purity, efficiency, and safety of viral therapeutics and vaccines, including a variety of bio- and cell-based assays. This also includes but is not limited to the determination of empty and full capsids, infectious and genomic virus particles, and virus aggregates.

CRO/CDMO business Customers of LMK range from biotech startup companies to Big Pharma. LMK has collaborations with academia to improve their state-of-the-art technologies, including universities in Aachen, Biberach, Hannover, Tübingen, Ulm, and Vienna.

LMK as end-to-end CDMO ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ··

Analytical method development MVB/WVB Adherent and suspension cell screening Media optimization MOI optimization Innovative process development GMP manufacturing of DS Formulation development Analytical characterisation Regulatory support Compliance with relevant guidelines

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Name · LenioBio GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Erkrather Straße 401 40231 Düsseldorf North Rhine-Westphalia Dr Remberto Martis +49-211-8909-4030-0 +49-211-8909-4030-110 info@leniobio.com www.leniobio.com

I 19 2016

Areas of Activity · Protein Synthesis Kits and Services

Applied nature for better science.

LenioBio is disrupting the way proteins are made with our cell-free protein production platform ALiCE ®.

LenioBio holds an exclusive licence from DowDuPont™ to develop and market their proprietary cell-free protein expression technology under LenioBio’s brand ALiCE®.

ALiCE® is fast, versatile, mobile, and rapidly scalable and therefore suitable for a broad range of applications.

Our ALiCE® expression kit and protein services generate revenues and open doors for strategic partnerships.

LenioBio is now focusing on scaling the technology to industrial scale. We received seed funding and a Horizon 2020 grant in 2019.

Who we are.

We believe that every person should have the opportunity to live a healthy and productive life. Based on this principle, the company was founded in 2016. We have our head office in Düsseldorf and our Technology Centre in Aachen, located in the Fraunhofer IME, which is one of the co-inventors of the technology.

Our mission is to provide our customers with innovative solutions that address their toughest challenges – more easily, quickly, and efficiently than ever before. Indeed, “Lenio” derives from the Latin “to ease, alleviate, make better”.

Our company is currently developing the technology further, launching innovations to harness the power of nature to accelerate synthetic biology. With the support of the Horizon 2020 grant we are scaling up our production capabilities from mL to L scale and will ultimately offer the possibility to synthesise kilograms of any protein needed.

Leniobio

Why ALiCE®?

This eukaryotic kit offers our customers protein yields in a single step, at yields higher than any other cell-free expression system currently available. The ALiCE® platform has years of validation as one of the cornerstone protein expression technologies in leading biotech companies.

Whatever your mission – vaccines, pharma, food, or cosmetics – ALiCE® shortens your development times, reduces R&D costs, increases yields, and fundamentally changes how you approach protein expression.

The key differentiator of ALiCE® compared with other cell-free expression systems is that its intact protein production machinery reflects that of the living cell. It has an active energy regeneration and includes everything necessary for protein folding, disulfide bonding, and glycosylation. Beyond its ease of use and unprecedented yields, ALiCE ® finally enables fully scalable cell-free eukaryotic expression.

Scalable platform & unmatched service.

To date, each scaling step requires adapting living cells to new conditions, which affects productivity and possibly even the protein candidates themselves. For example, the optimisation of protein expression when scaling up recombinant CHO cells can take more than one year. Scaling up in ALiCE® sidesteps many of the complexities of cell-based systems and allows for much faster process development. It is a flexible and diverse platform that integrates with your current protein expression systems for a seamless and easy solution – no more using multiple platforms for multiple amounts and types of proteins.

We also offer the flexibility of outsourcing your protein production in ALiCE ® to us directly. This way, your projects progress even when you are not in the lab. The offer of customised protein production is structured in an initial feasibility study which provides a fast yes/no result, followed optionally by a scaled protein production.

Curious? Try ALiCE® and challenge the standard!

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Name · LIFE & BRAIN GmbH

Address/P.O. Box Postal Code/City State Contact Persons

· · · ·

Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory

· · · · · · ·

Venusberg Campus 1 53127 Bonn North Rhine-Westphalia Prof. Dr O. Brüstle (CEO), Prof. Dr M. Nöthen (CEO), Ira Herrmann (Head of Business Development) +49-228-6885-100 +49-228-6885-101 info@lifeandbrain.com www.lifeandbrain.com 37 2002 S1, S2

Areas of Activity · | Development of novel strategies for the diagnosis and therapy of nervous system discorders | Automated stem cell-based applications | High throughput generation and interpretation of omics data | Electrophysiology Services | Neuroeconomics & Neuromarketing Biological Patents · Several international patents filed or granted covering in-house technologies External · Strong network with academic and Collaborations industrial partners

LIFE & BRAIN is a biomedical enterprise and commercial hub of the University of Bonn Medical Centre founded in 2002 located in Bonn, Germany. As a centre of innovation, LIFE & BRAIN acts as a revolving door between academic research and industry. Innovative research results are recognised early and developed further into marketable biomedical products and services. Scientific excellence, market-orientated translational research and plans for spinoffs grow together in a network structure supported by creative external collaborations.

Integrating a unique set of expertise in cellomics, genomics, transgenics and neurocognition research, LIFE & BRAIN aims at delivering the next generation of products for disease modelling and prediction, compound development and tissue regeneration. The combination of technological know-how and scientific excellence makes LIFE & BRAIN the perfect partner for academic and commercial research.

LIFE & BRAIN is based on a 3-pillar concept where academic research groups, the staff of LIFE&BRAIN GmbH and an incubator segment are combined in one organisational structure and all located under one roof. This 3-pillar model facilitates the efficient transfer of academic know-how to commercial application.

LIFE & BRAIN products and services LIFE & BRAIN Genomics is one of the leading service providers for all types of microarray and NGS experiments using Illumina technology in Europe and has longstanding experience in high-throughput generation of “omics” data from biomaterial of humans as well as model organisms. Having a close collaboration with the excellent and internationally renowned scientists from the Institute of Human Genetics in Bonn, LIFE & BRAIN Genomics is continuously developing new applications and pipelines for state-of-the-art generation and interpretation of these “omics” data, which form the basis for understanding the molecular pathogenesis of common diseases and the development of specific diagnostic and therapeutic tools.

Life & Brain

LIFE & BRAIN Cellomics provides market-ready stem cell-based cellular products, customised automated solutions for stem cell-based applications and stem cell-related genomic services. We address the unmet need of process standardisation and automation for the robust production of human iPS cell-based disease models with industrial scale and standards. In particular, we consult, develop and support customised solutions for the industrialisation of human pluripotent stem cellbased applications. Our proprietary technology enables the production of human pluripotent stem cell-derived neuronal, neuroglial and microglial cell types for cellbased disease modelling, identification and validation of drug targets and screening applications. LIFE & BRAIN offers complementary genomic services including molecular karyotyping and expression profiling of differentiated stem cell-derived cell types.

Within LIFE & BRAIN Electrophysiology Services, we support preclinical R&D programmes in the area of neurodegeneration, neurocognition and functional connectomics by providing electrophysiological characterisation of small molecules with focus on target engagement, efficacy and potency in acute rodent and human brain slices, cultures, neurons and animal models.

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Name · Metronomia Clinical Research GmbH

Address/P.O. Box Postal Code/City State Contact Persons

· · · ·

Telephone · Fax · Email Addresses · Internet Website Social Media Number of Employees Founded (year)

Paul-Gerhardt-Allee 42 81245 Munich Bavaria Rudolf Köhne-Volland (Managing Director) Denise Lee (Managing Director) +49 89-82 92 65-100 +49 89-82 92 65-099 rkvolland@metronomia.net dlee@metronomia.net www.metronomia.net

· · IQ · 80 · 1990

Areas of Activity · Data Science CRO (Contract Research Organisation) for l Biostatistical consulting l Biostatistical services and programming l Clinical data management l Medical writing Request for · We speak your language and are here Further Collaborations to help with any biostatistical, regulatory, or clinical issue that may arise during your product’s development and lifecycle.

Please do not hesitate to contact us: info@metronomia or https://www.metronomia.net/contact/ contact-form.html

Metronomia Clinical Research: DATA. PEOPLE. EXCELLENCE. For over 30 years, Metronomia has been a reliable partner to a wide range of pharmaceutical, biotech, and medical device companies, contributing expertise in biostatistical consulting, biostatistical services, clinical data management, and medical writing to clinical development programmes.

Located in Munich, our team of 80 highly skilled statisticians, data managers, clinical programmers, and medical writers are dedicated to the needs of customers and their projects in all clinical development phases and major therapeutic areas. Looking back over 30 years of partnership and 600+ clinical projects, Metronomia has carved out a strong and stable niche in the highly competitive contract research organisation (CRO) landscape.

Our strengths ·· Exceptional proactivity, flexibility, and dedication ·· Personalised and customised service through stable project teams ·· Focus on customer journey for long-lasting partnerships built on trust ·· Service provision based on quality, expertise, and integrity ·· Processes and state-of-the-art technology that work for our customers ·· Successful business model based on repeat business and referrals

Experience ·· ·· ·· ·· ··

600+ projects All clinical phases and NIS Non-clinical and pre-clinical support All major therapeutic areas Small molecules, biologicals, biosimilars, medical devices, orphan drugs, and pediatric clinical trials ·· Covid-19 trial experience and expertise

metronomia

Services Biostatistical consulting ·· Study design consulting ·· Statistical planning, sample size and power calculation, simulation studies ·· Supporting meetings with regulatory agencies

30+ at

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YEAR b e tt e r

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Biostatistical services ·· Statistical analysis plan ·· Full range of CDISC services incl. submission support ·· Statistical programming ·· Data review meeting ·· Integration of studies and pooled analyses ·· Independent DMC statistician & DSMB support ·· Randomisation / IWRS services Clinical data management ·· eCRF and Database set-up ·· Data validation ·· Medical review and coding ·· SAE management ·· (e)PRO support ·· Supported EDC systems: Quadratek Clincase and Medidata RAVE Medical writing ·· Study protocols and clinical trial reports ·· DSURs ·· Publications Non-clinical support ·· Non-clinical statistics ·· Biological data processing ·· Non-clinical medical writing Partnered full-service and tailored service packages ·· Feasibility studies and site recruitment ·· Project management, monitoring, RBM ·· Safety management ·· Regulatory services

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Name · Mettler-Toledo GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Email Address Internet Websites

· · · · · · ·

Ockerweg 3 35396 Gießen Hesse Carmen Wiederuh +49-641-507401 Carmen.Wiederuh@mt.com www.mt.com www.mt.com/global/en/home.html

Social Media · FL I  Number of Employees · 16,200 (worldwide) Founded (year) · 1989 Areas of Activity · Manufacturer and marketer of precision instruments and services for many applications in research and development, quality control, production, logistics, and retail to customers around the world.

UV/VIS Micro-Volume Spectrophotometry with Rainin specialised high-quality tools OneDrop UV/VIS Spectrophotometry, the Life Sciences Specialist The UV5Nano micro-volume spectrophotometer from METTLER TOLEDO stands out with its innovative technology and intuitive usability coupled with modern design. FastTrack™ technology combines a long-lasting light source with state-of-the-art array technology and enables very fast, accurate, and precise measurements.

Only a minimal amount of sample (concentration ranges: 6 ng/µL to 15,000 ng/µL of dsDNA) is required for accurate measurements. Large volumes are measured in the cuvette slot.

Spectrophotometry with LockPath™ Technology ·· Wide concentration ranges without further dilutions ·· Automatic or manual pathlength selection ·· Secure locking of the arm during measurement minimises errors ·· No drying out of sample during measurement for increased repeatability Predefined bio-applications The One Click user interface includes many predefined applications for the analysis of bio-molecules. Nucleic acids like dsDNA, ssDNA, or RNA can be easily tested for purity or concentration. For protein analysis, the One Click user interface provides direct determination at 280 nm and indirect determination with dyes or the commonly used assays (e.g.: Lowry, Bradford, Biuret, or BCA).

Advanced liquid handling solutions Through its Rainin brand, METTLER TOLEDO is a leading provider of advanced liquid handling solutions for life scientists worldwide. We offer a wide selection of pipettes, BioClean Ultra LTS and universal pipette tips, and expert pipette services. It is a complete pipetting solution that we call Pipetting 360°. Our commitment to quality, innovative design, and state-of-the-art production result in superior pipette products that deliver years of reliable operation. Rainin developed the Lite Touch

mettler toledo

System (LTS) to increase the accuracy and precision of pipettes while decreasing friction, making Rainin pipettes a leader in pipetting ergonomics. The risk of repetitive strain injuries (RSI) is greatly reduced when using ergonomic Rainin LTS pipettes and tips.

The EasyDirect pipette asset management software covers the customer along almost the entire workflow â&#x20AC;&#x201C; from creating high-quality asset lists to preparing for an all-lab audit. With just a few clicks, the user knows immediately which pipettes need service and calibration over the next month, quarter, or year. Customers can now pull up a pipetteâ&#x20AC;&#x2122;s entire history, including certificates, in one click. From there they can download certificates and other data.

Process analytical solutions for pH, dissolved oxygen and carbon dioxide Control of pH and dissolved oxygen during the fermentation process is essential for quality, yield, and batch-tobatch consistency. The concentration of dissolved carbon dioxide has become another important parameter and can now be measured in situ directly in the bioreactor instead of in the off-gas with a BGA, thus providing the exact activity of CO2 in the media.

Our digital online sensors using ISM (Intelligent Sensor Management) technology provide correct measurements as well as sophisticated diagnostics information about sensor performance, such as DLI (Dynamic Lifetime Indicator), ACT (Adaptive Calibration Timer), TTM (Time to Maintenance), SIP/CIP counter, and hours of operation.

With the iSense software tool the registration, maintenance, and calibration of a sensor is easily documented for quality purposes.

All sensors can be integrated in controllers for benchtop bioreactors in the R&D environment, used in combination with modern transmitters in the scale-up process, and finally used in large-scale fermenters in the production area. Sensors for O2 are available with classic amperometric technology or with modern optical technology based on fluorescence quenching.

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Name · Microcoat Biotechnologie GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · ·

Am Neuland 3 82347 Bernried Bavaria Dr Andrea Gräntzdörffer (Business Development) +49-8158-9981-34 +49-8158-9981-10 a.graentzdoerffer@microcoat.de www.microcoat.de

· · · · · I · > 150 · 1992 · S1/S2, GLP, GCP, GMP, ISO 9001, EN ISO 13485

Areas of Activity · | Contract manufacturing | Custom development | Laboratory services | Endotoxin and pyrogen testing service External · Business-to-business with industrial Collaborations partners in the pharmaceutical industry, diagnostic industry and life science industry Request for · Microcoat seeks joint projects and Further Collaborations service partnership with pharmaceutical, biotech and diagnostic companies, as well as with players in the field of food safety testing, crop science and instrumentation (medical devices).

Company profile Microcoat offers a wide range of individual and specialised services for the diagnostic and pharmaceutical industry. In close cooperation with our customers, we aim for best performance, building on a complete range of advanced technologies and uncompromised quality standards.

For pharmaceutical companies, we leverage our profound expertise in in-vitro diagnostics and assay development in order to become a preferred partner in early development, pre-clinical and clinical phases of drug development and patient sample testing.

For food safety, environmental testing and other specialised diagnostic fields, Microcoat aims to be the preferred OEM-partner for the development and manufacturing of reliable test components and kits.

Contract manufacturing Microcoat is an approved original equipment manufacturer (OEM) for diagnostic test kits, bulk and finished components. We manufacture according to ISO and IVD standards. Since all critical test components are produced and modified in house, we are able to control quality at all stages of the production process.

Production technologies: ·· Fermentation (30 litre scale) ·· Downstream processing ·· Protein chemistry ·· Microplate and particle coating ·· Dispensing/filling/labelling ·· Freeze-drying ·· Kit assembly Product categories: ·· Coated microplates ·· Lateral flow test strips ·· Recombinant proteins/antigens ·· Antibody/protein conjugates ·· Liquid components ·· Dried/lyophilized components ·· Diagnostic kits

Microcoat

Custom development Microcoat offers unique expertise in diagnostic assay and product development. A broad spectrum of methods, skilled staff and intensive communication with the customer are the cornerstones of successful project execution.

Development projects are based on detailed milestone plans and follow standardised development guidelines through the five project phases (feasibility, development, verification, validation and manufacturing).

We develop for you: ·· Immunological assays ·· Molecular assays ·· Sample and matrix preparation protocols ·· Depletion protocols

Laboratory services

B2B Diagnostics

In our certified facilities, we conduct a broad spectrum of GLP/GCP services to support drug development starting from early discovery to post-marketing surveillance. As an independent contract research organisation and preferred provider we serve pharma and life science industries worldwide. Based on long lasting experience in endotoxin and pyrogen testing, Microcoat offers a set of proprietary methods and skilled scientific personnel for non-routine projects. Services are run as flexible customer-specified projects including the search for root causes, exploration of realization alternatives, development of product-specific adaptions and GMP comliant validation of newly established methods.

Our services include: ·· Biomarker testing ·· Immunogenicity/PK assays ·· Endotoxin and pyrogen testing ·· Assay development and validation

Business model Microcoat is focused on business-to-business with industry customers, seeking a reliable and long-lasting partnership for outsourcing projects such as contract manufacturing (OEM), assay and product development, and bioanalytical testing in the context of pre-clinical and clinical studies.

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Name · Microsynth Seqlab GmbH Part of Microsynth AG Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Websites

· · · · · · · ·

Maschmühlenweg 36 37081 Göttingen Lower Saxony Dr Aaron M. Nuss +49-551-370-00-10 +49-551-370-00-12 info@microsynth.seqlab.de www.microsynth.seqlab.de www.microsynth.ch www.microsynth.at www.microsynth.fr www.ecogenics.ch Founded (year) · 1989 Type of Laboratory · S1/S2, GMP/GLP Areas of Activity · l Oligonucleotide synthesis l Sanger sequencing l Next generation sequencing l DNA/RNA isolation, qPCR, digital PCR, fragment length analysis, genotyping

The Company Microsynth is a leading European company in the field of nucleic acid synthesis and analysis. Its main activities are oligonucleotide synthesis, DNA/RNA analysis and sequencing, as well as contract research and outsourcing. For three decades, the company’s goal has been to serve its customers by delivering products and services of the highest quality, on time and with outstanding service – and all this at competitive prices. Microsynth has subsidiaries in Germany (Microsynth Seqlab GmbH), Austria (Microsynth Austria GmbH), and Switzerland (ecogenics GmbH). Altogether Microsynth employs a staff of about 100 people.

Products and Services Oligonucleotide synthesis Customers can choose from a broad range of different backbones (DNA, RNA, 2’-MOE, 2’-OMe, LNA, PTO), modifications (MGB, GalNac, >250 in total), and purifications. From small scales for primers to probes for molecular diagnostic kits up to pilot scale for therapeutic oligonucleotides, Microsynth is your complete solution provider in the field of oligonucleotide synthesis.

l Contract research/outsourcing Contract Research · l Contract manufacturing (e.g. ASOs, probes) l Assay Development l Assay Validation (ICH Guidelines) l GxP(-like) analysis of customer test items (Sanger, NGS, qPCR & dPCR) l Process outsourcing l Genomics research

DNA/RNA analysis With more than 25 years of experience in DNA Sanger sequencing, Microsynth has become one of the leading sequencing suppliers in Europe. Having established Sanger labs in Germany, Switzerland, and Austria, we are able to offer this service in these countries with unmatched speed and environmentally friendly pickup service. With its Ecoli NightSeq® – a new game-changing service for sequencing plasmids from E. coli much faster and costeffective – it has set another industry standard.

Microsynth offers a wide range of high-quality next generation sequencing services. Microsynth focuses on the small- to medium-sized Illumina sequencing platforms. In the fields of microbial sequencing, metagenome sequencing (16S/ITS), RNA sequencing, and deep amplicon sequencing, Microsynth offers an unmatched service. The proprietary bioinformatics analysis pipelines deliver reliable and ready-to-use results. The fast

microsynth seqlab

turnaround times and first-class consulting differentiate Microsynth from its competitors.

Beyond DNA sequencing, Microsynth has built up critical expertise in related analytical areas such as nucleic acids isolation, PCR (from classic to qPCR to digital PCR), fragment length analyses (e.g. cell line authentication, SNaPshot multiplex analysis) and genotyping by sequencing.

Contract research / outsourcing Microsynth has vast experience in running many different research projects for its customers, including the development of new protocols. Successful projects in basic, preclinical, and clinical research range from onemonth to multi-year projects. Experienced researchers with a solid track record in microbiology, genomics, molecular biology, and bioinformatics help you to define the best strategy to address your research questions.

A broad portfolio of validated techniques and protocols is available at Microsynth. Professional project management, high-throughput sample logistics, and close cooperation with the customer ensure that every outsourced project is completed cost-efficiently and on time.

Quality Management System Microsynth puts every effort into constantly improving the underlying production processes. All branches of Microsynth are EN ISO 9001:2015 certified. The NGS and Sanger sequencing department as well as the parentage testing and fragment length analysis of Microsynth AG are additionally ISO/IEC 17025:2017 accredited (STS 0429). Microsynth AG is also authorised

by SwissMedic to perform quality control of medicinal products using GMP Sanger sequencing. Further, Microsynth AG is EN ISO 13485:2016 certified for the analysis, production, and distribution of nucleic acids, in-vitro diagnostic (IVD) assays, and applications.

People Christof Wunderlin (CEO) Dr Aaron M. Nuss (Site Manager) 22 nd guide to german biotech companies 2021

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Name · MLM Medical Labs

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Dohrweg 63 41066 Mönchengladbach North Rhine-Westphalia Isabel Struik +49-2161-4642-108 +49-2161-4642-190 istruik@mlm-labs.com www.mlm-labs.com

FL I  120 1993 Central laboratory for clinical trials

Areas of Activity · Global central lab services for clinical trials External · Cenetron Diagnostics, Austin TX, USA Collaborations Teddy Clinical Research Laboratory, Shanghai, China

MLM Medical Labs is a global central laboratory dedicated exclusively to clinical trials with locations in Germany and the US. The team of over 120 highly skilled and experienced persons supports between 190 and 210 clinical trials, phase I–IV, at any given time. The broad range of analytical capabilities includes standard safety profiles, such as blood counts, coagulation, platelets, urinalysis, and clinical chemistry, as well as analyses of biomarkers, drugs and metabolites, and molecular diagnostic parameters. The MLM labs are operational 365 days a year to ensure valid results with a quick turnaround time. Especially after the expansion to the US in 2020, MLM is the perfect partner for fully harmonised central lab services across continents – being globally active in over 40 countries worldwide.

Further external collaborations include a strategic partnerships with Teddy Clinical Research Laboratory (Shanghai), China, and Cenetron Diagnostics (Austin, TX), USA, to expand MLM’s global range.

In December 2019 MLM became part of Great Point Partner’s impressive portfolio of growing, profitable health care companies. Great Point Partners, founded in 2003 and based in Greenwich CT, USA, is a leading health care investment firm with approximately $2.2 billion of equity capital currently under the management of 28 professionals, investing in the US, Canada, and Western Europe.

MLM Medical Labs runs trials in various therapeutic areas, including endocrinology, hematology, thrombosis and hemostasis, oncology, coagulation, and cardiology.

All members of the technical staff are certified research or medical assistants. Over half of the team has academic degrees in chemistry, biochemistry, biology, or quality management and over 20% have completed PhDs in relevant fields.

mlm

Global central laboratory services

Analytical services ·· Assay development and validation ·· Broad portfolio of validated biomarker, multiplex assays ·· Clinical chemistry, hematology, coagulation, serology, and urinalysis ·· Flow cytometry ·· Immunogenicity assays ·· Cell-based assays ·· PBMC preparation ·· Biosimilar characterisation ·· Platelet function testing

Clinical trial services

Operations based in Germany and the U.S.

·· Global study setup and project management ·· In-house manufacturing of study-specific sampling kits: MLM Kit Building® ·· Sample analysis 365 days a year ·· Online data-access and kit tracking: mlm online® ·· Worldwide transport of clinical samples, sampling kits, and supplies ·· Over 6100m2 (66,000 sq ft) lab and office space in Germany and the USA ·· Short- and long-term sample storage at –20/30 °C, –70/80 °C, and in liquid nitrogen ·· Sample Management Solutions: MLM Sample Storage System® ·· Regular and customised data transfer according to client’s DTA specifications ·· Validated LIMS, digital SOP system, and ERP ·· Site support in the USA

Standards for quality ·· ·· ·· ·· ·· ··

GLP certified CLIA approved ISO 15189 accredited CAP accredited NGSP certified GCLP compliant

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Name · Molecular Health GmbH – a dievini Hopp BioTech Company Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Kurfuersten-Anlage 21 69115 Heidelberg Baden-Wuerttemberg Thomas König (Head of Marketing & PR) +49-6221-43851-0 +49-6221-43-2270 thomas.koenig@molecularhealth.com www.molecularhealth.com

FL I Q  126 (Germany/USA) 2004

Areas of Activity · Computational Biomedicine/ Biotechnology External · l FDA Collaborations l SAP l Techniker Krankenkasse l Charité l dkfz l Universität Heidelberg l Hanse Merkur l Karolinska Institut l Berlin Institute of Health l Daten Capital LLP l etc …

Molecular Health: making precision medicine a reality Molecular Health is an international biotech company headquartered in Germany that has been developing innovative software in the field of in-silico and precision medicine since 2004. Our solutions enable the conversion of large volumes of data into evidence-based, medically relevant results for healthcare professionals.

We provide molecular pathologists, human geneticists, physicians, and patients with comprehensive information about diagnoses and treatment options. We support pharmaceutical and health organisations in optimising clinical studies and developing disease models. At Molecular Health, specialists from the fields of medicine, data science, biology, and bioinformatics, as well as software development, strive to make Big Data work for healthcare. The result is a range of intuitive high-performance applications tailored to a broad spectrum of requirements in healthcare.

Molecular Health Guide (MH Guide): transforming molecular data into evidence-based decisions MH Guide supports molecular pathologists and other qualified medical professionals in the clinical annotation of genetic variants, enabling physicians to make precision oncology decisions. MH Guide is approved as an in-vitro diagnostic medical device in Europe. The customisable software application provides access to data derived from the world-class knowledge database Dataome, so that treatment decisions are based on upto-date clinical and molecular information.

MH Guide also has two components specifically designed for the analysis of hereditary diseases. Molecular Health Guide BRCA (MH BRCA) is optimised for the diagnosis of hereditary breast and ovarian cancer syndrome (HBOC). It is designed for use by human geneticists and laboratories evaluating BRCA1, BRCA2, and other HBOC-related genes. Molecular Health Guide Mendel (MH Mendel) supports human geneticists in identifying clinically important genetic variants for hereditary diseases and predispositions other than HBOC.

Molecular health

Molecular Health Predict (MH Predict): pick the winners We support the pharmaceutical industry through intelligent simulations and analysis of clinical studies programmes with the goal of mitigating the risks inherent in the process of drug development. Using artificial intelligence (AI), our MH Predict software helps quantify the potential of development projects, identifying the parameters that drive success so that pharmaceutical companies can optimise their programmes and identify promising active substances early on.

Dataome: one of the worldâ&#x20AC;&#x2122;s knowledge platforms The foundation for all of our solutions is Dataome, one of the worldâ&#x20AC;&#x2122;s largest digital platforms for biomedical and pharmaceutical information and real-world patient data.

Dataome continuously analyses and structures billions of molecular and clinical data points so that our software solutions can evaluate them. Dataome is transforming worldwide biomedical knowledge and making it accessible for precision medicine.

A reliable partner in your search for better patient outcomes At Molecular Health, highly qualified scientists work with a wide variety of expert groups from the healthcare system to achieve the best results for patients. We provide worldwide support from our main locations in Heidelberg, Germany, and Boston, USA. For more information, visit www.molecularhealth.com or contact: thomas.koenig@molecularhealth.com

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Name · Molzym GmbH & Co. KG

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Mary-Astell-Straße 10 28359 Bremen Bremen Marina Linow +49-421-69-61-62-0 +49-421-69-61-62-11 info@molzym.com www.molzym.com

I 30 2003

Areas of Activity · Manufacturer and supplier of products: l CE IVD kits for infection diagnosis l Microbial DNA extraction (manual and automated) l PCR assays and master mixes l DNA-free PCR reagents and polymerases l Customised master mixes External · Molzym is interested in collaborations Collaborations that are directed to the development and manufacturing of individualised, pre-analytic, and analytic solutions, including automation.

Molzym was founded as a privately owned enterprise in Bremen, Germany, in 2003. Ever since, Molzym has been committed to the development of innovative solutions to serve biological research and diagnosis of infectious diseases. In December 2019, Molzym joined Gradian Diagnostics to accelerate growth of its molecular diagnostic solutions. Our developmental efforts are particularly focused on new processes enabling and facilitating the molecular diagnosis of infectious diseases caused by bacteria and fungi. Meanwhile, more than 50 high-quality products are available for molecular microbial analysis by PCR- and NGS-based methods in 30 countries worldwide.

Expertise Molzym manufactures ultra-clean and highly active amplification reagents and kits for microbial DNA extraction from a variety of clinical specimens. Reagents and consumables are supplied free of contaminating microbial DNA – guaranteed lot by lot. Our customers appreciate the ability to increase the number of amplification cycles and thus lower the limit of detection dramatically without false positive results arising from contaminating microbial DNA. Another core expertise is Molzym’s unique MolYsis™ technology for the depletion of host DNA from usually sterile human and animal samples, a well-known factor that negatively influences sensitive PCR and microbiome analysis at low microbial loads.

Products & automation MolYsis™ is Molzym’s proprietary technology of host DNA depletion, allowing targeted isolation of microbial DNA from a great variety of clinical samples. Ultra-pure, DNA-free PCR reagents and master mixes allow for the precise detection of microbes in humans and animal models. Complete assays for the broad-range amplification of selected regions of the 16S and 18S rRNA genes of bacteria and fungi are available. Basic and dye master mixes can be used with custom primers for PCR and real-time PCR analysis.

molzym

The latest development is a walk-away robotic system, SelectNA™plus, for the fully automated host DNA depletion and extraction of microbial DNA from clinical and other material. SelectNA™plus brings the utmost technical advances to the demands for contamination-free and low-hands-on processing of samples.

With SepsiTest™-UMD and Micro-Dx™, Molzym offers two CE-marked in vitro diagnostic solutions for the culture-independent detection of pathogens that cause various diseases. Both kits include reagents for the depletion of human DNA and the targeted isolation of microbial DNA from a variety of clinical samples, e.g. whole blood, CSF, BAL, joint aspirates, tissue biopsies, abscesses, and other specimens. Manual DNA isolation can be accomplished with SepsiTest™-UMD, and with Micro-Dx™ the process is fully automated on the SelectNA™plus robot. Precise detection is performed with broad-range 16S/18S PCR and sequencing analysis to identify the pathogens down to the species level.

Both assays are especially applicable for samples that were negative after culturing, e.g. due to prior antibiotic treatment or fastidious growth requirements.

Service Molzym offers customised manufacturing of master mixes decontaminated of microbial DNA for improved assay performance at increased amplification cycles.

The Molzym team appreciates your interest and is at your disposal for further information about our products and developmental issues.

Please call at: +49-421-69-61-62-0 or send your inquiries to info@molzym.com.

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Name · MorphoSys AG

Address/P.O. Box Postal Code/City State Telephone

· · · ·

Semmelweisstr. 7 82152 Planegg Bavaria +49-89-89927-0 +49-89-89927-222 Email Address · info@morphosys.com Internet Website · www.morphosys.com Social Media · L I Number of Employees · Approx. 500 Founded (year) · 1992 Areas of Activity · Discovery, development and commercialization of innovative therapies Annual Turnover · €71.8m (revenue) R&D Expenses · €108.4m External · l Incyte Collaborations l Novartis l Janssen l GSK l Bayer l I-Mab Biopharma among others

MorphoSys (FSE & NASDAQ: MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer.

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development.

In 2017, Tremfya®, marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys’ antibody technology to receive regulatory approval.

morphosys

In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of the companyâ&#x20AC;&#x2122;s proprietary product tafasitamab in combination with lenalidomide in patients with a certain type of lymphoma.

Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees.

More information at: www.morphosys.com or www.morphosys-us.com TremfyaÂŽ is a registered trademark of Janssen Biotech, Inc.

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Name · MYR GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · ·

Thomasstrasse 10–12 61348 Bad Homburg v.d.H. Hesse Thomas Christély +49-6172-4959 811 thomas.christely@myr-pharma.com www.myr-pharma.com

I 40 2010

Areas of Activity · l Hepatitis D l Hepatitis B l Various other liver diseases such as l Hypercholesterolaemia and l Non-Alcoholic Steatohepatitis (NASH) Management · Dr Dmitry Popov (CEO) Thomas Christély (CFO) Florian Vogel (CCO) Dr Norbert Dinauer (COO)

Fighting against Hepatitis D and B MYR Pharmaceuticals is a biotechnology company focused on the development and commercialization of therapeutics for the treatment of chronic Hepatitis D and B. On 31 July 2020, the European Commission granted Conditional Marketing Authorization (CMA) for MYR’s lead compound HEPCLUDEX® (INN = bulevirtide) for the indication of Hepatitis D. In September 2020, the company successfully launched HEPCLUDEX® in Germany, France, and Austria.

The technology was originally developed by Prof. Dr Stephan Urban of the University of Heidelberg (Germany) and Prof. Dr Phillipe Gripon of INSERM (France) and represents one of the most clinically advanced novel approaches for the treatment of Hepatitis D. HEPCLUDEX® blocks the NTCP receptor on the surface of hepatocytes and prevents the entry of HBV/HDV into hepatocytes and viral spread within the liver.

The company, headquartered in Bad Homburg, started its operation in 2010 and is supported by venture capital investors such as Maxwell Biotech Venture Fund and the High-Tech-Gründerfonds.

With HEPCLUDEX®, the now fully integrated biotech company provides a therapeutic that is used for the treatment of the most severe form of viral hepatitis, Hepatitis Delta; up to 70 to 80 per cent of those affected develop liver disease and cirrhosis. HEPCLUDEX® is the first approved therapeutic for this indication in the EU. It has been granted the Orphan Drug Designation from the European Medicines Agency (EMA) and U.S. Food & Drug Administration (FDA), the PRIority MEdicines (PRIME) scheme eligibility (EMA), and Breakthrough Therapy designation (FDA) as well as the Promising Innovative Medicine (PIM) designation from the British Medicines and Healthcare products Regulatory Agency (MHRA).

MYR

Global market potential About 15 to 20 million people worldwide are infected with Hepatitis D. According to the companyâ&#x20AC;&#x2122;s calculations, the global market potential in the field of chronic Hepatitis D amounts to more than EUR 1 billion.

With this drug MYR is currently covering an attractive niche market, while at the same time further exploring the clinical potential in various other indications such as Hepatitis B, hypercholesterolaemia, and non-alcoholic steatohepatitis (NASH).

Commercialisation strategy and future perspectives The company is currently active in Germany, France, and Austria. The focus is on close-to-patient care, and a first subsidiary has been established in France. With the aim of combining the growth of the organisation with commercial expansion, the successive opening of further European markets, such as Italy, Spain, UK, and Sweden, will take place in the course of the coming year. The move to the USA is planned for late 2021/ early 2022.

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Name · Neovii Biotech GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · ·

Am Haag 6+7 82166 Gräfelfing Bavaria Dr Christian Loss (CEO) +49-89-898888-0 +49-89-898888-16 info.germany@neovii.com www.neovii.com approx. 130 2003 BioStoffV S3**, cGMP certified production facilities, EU (Annex 1 EU-MP guideline) up to grade A respectively ISO 5 (according to EN-ISO 14644-1)

Areas of Activity · l Transplantation Medicine l Haematological Oncology External · Academic research institutions and Collaborations undisclosed companies

The company Neovii Biotech GmbH – as part of the Neovii Group – is dedicated to delivering targeted biopharmaceutical treatment options in transplantation medicine and haematological oncology. The focus of its activities is the development and commercialisation of immunologically active biopharmaceutical therapeutics based on innovative antibody technologies. Manufacturing is located in Germany with an additional development unit in the USA. Since its inauguration Neovii Biotech has been manufacturing and commercialising Grafalon® (former brand name ATG-Fresenius S), a medicinal product for the prevention of graft-versus-host-disease after stem cell transplantation and prevention/treatment of acute organ rejection following solid organ transplantation.

For further details please visit: www.neovii.com

Transplantation: Grafalon® – a polyclonal antibody Grafalon® is an antibody-based medicine for the targeted suppression of immune responses (immunosuppressant); it is a polyclonal antibody composed of antihuman T-lymphocyte immune-globulin from rabbits.

It suppresses immune responses by multiple mechanisms, such as immune cell depletion, inhibition of T-cell function, induction of regulatory immune cells. Its immunosuppressive properties are used mainly in solid organ transplantation and stem cell transplantation.

Neovii

In stem cell transplantation (SCT) Grafalon® is indicated for the prevention of graft-versus-host-disease (GVHD).

GVHD is recognised as a severe complication following SCT that negatively impacts on patient’s quality of life and is a major cause of morbidity and mortality. In GVHD, transplanted immune cells attack the recipient’s body, causing tissue and organ damage. By suppressing these immune reactions, Grafalon ® significantly lowers the incidence of GVHD. In solid organ transplantation (SOT), Grafalon® is indicated either for the prevention of organ rejection or to suppress active, acute rejection reactions. The rejection of a transplanted organ is primarily caused by immune cells of the recipient that start attacking the grafted organ, because it is recognised as foreign. By suppressing these immune reactions, Grafalon ® limits organ damage and prevents graft loss.

Grafalon® has been approved for more than 30 years in about 50 countries.

Grafalon delivers targeted immunosuppression

Neovii Grafalon – Anzeigenfläche PR 07.2019

More than 250,000 patients worldwide have already been treated with Grafalon®.

In 2011, Grafalon® was granted the MMW Pharmaceutical Drug Award (MMW-Arzneimittelpreis) in recognition of its 30-year success story in transplantation medicine.

210 mm (b) x 148 mm (h) + 3 mm Beschnittzugabe

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be INSPIRED

drive DISCOVERY

stay GENUINE

Name · New England Biolabs GmbH

New England Biolabs – be Inspired | drive Discovery | stay Genuine

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media Founded (year)

· · · · · · · · · ·

Brüningstr. 50 – Geb. B852 65926 Frankfurt am Main Hesse Dr Thomas Möllenkamp +49-69-305-23140 +49-69-305-23149 info.de@neb.com www.neb-online.de

FL I  H 1981

Founded in the mid-1970s as a collective of scientists committed to developing innovative products for the life sciences industry, New England Biolabs is now a recognised world leader in the discovery, development, and commercialisation of recombinant and native enzymes for genomic research.

New England Biolabs – putting science first Created “by scientists for scientists”, NEB is renowned for consistently providing exceptional product quality and unsurpassed technical support. For over four decades, NEB has been shaping the landscape of bioscience research by discovering, developing, and supporting superior research reagents. In addition to NEB’s commitment to scientific innovation and customer satisfaction, NEB notably ensures the environmental sustainability of the company’s business practices. Our passion is our promise. A supplier-of-choice for scientists across the globe, NEB offers the largest selection of recombinant and native enzymes for genomic research. While restriction enzymes remain part of our core product portfolio, our ever-expanding offering also includes products related to PCR and qPCR, gene expression, sample preparation for next-generation sequencing, synthetic biology, and CRISPR/Cas9 gene editing, as well as glycobiology, epigenetics, and RNA analysis. A recognised leader in the field of enzymes and reagents, NEB has earned a world-wide reputation for setting the highest standards for quality and value.

Basic and applied science New England Biolabs’ laboratories more closely resemble those of a research institute than a biotech company, and with good reason: NEB’s scientists are engaged in research in areas that include enzyme analysis and engineering, epigenetics, RNA biology, and parasitology. As a result, NEB researchers have authored or co-authored over 1,000 publications, many of which have been published in peer-reviewed journals. To foster science education, NEB scientists also supervise post-doctoral associates, student interns, and PhD students engaged in research

new england biolabs

projects. With this dual focus on both basic and applied research, NEB’s culture is collaborative and academic.

Latest innovation in enzyme technology Our outstanding expertise in protein engineering and evolution has led to the creation of unrivaled enzymes and unique workflows in the library preparation and target enrichment for the NGS space. These products set the benchmarks for optimal performance and ease-of-use in modern molecular biology laboratories. Moreover, NEB’s specialised offerings for alternative DNA assembly, isothermal amplification as well as novel reagents for CRSIPR/Cas9 based genome editing makes us a firstchoice supplier for today’s molecular biologists.

Quality, customer service, and the environment NEB is dedicated to providing research products of the highest quality. We are committed to processes that ensure the protection of the environment and our integrated quality and environmental management systems are certified to meet the requirements according to the standards ISO13485, ISO9001, and ISO14001.

Customised Solutions/OEM/GMP

Enzymes & Reagents for: Sample Preparation for Genome Editing

Next-Gen-Seq

Genomics

qPCR Glycobiology

RNA Analysis

Synthetic Biology

Amplification

DNA

Cloning PCR Modification

RNA Epigenetics Cellular Analysis

Protein Expression

Nucleic Acid Purification

Guide_2017.indd 1

NEB’s OEM business unit has been delivering customised manufacturing, tailor-made enzyme formulations, and packaging solutions to customers for over 25 years.

Relying on this extensive experience, we have recently completed building a new GMP manufacturing facility to offer a select set of tailor-made products enabling OEM customers and partners to use NEB’s top-class products directly in their specific applications, or to bring them to regulated markets.

New England Biolabs GmbH

CRISPR/Cas

The NEB subsidiary in Germany represents the service hub for Central Europe. From our location in Frankfurt, we serve scientists and industry customers in Germany, and Austria and support our network of distribution partners across Europe.

www.neb-online.de

For up-to-date information please visit our web site at www.neb-online.de.

Competent Cells Gene Expression

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Biotech

Name · Nordmark Arzneimittel GmbH & Co. KG

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Number of Employees Founded (year)

· · · · · · · · · ·

Pinnauallee 4 25436 Uetersen Schleswig-Holstein Dr Jan Heyland +49-4122-712-907 +49-4122-712-545 projects@nordmark-biotech.de www.nordmark-biotech.de ~ 550 1927

Areas of Activity · l Process development l Microbial fermentation l Mammalian cell culture Annual Turnover · ~ €100m

Founded in 1927, Nordmark is an internationally leading specialist for the development, manufacturing, and commercialisation of active pharmaceutical ingredients (APIs) and drug products of biological and biotechnological origin under GMP conditions. Headquartered in Uetersen near Hamburg (Germany), and family owned again after a management buyout from the BASF group in 2001, Nordmark today employs around 550 employees and generates revenues of around EUR 100 million.

Inspired by the organisation and high-quality standards of our former parent company, as an independent pharmaceutical enterprise, we successfully develop and produce biological active pharmaceutical ingredients and drug products through all stages of the value chain.

Nordmark Biotech, the biotechnological division of Nordmark, is a specialist for providing tailor-made solutions for the development and manufacturing of biopharmaceuticals from lab to production scale. In this context, we are able to offer expertise in both systems – microbial as well as mammalian – to our customers.

Services cover the entire value chain from process development to marketed drugs: ·· Strain and Cell Line Development ·· Microbial Fermentation – Upstream Process Development ·· Mammalian Cell Culture – Upstream Process Development ·· Downstream Process Development ·· Formulation and Filling – Pharmaceutical Development ·· Biomanufacturing under GMP Conditions ·· Analytical Services ·· Regulatory Service

nordmark

Nordmark Biotech connects flexible partnerships with a unique expertise and know-how in developing and delivering drugs to market. As a family-owned business we work with maximum care and attention and with fast and simple decision-making processes. We are focused on success â&#x20AC;&#x201C; regardless of project size.

Nordmark can refer to a significant track record in the industry with different successful process development and manufacturing projects in various stages of clinical development as well as approved and marketed products for more than 40 international partners. With more than 90 years of excellence and commercial success, Nordmark is the ideal partner to bring your ideas to market.

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Name · PeproTech GmbH

Address/P.O. Box Postal Code/City State Contact Persons

· · · ·

Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · ·

Winterhuder Marktplatz 6–7a 22299 Hamburg Hamburg Anna Seymour Dr Peter Bubeck +49-40-73435-777-0 +49-40-73435-777-9 info@peprotech.de www.peprotech.com

FL I 9 (Germany), >150 (Worldwide) 2006 (Germany), 1988 (USA) S1, ADCF, GMP l Molecular biology l Cell culture l Stem cell and cell line development l Cell preparation l Fermentation l Protein purification l Antibody production l Kit development l Process development

External · Researchers from academia, industry Collaborations and biotech companies Request for · PeproTech encourages researchers Further Collaborations to convey their particular needs, especially if they need ancillary products for cell, gene and tissue therapy.

Company profile PeproTech creates the building blocks of your life science research by manufacturing high-quality products that advance scientific discovery and human health.

Since 1988, we have grown into a global enterprise with state-of-the-art manufacturing facilities in the US, and offices around the world. With over 2,000 products PeproTech has developed and refined innovative protocols to ensure quality, reliability, and consistency. ·· Quality Policy – PeproTech is committed to supplying our customers with the highest-quality products and services to achieve customer satisfaction, as well as to ensure compliance with the requirements of the quality management system and its continuing improvement.

Proteins ·· RUO – Full-length and fully biologically active Research Use Only cytokines are developed in-house by our experienced protein scientists. The process starts in our molecular biology labs with gene design and expression, continues to cell banking, and on to fermentation/cell culture, purification, QC testing, and finally QA review and release. ·· Animal-Free Product Line – This product line is designed to minimise potential risks that can arise from trace amounts of animal-derived adventitious agents.

These proteins maintain identical high biological activity and purity to the corresponding proteins that are produced using standard techniques. ·· GMP – PeproTech ensures that all aspects of our quality management system – from management of raw materials and equipment to facilities maintenance (environmental monitoring), manufacturing processes, internal audits, and inspection processes – are in compliance with GMPs and all applicable regulatory and standards requirements. We perform extensive quality control testing to verif y that PeproGMP® Cytokines meet rigorous standards for purity, identity, safety, activity, and consistency.

PeproTech

Antibodies, ELISA Kits & Media ·· Polyclonal Antibodies – These are purified through the isolation of specific polyclonal antibodies from antiserum by antigen affinity chromatography. This procedure exploits the specificity of the antibodyantigen interactions and typically yields >95% pure specific antibodies. ·· Biotinylated Antibodies – PeproTech’s biotinylated antibodies are produced from highly pure and specific antigen affinity-purified polyclonal antibodies, and are therefore ideal for use in any analytical procedures that require biotinylated antibodies. ·· Monoclonal Antibodies – PeproTech’s monoclonal antibodies are raised against full-length recombinant antigens and have been thoroughly screened for performance in a variety of applications. ·· ELISA Development Kits – PeproTech’s ELISA Development Kits contain the necessary key components for the quantitative measurement of natural and/or recombinant proteins in a sandwich ELISA format. ·· Media – We offer a comprehensive line of cell culture media products, designed around our high-quality recombinant growth factors and manufactured by PeproTech in state-of-the-art cell culture laboratories.

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Name · Pharma Waldhof GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Hansaallee 159 40549 Duesseldorf North Rhine-Westphalia Dr Holger Olbrück +49-211-52-60-2-0 +49-211-52-60-2-60 Contact.dus@aceto.com www.pharmawaldhof.de

I 12 1974

Areas of Activity · l Nucleotides l Nucleosides l Pharmaceutical intermediates l Pharma ingredients/excipients l Life Sciences l Diagnostic reagents l Cosmetic ingredients l Nutraceuticals

70 years of know-how and expertise Ever since its first technical developments in 1947, our company, legally independent since 1974, has devoted itself over more than seven decades to the most scientifically interesting and forward-looking field of nucleic acid biochemistry. Today, Pharma Waldhof’s field of expertise is the development and commercialisation of active substances, key intermediates and reagents for multiple applications : ·· Pharmaceuticals including intermediates, ingredients, and excipients ·· Life sciences including diagnostic, cell biology, and biopharmaceutical reagents ·· Cosmetic ingredients ·· Nutraceuticals

New developments are our strengths Pharma Waldhof is active in new product developments and advanced manufacturing techniques to position the company as a preferred supplier to the highly regulated in vitro diagnostics, cell culture, and biopharmaceutical industries.

Annual Turnover · $400m (Aceto Group)

For Pharma Waldhof, however, innovation also means to steadily improving the traditionally high and recognised quality standards of our existing products and services.

It is our aim not only to meet the growing requirements of the market and the regulatory conditions but also to establish new standards at a higher level.

Our ongoing commitment to quality and sustainability reached another milestone in 2017, when Pharma Waldhof GmbH was awarded the title Best Biochemical Products Provider Germany & Europe. In 2018 our company was also awarded with the label of Biochemical Supplier of the Year and received the Innovations Award in Biotechnology Discipline Bridging, honouring our multi-disciplinary approach.

pharma waldhof

Global footprint The current range of Pharma Waldhof products roughly comprises 200 compounds enjoying regular scientific and commercial interest. Our affiliation with the multinational ACETO group since 2004, headquartered in the U.S., has increased our global footprint.

With business operations in nine countries, Aceto is a leading global chemical distributor and virtual manufacturer providing over 1,100 compounds used principally by the pharmaceutical, nutraceutical, and cosmetic markets. Acetoâ&#x20AC;&#x2122;s global operations are distinctive in the industry and enable its worldwide sourcing, supply chain excellence, and regulatory capabilities.

Pharma Waldhof also maintains manufacturing and technical collaboration with selected and world-renowned biotechnology companies and research institutions as well, qualifying us to flexibly respond to specific demands and developments in biochemistry and biotechnology, pharmacy and diagnostics, cosmetology, and in the nutrition physiology of today and tomorrow.

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Name · Pharmaplan GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees

· · · ·

Siemensstraße 21 61352 Bad Homburg Hesse Anna Fey (Head of Business Development & Marketing) +49-6172-8502-100 +49-6172-8502-501 germany@pharmaplan.com www.pharmaplan.com

· · · · · I · 521 (Pharmaplan EU) 989 (TTP Group) Founded (year) · 1974

Areas of Activity · l Project Management (Project Management, Project Controls & Scheduling, Procurement, Construction Management) l GMP & Quality Consulting (GMP Consulting, Qualification) l Process Engineering (Biotech, Chemical API, Fill & Finish, OSD, Packaging & Logistics, Process Media) l Digital Factory (Digital Engineering, Manufacturing IT & Automation) l Facility Design (Architecture, Laboratories, Technical Building Services, Electrical & BMS) l Feasibility Study l Conceptual Design l Basic Design l Detail Design l EPCM l Procurement Support l Construction Management / Supervision l Installation and Commissioning Support l Qualification

For us at Pharmaplan, “Passion for Pharma Engineering” is our guiding principle.

Founded and developed by two well-known pharmaceutical companies, Pharmaplan regards pharmaceutical engineering and all the associated regulatory and other specific requirements of the pharmaceutical industry as part of our DNA. As one of the leading companies for pharma consulting and engineering, it is our constant endeavour to provide customised solutions for the individual needs and production requirements of our customers in the pharmaceutical industry.

One of our success factors is the seamless integration of GMP, process, automation, facility, and project management in agile and digital environments. All major global pharmaceutical manufacturers and several small and medium-sized pharmaceutical companies have been counting on our expertise for years.

Our services Pharmaplan is a consulting and planning company that – preferably as a general planner – provides integrated services in the disciplines GMP, process, automation, facility, and project management tailored to the needs of the pharmaceutical industry from a single source.

Pharmaplan is divided into three business units: Consulting & front-end projects Execution of feasibility and concept studies, site planning, analyses, and consulting with regard to product portfolio, production capacity, and regulatory compliance. The goal is to develop plant standards, innovative technologies, modular concepts, and optimal project implementation strategies on a global level, which can be translated into site and project-specific concepts and requirements.

Investment projects Implementation of investment projects of all sizes, from reconstruction projects to the construction of entire production sites. Pharmaplan is usually responsible for the entire project as general planner and site manager.

pharmaplan

Site projects Once an investment project is completed, Pharmaplan continues to support the site with a broad portfolio of services. The services include engineering for product change, capacity optimizsation, and for all kinds of plant renewals or conversions as well as (re-)qualification and validation services including the preparation of all necessary GMP documentation and the execution of qualification and validation.

Our departments and team reflects the typical work packages of our projects: ·· Project Management (Teams: Project Management, Project Controls & Scheduling, Procurement, Construction Management) ·· GMP & Quality Consulting (Teams: GMP Consulting, Qualification) ·· Process Engineering (Teams: Biotech, Chemical API, Fill & Finish, OSD, Packaging & Logistics, Process Media) ·· Digital Factory (Teams: Digital Engineering, Manufacturing IT & Automation) ·· Facility Design (Teams: Architecture, Laboratories, Technical Building Services, Electrical & BMS) Embedded in the TTP Group, Pharmaplan is an equal sister company of TRIPLAN. As a group of companies, the TTP Group, with almost 1,000 employees at 20 locations in Germany, Switzerland, France, Belgium, and India, specialises in consulting and engineering services for the process industry.

TRIPLAN offers comprehensive engineering services for the chemical and petrochemical industry and for life sciences. As a general planner (EPMC), planner, and consultant with close operational ties, TRIPLAN assumes responsibility for all project phases and trades for new construction, conversion, modernisation, and optimisation.

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Name · Phyton Biotech GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Number of Employees Founded (year)

· · · · · · · · · ·

Alter Postweg 1 22926 Ahrensburg Schleswig-Holstein Kai Schütte +49-4102-4906-64 +49-4102-4906-69 kai.schuette@phytonbiotech.com www.phytonbiotech.com 55 1990

Areas of Activity · Comprehensive services for the development and commercialisation of high-value compounds using our award-winning Plant Cell Fermentation (PCF®) Technology.

Established in 1990, Phyton Biotech offers comprehensive process development and commercial manufacturing services for fermentation-based products.

Best known for our award-winning and environmentally responsible Plant Cell Fermentation (PCF®) platform, we have expanded our profile into other cell systems, offering development and supply solutions for a wide array of products including phytochemicals, biopharmaceuticals, and other high-value compounds. This PCF® technology coupled with our extensive experience allows Phyton Biotech to serve a variety of global markets, including pharmaceutical, traditional medicines, agricultural, food ingredients, natural health, and cosmetics industries.

Our PCF® technology PCF ® promotes the natural processes of plant cell growth and biosynthetic pathway expression of plant material in a controlled and fully defined bioreactor environment. Starting material is sourced without any environmental impact and the optimal cell cultures are developed in-house. Selected cell lines are scaled up in stirred tank bioreactors without the sunlight requirement.

Finally, Phyton Biotech’s specialised product recovery and downstream technology allows for the preparation of extracts and purification of molecules.

Utilising this cutting-edge technology, Phyton Biotech offers a time, risk, and cost balanced path to commercially viable production processes, adding sustainability, reliability, quality, and scalability to the supply chain.

Our unique capabilities address the entire development chain. Phyton Biotech maintains one of the world’s largest plant cell culture collections, allowing for the unique selection and sourcing of plant material. Subsequent cell line development, process development, downstream development, chemical processing, scaleup, and commercial GMP production in up to 75,000L bioreactors guarantees Phyton Biotech’s position as the global leader in PCF®.

phyton biotech

Specialty fermentation solutions Phyton Biotech’s unique state-of-the-art facilities and impressive history of expertise in development and production enable us to carry out other Specialty Fermentation solutions beyond PCF® hand-in-hand with our customers — from first cells to scale-up and through to product recovery. We offer comprehensive services for the development and commercialisation of manufacturing processes for high-value compounds including small molecules and biologicals.

Our API business Phyton Biotech operates two GMP-certified, FDA and EDQM inspected facilities in Germany and Canada with full in-house QA/RA and QC capabilities, and supplies substantial amounts of Paclitaxel and Docetaxel with full control over the entire upstream and downstream production process. By providing a safe, reliable, high-quality supply of finished Active Pharmaceutical Ingredient (API) product that meets USP and EP standards, Phyton Biotech is the largest global commercial provider of Paclitaxel and Docetaxel API via PCF® to a customer base of pharmaceutical manufacturers around the world.

In summary Through our expertise and experience, Phyton Biotech continues to offer world-class development, supply, and commercial manufacturing solutions in an environmentally responsible and sustainable way through our PCF® and Specialty Fermentation platforms for a wide range of high-value fermentation-based compounds.

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Name · Pieris Pharmaceuticals

Address/P.O. Box Postal Code/City State Contact Person Telephone Email Address Internet Website Number of Employees Founded (year)

· · · · · · · · ·

Zeppelinstraße 3 85399 Halbergmoos Bavaria Sandra Kutter +49-811-12-447-0 info@pieris.com www.pieris.com 100+ 2001

Areas of Activity · Discovery and development of Anticalin® proteins for the treatment of oncological, respiratory, and other diseases External · l AstraZeneca Collaborations l Seattle Genetics l Servier Request for · Strategic partnerships that deploy Further Collaborations the Anticalin® platform in high-value therapeutic areas

Company profile Pieris is a clinical-stage biotechnology company that discovers and develops Anticalin protein-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes inhalable Anticalin proteins to treat respiratory diseases and immuno-oncology multi-specifics tailored for the tumour microenvironment. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies.

Anticalin proteins Anticalin proteins are engineered lipocalins – proteins that naturally bind and transport different molecules throughout the body. They are small, monovalent molecules that can be genetically linked to each other or to monoclonal antibodies, creating multispecific candidates with a broad range of therapeutic applications.

Pieris’s discovery platform benefits from its newest iteration of libraries, which have a diversity of up to 1 x 1011 and ensure a high probability of obtaining a drug candidate against any candidate of interest.

Advantages of Anticalin proteins over traditional mAbs ·· Formatting flexibility for multispecific drugs ·· Alternative delivery routes (e.g. inhaled) ·· Potential for more cost-effective prokaryotic expression ·· Tunable pharmacokinetics to match biological need ·· Dominant patent position and positive FTO position Pieris strategy ·· Address validated targets in novel ways ·· Develop and broaden core focus areas of respiratory diseases and immuno-oncology ·· Expand our platform through proprietary asset discovery and strategic collaborations ·· Become a fully-integrated biotechnology company

Pieris

Pipeline Highlights Anticalin Protein Antibody Fc

Anticalin Protein

Bispecific Anticalin Protein

Fc-Anticalin Protein Fusions

Tetraspedific Anticalin Protein

Antibody-Anticalin Protein Fusions

Unique Formatting Options • Potent Multi-Target Engagement Target

PRS-060 (IL-4Rα Antagonist) ·· Lead respiratory programme targeting IL-4R α for asthma ·· Differentiated from injectable antibodies against IL-4 and IL-13 through inhaled delivery directly to the lungs, potentially offering more convenient delivery, a significant cost-of-goods advantage and an expanded patient population over systemic antibodies ·· Being developed in a collaboration with AstraZeneca ·· Phase 1a showed drug to be safe and well-tolerated in healthy volunteers, with no SAEs, a favorable PK profile, and robust target engagement PRS-343 (4-1BB/HER2 Bispecific) ·· Bispecific drug candidate with 4-1BB-targeting Anticalin proteins (key costimulatory target for tumourspecific T cells) and a HER2-targeting antibody (validated expression in bladder, gastric, breast cancer, and others) ·· Demonstrated strong tumor growth inhibition and lymphocyte infiltration in vivo, while avoiding undesirable peripheral T-cell activation ·· Phase 1 monotherapy trial and phase 1 combination trial with PD-L1 for HER2+ solid tumours showed clinical benefit and biomarker data indicative of a 4-1BB mechanism of action PRS-344 (4-1BB/PD-L1 Bispecific) ·· Bispecific drug candidate with 4-1BB-targeting Anticalin proteins (enhancing mitochondrial function in T cells) and a PD-L1-targeting antibody, a target combination that has demonstrated robust preclinical anti-tumour activity ·· Being developed in collaboration with Servier; Pieris retains U.S. commercial rights For more information, please visit: www.pieris.com

Anticalin Protein

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Name · PlasmidFactory GmbH & Co. KG

Address/P.O. Box Postal Code/City State Contact Persons Telephone Fax Email Website Social Media Number of Employees Founded (year)

· · · ·

Meisenstr. 96 33607 Bielefeld North Rhine-Westphalia Dr Martin Schleef Dr Marco Schmeer +49-521-29973-50 +49-521-29973-55 info@plasmidfactory.com www.plasmidfactory.com

· · · · ·  · 27 · 2000

Areas of Activity · l Contract Manufacturing of plasmid and minicircle DNA in different quality grades for research up to clinical applications l Analysis of plasmid topology l In Stock Service of AAV Helper & Packaging Plasmids (pDG/pDP) and of further plasmids Request for · PlasmidFactory is always happy to Further Collaborations collaborate with Pharma and Biotech companies needing plasmid or minicircle DNA for (pre-) clinical applications.

PlasmidFactory is a leading contract manufacturer of plasmid and minicircle DNA and the driving force in the development of gene vectors for gene and cell therapy and genetic vaccination. PlasmidFactory’s research and development as well as the complete services are located in Bielefeld, Germany.

Customised plasmids and minicircles PlasmidFactory’s individual manufacturing service is frequently used by researchers from the fields of transfection and drug delivery, virus production, nano-biotechnology, gene therapy, cell or tumour therapy, and DNA vaccination. The company offers the production of plasmid and minicircle DNA in several quality grades: Research Grade and ccc Grade qualities for research purposes and pre-clinical applications, High Quality Grade as starting material for e.g. GMP production of RNA, viral vectors, and CAR-T cells.

In Stock service Besides production of individual plasmids and minicircles, In Stock products that are deliverable immediately “off-the-shelf” – e.g. reporter genes (gfp, lacZ, luc), AAV Helper & Packaging vectors (pDG/pDP family, several serotypes) or pEPI plasmids (containing S/MAR elements) – are also provided.

Other services On request, plasmid DNA storage and logistics can be organized, supplementing the company’s service portfolio.

PlasmidFactory’s proprietary method for quantification of the structural diversity of plasmid DNA by means of capillary gel electrophoresis (CGE) is the only reliable method able to determine the stability of plasmid DNA during storage.

plasmidfactory

20 YEARS

Minicircle â&#x20AC;&#x201C; a safe vector system Minicircles (MC) are circular DNA molecules that are generated e.g. by an intramolecular (cis-) recombination from a parental plasmid (PP). The difference between MC and standard plasmid vectors for gene therapy or nucleic acid vaccination is that the MC contains neither the bacterial origin of replication (needed only in bacteria for the amplification of plasmids in cell division) nor the antibiotic resistance markers or other selection systems to keep the plasmid in high amounts within the producer cell.

Hence, minicircles are the most promising tools to achieve both, increased efficacy as well as regulatory requirements for future clinical applications.

PlasmidFactory is the exclusive owner of all relevant patents and IP in this field and provides service production of these supercoiled monomeric constructs, according to clientsâ&#x20AC;&#x2122; requirements.

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High Quality Grade DNA for GMP production of viral vectors and RNA Helper & Packaging plasmids for AAV production In Stock QC including CGE service for topology analysis

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Customized minicircle & plasmid production J Extensive expertise in manufacturing of minicircles for CAR-T cell production

PlasmidFactory.com

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Name · ProBioGen AG

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Emails Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · ·

Herbert-Bayer-Str. 8 13086 Berlin Berlin Dr Lutz Hilbrich (CEO) +49-30-322-935-100 +49-30-322-935-400 info@probiogen.de cmo@probiogen.de · www.probiogen.de · IQ · 175 · 1994 · S1, S2 · |B iopharmaceutical development and GMP Production Facility |B iopharmaceutical contract development and manufacturing | T echnologies for improving product characteristics and process efficiency

Biological Patents · ProBioGen holds numerous international patents on technologies to improve product quality/potency and enhance cellular productivity.

External · With many international companies Collaborations and research organisations, e.g. LTC, Boehringer-Ingelheim, Max-PlanckInstitutes, etc.

Request for · ProBioGen works with biotech and Further Collaborations pharma companies developing complex therapeutic glycoproteins or viral vaccines. Services include cell line and process development, up to GMP-manufacturing, based on animal or human cell lines. In addition, proprietary product/process-improving technologies are out-licensed.

Intelligent biopharmaceutical solutions Internationally renowned specialist for developing and manufacturing complex therapeutic glyco-proteins; state-of-the-art service packages plus innovative platform technologies. Manufacturing authorisation for human biopharmaceuticals and operating to quality standards of the EMA and FDA.

Experience & client feedback Over 25 years a successful development partner for leading biotechs & pharmas on novel products, biosimilars, and biobetters, e.g. Fc-fusion proteins, clotting factors, enzymes, or others. Clients value our scientific expertise, excellent working relationships, and outstanding flexibility.

Services Quality development services Offer as true “one-stop-shop” complete service packages from early lead optimisation, rapid and integrated development of high-producer cell lines, processes and analytical methods, up to full GMP manufacturing programmes.

Comprehensive analytics portfolio, incl. standard inprocess & release tests, and in vitro bioactivity assays.

Innovative technology platforms to optimise yields, boost product potency, increase development speed, or cut manufacturing costs; all independently licensable.

Integrated cell line and process development Pharmaceutical cell line development platform, CHO.RiGHT TM, based on proprietary, royalty-free expression vector technology, various pre-selected CHO host cells, and own chemically defined media platform.

Excellent reputation of cell line development skills based on fine-tuned, individually adjusted clone selection procedures and early integration of upstream and downstream selection parameters. This allows selecting the optimal expression strategy for each protein and enables rapid, economic upstream process development.

Reliable and flexible contract manufacturing Offers GMP production in fully state-of-the art disposable systems in fed-batch and continuous processes in up to 1,000 L bioreactors, incl: ·· Downstream Process Development

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We Wemake makeour ourexperience experienceyours. yours.

·· Cell Banking (MCB/WCB) ·· GMP Manufacturing ·· Analytical Development Cell-based activity assays An range of cell-based activity assays for potency and mode-of-action analyses is established.

Technologies GlymaxX® ADCC Enhancement Glyco-engineering technology preventing cellular fucose synthesis and thus antibody fucosylation for maximised ADCC cell-killing activity against tumour and infected cells. Works for novel and existing producer cell lines, external expression platforms, or can be licensed alone.

Glyco-engineering Fucose, galactose, and sialic acid levels of glyco-proteins can each be adjusted, e.g. in biosimilar projects.

DirectedLuck – Transposase technology for superior titres Novel, proprietary, epigenetic-guided transposase technology for transgene insertions into transcriptionally active genomic regions; available for licensing or service projects.

Productivity-boosting pathway modulator Stable introduction of an engineered cdc42 enzyme typically increases cellular productivity 2-fold. Applicable to existing cell lines and expression platforms, independently licensable.

Human artificial lymph node: immunofunction Fully human mini-bioreactor technology to test longterm drug effects on the immune system in vitro. Unique 3D-matrix-assisted system uses primary cells to mimic immune reactivity in vivo, to analyse immunogenicity, immune-modulation, and -toxicity.

AGE1.CR® viral vaccine manufacturing platform AGE1.CR® duck cell line replaces primary chicken fibroblasts for GMP-compliant viral vaccine production, incl. highly attenuated ones, e.g. MVA and viral vectors.

Chemically defined media platform and scalable suspension processes for industrial production.

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Name · PROGEN Biotechnik GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Maaßstraße 30 69123 Heidelberg Baden-Wuerttemberg Caroline Odenwald +49-6221-8278-0 +49-6221-8278-24 odenwald@progen.com www.progen.com

I 30 1983 S1, S2, L2 class laboratories, DIN ISO 13485 certification for the production of in vitro diagnostic kits and research reagents.

Areas of Activity · Antibodies and reagents for biomedical research, in vitro diagnostics, ELISA, AAV gene therapy tools, antibody phage display technology, density gradient media Annual Turnover · €5.6m External · Strong network with industrial and Collaborations academic institutions Request for · PROGEN is actively seeking partners Further Collaborations for the advancement and distribution of its gene therapy and antibody-based products & services.

Immunochemicals that advance life science R&D Starting out in 1983 as a pioneer in antibody manufacturing, PROGEN has since become a globally operating biotech company that serves the life sciences and pharma sectors. We believe that our research antibodies and test kits are more than commodities; they are tools for the advancement of research and development in academia and industry alike. Our goal is to deliver innovative and reliable products that fuel biopharmaceutical and diagnostic progress along the complete value chain – from the lab to manufacturing and quality control.

PROGEN is continuously expanding its selection of over 1,000 research antibodies in different formats to enable novel applications that facilitate and accelerate the workflow at the bench. Building on our core competence in immunochemistry, PROGEN’s portfolio includes adeno-associated virus (AAV) gene therapy tools, phage display technology, and libraries for the generation of novel recombinant antibodies as well as density gradient media for easy cell fractionation.

AAV test kits for safe gene therapies PROGEN has become a leading manufacturer of ELISA kits for the assessment of AAV titers for safe and effective gene therapies, and some of these assays have earned reference standard status in gene therapy centers around the world. Our tests are widely used in research and development as well as in gene therapy manufacturing and quality control. The company has secured exclusive rights from the German Cancer Research Center (DKFZ) for their AAV research antibodies and test systems, providing more freedom to operate in the highly competitive AAV gene therapy research market.

PROGEN aims to further expand its leading role and to access new customer groups with its AAV test systems and innovative antibody technologies.

progen

Cell fractionation with density gradient media

Research antibodies AAV tools Density gradient media Phage display technology

Research and routine clinical applications demand effective separation technologies that enable the isolation of pure, functionally intact populations of cells, subcellular organelles, and macromolecules in high yield. PROGEN offers a range of iodinated density gradient media for separating and fractionating cells down to subcellular components. Our products comply with FDA and EU cGMP standards and regulatory requirements.

Ultimate commitment to quality, validation, and service

MOVING

IMMUNOCHEMISTRY!

PROGEN specifically serves the urgent need of todayâ&#x20AC;&#x2122;s customer for premium antibody quality. As a DIN ISO 13485-certified company, we have established multilevel validation steps for many products. Every new lot of antibodies for IHC/ICC undergoes independent quality control on relevant tissue sections or cells by external institutions. Antibody performance on western blot is evaluated, and sample sizes and positive controls are provided to customers for internal validation and assay calibration.

Collaborations to meet existing and future demands Since 2012, PROGEN has been a 100% subsidiary of R-Biopharm AG, based in Darmstadt/Germany, a developer of test solutions for clinical diagnostics and food & feed analysis. This corporate affiliation provides continuity for the growth of PROGENâ&#x20AC;&#x2122;s product & service portfolio. In addition, joint Managing Directors Katja Betts and Maik Lander are steadily expanding the broad network in academia and industry that has been established over the past 37 years: the company is reaching out to potential partners in its endeavour to further advance its life sciences reagents business.

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Name · ProJect Pharmaceutics GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Founded (year) Type of Laboratory

· · · · · · · · · · ·

Fraunhoferstrasse 22 82152 Martinsried Bavaria Dr Daniela Woide +49-89-45-22-89-700 +49-89-45-22-89-717 info@project-pharmaceutics.com www.project-pharmaceutics.com

LI

2010 Contract research and development; chemistry; cytotoxic; S1 (BSL-1); S2 (BSL-2) Areas of Activity · Analytical characterisation; preformulation screening; formulation development; freeze drying cycle development; lyophilisation process and scale-up; pre-clinical batch manufacturing; technology transfer Biological Patents · Several patents in freeze-drying and formulation External · Operating a network for seamless deCollaborations velopment from expert to expert, from pre-clinic to fill/finish. Competence network player as formulation specialist for DS and DP CMOs worldwide / process specialist for scalable drug products ensuring manufacturability.

Cross-country competence hub with business partners in Asia.

Credited laboratory for Wyatt Technology in Europe.

Request for · We partner with small biotechnology, Further Collaborations mid-size pharma, as well as large top players in pharma/biotechnology – from DSP development to early and late drug product phases up to life cycle management. We offer customised solutions for challenges in formulation, analysis or process and particularly for unmet needs not yet supported by the industry.

ProJect Pharmaceutics is one of the leading European CRO service providers specialised in formulation and manufacturing process development for parenteral drug products including biologics, ADCs, cytotoxics, small molecules, generics, viral therapeutics, GMOs, ATMPs, VLPs, and other nanoparticular drug delivery systems.

We pursue innovative, quality-by-design based, rational concepts of pharmaceutical development following ICHQ8 and other guidelines. We support our worldwide clients to develop a consistently high-quality pharmaceutical product, transferable, scalable, and manufacturable under GMP conditions.

Drug formulation ·· ·· ·· ·· ·· ··

Accelerated development – faster to clinic and market Pre-formulation, early state, and late phase formulation Liquid and lyophilised forms Aqueous and non-aqueous systems Liposomal encapsulation In-depth analytical characterisation

High concentration protein formulation ·· ·· ·· ·· ··

Low viscosity formulation (DoE) Concentration studies using UF/DF Particle size distribution and aggregate analysis Analysis of subvisible particulate matter Viscosity determination & syringeability testing

Process and manufacturing ·· ·· ·· ·· ·· ··

Container closure system compatibility testing Thermal characterisation Forced stress studies Real-time, accelerated, and in-use stability studies Detergent quantification Fill&finish process mock-up (e.g. sterile filtration / filling studies) ·· Manufacturability assessment ·· Aseptic pre-clinical batch manufacturing ·· Originator analysis

Downstream process ·· Smart optimisation of UF/DF & purification steps ·· Stabilisation concepts (e.g. higher yield, decreased loss) ·· Testing common formulation for BDS and DP

project pharmaceutics

Freeze drying ·· Rationale cycle development (robust, collapse-safe, cost and time efficient) ·· Bulk lyophilisation (solid or powder) ·· Freeze drying out of organic solvents ·· Residual solvent analysis ·· Annealing and controlled nucleation ·· Easy lyophilisate reconstitution ·· Pre-clinical batch manufacturing ·· Robustness testing (definition of design space) ·· Smooth technology transfer and process scale-up ·· Lyophilisation in vials, (dual chamber) systems and syringes, bulk trays, containers in nest&tub configuration ·· Scanning electron microscopy (SEM) ProJect Pharmaceutics is led by experts with >25 years of experience in pharmaceutical industries. In about 850 m2 we operate dedicated labs for biologics, cytotoxics (OEL4), and a BSL-2 unit for handling GMOs and classified samples up to S2.

ADCs and cytotoxics A deep understanding of the challenges when processing highly potent drugs, such as limited solubility in water and rapid degradation, paired with long experience and comprehensive know-how of lyophilisation from various organic solvents and solvent / water mixtures enables us to provide specific solutions for cytotoxics and ADCs (incl. DoE-derived intermediate mAb formulation for coupling and DoE-derived ADC stabilisation).

Viral therapeutics and GCT products ·· ·· ·· ·· ··

Virus particle stabilisation (lyophilised formulation) Full factorial DoE formulation design Aggregation tendency screening Lyo cycle development Aseptic pilot batch manufacturing

Fill&finish As state-of-the-art development experts we are teamed up with state-of-the-art contract manufacturing experts to provide high-quality parenterals from pre-clinical to clinical and large commercial scale.

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Name · Protagen Protein Services GmbH

Address/P.O. Box · Inselwiesenstr. 10 Postal Code/City · 74076 Heilbronn State · Baden-Wuerttemberg Site Dortmund: Otto-Hahn-Str. 15, 44227 Dortmund Site Cambridge: 790 Memorial Drive Cambridge, MA 02139, United States Contact Person · Martin Blüggel Telephone · +49-7131-74504-0 Fax · +49-7131-74504-299 Email Address · contact@ProtagenProteinServices.com Internet Website · www.ProtagenProteinServices.com Social Media · L I Q Number of Employees · 120 Founded (year) · 1997 Type of Laboratory · Protein GMP-Compliant Areas of Activity · Analytical Services for Biopharmaceutical Development: AAVs in Gene Therapy, Antibody Drug Conjugates (ADCs), Antibodies, including Bispecific Antibodies, FAB Fragments, Fusion Proteins, Biosimilars, Vaccines, other Protein Formats | Developability | Process Development | Protein Characterisation | Formulation Support | Comparability Demonstration | HCP Analytics | Method Validation and Verification | Forced Degradation Studies | Stability Testing | Release Testing | Sourcing of Reference Materials Strategic Partners · Vela pharmazeutische Entwicklung und Laboranalytik GmbH Vienna, Austria

Protagen Protein Services (PPS) is a leading global provider of contract analytical services in protein science. More than 20 years of market experience and our comprehensive spectrum of validated analytical methods ensure the highest quality for our customers in the pharmaceutical, biotech, and life sciences industries.

PPS provides strategic approaches entirely tailored to our customers’ needs e.g. for characterising biopharmaceutical products and supporting biosimilar developers in achieving and demonstrating biosimilarity. Analysis is performed in a GMP-certified environment.

From clone to clinic From the earliest (clone-selection) stage of development through drug approval to commercialisation, PPS offers state-of-the-art protein analytics for: Comparability studies – characterisation, physicochemical properties, biological activity, purity, impurities, and stability.

Stability studies – assessment of shelf life for new drugs, study of possible degradation pathways in more detail.

Release testing – cGMP testing for products entering the pharmaceutical market and in accordance with regulatory standards Process development – determination of critical quality attributes supporting the development of up- and downstream processing Good manufacturing practice (GMP) – GMP batch release testing for the safe release of drugs onto the market Structural characterisation according to ICH Q6B – characterisation of biotechnological and biological products following a set of internationally accepted specifications; detailed comparison of originators and biosimilars The analysis is carried out for all biological molecules, such as antibodies, antibody drug conjugates, vaccines, new biological entities and biosimilars. Analytical reports are regularly accepted by multiple regulatory authorities worldwide including the FDA (USA), EMA (EU), and other regulatory authorities, which take into consideration all stages of development: scientific advice, phase I through phase III, up to marketing authorisation.

protagen protein services

Standard and innovative analytics used on analytic platforms, programs and by highly experienced teams based in the FDA and EMEA territories, we focus on delivering analytic excellence in advancing, de-risking and accelerating all stages of biotherapeutic development including innovative areas such as HDX-MS and in-vivo CQA mapping.

Our analytical services for Adeno Associated Virus (AAV)-based products quantify the strength/dose of the AAV vector and full/empty particles as well as particles carrying wrongly encapsulated DNA. This ensure the identity, purity, potency, and safety of the final gene therapy product.

PPS provides you with the full range of services from drug discovery and development to release testing and regulatory compliance we offer: Protein quantification by means of amino acid analysis and extinction coefficient Protein primary structure analysis, which involves a combination of different techniques (i.e. peptide mapping, denovo sequencing, intact mass, N/C-terminal sequencing, and disulfide linkage) Glycosylation analysis to identify common and biologically relevant modifications (i.e. N-linked glycosylation, O-linked glycosylation, sialic acid, site of modification, quantification, monosaccharides) Impurities analysis, based on state-of-the-art HPLC methods (IEX, SEC, HIC, RP), to assist you with the purification of proteins and enable you to use them in research or medical applications Forced degradation studies, helping you to understand the potential consequences a degradation effect can have for your biopharmaceuticalâ&#x20AC;&#x2122;s safety and efficacy as early as possible MAM (Multi Attribute Method) as a powerful MS-based approach that allows the extraction of a large number of different quality parameters of a protein within a single analytical approach HCP (Host Cell Proteins) MS enabling the conclusive identification of process-related impurities.

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Name · Peptide Specialty Laboratories GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · ·

Im Neuenheimer Feld 515 69120 Heidelberg Baden-Wuerttemberg Dr Adrian Glas +49-6221-889612 +49-6221-889613 info@peptid.de www.peptid.de 7 2000 Peptide Synthesis

Areas of Activity · Customised peptide synthesis and peptide-specific antibodies

Peptide Specialty Laboratories Peptide Specialty Laboratories (PSL) GmbH is located in the Technology Park in Heidelberg, Germany. It was founded in August 2000 by Dr H.-R. Rackwitz as a spin-off laboratory of the German Cancer Research Center (DKFZ). The team of PSL has gained a long wealth of experience in peptide synthesis and antibody preparation.

The main goal of PSL is based on the production, to a very high standard, of unmodified as well as modified peptides from mg to gram amounts and with lengths from 2 to about 100 amino acids. PSL guarantees that peptides are all HPLC purified and analysed by mass spectrometry. PSL also offers syntheses of peptides with rare amino acids, unnatural amino acids, peptides with fluorescent moieties, biotinylated peptides, branched peptides, and cyclic peptides. Furthermore, PSL produces bio-conjugates between peptides and proteins as well as column matrices, and PSL is a main contributor of peptide specific antibodies for scientific and industrial research. PSL antibodies are primarily produced in rabbits or guinea pigs and other species on request. In addition, PSL is specialised in the production of phosphospecific antibodies.

Peptide-specific antisera service We offer a customised peptide-specific antisera service.

By using high-quality peptide conjugates for the preparation of our antisera, we have achieved a high success rate in the generation of specific antisera.

peptide specialty laboratories

Special purpose research peptides We are specialised in research peptides, and strive to assure high quality for our products. Our company’s experience has demonstrated that only a qualitatively “good” peptide will result in a “good” antiserum or “good” research results.

Modifications & special services We have the capacity to incorporate modified or special amino acids into peptides (i.e. acetylated, myristoylated, phosphorylated, stable isotope amino acids, etc.). We also provide different labels (i.e. fluorescent dyes, toxins, chelators). Furthermore we offer cyclic peptides (i.e. head-to-tail, side-chain-to-side-chain, disulphide).

Synthesis scale We provide peptide services in which you can select from different coupling prices. Peptides are available in four scales. To obtain a specific amount of a peptide you may choose between a minimum of 1–2 mg, 2–3 mg, 5 mg, or 10 mg of an HPLC purified peptide. Higher quantities up to 1,000 mg are available on request.

Purification We believe that unpurified peptides are not appropriate for immunisation or other research purposes. That is why our peptides are provided with a purity of >90 %. Higher purities are available upon request. We do not routinely provide unpurified peptides. If customers have their own purification facilities we may also provide unpurified peptides on special request.

Delivery It will take approximately two to three weeks to receive your product once the order has been confirmed.

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Name · Rentschler Biopharma SE

Address/P.O. Box Postal Code/City State Contact Person

· · · ·

Telephone · Fax · Email Address · Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

Erwin-Rentschler-Str. 21 88471 Laupheim Baden-Wuerttemberg Dr Cora Kaiser (Senior Director Corporate Communication) +49 7392 701-0 +49 7392 701-300 communications@ rentschler-biopharma.com www.rentschler-biopharma.com

· · FIQ · 1,000 · 1927 · S1

Areas of Activity · l Contract development and manufacturing organization (CDMO) for biopharmaceuticals External · Strategic alliance with LEUCOKARE AG, Collaborations located in Munich, Germany, for bestin-class formulations Strategic collaboration with Vetter, headquartered in Ravensburg, Germany, for high quality aseptic filling and secondary packaging Request for · Rentschler Biopharma offers Further Collaborations bioprocess development and cGMP manufacturing solutions from concept to market for pharma and biotech companies in long-term collaborations and strategic collaboration settings.

A world-class biopharmaceutical CDMO Rentschler Biopharma is a leading global contract development and manufacturing organisation (CDMO), focused exclusively on client projects. From its headquarters in Laupheim, Germany, and its site in Milford, MA, USA, Rentschler Biopharma offers process development and manufacturing of biopharmaceuticals. The company’s high quality is proven by its long-standing experience and excellence as a solution partner for its clients.

Rentschler Biopharma is a family-owned company with about 1,000 employees.

Your trusted partner from concept to market Rentschler Biopharma’s end-to-end offering includes biopharmaceutical process development and manufacturing as well as related consulting activities such as project management and regulatory support. Rentschler Biopharma is highly experienced in the development and cGMP manufacturing of monoclonal antibodies, designer proteins, and other therapeutic proteins in compliance with international standards (EMA/FDA).

Working collaboratively with its clients, Rentschler Biopharma provides customised solutions with optimised work packages for each development stage.

State-of-the-art cGMP facilities and cell culture processes are leveraged for manufacturing for both, clinical studies and commercial supply. Consistent monitoring of the international regulatory landscape and in-depth understanding of the necessary regulatory documentation (CMC), ensures that each project is properly documented in accordance with international regulatory requirements.

In order to offer value-adding solutions across the entire process chain, the company has entered into a strategic alliance with LEUKOCARE AG for formulation development.

Another strategic collaboration is with Vetter for aseptic manufacturing and packaging. The desired goal of the collaboration with Vetter is the alignment of manufacturing approaches that enable clients to bring their products to patients more easily and faster.

Rentschler biopharma

Bioprocess development ·· Fast and efficient supply for multiple candidate screening ·· Robust and scalable CHO cell lines for cGMP manufacturing ·· Efficient cell culture and purification processes ·· Well-established analytical methods ·· Advanced formulation development exclusively by LEUKOCARE AG

Best-in-class formulation development Rentschler Biopharma’s strategic alliance with LEUKOCARE offers best-in-class formulation development considered at every step of the biopharmaceutical development and manufacturing process.

Operating at the interface of drug substance and drug product development, LEUKOCARE combines sound knowledge of formulation development with bioinformatics and artificial intelligence (BI/AI).

By utilising BI/AI elements such as self-learning algorithms, statistical software as well as state of the art design of experiment (DoE) matrices, LEUKOCARE is able to specifically combine excipients leading to stabilising formulations tailored to the drug product’s needs.

cGMP biomanufacturing ·· Multiple stainless steel bioreactor lines, including a twin system with 2x 3,000 L ·· Flexible single-use bioreactor lines up to 2,000 L ·· State-of-the-art purification processes ·· Guaranteed product quality and purity in accordance with cGMP guidelines As a world-class solution provider, we ensure optimum time-to-clinic and time-to-market by accelerating timelines to create competitive advantage for our clients. For seamless market approval, we consult and assist clients with regulatory queries, develop optimised strategies, and generate complete documentation for approval of clinical studies and market launch.

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Name · RheinCell Therapeutics GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Berghausener Straße 98 40764 Langenfeld North Rhine-Westphalia Jürgen Weißer +49-2173-32820 +49-2173-3282015 contact@rheincell.de www.rheincell.de

The field of cell therapy is one of the most promising developments in modern medicine. But autologous approaches – based on cells made patient-by-patient – are extremely expensive and time-consuming and thus, unsuited for routine applications. Instead, regenerative cell therapy requires allogeneic off-the-shelf therapeutics.

RheinCell Therapeutics GmbH specialises in the GMPcompliant generation of human induced pluripotent stem cells (iPSC) from allogeneic umbilical cord blood (CB).

I 22 2017

Areas of Activity · l iPSC l Cell therapy

Our main focus is on setting up an iPS cell library consisting of various HLA-homozygous iPS master cell banks. The key idea behind this is that only a limited number of iPSC lines are needed to set up an allogeneic resource that prevents immune rejections in a large number of recipient patients. Thus, this master cell library serves as an “off the shelf” platform for various types of cell therapeutics and has the potential to become the starting material of any future iPSC-based therapy in the western world – and beyond.

rheincell therapeutics

Our operations cover the entire spectrum of the medically oriented iPSC workflow and are based on our long-standing expertise in human iPSC technology. This includes cellular reprogramming under GMP conditions, GMP/ATMP-grade iPSC expansion and cryopreservation, targeted genetic manipulation (optional), and directed differentiation.

Our interdisciplinary team of scientists and engineers is composed of experts in the areas of iPSC technology, stem cell differentiation, cell banking, medicine, GMP production, and regulatory affairs. RheinCell scientists have internationally recognized knowledge and experience in cellular reprogramming and stem cell research.

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Name · Richter-Helm BioLogics GmbH & Co. KG

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · ·

Suhrenkamp 59 22335 Hamburg Hamburg Dr Antje Weingarth +49-40-55290-436 +49-40-55290-888 BusinessDevelopment@ richter-helm-biologics.eu · www.richter-helm-biologics.eu · I · ~240 · 1987

Areas of Activity · Contract development and manufacturing of biopharmaceuticals derived from microbial systems Biological Patents · Several patents on the manufacture of recombinant proteins External · Richter-Helm is working with biotech Collaborations and pharma companies worldwide Request for · Richter-Helm’s Business Development Further Collaborations team will be pleased to learn more about your needs for development and GMP manufacturing services to bring your project one step further.

For more detailed information please contact us.

GMP-compliant microbial production of biopharmaceuticals – flexibility makes the difference Richter-Helm BioLogics is a leading Hamburg, Germany-based GMP-compliant contract manufacturer of biopharmaceuticals specialised in products derived from bacteria and yeasts.

Over the past 30 years Richter-Helm has gained substantial experience in the development and manufacture of different product classes such as recombinant proteins, antibodies, plasmid DNA, and vaccines. The company currently operates a development facility and two cGMP manufacturing facilities with bioreactor capacities of up to 1,500 litres, enabling GMP manufacturing for phase I to III up to commercial supply.

With flexibility, commitment to good manufacturing practice, and total transparency our seasoned, 240strong team offers highly specialised contract development and manufacturing services to support the global pharmaceutical and biotechnological industries.

To meet the high quality requirements, Richter-Helm consistently works to the highest standards of pharmaceutical quality.

This has been verified by major regulatory bodies including EMA, FDA, ANVISA, PMDA, and MFDS as well as by numerous customer audits.

Products and services The highly motivated and experienced teams at RichterHelm have excellent expertise in the development and GMP-compliant production of biopharmaceuticals. To ensure efficient and transparent work, we apply professional project management methods.

Our process development team possesses extensive experience in developing and optimising fermentation and purification processes. For initial strain development, a variety of proprietary E. coli expression systems

richter-helm biologics

are available to support strain selection. Small scale models of existing processes provide helpful tools for trouble shooting, process characterisation, and validation. Furthermore, small scale models also ensure a smooth scale-up to large-scale GMP-compliant manufacture.

The quality system at Richter-Helm meets the strictest standards of quality in biopharmaceutical production.

Our in-house QC testing covers development and validation of a variety of analytical methods (incl. biological assays), performance of stability studies, and characterisation of reference standards.

Richter-Helm offers a full range of biopharmaceutical manufacturing services, including: ·· Establishment of cell banks (MCB/WCB) ·· GMP manufacturing for phase I to III ·· Commercial GMP manufacturing Thanks to the broad knowledge of Richter-Helm’s experts and many years of experience gained from different kinds of projects, Richter-Helm works out tailor-made solutions for its worldwide customers, which include large pharmaceutical companies as well as advanced biotech companies. We treat each of our customers’ projects individually and with the highest flexibility – guaranteeing a successful partnership.

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Doing now what patients need next Name · Roche Diagnostics GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · ·

Nonnenwald 2 82377 Penzberg Bavaria Dr Johannes Ritter +49-8856-60-2600 +49-8856-60-3417 penzberg.allgemein@roche.com www.roche.de 6,400 1896 (Group) S1–3

Areas of Activity · Biotechnology based research, development, production of diagnostics and raw materials (including Custom Biotechs), active pharmaceutical ingredients Annual Turnover · CHF 61.5 bn (Group) Relevant R&D Budget · CHF 11.7 bn (Group) Request for · www.roche.com/partnering.htm Further Collaborations

Company profile Penzberg is the Bavarian location of Roche Diagnostics GmbH. Situated south of Munich on 434,000m2, and with a workforce of around 6,400 employees, it is one of Europe’s largest biotech centres for research, development and the production of active pharmaceutical ingredients and diagnostics. With more than 45 years of experience, this site is a pioneer in the industrial scale of the biotechnology discipline. At the same time, Roche at Penzberg is the largest employer with significant economic impact in the region. Roche continues to expand the biotechnology competence in Penzberg.

This is how the site has been strongly expanded over the past years. Investments focused on production capacities for active pharmaceutical ingredients, diagnostics and overall infrastructure. This well exceeds a total of €1.3bn in the last five years that Roche has invested in the Greater Munich biotechnology.

Personalised Healthcare The Penzberg Biotech Center is the only Roche location in the world that performs research, development and production for both Roche Divisions: Diagnostics and Pharma. This results in extensive synergetic cross-networking between the two divisions and thus Roche is uniquely positioned to drive Personalised Healthcare (PHC) forwards. PHC is about providing the right treatment for the right group of patients. Roche’s strengths in pharmaceuticals and diagnostics along with advances in science and technology have made fitting treatments for patients possible. Previously, only five out of ten patients, on average, benefited from their treatment. Today, up to 80% of patients respond to their targeted therapies.

Targeted treatments are based on the molecular causes of disease. That means treatments are based on the presence of biomarkers and through companion diagnostic tests indicating mutations or genetic expressions in the patients’ tissue. For example, in the past, nonsmall cell lung cancer (NSCLC) was just diagnosed as NSCLC. Today, over a dozen gene mutations are known to play a role in this type of cancer. The detection of biomarkers via diagnostic tests allows for a more targeted treatment that patients can benefit from.

Roche Diagnostics

Diagnostics For the Roche Centralised and Point of Care Solutions business unit, Penzberg performs research, development and production of systems reagents and control sera for automated analysers in a professional lab environment or hospital related use. Growth drivers are immunological tests, the development of new biomarker tests and enzymatic clinical chemistry tests. Examples are thyroid parameters, lipid analysis, glucose metabolism, osteoporosis markers, cardiovascular diseases, womenâ&#x20AC;&#x2122;s health and fertility, infectious diseases and tumour markers. All components of the immunological tests and control sera are manufactured on site. Operations in Penzberg therefore produce over 700 different raw materials for all Diagnostics business units. It is safe to say that nearly all Roche Diagnostics tests contain components from Roche Penzberg. Furthermore, Roche is a renowned partner for custom biotech solutions in various fields.

Pharma The Greater Munich site also stands for units of Pharma Research and Early Development. The Roche Innovation Center Munich focuses on therapeutic proteins, including next generation monoclonal antibodies, and innovative gene therapy concepts. The portfolio comprises Rocheâ&#x20AC;&#x2122;s five major focus areas: oncology, immunology, infectious diseases, ophthalmology and neuroscience.

Biological and preclinical research for immuno oncology, biomarkers, the identification of tissue markers and histopathology are also located here, as is the management of clinical studies up to phase II. The department Technical Development Europe is at the cutting edge in developing manufacturing processes of high quality drug substance, parenteral drug product, devices, packaging and robust control strategies. It brings game-changing therapies from clinical phase I into the market. That core business is supported by a strong technical science and innovation pipeline assuring end-to-end technical excellence.

And moreover, Roche at Penzberg in the Greater Munich area is a large scale biotechnological production facility of active pharmaceutical ingredients (API), including monoclonal antibodies. Therapeutic APIs made in Penzberg target disease areas like cancer or anemia.

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Name · ScheBo®• Biotech AG (Head office) ScheBo®• Biotech UK Ltd. ScheBo®• Biotech USA Inc. Address/P.O. Box Postal Code/City State Contact Persons

· · · ·

Telephone Fax Email Website Number of Employees

· · · · ·

Founded (year) · Areas of Activity · Biological Patents ·

Netanyastrasse 3 35394 Giessen Hesse René M. Kröger, PhD Sonja Scheefers Jeffrey Scheefers +49-641-4996-0 +49-641-4996-77 schebo@schebo.com www.schebo.com 48 The academic staff has many years of experience in the research and development of diagnostics 1989 Development, production and marketing of diagnostics ScheBo®• Biotech AG holds many international patents in the above fields and owns a good intellectual property-position.

External · ScheBo®• Biotech AG has academic Collaborations alliances with several universities and university hospitals in Europe, the USA, Japan, Israel and Canada.

Awards · 1993 – Hessian Innovation Award of and Certificates the MBG 1998 – Hessian Innovation Award of the MBG 2002 – “Hidden Champion 2002” 2002 – “Innovationspreis der deutschen Wirtschaft“ (4 certificates) 2004 – Among the finalists for the “Innovationspreis der deutschen Wirtschaft”

Company profile ScheBo®• Biotech AG is an innovative biotech company that is active in the fields of development, production and marketing of diagnostics. ScheBo®• Biotech AG’s mission is to improve quality of health care by providing the best diagnostics with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION and SIMPLICITY. ScheBo®• Biotech AG was founded by the biochemists and molecular biologists Ursula Scheefers-Borchel, PhD, and Hans Scheefers, PhD.

Subsidiaries ScheBo®• Biotech UK Ltd., founded: 1999 ScheBo®• Biotech USA Inc., founded: 2001

The company ·· i s completely privately funded and independent, ·· operates internationally, ·· develops innovative diagnostics.

25 years of leading innovations R&D and manufacturing led to the successful launch and sales of the following products: ·· ScheBo®• Pancreatic Elastase 1 Stool Test ·· ScheBo®• Pancreatic Elastase 1 Serum Test ·· ScheBo®• Tumor M2-PK™ EDTA Plasma Test* ·· ScheBo®• Elastase Canine Test ·· ScheBo®• Quick-Prep™ ·· ScheBo®• Tumor M2-PK™ Stool Test* ·· ScheBo®• M2-PK Quick™ (lateral flow test)* ·· ScheBo®• 2in1 combi (M2-PK + Hb)™ (lateral flow & ELISA test)* ·· ScheBo®• Pancreas Elastase 1 Quick™ (lateral flow test) ·· ScheBo®• Pancreas Elastase 1 Quick™ Canine (lateral flow test) ·· ScheBo®• Hb Smart™ ·· ScheBo®• Lactoferrin Smart™ Stool Test ·· ScheBo®• Calprotectin Smart™ Stool Test ·· ScheBo®• SARS-CoV-2 Quick™ IgM/IgG (lateral flow test)

Schebo Biotech

·· ScheBo®• SARS-CoV-2 Antigen ELISA Test ·· ScheBo®• SARS-CoV-2 Antigen (lateral flow fluorescence test) * www.metabolic-database.com

Unique selling proposition Innovative diagnostics 1993 ScheBo®• Biotech AG launched the world’s first non-invasive, cheap routine test procedure for monitoring the exocrine function of the pancreas. Today highlyregarded clinicians and medical text books regard the ScheBo®• Pancreatic Elastase 1 ELISA, based on two monoclonal antibodies, as the “gold-standard” for noninvasive pancreatic exocrine function testing. ScheBo®• Biotech AG is world market leader for this FDA-cleared product. In 2013 the ScheBo ®• Pancreas Elastase 1 Quick™ test has been introduced as a point of care rapid test for the fast and reliable diagnosis/exclusion of Exocrine Pancreatic Insufficiency. Continuous innovation and strong customer focus have made ScheBo®• Biotech AG a leading molecular diagnostic company.

Closing a gap The ScheBo®• Tumor M2-PK™ EDTA-Plasma Test is the first test in the world which detects a metabolic state, specific to 11 cancer entities. The predictive value of Tumor M2-PK reflects tumour activity and aggressiveness. Thus, the ScheBo ® • Tumor M2-PK™ EDTAPlasma Test closes a gap in the clinical practice of cancer treatment management.

Fighting cancer, colorectal cancer screening The ScheBo®• Tumor M2-PK™ Stool Test is the first test detecting pyruvate kinase in stool, an excellent biomarker for colorectal cancer screening. This test has a sensitivity of 85% and a specificity of 95%. In 2012, ScheBo ®• Biotech launched ScheBo ®• 2in1 Quick™ (M2-PK+Hb), a brand new innovative combined rapid test to simultaneously detect the enzyme biomarker M2-PK and human haemoglobin for improved colorectal cancer screening. By simultaneously testing for M2-PK and haemoglobin (Hb), both non-bleeding and bleeding colorectal cancers and polyps can be detected.

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Name · SERVA Electrophoresis GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Number of Employees Founded (year)

· · · · · · · · · ·

Carl-Benz-Straße 7 69115 Heidelberg Baden-Wuerttemberg Dr Barbara Müller +49-6221-13840-0 +49-6221-13840-10 info@serva.de www.serva.de 45 1953

Areas of Activity · Laboratory (reagents, instruments), electrophoresis (precast gels, stains, markers, reagents and consumables, equipment); protein analysis (IEF, SDS PAGE, 2D, Western blotting)

Who we are “SERVA Serving Scientists” is our mission to supply top quality products that meet the demands of the life sciences research community. The SERVA portfolio comprises fine biochemical reagents and products for the separation of biomolecules with a focus on electrophoresis specialties. All processes are subject to SERVA’s quality management system certified according to ISO 9001:2015.

The name “SERVA” has been well-known for more than 60 years. SERVA Electrophoresis GmbH was founded in 1998 as a mid-sized private-owned entity. As the successor of the former SERVA Feinbiochemica GmbH & Co KG originally established in 1953, the know-how and expertise in biochemistry and protein separation stay with us until today. The company is located in the heart of Heidelberg, a centre of excellence in life sciences research. Heidelberg is situated within the enlarged Rhine-Neckar metropolitan region, a multi-industrial area where many biotech companies, pharmaceutical, and chemical enterprises are based.

What we do: continuing product development in electrophoresis Our strategy is to provide a comprehensive assortment of traditional as well as innovative specialties – all you need for your experiment. Well known in the community of Isoelectric Focusing (IEF) are the SERVALYT™ carrier ampholyte buffers. At SERVA, we develop and produce special reagents for protein electrophoresis, e.g. precast gels (SERVALYT PRECOTES™, FocusGel), markers, solutions, and stains. One of our latest and most famous technologies is “HPE™” (High Performance Electrophoresis) – a workflow in protein analysis which combines horizontal conventional electrophoresis with superb resolution by applying a large gel format using a unique equipment (HPE™ BlueHorizon™ flatbed system). Based on requests from customers we have developed the complete workflow and protocols for various applications, e.g.: ·· Isoelectric Focusing, analysing samples from food, plant, seeds, and diagnostics (e.g. urine, EPO)

serva electrophoresis

·· SDS PAGE 1D and 2D / DIGE Western blotting (proteomics, HCP coverage analysis) ·· Fluorescent, colorimetric and chemiluminescent detection and documentation

Separation of antibodies/antibody conjugates by HPE™ horizontal isoelectric focusing, kindly provided by Tobias Wagner, Roche Diagnostics GmbH, Penzberg/ Germany (2019).

But that’s not all. SERVA offers everything for common slab gel mini electrophoresis, calling it “PRiMETM” (Premium Resolution in Mini Electrophoresis) – precast gels, gel media, buffers, and blotting. Our equipment line called “BlueLine” supports electrophoretic separation and is exclusively available from SERVA and “made in Germany”.

You have protocols in place that utilise products that are no longer available? Looking for replacement of “ExcelGel™”, “PhastGel®”, or “Multiphor™ II” or even an automated gel-staining device? No problem. We have the solution (and the products) to transfer those applications to state-of-the art technology utilising HPE™.

What we offer: service and support – our application specialists are ready SERVA HPE™ BlueHorizon™ Flatbed Electrophoresis Chamber, with BluePower™ 3000 HPE™ PowerSupply

Our technical service department supports you with online services, videos, webinars, and workshops.

Need assistance beyond the standard support? Our experts can help you to establish your workflow – e.g. antibody separation by IEF or 2D Western blot-based HCP analysis. From sample preparation to evaluation we provide confidential consultation for our customers – our know-how for your success.

Quality matters Particularly in biotechnological production, compliance with quality standards is crucial for companies. SERVA offers qualification services (IOPQ) for our equipment line “BlueLine”. It is a unique service only available with us, carried out by our experts – from installation and operation quality assurance to process quality assurance within the framework of maintenance contracts, adapted to your needs at the silver, gold, or platinum level.

Blot scan of 2D separated HCP antigens – HCP sample was pre-labelled with SERVA Lightning Sci5, kindly provided by C. Geserick, BioGenes GmbH, Berlin/ Germany (2017).

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Name · Sino Biological Europe GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees

· · · · · · · · · ·

Düsseldorfer Str. 40 65760 Eschborn North Rhine-Westphalia Bin Hu, Ph.D. +49-6196-96786-56 +49-6196-96786-57 order_eu@sinobiological.com www.sinobiological.com

FL I 300

Areas of Activity · Focus on providing high-quality recombinant proteins, antibody reagents, and one-stop technical services for life sciences researchers around the world.

About Sino Biological Sino Biological is an international reagent supplier and service provider. The company specialises in recombinant protein production and antibody development.

All of Sino Biological’s products are independently developed and produced. The company’s ever-growing portfolio of products includes recombinant proteins, monoclonal antibodies, ELISA assay kits, expression clones, cell culture media, and other molecular biology tools. Sino Biological also offers a variety of customised services, mainly focusing on recombinant production of antigens and antibodies. Sino Biological is the researchers’ one-stop technical services shop for the advanced technology platforms they need to make breakthrougs.

In addition, Sino Biological offers pharmaceutical companies and biotechnology firms pre-clinical production technology services for hundreds of monoclonal antibody drug candidates.

Strengths of Sino Biological Sino Biological is also dedicated to virology and infectious disease research, and its newly launched ProVirTM virus-based reagent collection is the world’s largest viral antigen bank, carrying over 800 products from 50+ different types, 350+ strains of viruses. The ProVirTM viral antigen bank features an exclusive coronavirus catalog, a comprehensive collection of influenza antigens, and many other hard-to-find viral proteins such as Zika, RSV, Ebola, and Cytomegalovirus. These reagents are specifically developed to help the research and development of vaccines, treatments, and diagnostic assays.

sino biological europe

ProVir

TM

Viral Antigen Bank 800+ Viral Antigens from 350 Virus Strains Covering 50 Kinds of Viruses

The Global Leader in

Recombinant Technology

Sino Biological is the first company to produce the SARS-CoV-2 (COVID-19) viral antigens. Now, Sino Biological has developed the worldâ&#x20AC;&#x2122;s largest collection of antibodies and antigens for SARS-CoV-2, including recombinant antigens (the N protein, S protein, the S1 and S2 subunits of the S protein, and the RBD domain of the S proteins, Plpro protein), antibodies, antigen detection kits, coronavirus antigen array, and genes.

These reagents have supported hundreds of research groups around the globe in their vaccine and antibody development works. Sino Biological is also offering pseudovirus-based infection assay services, allowing rapid screening of antibodies and compounds for neutralisation potential.

Sino Biological offers comprehensive recombinant expression services to clients in the biomedical industry from gene synthesis to final products. The technical team stands behind years of experience from varieties of platforms, including mammalian cells, insect cells, and E. Coli.

Sino Biologicalâ&#x20AC;&#x2122;s location Sino Biological Europe is located in Frankfurt, Germany, providing close-to-customer local services. If you have any questions, please feel free to contact our local team in Germany (order_eu@sinobiological.com).

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Name · Sirius Fine Chemicals SiChem GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Number of Employees Founded (year)

· · · · · · · · · ·

Fahrenheitstr.1 28359 Bremen Bremen Dr Miriam Rittner +49-421-2208-228 +49-421-2208-226 mrittner@sichem.de www.sichem.de 15 2001

Areas of Activity · l Tools for Life Sciences l Custom syntheses l Purification / (Enantio)separation

Sirius Fine Chemicals SiChem GmbH (SiChem) is a privately held company founded in 2001 in Bremen.

SiChem’s unique expertise is based on the synthesis of masked derivatives of compounds with biologically and pharmacologically increased bioavailability (prodrugs) that are usually not suitable for drug development.

The masked drug candidates are successfully tested against several pathological conditions, for instance cystic fibrosis (CF), diarrhea, and inflammation. Some products have tested positively in animal and ex-vivo patient experiments.

Custom synthesis / contract research To complete complex projects for clients mainly from the biochemical, biomedical, and pharmaceutical sector requires concentration, flexibility, innovation, and also creativity. SiChem’s extensive experience in the area of custom synthesis / contract research helps to find optimum solutions for new tasks as well.

The SiChem team assists its clients competently until the agreed objectives are met, keeping in dialogue with them. Professional documentation is a matter of course.

SiChem’s chemical and technical know-how, which is constantly growing due to numerous custom syntheses from the pharmaceutical industry and biotech companies, is made available for new synthetic tasks and innovative research. Support is offered in the following areas: ·· classical custom synthesis (building blocks and target structures) for the areas of medicinal research, pharmaceutical development, lead compound, and prodrug development from mg to kg scale. ·· Synthesis of (API) metabolites (made synthetically or enzymatically) or stable labelled isotopes. ·· FTE based research & development

sirius fine chemicals

Custom purification / enantioseparation (www.prep4U.de) SiChem offers comprehensive services around preparative HPLC: ·· Purification of compounds (e.g. peptides, phamaceuticals, pesticides, and natural products) ·· Enantioseparation of racemic mixtures SiChem has profound and longstanding experience in the area of preparative HPLC – regardless of whether it is 100mg or 100kg that needs to be separated and regardless of whether this is reversed phase (RP) or normal phase (NP). Columns of (almost) every size and various stationary phases from polar to nonpolar and chiral are available. For sensitive compounds, supercritical fluid chromatography (SFC) with CO2 as solvent is used. This technology makes a valuable contribution to the environment (Green Chemistry).

Tools for life sciences SiChem synthesises fine chemicals and diagnostic tools for biochemical, biomedical, and pharmaceutical research. The core expertise is in the field of intracellular signaling, e.g. on derivatives of inositol phosphates.

SiChem constantly develops new tools for R&D, especially photoactivatable and fluorescent compounds for which there is a fast growing demand. The portfolio is supplemented by clickable unnatural amino acids and other innovative (PEGylated) tools for Click-Chemistry.

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Name · SphingoTec GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Neuendorfstr. 15A 16761 Hennigsdorf Brandenburg Dr Achim Plum +49-330-220-56-50 +49-330-220-56-555 info@sphingotec.de www.sphingotec.com

LI 70 2002

Areas of Activity · l Novel acute care diagnostics l Medical devices: Point-of-Care Testing External · SphingoTec is collaborating with Collaborations leading hospitals in Europe, the US, and Asia, a growing network of distribution partners, global IVD companies (out-licensing), and pharmaceutical companies (companion diagnostics).

Management · Dr Andreas Bergmann (CEO) Dr Achim Plum (CCO)

About SphingoTec SphingoTec GmbH develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction, and monitoring of acute medical conditions such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiterplate tests as well as point-ofcare tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of established and commonly used tests for acute and critical care.

Novel acute care biomarkers Following a deep understanding of disease biology, SphingoTec has developed novel biomarkers addressing diagnostically underserved critical care conditions.

The biomarkers have been clinically validated in over 100,000 patients and are available as rapid tests on the whole-blood point-of-care platform Nexus IB10.

Endothelial function biomarker bio-ADM® Bioactive Adrenomedullin (bio-ADM ®) is a dynamic biomarker for the real time assessment of endothelial function. Loss of endothelial function causes the formation of oedema, shock, and subsequent organ failure in critically ill patients.

Kidney function biomarker penKid® Proenkephalin (penKid®) is a dynamic biomarker for the real time assessment of kidney function. penKid® is a bloodbased alternative for detecting true glomerular filtration rate (true GFR) that is applicable in routine laboratory testing independent from inflammation and comorbidities.

Cardiac depressant factor DPP3 Dipeptidyl Peptidase 3 (DPP3) is a dynamic biomarker for assessing DPP3 release – one major cause of cardiac depression. The enzyme is at the core of a recently discovered disease mechanism leading to vasopressorresistant shock and short-term organ dysfunction.

sphingotec

Proprietary point-of-care technology: Nexus IB10 Nexus Dx Inc., a wholly-owned subsidiary of SphingoTec headquartered in San Diego, CA, USA, is a global provider of a near patient testing system and advanced diagnostic solution. The IB10 analyser system, without the need for sample preparation automatically separates plasma from whole blood samples with subsequent reliable and quantitative detection of biomarkers in the plasma by means of antibodies. With a hands-on time of less than 3 minutes the easy-to-use system provides in only 20 minutes test results for biomarkers that are crucial in the management of critical care patients. The portfolio of IB10 assays includes tests for established critical care parameters such as Procalcitonin, Troponin I, CK-MB, Myoglobin, NT-proBNP, and D-Dimer as well as tests for SphingoTec’s proprietary biomarkers such as bio-ADM®, penKid®, and DPP3.

Beyond SphingoTec’s own products, Nexus Dx offers the contract development and manufacturing of IB10 diagnostic and companion diagnostic tests to third parties in the diagnostic and pharmaceutical industries.

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Name · SSS International Clinical Research GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Landsberger Straße 23/25 82110 Germering Bavaria Dr Lars Behrend +49-89-8006500 +49-89-800650555 info@cro-sss.de www.cro-sss.eu

I 55 1993

Areas of Activity · Clinical Research

Short description SSS International Clinical Research is a specialist in clinical studies for medicines and medical devices in Europe with 28 years of market presence. Thus far the CRO (Clinical Research Organisation) has operated clinical trials in 22 countries on three continents.

As an operations specialist, SSS has developed accSIS, a proprietary Clinical Trial Management Software (CTMS) that enables the company to organise multinational trials with maximum project oversight and control.

Another key success factor is the team of senior specialists with deep insights into clinical operations and a high dedication to the projects of the customers. The results speak for themselves: SSS receives more than 90% of its business from existing customers. In addition, more than 95% of the study sites SSS is working with rate their services as good or very good.

Field of activity SSS is a full-service CRO covering all aspects of clinical operations in phase I to IV and non-interventional studies. ·· Feasibility and site selection ·· Regulatory consultancy ·· Clinical operation ·· Data management & biostatistics ·· Medical monitoring ·· Medical writing ·· GCP (AMG and MDR) trainings

Ownership structure and financing SSS International Clinical Research is a privately-owned company with its head office in Munich and two affiliate companies located in Romania and Poland.

SSS

Partners With its partners, SSS covers all of Europe, as well as the USA and Asia. Moreover, the CRO has a network of medical and regulatory specialists.

Technology The CTMS accSIS allows all team members in and outside the company to work with the same IT solution.

The results: avoidance of data silos and data loss as well as full control and oversight over all relevant aspects of the project.

Products & services SSSâ&#x20AC;&#x2122;s clients are big pharma, biotech, diagnostic and medtech companies. SSS consults throughout the complete project including the very first conception, the clinical conduct and the preparation of the clinical study report.

Unique selling point SSS offers a unique combination: as a mid-sized CRO, SSS is highly flexible and dedicated but at the same time has the experience, network, and IT systems to perform global trials.

Membership in networks & associations Member of BVMA Member of Bio Deutschland Associated member of EUCROF

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Name · Taconic Biosciences GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Marie-Curie-Str. 10 51377 Leverkusen North Rhine-Westphalia John DelliSanti +49-214-312-012-0 +45-69-80-35-99 info@taconic.com www.taconic.com

FL I 800 worldwide 1952 S1

Areas of Activity · Taconic Biosciences is a fully-licensed, global leader in genetically engineered rodent models and services

Taconic Biosciences is a fully-licensed, global leader in genetically engineered rodent models and services.

Founded in 1952, Taconic helps biotechnology companies and institutions acquire, custom generate, breed, precondition, test, and distribute valuable research models worldwide. Specialists in genetically engineered mouse and rat models, precision research mouse models, and integrated model design and breeding services, Taconic operates three service laboratories and six breeding facilities in the USA and Europe, maintains distributor relationships in Asia and has global shipping capabilities to provide animal models almost anywhere in the world.

Taconic’s main goal is always to provide our customers with the best solution, and this begins with superior products. From high-performance standard strains, to exclusive best-in-class models, to the most comprehensive genetic and health quality programme, Taconic sets customers up for success. In addition to offering superior products, Taconic also has the most comprehensive gene modification toolkit in the industry. Offering CRISPR gene editing, Easi-CRISPR, homologous recombination gene targeting, shRNAi silence targeted gene expression, pronuclear injection, and targeted transgenesis, Taconic’s model generation team is able to help customers find the right solution by being able to leverage all relevant technologies, in combination with 20 years of experience.

taconic

Finally, Taconic is the only comprehensive and integrated model design and breeding services provider, allowing seamless planning and integration of model generation and breeding projects. With PhD scientists managing and dedicated to each project from start to finish, Taconic starts each breeding discussion with a clear understanding of the customerâ&#x20AC;&#x2122;s goal and then creates a custom breeding plan with defined milestones. From the routine to the highly customised, Taconicâ&#x20AC;&#x2122;s quality and dedication to help customers succeed is what has made us an industry leader for over 60 years.

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Name · TETEC – TISSUE ENGINEERING TECHNOLOGIES AG Address/P.O. Box Postal Code/City State Contact Persons Telephone Fax Email Address Internet Website Number of Employees Founded (year)

· · · · · · · · · ·

Aspenhaustraße 18 72770 Reutlingen Baden-Wuerttemberg Dr Detlef Schumann +49-7121-16-26 111 +49-7121-16-26-249 detlef.schumann@tetec-ag.de www.tetec-ag.de 120+ 2000

Areas of Activity · Large-scale manufacturing of ATMPs, cell-based therapies, mACT (matrixassociated chondrocyte transplantation), and drug carrier development (hydrogels, collagen matrices) Request for · TETEC is interested in collaborations in cell-based therapies for research and product development, as well as contract manufacturing for biotech &

Further Collaborations

pharma companies entering the clinical stage with their developmental products. TETEC provides expertise in the manufacturing and registration of cell-based ATMPs, bioprinting of tissues and organs, and biohybrid product solutions. The company is looking into cell diagnostic solutions, products in advanced wound care, drug development in the therapeutic area of osteoarthritis, sports medicine/orthopaedics, immunotherapy, cardiovascular, and neurosurgery.

The company TETEC AG was founded in 2000 as a biotech spin-off of the University of Tuebingen and the Clinic for Trauma Surgery (Berufsgenossenschaftliche Unfallklinik) to develop, manufacture, and distribute advanced therapy medicinal products (ATMPs) in the field of orthopaedics using human cells and bioresorbable materials. Today, the company is European market leader in cell-based ATMPs by numbers – an affiliate of the AESCULAP AG and part of the B.Braun group.

A leader in the production of autologous cell therapies TETEC AG believes in the innumerable possibilities of cellbased therapies. With NOVOCART® 3D and NOVOCART® Inject the company has brought two proprietary products to the German and Swiss market intending to open new therapeutic options for patients with cartilage defects in knee and hip, and to restore their abilities to participate in daily life, and sports activities. More than 22,000 individual ATMPs have been manufactured by TETEC since 2004. In 2020, the company has filed for European market authorisation of its first product, and intends to enter the Asian Pacific market in the near future.

TETEC has become a specialised company with strong assets in ATMP development, and large manufacturing capacities. The company is operating under a full GMP manufacturing licenc and ISO 13485 certification, with two separated state-of-the-art, multi-purpose manufacturing facilities and a total of almost 800 m2 of multistaged clean rooms (C/D) equipped with class A isolators, dedicated quality control laboratories, proprietary logistics, and departments for clinical development and regulatory affairs.

TETEC

Full pipeline for cartilage repair, osteoarthritis, and beyond TETEC’s know-how in chondrocyte cell culture and smart biomaterials sets new benchmarks in the biotechnology industry. The company is conducting an extensive research & development programme with a focus on biomaterials as drug carriers and as a treatment for osteoarthritis. TETEC collaborates with a number of prestigious national and international cooperation partners from hospitals, universities, and industry, and invites other companies to get in contact for contract manufacturing or to partner up for ATMP projects in product development, GMP manufacturing, and registration, from early clinical development up to market access.

TETEC –Tissue engineering Technologies AG is located in Reutlingen, Baden-Wuerttemberg, close to Stuttgart.

The managing directors of TETEC AG are Dr Detlef Schumann, Dr Sebastian Braun-Lüdicke, and Dr Christoph Gaissmaier.

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Name · Thermo Fisher Scientific

Address/P.O. Box · 168 Third Avenue Postal Code/City · 02451, Waltham, MA Country · United States Subsidiary: Address/P.O. Box · Frankfurter Str. 129B Postal Code/City · 64293 Darmstadt State · Hesse Contact Person Telephone Email Address Internet Website Number of Employees Founded (year)

· · · · · ·

Matthias Saner +41-79-7775041 matthias.saner@thermofisher.com www.thermofisher.com >75,000 employees 2006

Areas of Activity · l Analytical l Pharma services l Biotech l Cell therapy l Gene therapy l Biosciences l Bioproduction l Viral vector services l Diagnostics l Instrument services l Applied sciences l Antibodies l Cinical services l Lab solutions l Microbiology l Digital solutions Relevan R&D Budget · >$1bn invested in R&D

Research Solutions for Biotech Companies Our mission at Thermo Fisher Scientific is to enable our customers to make the world healthier, cleaner and safer. We view our partners in the biotechnology sector as vital to fulfilling this mission.

As a company with the resources and expertise to support every aspect of your development process, we are positioned to help you succeed.

You are the innovators who introduce effective new therapeutics; enhance the reliability and consistency of diagnostics; and provide services that help researchers and manufacturers conduct their essential work. We are an industry-leading team that has your back; your extra edge in a tough environment; the only partner you need to source the products, services, resources, and support – backed by unrivaled scientific and market knowledge – that can help you make a difference for the future of health care.

Partner with us and you are connected to a team of consultative professionals with knowledge across the biotechnology industry, from the lab, to compliance, to commercialization. We empower you with expert, hands on technical support. Our proven track record of helping to facilitate scientific advancements is built on the foundation of our unmatched portfolio of trusted, highquality products and technologies, widely regarded as best-in-class in the industry.

Everything we do to support our biotech partners is ultimately driven by our mutual goal of improving health outcomes. At Thermo Fisher Scientific, we help you anticipate and conquer the inevitable challenges with highly informed, fast, reliable, scalable, and costeffective solutions.

thermo fisher scientific

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.

For more information, please visit www.thermofisher.com.

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Name · TheryCell GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · ·

Schlossstrasse 110 12163 Berlin Berlin Dr Steffen Hennig +49-30-548298-90 +49-30-546116-98 hennig@therycell.de www.therycell.com 5 2017 Molecular Biology Lab

Areas of Activity · l Cancer immunotherapy l T cell profiling l Immune system l Tumour-reactive T cells Biological Patents · EP2746405 ‘Methods and primer sets for high throughput PCR sequencing’ EP3180433 ‘Method for providing tumour-specific T cells’ External · l Vivantes Clinics Berlin Collaborations l Charité Berlin l UMC Mainz l University Hospital Kiel l NMI Reutlingen Request for · Pharma companies with R&D in Further Collaborations immunotherapies

Background The insight that the immune system is capable of eliminating malignant cells has stimulated the development of a variety of immunotherapeutic approaches. During the last decades, this has resulted in clinically proven treatments for many cancers. Particularly successful and revolutionary was the more recent introduction of the checkpoint inhibitors, which effectively restore the function of silenced T cells. In some of the patients they induce a complete and durable response with the hope of a permanent cure. Nevertheless, checkpoint inhibitors show activity only in a sub-fraction of patients and due to their underlying mechanism they increase the risk of autoimmunity. There is, therefore, still the need for effective treatments with much broader activity and high tumour specificity.

TheryCell was founded in 2017 by a small team of people bringing together expertise in T-cell analysis, bioinformatics, sequencing, and molecular biology technologies, as well as business and management experience in biotech start-ups and Big Pharma companies.

From the beginning our clear focus has been the development of a novel therapy against various cancers based on tumour-reactive T cells, which we identify in a patient’s individual tumour tissue.

The principles of our technology are patent protected and tested in dozens of tumour samples. We are currently active in several cooperations with clinics and research institutes to promote our concept and to prove the tumour killing potential of our dedicated T-cell selections.

Principles of a novel immune therapy Our approach is based on natural tumour-specific T-cell receptors (TCRs). We focus on T cells that have escaped negative selection in the thymus and after their encounter with tumour antigens have evolved into dominant tumour-specific T-cell clones. Employing proprietary

Therycell

DNA Sequencing is our key to identify the tumor-reactive T-cells

technologies of immune-sequencing and special tissue handling, TheryCell is able to decipher complex T-cell repertoires in the tumour (TILs) and to identify the most relevant ones: the tumour reactive T cells. Sequencing their alpha/beta TCRs provides us with the basis for a truly tumour-specific personalised TCR-gene therapy. For such treatment safety and high efficacy can be expected and it will be fully compatible with the individual spectrum of HLA subtypes of the patient.

What makes us different?

TheryCell’s patented technology is able to identify tumour-reactive T cells by comparative sequencing – without any a priori knowledge of tumour antigens. In addition, we employ cutting-edge single-cell sequencing technology to unravel all the details of the respective T-cell receptors.

Our mission T-cells attacking and killing a cancer cell.

Engaging a patient’s own immune system against her/ his cancer is the most promising strategy for future tumour therapies.

At TheryCell we are developing a new approach to learn from a patient’s own T cells how to direct them against her/his individual cancer. It is our strong belief that following these lines we can implement a new kind of personalised immunotherapy for solid tumours with improved efficacy and safety.

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Name · Tosoh Bioscience GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · ·

Im Leuschnerpark 4 64347 Griesheim Hesse Regina Roemling +49-6155-7043700 +49-6155-8357900 Info.tbg@tosoh.com www.tosohbioscience.de >20 1989 Supplier of chromatography media, HPLC and UHPLC columns Application support in analysis and purification of biomolecules.

Tosoh Bioscience is an acknowledged global leader in the field of liquid chromatography with a focus on bioseparations. For more than 30 years, Tosoh Bioscience is providing cutting-edge solutions to meet the needs of customers developing and producing new biologics, biosimilars or biobetters, such as plasma products, monoclonal antibodies, recombinant proteins, vaccines and oligonucleotides.

Our product portfolio encompasses SEC instruments and a comprehensive line of media and prepacked process development, HPLC, and UHPLC columns. These products are popular in the biotech and biopharmaceutical industry and used in R&D, downstream processing, and quality control. Typical applications comprise the purification of therapeutic proteins in lab, pilot, and commercial scale, as well as their characterisation by HPLC or UHPLC. Latest developments comprise TOYOPEARL rProtein A and L for the capturing of antibody constructs, salt tolerant ion exchange and mixed-mode media, and a revolutionary HPLC column for the analysis of IgG glycoforms based on their affinity to the Fc receptor, TSKgel FcR-IIIA-NPR. Recently, the award winning LenS3TM MALS detector for(U)HPLC and GPC - the most profound innovation in light scattering technology for decades – has been introduced in Europe.

Headquartered in Griesheim Germany, in the Frankfurt/ Rhine-Main Metropolitan Region, Tosoh Bioscience’s European operations offer extensive technical support like application development, on-site training and workshops. One of the services that stand out in the industry is the Tosoh Chromatography Workshop Series providing a comprehensive background to the chromatographic purification of biomolecules.

Tosoh Bioscience

Tosoh Bioscience is part of the Tosoh Group, a Japanese chemical and speciality products and materials group, founded in 1935, which comprises over 100 companies worldwide and a workforce of more than 11,500 people.

Our brands TOYOPEARLÂŽ and TSKgelÂŽ are renowned for their quality and reliability. The stationary phases cover all common modes of liquid chromatography, including ion exchange, hydrophobic interaction (HIC), mixed-mode, reversed phase, hydrophilic interaction (HILIC), size exclusion (SEC) and affinity.

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Name · TRIGA-S Scientific Solutions

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Mühltal 5 82392 Habach Bavaria Sabine Radiske (CEO) +49-8847-695-78-0 +49-8847-695-78-29 info@triga-s.de www.triga-s.de

LI  96 1998 Contract laboratory (BSL 2)

Areas of Activity · Analytical and clinical performance evaluations of in vitro diagnostics (IVD), companion diagnostics (CDx), and medical devices (MD): l Study management l Study monitoring l Laboratory testing services l Sample management (sourcing, processing, storage) lR egulatory affairs l Biostatistics l Study logistics External · Research institutes, clinics, contract Collaborations developing, and manufacturing organisations Request for · TRIGA-S seeks synergistic Further Collaborations collaborations in the field of clinical development of IVD and medical devices

Company profile TRIGA-S is a full-service Contract Research Organization (CRO) for in vitro diagnostics and medical devices, certified according to DIN EN ISO 13485 and 9001. As a well-established partner of the diagnostics industry, we offer tailor-made solutions for technical and clinical studies as well as laboratory testing services – from feasibility to routine. Our GCP/GCLP-qualified teams work according to IVDR, MDR and national regulations.

How we support IVD development (ISO 13485) We support manufacturers in all stages of the IVD product development process from early proposal phase through feasibility, design, verification, and validation to launch and post-market clinical follow-up. Our expertise includes intended use, feasibility study design and conduction, analytical and clinical performance evaluations, risk management, regulatory affairs, and market surveillance.

Enabling IVDR compliance The new EU-IVD regulation (IVDR) is planned to be enforced 26 May 2022, including a new risk-based classification system and increased requirements for documentation, clinical evidence, post-market surveillance, economic operators, transparency, and traceability. TRIGA-S supports manufacturers in the transition to IVDR with: ·· Classification of products/gap assessment ·· Development of IVDR compliance strategies for marketed and new products ·· Analytical and clinical performance evaluations ·· Project management that coordinates client requirements, development partners, suppliers, and the liaison with notified bodies/regulatory authorities.

triga-s

Covering the full study continuum Study management ·· Planning/execution of performance evaluations (IVDR/MDR/CFR-FDA) ·· Risk-based planning and surveillance of processes ·· Regulatory consulting ·· Biostatistics and data management Study monitoring ·· Selection of study sites, study initiation, monitoring, and close-out ·· Site training ·· SAE-reporting ·· Post-market clinical follow-up (PMCF) Contract laboratory (S2) ·· Measurements on several platforms for clinical chemistry, immunology, NAT, ELISA, and PCR ·· Client-specific analytical performance evaluations ·· Feasibility testing and exploratory studies Study logistics ·· Worldwide coordination of sample and material shipments ·· Full traceability, barcoding, and temperature control Sample processing ·· Sample kit preparation – customised, small to large volumes ·· Collections of clinical samples ·· Sample management (LIM-System) ·· Pooling and aliquoting Sample storage ·· Long-term storage of human samples and study materials at –80 °C, –20 °C, 2–8 °C, RT, and 37 °C ·· Temperature monitoring 24/7 and backup systems

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Name · UGA Biopharma GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · ·

Neuendorfstr. 20a 16761 Hennigsdorf Brandenburg Dr Lars Kober +49-3302-2024-900 +49-3302-2024-901 info@ugabiopharma.com www.ugabiopharma.com 38 2009 S1

Areas of Activity · l Cell Line Development Services l New Biological Drug Development l Biosimilar Development l Ready-to-Use Biosimilar Cell Lines l Cell Culture Media and Feeds Request for · UGA Biopharma is seeking l Strategic partnerships for upscaling and GMP manufacturing l Collaboration for development of

Further Collaborations

NBEs or biosimilars l Cooperation partners for in-licensing our Ready-to-Use Biosimilar Cell Lines We would be happy to discuss your request.

UGA Biopharma is an expert in the area of developing mammalian cell lines for biopharmaceutical products.

We offer customised cell line development services for new biological entities (NBEs) and biosimilars. UGA’s mission is to deliver high-end contract services that satisfy and exceed customer expectations. With our dedication to constantly improving our operations, we see ourselves as a reputable and prosperous player known for quality and reliability.

Customised Cell Line Development Services UGA Biopharma is the right partner for industry and academia when it comes to the development of cell lines expressing biologics for clinical trials and market access. We guarantee consistently high quality and full traceability of Cell Line Development activities. Our proprietary approach for success is a combination of host cell line, optimised expression vector, and high performance First CHOice® medium and feeds. Unique and long lasting expertise in cell line development, bioprocess optimisation, downstream processing, and analytics complete our services.

Ready to Use Biosimilar Cell Lines* Biologics are one of the most cost-intensive treatments on the global market today, which implies the need for low-cost alternatives. UGA has gained its expert knowledge by developing biosimilar cell lines for eleven years now. UGA ensures high analytical biosimilarity by balancing clone choice, USP process, and DSP development carefully for each biosimilar. Besides developing a biosimilar cell line on request, we promote a broad spectrum of Ready to Use Biosimilar Cell Lines, including documentation, which are ready to out-license to a collaboration partner: ·· Adalimumab ·· Bevacizumab ·· Darbepoetin alfa ·· Ipilimumab ·· Natalizumab ·· Nivolumab

uGA biopharma

·· ·· ·· ·· ··

Omalizumab Panitumumab Pembrolizumab Pertuzumab and many more …

High Performance First CHOice ® Medium and Feeds First CHOice® Medium is a high performance cell culture medium optimised for mammalian cell lines. In combination with First CHOice® Feeds it has been optimised to boost the cell growth and productivity in batch, fed-batch, and perfusion processes. The completely chemically defined, animal component- and protein-free medium has been developed in close cooperation with customers using CHO-S, CHO-DG44, and CHO-K1 cell lines in order to minimise stress-related metabolites such as lactate and ammonia. In this way high product quality and cell viability is guaranteed during all cultivation phases.

*Disclaimer: Until the expiration of the patent and potential supplementary protection certificates related to the reference medicinal product the client must not (i) produce, offer or put on the market the respective medicinal product or possess the product for such purposes, or (ii) use the cell lines or products offered by UGA Biopharma except for experimental use or for studies and trials necessary to obtain a marketing authorization for medical products in accordance with Art. 11 No. 2 and 2b of the German Patent Act. The client undertakes to pay to the patent holder for each case of contravention against the undertaking set forth in the preceding sentence a penalty, the amount of which shall be determined by the patent holder at its reasonably exercised discretion and in case the PARTNER considers patent holder’s determination of the penalty to be not equitable judicially reviewed upon request of the PARTNER by the patent litigation chamber of the district court in Düsseldorf (Germany).

Brand names of reference medicinal products within this presentation are the trademarks of different pharmaceutical companies with whom UGA does not have any business or licensing relationship.

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Name · VAXIMM AG

Address/P.O. Box · Technologiepark Basel Hochbergerstrasse 60c Postal Code/City · 4057 Basel Country · Switzerland Operations: VAXIMM GmbH Address/P.O. Box · Landteilstrasse 24 Postal Code/City · 68163 Mannheim Country · Germany Contact Person Telephone Email Address Internet Website Number of Employees Founded (year) Type of Laboratory

· · · · · · ·

Dr Heinz Lubenau, CEO & Co-Founder +49-621-8359687-0 info@vaximm.com www.vaximm.com 10 2008 R&D

Areas of Activity · l Oncology drug development l Oral T-cell immunotherapies l Neoantigens l COVID-19 program External · Clinical collaboration with Merck KGaA Collaborations and Pfizer Inc. to evaluate VXM01 in combination with avelumab Development and commercialization agreement with China Medical System Holdings for China and other Asian countries (excluding Japan) Clinical trial collaboration with NEC Corporation to develop personalized neoantigen cancer vaccines Request for · New development partnerships and Further Collaborations collaborations with both industry and academia for the proprietary oral T-cell activation therapy platform and product candidates are welcomed

VAXIMM AG is a privately held, clinical-stage, Swiss/ German biotech company developing oral T-cell immunotherapies for patients suffering from cancer.

VAXIMM is headquartered in Basel, Switzerland. Its wholly owned subsidiary, VAXIMM GmbH, located in Mannheim, Germany, is responsible for the Company’s development activities.

Technology VAXIMM’s plug and play technology is based on first-inclass oral T-cell activators that can be readily adapted to target a wide range of cancer-related and other antigens.

The platform is based on the live attenuated bacterial vaccine strain Ty21, which has been administered to millions of people as a prophylactic vaccine to temporarily protect them from typhoid fever. This strain has been proven to be safe and well tolerated. All immunotherapies resulting from this platform are taken orally by the patient.

After oral ingestion, the modified Ty21a bacteria, which contain the cDNA of the desired cancer target(s), pass the stomach and invade the patient’s Peyer’s patches located in the small intestine. Uptake of the bacteria in macrophages, the eating cells present in these lymphoid tissues, leads to strong expression of and subsequently to a specific cellular immune response towards the encoded cancer antigen(s). These so-called “killer” T-cells then destroy the respective antigen-expressing tumor or tumor stroma cells.

The oral bacterial technology enables delivery to the most immunocompetent organ of the body, targeting the lymphatic tissue of the gut, and has been shown to generate robust T-cell responses against many different antigens in animals and humans in first clinical studies.

The low therapeutic doses required for specific T-cell activation make this approach suitable for continuous dosing (prime & boost administrations), without raising anti-carrier immunity, and provide another safety margin for carrier-related toxicity.

The platform is suitable for addressing multiple targets with one treatment and can be combined with additional

vaximM

immune therapies. Other major advantages of this approach include the high modularity (plug and play), the low cost and robustness of the production process, and the rapid development timelines to take products from concept to clinic.

Product pipeline

Mode of Action Intra-lymphatic Delivery via Oral Administration

The Company’s lead product candidate, VXM01, is an investigational oral T-cell immunotherapy targeting VEGFR2 that is designed to activate T-cells to attack the tumour vasculature, and, in several tumour types, attack cancer cells directly. A Phase I/II trial in advanced pancreatic cancer showed that VXM01 was well tolerated and led to the activation of VEGFR2-specific cytotoxic T-cells, which was associated with significantly improved patient survival. An additional clinical Phase IIa trial in metastatic colorectal cancer has been completed. In a Phase I trial in recurrent glioblastoma, two objective responses were observed – one with VXM01 as a monotherapy and one in combination with a checkpoint inhibitor – in addition to long-term survival.

Based on these data, VXM01 has received orphan designation from the European Commission and from the US Food and Drug Administration (FDA) for the treatment of glioma, a difficult-to-treat form of brain cancer.

Additionally, VAXIMM has a collaboration agreement with Merck KGaA, Darmstadt, Germany, and Pfizer Inc. to evaluate avelumab, a human anti-PD-L1 antibody, in combination with VXM01. Under the terms of the agreement, VAXIMM has started an open-label Phase I/II trial in progressive glioblastoma patients, which is ongoing.

In the first nine patients treated, three objective clinical responses were observed, supporting the findings from the earlier study conducted in glioblastoma.

VAXIMM’s neoantigen program is in pre-clinical development and has already shown immune proof of concept; the Company’s platform allows for fast generation and delivery of personalized T-cell vaccines and may overcome key issues with other neoantigen approaches. A clinical Phase I basket study in collaboration with NEC is currently in preparation. Additional programs are in pre-clinical development and can be developed as stand-alone therapies or in combination with other immunotherapies.

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Fast Screening of Functional Antibodies

Name · Velabs Therapeutics GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Number of Employees Founded (year)

· · · · · · · · · ·

Meyerhofstraße 1 69117 Heidelberg Baden-Wuerttemberg Dr Christoph Antz +49-6221-387-8194 +49-6221-387-8306 info@velabs-therapeutics.com www.velabs-therapeutics.com 5–20 2017

Areas of Activity · Fast screening for functional therapeutic antibodies

About Velabs Velabs Therapeutics (www.velabs-therapeutics.com), is a spin-off company founded by Europe’s most renowned life science research institute, the European Molecular Biology Laboratory (EMBL, www.embl.de) and its technology transfer arm EMBLEM Technology Transfer GmbH (EMBLEM, www.embl-em.de). The institute has an outstanding track record in instrument development and is a world leader in microfluidic-based screening technology and application. The company is currently hosted on EMBL’s Campus area in Heidelberg. Current active investor is Xlife Sciences AG (m:access: XLS; www.xlifesciences.ch), a Swiss company focusing on the performance of promising life science technologies.

Xlife cooperates with industrial partners and universities, leads projects through the proof of concept phase and offers investors the advantage of a very early and direct entry into the further development of innovative, future-oriented technologies.

Velabs’ technology Velabs is a pioneer in droplet-microfluidic technology for the screening of antibodies with modulatory function on complex signaling proteins. Its proprietary highthroughput screening platform makes it possible to test millions of correctly paired, fully natural human and mouse IgGs for therapeutic effects. Results are achieved in only a fraction of the time required by other technologies.

The Company offers customized screening services for users worldwide. In addition to the execution of service projects, Velabs is currently building its own pipeline of therapeutic antibody candidates for further joint development with pharmaceutical partners.

Velabs is currently hosted on EMBLâ&#x20AC;&#x2DC;s Campus area in Heidelberg

velabs

Competitive advantage Workflow of functional antibody screening

In terms of functional screening of antibodies, Velabsâ&#x20AC;&#x2122; system is superior to current available microfluidic and other systems: 1) in initial signal normalization and quantification (Velabs filters directly and in real time on screen for the quantity of the mAb induced functional modulation, i.e. the strength of antagonistic or agonistic action),

Time point optimization of signal readout

2) in the fact that compared to existing conventional (microtiter plates) and microfluidic (e.g. valve-based arrays) systems only Velabs offers a temporal resolution for monitoring transient cell signals, i.e. Velabs analyzes every single mAb at identical timepoints after initial incubation with reporter cells (few milliseconds up to several minutes or even longer). This is crucial for optimized S/N ratios in the case of GPCRs (Ca influx after stimulation) or ion channels (ion flux after modulation).

Business model Currently, Velabs has established and optimized processes and assays for ion channels and GPCRs and is also working on other screening formats (T-cells, beadbased peptide or small molecule libraries or analyses of different Ab display systems).

Cell-based functional Ca-flux assay with antibodies

Up to date, Velabs has set up several industry partnerships (license deals up to sales royalties) in the development of functional therapeutic mAbs against GPCRs/ion channels and in other cell-type screenings (T-cell repertoire).

The company currently explores and expands further pharma partnerships.

Moreover, the company develops a portfolio of own pipeline candidates on a pre-selected and well filtered set of highly disease relevant orphan GPCRs, ion channels and other proteins. Related indications are Inflammatory bowel diseases (IBD), senescence related degeneration and immune-related oncology, most of those with unmet medical need and enormous market potential.

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Name · Vetter Pharma International GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Emails

· · · · · ·

Eywiesenstrasse 5 88212 Ravensburg Baden-Wuerttemberg Johannes Clemens +49-751-3700-0 EU and other international inquiries: info@vetter-pharma.com US inquiries: infoUS@vetter-pharma.com Asia Pacific inquiries: infoAsiaPacific@vetter-pharma.com Website · www.vetter-pharma.com Number of Employees · Approx. 5,000 Founded (year) · 1950 Areas of Activity · Development support, aseptic contract filling and packaging of compounds into syringes, vials, and cartridges External · Strategic alliance with Rentschler Collaboration Biopharma SE, headquartered in Laupheim, Germany, for bioprocess development and API production (since July 2020)

A strategic partner focused on your success Vetter is an international specialist in the production of aseptically prefilled syringe systems, cartridges, and vials. We are a family-owned, independent company and do not manufacture our own drugs. Our focus is on providing highly skilled support and state-of-the-art manufacturing resources – from the initial phases of clinical development and the regulatory approval process to successful product launch, commercial manufacturing, and life cycle management. Vetter has extensive experience with biologics and other complex compounds. More than 80% of Vetter’s active projects are biologics.

Resources for every stage of growth Vetter’s full portfolio of services includes dedicated resources for both clinical development and commercial manufacturing. In addition, we provide expert packaging technologies and solutions tailored to your product’s specific market needs.

Vetter Development Service Planning for success Preclinical through Phase III is a pivotal and unpredictable period for new molecules. Vetter Development Service helps smooth the path to clinic with dedicated support for key stages of development, testing, clinical manufacturing, and regulatory approval. We also help you integrate thoughtful, efficient life-cycle solutions for long-term growth and success. Vetter Development Service provides: ·· Formulation support ·· Process development ·· Clinical trial manufacturing ·· Analytical services ·· Regulatory support Vetter Commercial Manufacturing Filling your potential Precise manufacturing. Creative thinking. It takes both to succeed in a competitive marketplace. Vetter Commercial Manufacturing supports your injectable with more than 40 years of expertise in high-quality, state-

vetter pharma international

VETTER DEVELOPMENT SERVICE

VETTER COMMERCIAL MANUFACTURING

of-the-art aseptic filling – and experience-based solutions that add value and increase efficiency. Vetter Commercial Manufacturing provides: ·· Fill and finish ·· Analytical services ·· Regulatory support ·· Life cycle management Vetter Packaging Solutions Packaging matters Material compatibility. Patient convenience. Market differentiation. There are many factors to consider in the selection of your primary and secondary packaging materials. Which ones matter most to your compound’s performance and long-term potential? Vetter’s packaging experts help you find the right solutions throughout your product’s life cycle. Vetter Packaging Solutions provides: ·· Customised packaging development ·· Systems & technologies ·· Proven platform technologies ·· Packaging services ·· Serialisation services ·· Logistic services ·· Sterile water for injections

Fast facts: Vetter-at-a-glance

VETTER PACKAGING SOLUTIONS

·· Headquarters in Ravensburg, Germany ·· Commercial production sites in Ravensburg and Langenargen, Germany ·· Additional clinical development facility in Chicago, US ·· Branch offices for Asia Pacific in Singapore and South Korea, as well as a subsidiary in Japan ·· Approximately 5,000 employees ·· Worldwide specialist in the aseptic production of prefilled drug delivery systems ·· Global experience and expertise with regulatory authorities including FDA, EMA, PMDA (Japan), and RP (Germany) ·· Service offering for small and large pharma/biotech firms worldwide ·· Numerous patents including technologies for protection against tampering and counterfeiting ·· Lyophilisation (freeze-drying) and siliconisation specialist 22 nd Guide to german biotech companies 2021

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Name · Vibalogics

Address/P.O. Box Postal Code/City State Contact Person Telephone Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · ·

Zeppelinstr. 2 27472 Cuxhaven Lower Saxony John Shaw +49-4721-565-400 experts@vibalogics.com https://vibalogics.com/

I 70 2006 Biologics CDMO

Areas of Activity · l Virotherapy products l Oncolytic viruses l Viral vector vaccines l Viral vector gene therapy l Process development l Formulation development l GMP manufacturing l Fill and Finish l Lyophilisation l Drug substance l Drug product

Vibalogics is a global contract development and manufacturing organisation (CDMO) offering process development, manufacturing, testing, and fill-finish services to innovators developing revolutionary virotherapy products.

From our GMP-BSL-2-classified facility in Germany, we offer activities for clinical drug development, from feasibility assessment to product release. Our latest expansion in the U.S will enable us to deliver late-phase and commercial manufacturing to support clients across the complete product journey.

With a track record in oncolytic viruses and viral vectors that spans over 15 years, our team offers a unique understanding of virotherapy manufacturing that enables high quality and efficient delivery.

Vital expertise in virus production Our scientists have experience manufacturing with highdemand organisms and live viruses. ·· ·· ·· ·· ·· ·· ·· ·· ·· ··

Cell banking and characterisation Virus seed stock generation and characterisation Feasibility studies and productivity optimisation Genetic stability studies Assay development including infectious particle, genomic virus particle, and total particle Primary cell culture (CEFs) suitable for viruses such as MVA Production of oncolytic viruses and gene vectors Production in roller bottle, Cell FactoryTM, T-flask, HYPERFlaskTM, and iCELLisTM systems Single-use, scalable bioreactor technology Specific Pathogen Free (SPF) eggs and Chicken Embryonic Fibroblasts (CEF) for live products

cGMP Manufacturing Our operations are designed around the GMP production of drug substance and drug product, so that we can support our customers through each phase of the clinical and commercial journey.

vibalogics

We save time and facilitate a seamless transition between process development and GMP activities by avoiding the need for internal process technology transfer.

cGMP Fill/Finish Our team delivers a fully integrated, fill-finish service for liquid and lyophilised products from a dedicated BSL-2 and GMP-compliant suite.

We offer fill-finish services for: ·· Viral vaccines ·· Monoclonal antibodies ·· Recombinant proteins ·· Diluents and placebos Our capacity: ·· Validated manual fills up to 1,500 vials per batch ·· Validated automatic fills up to 30,000 vials per batch

Lyophilisation Lyophilisation is recognised as one of the most effective ways of stabilising and protecting sensitive virotherapies when cold chain maintenance proves difficult. The technique also offers financial benefits by eliminating the need to produce additional batches for trials.

Our lyophilisation capabilities include: ·· State-of-the-art technologies to optimise your lyocycle, including wireless temperature sensors and comparative temperate analysis with pirani. ·· Christ Epsilon 2-6D LSC plus equipment with up to 800 DIN 2R glass vial capacity (for GMP transfer). ·· Martin Christ Epsilon 2-12D lyophiliser, with a maximum capacity of around 3,000 DIN 2R glass vials.

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Name · Vivoryon Therapeutics AG

Address/P.O. Box · Weinbergweg 22 Postal Code/City · 06120 Halle (Saale) State · Saxony-Anhalt Address/P.O. Box · Franz-Josef-Delonge-Strasse 5 Postal Code/City · 81249 Munich State · Bavaria Contact Person Telephone Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · ·

Dr Ulrich Dauer +49-345-555-99-00 info@vivoryon.com www.vivoryon.com

LI 17 1997

Areas of Activity · l AD l Cancer l Fibrosis

Vivoryon Therapeutics (Euronext Amsterdam: VVY) has an experienced discovery and development team with a strong track record in delivering therapies to patients. We have product candidates in both clinical and preclinical development and are focusing on firstin-class drugs that target post-translational modifying enzymes.

Vivoryon Therapeutics is focusing on the discovery of novel therapeutics with action on disease relevant enzymes. Our most advanced clinical-stage programme, varoglutamstat (PQ912), is a selective inhibitor for glutaminyl cyclase (QPCT), which is primarily expressed in the brain. An isoform of QPCT is QPCTL, which is more broadly expressed in healthy and cancerous tissues. Both enzymes catalyse the transformation of an N-terminal residing glutamine or glutamate amino acid into their cyclic form called pyroglutamate.

The main physiological functions of this cyclisation could be exemplified by PQ912’s mode of action in both Alzheimer’s disease and cancer.

QPCT in Alzheimer’s disease QPCT is a post-translational modifying enzyme which catalyses the pyroglutamate formation of N-terminal residing glutamine or glutamate amino acids in substrate proteins. This cyclisation has two main physiological functions: one is the mediation of protein-protein interactions, the other is the stabilisation of peptides and chemokines. Both of these events can have significant impact on protein functionality in healthy and diseased tissue.

In Alzheimer’s disease QPCT has been identified as the crucial human brain enzyme for the generation of very stable and sticky pyroglutamate (pGlu) species of Abeta. Findings from various parties strongly support that these pGlu species are especially neuro- and synaptotoxic and correlate with AD disease progression.

Vivoryon

QPCTL in cancer The CD47-SIRPa interaction is an important myeloid immune checkpoint whose clinical relevance has been shown by successful application of CD47 antibodies in cancer therapy. CD47 is expressed on cancer cells and SIRPa on myeloid cells such as macrophages and NK cells. QPCTL is critical for pyroglutamate formation on the N-terminus of CD47 shortly after biosynthesis. The formation of pyroglutamate on CD47 is essential for the binding of SIRPa. Thus, QPCTL is a novel and attractive target to silence the “do not eat me” signal provided by the CD47-SIRPa interaction.

As opposed to antibody approaches in clinical development our small molecule QPCTL inhibitors are a first-inclass and innovative therapeutic approach for boosting the efficiency of cancer immunotherapy.

Meprin in acute and chronic kidney disease Meprin beta knock-out mice have demonstrated significant protection against cisplatin induced nephrotoxicity and renal ischemia-reperfusion injury. This indicates an essential role in disease pathogenesis and thus represents an attractive target for intervention. As cisplatin is still a commonly used cancer treatment, reduction of side effects would provide a significant benefit for patients.

The risk factors for chronic kidney disease are more diverse and include diabetes or high blood-pressure – all resulting in elevated deposition of (extra cellular matrix) ECM proteins. As meprin proteases are a major activator of ECM remodelling we also see potential application for a meprin inhibitor in chronic kidney and fibrotic diseases.

Characterisation of relevant biomarkers will accompany our small molecule inhibitor development.

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Name · X-act Cologne Clinical Research GmbH

Address/P.O. Box Postal Code/City State Contact Persons

Telephone Fax Email Website Social Media Number of Employees Founded (year)

· · · ·

Rudi-Conin-Str. 4 50829 Cologne North-Rhine Westphalia Jasmin Atarodi (Managing Director) Ilka Strehlau (Head of Data Management) +49-221-55922-0 +49-221-55922-33 welcome@x-act-cologne.com www.x-act-cologne.com

· · · · · IQ · 25+ · 1994

Areas of Activity · l Regulatory affairs l Project management l Monitoring services l Clinical data management l Biostatistical services l Medical services l Medical writing l Quality assurance l Audits on behalf of clients l Workshops for SOP development

X-act Cologne Clinical Research GmbH is an independent and privately-managed contract research organisation in Cologne, Germany. Clinical data management and biostatistical services have been our core competencies since the company’s foundation. Our clients in the pharmaceutical, medical-device, and biotechnology industry have valued our expertise for more than 25 years.

We are a team of seasoned as well as tech-savvy professionals providing monitoring services, smart data management solutions, biostatistical services, medical services, and quality management support to the industry. Our wealth of experience enables us to tailor solutions to match your project-specific requirements with budget-consciousness and creativity.

Since 1994, we have performed about 400 interventional and non-interventional clinical studies in various countries with pharmaceutical products and medical devices, including investigator-initiated studies in over 25 therapeutic areas. Many of them were managed as full-service projects in the framework of our established partnerships.

Full service: Let us manage your project starting from the planning phase to the final submission. In close collaboration with our long-standing cooperation partners, we jointly offer services supervising and managing your projects: ·· Clinical development programmes ·· Regulatory affairs (legal notifications and submissions) ·· Feasibility studies & recruitment ·· Project management ·· Clinical monitoring services ·· Clinical data management ·· Biostatistical services ·· Pharmacovigilance ·· Medical services/medical writing ·· Quality assurance services / audits You may also contract single services from our service portfolio: Clinical monitoring services: ·· oversee data collection ·· perform source data and eCRF/pCRF review

x-act cologne

·· ensure regulatory compliance/review regulatory documents ·· monitor protocol violations/deviations ·· perform drug or device accountability Clinical data management: ·· consulting on data management strategies ·· EDC solutions ·· eCRF design and database development/CDISC CDASH standards ·· integration of external study data ·· development of data management documents ·· data review and query management ·· coding of medical terms with MedDRA and WHOGlobal ·· SAE reconciliation ·· CDISC SDTM mapping ·· lead data management on behalf of clients Biostatistical services: ·· statistical advice ·· sample size determination ·· randomisation schedules ·· development of statistical analysis plan ·· statistical evaluation with SAS™ ·· implementation of CDISC ADaM standards ·· SAS™ programming ·· reporting and interpretation of statistical results ·· publications/dossiers Medical services: ·· medical consulting ·· development of study synopsis ·· development of clinical study protocol ·· preparation of case narratives (safety narratives) ·· clinical study report writing Quality management support: ·· process analysis & improvement ·· problem solving & corrective and preventive action planning ·· SOP development ·· independent auditing (in-house, on-site, vendor) ·· system, process, data, document 22 nd guide to german biotech companies 2021

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Name · Xell AG

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Alte Verler Str. 1 33689 Bielefeld North Rhine-Westphalia Lara Riedel +49-521-96989-200 +49-521-96989-201 info@xell.de www.xell.de

IQ > 35 2009 Analytical and cell culture laboratory (S1, S2)

Areas of Activity · l OTS cell culture media and feeds l Analytical services l Customised production (CMO) l Research and development services (CRO) l Contract manufacturing of powder and liquid products l Distribution of OTS products

Xell is an innovative and agile partner for the biotech and pharmaceutical industry that provides highly efficient solutions in cell culture technology. Since our formation, we have maintained a dedicated focus on cell culture media development, and have continuously strengthened our proprietary technology. A broad range of successful projects throughout different applications in biopharmaceutical production has helped us to gain a reputation as a reliable partner for the biotech industry.

We have been working with recognised (bio)pharma companies including BeiGene, Boehringer Ingelheim, and Sanofi, as well as CMOs and SMEs to improve their process efficiency, yields, and quality in biopharmaceutical production.

Production In 2019, our new production site for certified dry powders and liquids was established, enabling us to massively up-scale production to 1,000 kg powder/ batch (≈40,000L liquid) and 1,000 L liquid/batch. In this context, we are already successfully manufacturing our OTS media in addition to customised products, which include media, buffers, medical products, and more.

l R&D collaborations

OTS Cell Culture Media and Feed Availability ·· liquids and dry powders ·· bottles, bags, and customised solutions Applications ·· for HEK, CHO, BHK, hybridoma, and more ·· transient and stable gene expression ·· biopharmaceutical and vaccine production ·· batch, fed-batch, and perfusion processes ·· suitable for GMP manufacturing

xell

Analytical services Our in-depth work in the field of cell culture technology makes us an excellent choice of partner to provide additional services and take on your analytical and process-related challenges. From raw material, food, and feed to spent media analyses, we offer a complete range of analytical tools. These include the analysis of amino acids, vitamins, polyamines, and trace elements.

Further services comprise of media lot consistency testing as well as media stability or stress testing studies.

With a highly capable team of scientists, we generate comprehensive data sets for your cultures or samples, enabling you to better understand complex cell behaviour and processes.

Customisation services With our broad experience in cell culture technology, we can assist you in: ·· customised medium and feed development ·· process development and optimisation ·· preliminary cell studies … and much more. We design solutions that are tailored to you.

Quality statement All of our products meet the necessary quality standards required by the regulatory authorities for GMP manufacturing. They also have the following additional benefits: ·· 100% animal-component free ·· chemically defined ·· little or no adaption required from other serum-free media ·· approved by ISO 9001:2015

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Name · YUMAB GmbH

Address/P.O. Box · Science Campus Braunschweig-Süd Inhoffenstr. 7 Postal Code/City · 38124 Braunschweig State · Lower Saxony Contact Person · Dr Linda Kirchner Telephone · +49-531-481170-0 Email Address · info@yumab.com Internet Website · www.yumab.com Social Media · I Q Number of Employees · 24 Founded (year) · 2012 Type of Laboratory · S1, S2 Areas of Activity · l Fully human antibody discovery & lead development l Antibody Libraries l Engineering & Humanisation l Professional R&D services (CRO) l Optimised conditions for start-up, biotech & biopharma companies l Flexible entry & exit points at any project stage l Partnered innovation Request for · YUMAB seeks clients & partners in Further Collaborations biopharma, biotech & diagnostic industry as well as partners with innovative research projects, who need a reliable partner in human antibody development

YUMAB is a contract developer of fully human antibodies for the global biotechnological and biopharmaceutical industry. Starting in 2012 with the goal to bridge the gap between innovative research and novel therapies, the company has become an important driver of the general trend in immunotherapy toward the use of fully human antibodies.

The versatile technology platform combined with a longstanding and proven expertise makes YUMAB the partner of choice for the development of novel antibodies for therapeutic applications, diagnostics, or vaccines tailored to the clients’ needs. R&D projects customised with flexible entry and exit points at any stage and for any immunotherapeutic strategy appeal to start-ups, biotech, or biopharma companies.

With the starting pandemic early 2020, YUMAB collaborated with the University Braunschweig and other partners to develop antibodies against SARS-CoV-2.

The promising results ended in the YUMAB spin-out CORAT Therapeutics GmbH, founded in May 2020.

The collaboration and its success were honored with the Innovation Award of the state of Lower Saxony at the end of September 2020.

The YUMAB® platform: fast & reliable translation from innovation to drugs The YUMAB® R&D platform delivers fully human antibodies, the closest to natural germline among those on the market, using fast and reliable in vitro discovery technologies.

The company’s highly diverse, human antibody libraries contain 1011 natural antibody sequences and specificities to all types of antigens. Unlike animal-derived, chimeric, humanised, or synthetic antibodies, each YUMAB® antibody sequence has been shaped in the human body, which maximises epitope diversity and overcomes restriction by in vivo immune responses while minimising immunogenicity and potential adverse effects in clinical development.

yumab

Our advanced in vitro selection technology is also efficient for rare and difficult target antigens and allows pre-design of epitope specificity, interspecies X-reactivity, affinity, stability, and other properties early in the discovery and development process. First antibody candidates are identified swiftly within a few weeks and are highly developable into all types of antibody drug formats such as full-length IgGs, Fabs, scFvs, bispecifics, CARs, fusion proteins, and ADCs. YUMAB provides tailored service and partnering concepts to jump-start translation from research innovation to drug development with affordable entry costs, flexible licensing options, and no additional third-party obligations.

YUMAB at a glance Human antibody discovery platform ·· Natural fully human libraries for low immunogenicity ·· Optimised in vitro selection to address difficult targets ·· Rapid discovery within weeks Direct link to lead development ·· Advanced antibody lead development & optimisation ·· All antibody drug formats, all disease areas ·· Robust & fast process with high success rates

FULLY HUMAN ANTIBODY DISCOVERY PLATFORM

YUMAB® platform ·· Fully integrated discovery & development platform from target to optimised lead ·· Customised project plans with flexible entry & exit points ·· Smooth translation from bench to bedside Flexible services, collaborations & partnering ·· Contract R&D as fee-for-service & flexible licence options ·· No technology access fees ·· Partnered collaboration to translate research innovation into drug development

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Profiles of Service Providers

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Name · BIO.NRW The Home of Biotech

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Merowingerplatz 1 40225 Dusseldorf North Rhine-Westphalia Dr Nils Schrader +49-211-385-469-9200 +49-211-385-469-9220 bio.nrw@bio.nrw.de www.bio.nrw.de

LI  6 2008

Areas of Activity · | Technology transfer | Support of biotech companies, esp. SME | Support of biotech start-ups, coaching & financing | National and international fairs, exhibitions, and conferences | Analysis of biotechnology in North Rhine-Westphalia for location data | Marketing & PR for the biotech state of North Rhine-Westphalia | Promotion of young academics | Online jobfair External · | EIT Health e. V; local to international Collaborations companies, research institutions, financiers, and further biotech stakeholders | ChInValue – China-NRW-cooperation (BMBF)

BIO.NRW – Business for biotech Since 2008, BIO.NRW has been the official biotechnology network of the federal state North Rhine-Westphalia (NRW). We catalyse the sustainable development of the state’s biotech sector by building on NRW’s strengths in industrial and pharmaceutical biotechnology, bioeconomy, and in enabling technologies. BIO.NRW is actively supporting the implementation of life sciences technologies, which are key to answering the most challenging tasks of our society.

Our services include: Technology Transfer Tech transfer support is a key contribution from BIO.NRW. We organise events, congresses, workshops, expert panels, and roundtable discussions to promote the dialogue between business, research, investors, and policymakers to activate cooperation.

Biotech business & sciences BIO.NRW compiles comprehensive and current online databases of academic institutions and companies active in the life sciences in NRW. Free to access and easy to use, these resources are valuable tools for identifying business partners. More information on www.bio.nrw.de Fairs, exhibitions, and conferences Companies and academic institutions can generate awareness of their activities locally, nationally, and internationally by being a part of the BIO.NRW shared booths at fairs, exhibitions, and conferences.

Support of young professionals BIO.NRW takes a special interest in supporting young professionals in biotechnology. We participate in conventions and exhibitions to bring graduates and founders in contact with representatives from industry and academic science. The ‘Business Angel Network – BIO.NRW’ helps to finance and fund biotech start-ups. In addition, the idea of our annual ‘BIO.NRW Business Angel Congress’ is to assist and to supply the highly diverse investors community of business angels, venture capitalists, institutional investors, founders, and SMEs with the most recent finance and investment information.

BIO.NRW.red Sustainable network in pharmaceutical biotech

BIO.NRW

Thematically focused working platform A snapshot of NRW’s biotech sector North Rhine-Westphalia is situated at Europe’s geographic and economic centre. NRW is the state with Germany’s highest gross domestic product (GDP), corresponding to 5.1% of the European GDP (EU-28). If classified as an independent nation, NRW would rank 19th in the world. In this vibrant industrial location the chemical and pharmaceutical industry traditionally plays an essential role. New companies and start-ups founded by young academics have been stimulating the corporate landscape in the life sciences sector for years.

Bioeconomy and Circularity

For the first time Co-exhibit with BIO.NRW in Cologne

Financing and Funding • Regular BIO.NRW Business Angel Circles • International BIO.NRW Business Angel Congress • Financing platform startups4.eu • Up to date funding information

March 8th

Hyatt Regency Düsseldorf

2021

10th BIO.NRW Business Angel Congress

NRW has the densest network of universities and academic institutions in Europe. 25 out of 78 universities and other institutions of higher education conduct life sciences research. More than 20 Max Planck Institutes, Fraunhofer Institutes, Leibnitz Association facilities and Helmholtz research centres complement the academic research in the field of life sciences in NRW. One notable strength of NRW’s biotech industry is industrial (white) biotechnology, which benefits from the state’s strong chemical industry, e.g. Evonik, Henkel, Covestro, Lanxess. The sector is connected to the bioeconomy and circular-economy activities of BIO.NRW and the Cluster of Industrial Biotechnology, known as CLIB. Most NRW biotech companies are active in the pharmaceutical biotech sector. The red biotech landscape includes global players like Bayer, Grünenthal, and UCB as well as “new” stars like Qiagen, Miltenyi, and AiCuris. During the corona crisis these highly innovative NRW biotech companies have been receiving special attention. By developing new reliable diagnostic methods and potential therapeutic agents and by providing key components for vaccine development, NRW’s biotech companies are playing an indispensable role in combatting the pandemic and its effects.

Never before has attention been so focused on medical biotechnology companies as it has been these days.

Founded in 2010, the strategic initiative BIO.NRW.red aims to establish a sustainable network that bundles the most important contributions to medicine, health, the pharmaceutical industry, and red biotechnology in NRW. 22 nd Guide to german biotech companies 2021

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Name · BioM Biotech Cluster Development GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Am Klopferspitz, 19a 82152 Martinsried, Munich Bavaria Prof. Dr Horst Domdey +49-89-899679-0 +49-89-899679-79 info@bio-m.org www.bio-m.org

LI 18 1997

Areas of Activity · l Supporting start-ups regarding foundation and financing with specialised coaching, training, and mentoring programmes l Supporting biotech and pharmaceutical companies with an extensive network l Connecting Bavarian life sciences companies with national and international companies, investors, and relevant stakeholders l National and international conferences, exhibitions, and fairs l Seminars and workshops l Company database l Online job market

BioM – Biotechnology Cluster Management for Munich and Bavaria BioM is the central network organisation for the biotechnology sector in Munich and Bavaria, commissioned by the Bavarian Ministry of Economic Affairs. As a non-profit organisation, BioM supports the biotech community in a variety of ways with its extensive network. The cluster management offers centralised access and connects Bavarian life science companies with relevant national and international partners.

BioM – central point of contact ·· non-profit organisation funded by the Free State of Bavaria ·· supporting startups and SMEs through specialised and customised business support services since 1997 ·· bringing together the key life sciences actors in Bavaria ·· attracting international investors and industrial partners ·· coaching founders and founders-to-be ·· preparing the ground for a thriving and sustainable biotech economy in Bavaria ·· connecting Bavarian biotechnology world-wide

Bavaria: the place for the medicine of the future BioM recognises the challenges of the medicine of the future and promotes the innovation process by identifying and connecting matching partners from science, industry, medicine, and finance. By organising individual partnerings with global and local companies as well as scientific institutions, we help companies to find the right contacts and to cooperate with leading organisations. In addition, BioM offers a variety of workshops and training courses on industry-specific topics and advice on funding opportunities for small and medium-sized enterprises.

One of the most promising developments in medicine is the integration and analysis of clinical, real world, and research data. The five-year lighthouse project DigiMed Bayern focuses on developing P4 medicine, with coronary heart disease as clinical use case. The project

bio m Biotech cluster development

BioM - Biotechnology Cluster Management Gateway to the Bavarian Biotech Community

is funded with over EUR 20 million from the Bavarian State Ministry of Health and Care as part of the regional BAYERN DIGITAL II programme. BioM is responsible for management and project coordination of DigiMed Bayern. The scientific management of the project is led by the German Heart Centre Munich.

BioM inQlab Bio M supports Bavarian biotech companies at every stage of setting up their business. Therefore, BioM has developed a unique support programme tailor-made for aspiring start-ups and entrepreneurs in the life sciences sector – the virtual incubator BioM inQlab. In total, BioM has supported more than 200 start-up companies in 20 years.

Spotlig ht: COVID-1 9 Special

REPORT

2019/20

including more than 350 company RTQƂ NGU

managed by

inQlab – from idea to success: ·· Startup Coaching – get hands-on support ·· Mentor Circle – inspired by experience ·· Pitch Doctor – how to convince investors ·· BioEntrepreneur Boot Camp – validate your business idea ·· BioEntrepreneur Lounge – join the community ·· BioAngels – find the right investor ·· m4 Award – create the future of medicine ·· BioEntrepreneurship Summit – connecting the ecosystem In addition, BioM offers comprehensive information on its website www.bio-m.org: current news, a company database, event information, a job exchange, and much more. Every year BioM publishes the Bavarian Biotech Report, a compilation of current business figures of the Bavarian biotechnology and pharmaceutical industry with a comprehensive company list and detailed company profiles.

www.bio-m.org

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Name · BIOPRO Baden-Württemberg GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Alexanderstraße 5 70184 Baden-Wuerttemberg Dr Barbara Jonischkeit +49-711-21818500 +49-711-218185-02 jonischkeit@bio-pro.de www.bio-pro.de

LI 22 2003

Areas of Activity · Bioeconomy, Healthcare Industry

Our mission: Pooling competencies – pushing innovations BIOPRO Baden-Württemberg comes under the auspices of the Baden-Württemberg government and is specifically focused on the following themes: bioeconomy, biotechnology, pharmaceutical industry and medical technology (healthcare industry). ·· We work in partnership with science, the economic sector and business and science networks. ·· We contribute to cross-sectoral cooperation across the entire value creation chain and hence to innovation. ·· We offer support for technology transfer and start-up projects. ·· We provide you with comprehensive information.

All these activities help contribute to the positive development of Baden-Württemberg. One of our major objectives is to present and explain the healthcare industry and the bioeconomy to the public and highlight the benefit of innovations. As a central point of contact for issues relating to the healthcare industry and the bioeconomy, we represent Baden-Württemberg on both the national and international level.

Our projects involve networking with our partners where the goal is to work together for the betterment of the whole sector. One key example is our guidance for the new Medical Device Regulation of the European Union.

Not only do we bring key contributors into the mix, we also work towards a healthy cooperation atmosphere – even among competitors. Our vast experience as coordinator allows us to help firms, players and institutions to find the right and fitting way to solve their problems individually and thus overcome serious obstacles.

biopro

The entire value creation chain is represented in Baden-Württemberg from research and development to production and sales. Baden-Württemberg is home to successful small and medium-sized companies as well as to global players such as Roche, Boehringer Ingelheim and Aesculap. The 3 branches of the healthcare industry – biotechnology, medical technology and pharma – are embedded in a dense network of (university) hospitals and research institutions. In addition, numerous suppliers and service providers from related fields benefit from the cooperation with the well positioned healthcare industry.

BIOPRO is the central partner for companies and scientific institutions in the field of Biotechnology and Life Sciences with a keen focus on local development, communications and networking. We excel in bringing key players together and offer support through our evergrowing network.

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Name · btS – Biotechnologische Studenteninitiative e.V. Address/P.O. Box · c/o BIOCOM AG Lützowstraße 33–36 Postal Code/City · 10785 Berlin State · Berlin Contact Person · Yanni Morgenroth Telephone · +49-30-264-921-26 Email Address · bundesvorstand@bts-ev.de Internet Website · https://bts-ev.de/ Social Media · F I I Number of Employees · > 1,100 members Founded (year) · 1996 Areas of Activity · On a nationwide level, we regularly organise career fairs (ScieCon) and workshops. At the local level, we organise excursions, lectures, company presentations, application trainings, and various other events.

External · The success of our commitment to life Collaborations sciences students is enabled by the support of our various partners, such as jobvector.de, Sartorius Stedim Biotech GmbH, Bayer AG, F. HoffmannLa Roche Ltd, BIOCOM AG, DECHEMA e.V., HOX Life Science GmbH, and ATV GmbH. Request for · The btS is always interested in new Further Collaborations partners and collaborations. There is a wide variety of possible projects and events you can be part of. Please feel free to contact us if you are interested.

Overview The Biotechnologische Studenteninitiative e.V. is a Germany-based student initiative which is active in 27 cities all over Germany. It creates an interface between students, universities, research institutes, and companies. For this purpose, career fairs, excursions, networking events, lectures, workshops, and scientific symposia are organised by the btS. Our motivation is: Let Life Sciences meet you – Get connected!

With more than 1,100 members, the btS is the largest student’s initiatives in the life sciences sector. In addition to the wide network of students, we are supported by committed alumni and associate members from both the university and industry backgrounds.

We offer students the great opportunity to realise their creative ideas. In doing so, the students gain valuable experience for their personal development.

True to the motto “Development by responsibility” the students broaden their skills by being part of the different activities of the btS as they take over responsibility for a wide range of different tasks.

Furthermore, they build a personal network. In addition to the acquisition of key competences in areas such as project management, communication, time management, and teamwork, members get insights into various fields of work early during their studies since we cooperate with different partners from science and industry.

Opportunities for partnering up with btS Would you like to get into contact with well-skilled life sciences students? In this case, the btS is the perfect cooperation partner for you! We offer a wide range of events, newsletter articles, and cooperation opportunities. For example, it is possible to give a talk or a workshop at our biannual general assembly or at one of our local groups. In addition to bringing you to the university, we are also interested in organising an excursion to your

bts

company. Such local events are very interesting for us as well as for external students. Many of them visit our events since they appreciate our wide range of training and networking opportunities.

This means that you can reach far more students than we have members at a location with a local event in cooperation with the btS. Furthermore, we allow you to communicate job postings or other company news through our mailing list for members as well as our newsletter for interested students.

Another great chance to get in direct contact with life sciences students is the ScieCon. The ScieCon is the career fair organised by the btS, which is specifically aimed at students, graduates, and doctoral candidates in the field of life sciences. The ScieCon offers a perfect link between industry and academic education.

The fair attracts students from local universities as well as interested students and graduates from all over Germany. It serves companies as a platform for self-presentation and the recruiting of new employees.

Are you interested in presenting your company to a broad audience at the ScieCon? Then do not hesitate to contact us!

Do you want to ensure the long-term success of your life sciences company? Get the attention of the most committed students with a nationwide partnership with the btS. Even a completely new format of cooperation is feasible.

Feel free to contact us at any time!

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Name · Central BioHub GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · ·

Neuendorfstrasse 17 16761 Hennigsdorf Brandenburg Sandra Schuster +49-3302-23091-66 info@centralbiohub.com www.centralbiohub.com

FL I   10 2017

Areas of Activity · Human biospecimens for R&D Request for · Central BioHub seeks companies in Further Collaborations need of human biospecimens for R&D and helps customers to choose the right samples for their projects.

Central BioHub is the online marketplace for human biospecimens. We accelerate medical innovation by providing access to precious human biosamples – fast, easy, and compliant. Find 500,000+ samples tested for 500+ clinical parameters and biomarkers on one single platform. A global network of validated suppliers guarantees an unmatched portfolio of clinical specimens with the highest quality standards.

Our mission Located on the doorstep of Berlin, Central BioHub can rely on the expertise of professionals from the city’s life sciences cluster area. The goal is to digitise and revolutionise sample procurement for the diagnostic and pharmaceutical industry. Our drive is to accelerate science and to advance the development of new diagnostic methods.

Our services at a glance ·· Click-and-Buy web shop for blood-derived products, tissues, and other biofluids ·· Comprehensive validation of all suppliers contributing to the marketplace ·· Custom specimen procurement services via our international network ·· Professional customer support from our trained scientists for individual inquiries

High-quality biospecimens ·· ·· ·· ·· ·· ·· ··

Plasma (K2/3 EDTA, Lithium/Sodium Heparin, CPD) Serum (off the clot) Cerebrospinal Fluid (CSF) Urine/Faeces Tissue (FFPE, fresh frozen) Swabs (NP, OP, vaginal) Other matrices on request

We cover all disease areas ·· ·· ·· ·· ·· ·· ··

Allergy Autoimmunology Clinical chemistry Infectious diseases Neurology Oncology Healthy donors and many others

central biohub ®

Order advantages ·· 24/7 accessibility: order your samples from any PC or mobile device worldwide ·· Direct search for clinical parameters, biomarkers, and diseases (ICD-10) ·· Additional filters for matrices, age, gender, and disease state ·· Benefit from the large variety of our worldwide supplier network ·· Ensured access to sample-related information and comprehensive disease documentation

The revolution of procurement Easy access to human sample materials has been one of the greatest challenges in the entire value chain of in vitro diagnostics (IVD) so far. Central BioHub is removing this bottleneck by connecting biospecimen suppliers and customers for research and development worldwide. For the first time there is a platform that provides customers with all sample specifications such as pre-analytical data, medication, and measured laboratory parameters transparently and clearly online.

Supplier network All suppliers are validated in a multi-step process including transport safety, on-time delivery and ethical compliance. Central BioHub is fully committed to the Declaration of Helsinki and Declaration of Taipei.

Experience Rely on profound experience in the field of life sciences.

In the last three years, Central BioHub has supplied specimens to hundreds of diagnostic companies, governmental institutes, and pharmaceutical manufacturers on all continents.

Central BioHub is a game changer.

Our platform enables worldwide access to high-quality biospecimens, thereby providing the foundation for efficient and seamless research.

You have a biorepository? Increase your revenue and use Central BioHub as an additional sales channel. Let’s get in touch.

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Name · Fördergesellschaft IZB – Innovations- und Gründerzentrum Biotechnologie mbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · ·

Am Klopferspitz 19 82152 Planegg/Martinsried Bavaria Dr Peter Hanns Zobel +49-89-5527948-0 +49-89-5527948-29 info@izb-online.de www.izb-online.de 36 1995 S2 labs | Biotechnology | Life Sciences

Number of Firms · 50 start-ups External · Collaborations with the scientific faculties on the Campus Martinsried

Collaborations

Hotspots for life science start-ups The IZB, founded in 1995, is the operating company for the Innovation- and Start-up Centers for Biotechnology located in Planegg-Martinsried and Freising-Weihenstephan, and has developed into one of the top ten biotechnology centers in the world. Currently, in an area totaling 26,000 m2, over 50 biotech companies with over 600 employees are located. An essential criterion for the success of the IZB is its close proximity to outstanding research at the Ludwig-Maximilians-University (LMU) and renowned biotechnology research establishments on the Campus Martinsried, such as the Max-PlanckInstitutes für Biochemistry and Neurobiology.

Magnet for biotech start-ups Since 1995, the Planegg-Martinsried location, now covering 23,000 m2, has accommodated Start-ups focusing on medical biotechnology. Since 2002, the IZB in Freising-Weihenstephan with 3,000 m2 of space offers optimal conditions for establishing companies in the sector of life sciences.

Here, young entrepreneurs and company founders come upon an optimal infrastructure for transforming their products or services into business propositions, within a competence cluster for life sciences that is one of the best in the world. S1 labs for fair rental prices, internal property management, close contact to the venture capital scene, as well as joint location marketing are also factors for our success, as is the flexibility to adapt space requirements to the development of our tenants.

Top research at the Campus Martinsried Today the scientific and business Campus Martinsried is one of the largest centres in Europe where teaching, basic scientific and clinical research, as well as technology innovation are combined on one campus. Located in the direct vicinity are other institutes such as the MaxPlanck-Institutes for Biochemistry and Neurobiology, the Helmholtz Zentrum Munich Hematology Unit and the following institutes of the LMU: the Biology Faculty, the Clinical Center Grosshadern, the Pharmacy and Chemistry Faculty, the Neurological Research Center, the Center for Neuropathology and Prion Research (ZNP),

IZB

the Gene Center and Institute for Biochemistry, the Biomedical Center, the BioSysM Bavarian Research Network for Molecular Biosystems and the Surgery Center of the Clinical Center Grosshadern.

The close proximity of the scientific institutes around the Campus Martinsried confers a huge competitive advantage. Young scientists can profit from incorporating expertise in science and research into their own business enterprises; short distances promote interaction and cooperation between biotech companies – in terms of globalisation both factors are essential requirements for successfully entering world markets.

IZB Residence and Faculty Club G2B The 28-meter high IZB Residence CAMPUS AT HOME that opened in October 2014 is the architectural and communicative centre point of the Campus Martinsried.

The sevenstorey building with 42 rooms and its own restaurant will accommodate visiting scientists from all over the world. The core element is the Faculty Club G2B. Its purpose is to promote the transfer of research results into marketable products and services, and intensify the dialogue between top class scientists.

IZB – in brief ·· 2 6,000 m2 laboratory and office space for start-ups and growing companies ·· Home for 50 start-ups ·· Business development support ·· In-house estate management ·· Center of an impressive research campus ·· Access to an international network ·· Flexible lab and office structures ·· Close contacts with investment partners ·· Joint location marketing ·· Attractive, modern conference rooms, also for external booking ·· IZB Residence CAMPUS AT HOME (42 Rooms) ·· Faculty Club G2B ·· Restaurants: SEVEN AND MORE and Café Freshmaker ·· 2 day care centres (Bio Kids & Bio Kids2)

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Name · HealthCapital – Cluster Healthcare Industries Berlin-Brandenburg Address/P.O. Box Postal Code/City State Contact Person

· · · ·

Telephone Email Website Social Media Areas of Activity

· · · · ·

Fasanenstr. 85 10623 Berlin Berlin Dr Kai Bindseil, Clustermanager HealthCapital Berlin-Brandenburg +49-30-46302-463 info@healthcapital.de www.healthcapital.de L #HealthCapitalBB l Technology transfer between science and industry l Initiation and support of networks l Support for technology-oriented start-ups l Funding support for innovative project concepts l Providing and presenting regional life sciences information l Building and coordinating of scientific and interdisciplinary networks l Establishing contacts between experts from all disciplines l Organisation of events and seminars, Public Relations work for the life sciences region

External · l Member of the Council of European Collaborations Bioregions l ScanBalt l Member and contact point in Berlin for Enterprise Europe Network (EEN) l Collaborations with European Life Science clusters and SMEs in several Horizon 2020 projects and other activities

The Berlin-Brandenburg BioRegion … … a Leading Hub for Life Sciences The Berlin-Brandenburg region is one of the leading, international locations for life sciences. The area concentrates on clinical research via a dense and compact healthcare network, and boasts a state-of-the-art IT infrastructure. It is no coincidence that the region is Germany’s ‘health capital’ as it is home to both the German government, as well as the centre for healthcare industries.

The region’s distinction is anchored in its unique research and clinical landscape, as well as its ability to closely link the key players in the life sciences and healthcare. Biotechnology, in particular, is a strong driving force within the Berlin-Brandenburg healthcare industries cluster – HealthCapital – generating innovation and growth there and beyond. Through networking the pharmaceutical, diagnostics and medical technology sectors completely new fields of business are created.

More than 250 biotechnology and around 30 pharmaceutical companies are located in the German Capital Region. They include market leaders like Bayer, Bausch & Lomb, B. Braun Melsungen, Berlin-Chemie, Pfizer, Sanofi and Takeda. Along with the sector’s many small and mid-sized companies, they benefit from close cooperation, both with science and with more than 130 hospitals – above all, one of Europe’s largest university hospitals: Charité – Universitätsmedizin Berlin. Customers from research and industry have access to patient cohorts of urban and rural populations of about 180 ethnicities, covering all medical indications. The many technology parks and networks in the various branches of modern biotechnology create the excellent infrastructure and technological support that characterize the Berlin-Brandenburg life sciences area. Focus of biotech activity within the region are biomedicine and diagnostics, therapeutics and regenerative medicine as well as industrial biotechnology.

HealthCapital

… connected to the European Hotspots Active cooperation in the networks of Europe’s BioRegions has played a central role in the internationalisation efforts in the region. The region is a member of the Council of European Bioregions (CEBR) and ScanBalt.

… offering Service and Support for Life Sciences in the Capital Region The central contact and coordination office for all issues concerning life sciences in the German Capital Region is HealthCapital. At the interface of business, science and clinics, the HealthCapital cluster management drives networking and the technology transfer and supports companies interested in relocating to the region.

Berlin Partner for Business and Technology and the Economic Development Agency Brandenburg (WFBB) are responsible for managing the cluster.

Meet us 2021 at Health Innovation Week Toronto BIO International Convention BIO Japan BIO Europe

See you at BIONNALE 2021 May, 12

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Name · L&R Kältetechnik GmbH & Co. KG

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Number of Employees Founded (year)

· · · · · · · · · ·

Hachener Str. 90a–c 59846 Sundern North Rhine-Westphalia Christoph Wiemer +49 2935 9652 0 +49 2935 9652 501 info@lr-kaelte.de www.lr-kaelte.de 130 1991

Areas of Activity · l Industrial refrigeration systems 5–5000 kW l Ultra low temperature technology down to -110 °C l Proprietary control technology

Process-safe refrigeration for biotechnology When it comes to process-safe refrigerant or cryogenic temperatures to be provided for biotechnology or pharmaceutical production, L&R Kältetechnik GmbH & Co. KG can demonstrate comprehensive competence and provide numerous references.

For almost thirty years, L&R has been designing sophisticated industrial refrigeration systems and cryogenic temperature refrigeration systems, always customerspecific, with high-quality components and in accordance with respective customary industry standards, such as “GMP”. The systems provide refrigeration down to -120 °C and meet the highest demands in reliability and availability.

In addition, L&R has developed custom designs for refrigeration systems, for example, -60 °C plate freezers for time-critical contact cooling of sensitive base materials in pharmaceutical production.

The areas of application of the refrigeration systems include the production of bio-technology products, especially in the pharmaceutical industry. This requires the cooling of e.g. reaction tanks but also work tools such as mixers and agitators. Another field of application is the cryogenic storage of base, intermediate, and end products of biotechnology. For this task L&R designs and installs complete accessible warehouses maintaining temperatures as low as -80 °C, whose operation is usually more economical than storing products in individual deep-freeze cabinets.

Global market leaders in the pharmaceutical industry rely on the refrigeration competence of L&R. For one of those companies, for example, L&R recently designed and built cryogenic systems with twelve refrigeration circuits and a total cooling capacity of 2.5 MW; the system provides temperatures from -15 °C to -25 °C and uses natural refrigerant R 1270 (propene).

L&R K ältetechnik

L&R Head Office

Plate freezer for pharmaceutical production

With this and many other systems, L&R presents itself as an efficient partner who manages and complies with the requirements of biotechnology and related fields (chemical and process engineering, pharmaceutical production, etc.). Our refrigeration systems integrate themselves into the userâ&#x20AC;&#x2122;s process in the best possible way and are characterised by a long service life.

Furthermore, our refrigeration systems are extremely energy-efficient, as L&R considers a variety of energysaving measures suitable for the intended application of the system. These include, among other things, smooth condensation temperature control, winter relief via a free cooling unit, and speed-controlled pumps and compressors. Through these measures, in practice, the user can achieve energy savings of up to 50%, depending on the application.

Another core competence of L&R is the design of refrigeration plants with natural, environmentally friendly refrigerants such as CO 2 and propane. Here L&R is con-sidered an expert in the trade and has designed and installed various reference sys-tems, even for critical and very demanding applications.

Energy-efficient refrigeration technology

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Name · Life Science Nord Management GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Falkenried 88 20251 Hamburg Hamburg Dr Hinrich Habeck (Managing Director) +49-40-47196-400 +49-40-47196-444 info@lifesciencenord.de www.lifesciencenord.de

FQ 15 2004

Cluster profile The Life Science Nord Cluster in the federal states of Hamburg and Schleswig-Holstein embraces over 500 biotechnology, pharmaceutical, and medical technology companies, clinics, and research institutes. About 52,000 employees work in the health industry.

Particular features of the cluster are the broad business base and the complete value chains from basic and applied research to clinical studies and the marketable end product. The good, close cooperation between researchers, clinicians, and industrial partners in many fields is reflected in innovative products, projects, and technologies.

Areas of Activity · Cluster Management External · l BIO Deutschland e.V. Collaborations l Arbeitskreis der Deutschen BioRegionen l ScanBalt

Cluster management and the association The cluster management organisation Life Science Nord was set up by the Northern German federal states of Hamburg and Schleswig-Holstein to develop the cluster into a leading international life sciences network. The cluster agency Life Science Nord Management GmbH and the registered association Life Science Nord e.V. work together to achieve that goal.

Over 270 regional firms and institutions in the health industry are organised in Life Science Nord e.V.. In a joint Life Science Nord partner programme, the agency and Life Science Nord e.V. offer their members numerous activities aimed at promoting regional networking, sharing experiences and know-how, and jointly representing the regional life sciences industry on a national and international level.

In 2018, Life Science Nord was awarded the Gold Label of the European Cluster Excellence Initiative for the second time.

Life science nord

What Life Science Nord offers

Picture: Christina Körte, Torsten Kollmer

·· Comprehensive support in initiating innovative projects, arranging contacts to experts, and providing know-how ·· Fast and uncomplicated access to regional, national, and EU funding programmes ·· Admitting members to the network and helping them position themselves within the Life Science Nord Cluster ·· Extensive opportunities for collaboration within an international industry network ·· Participation in leading international and national industry trade shows ·· Providing data on business and technological capabilities in medical technology, biotechnology, and pharma in Northern Germany ·· Providing the latest information on developments in business and science ·· Access to platforms on which the cluster players can exchange information and which support the dissemination of new developments in the cluster. This also includes the online newsletter and the Life Science Nord print magazine, both of which can be subscribed to via the website free of charge.

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Name · Maiwald Patentanwalts- und Rechtsanwaltsgesellschaft mbH Address/P.O. Box · Elisenstraße 3, Elisenhof Postal Code/City · 80335 Munich State · Bavaria Contact Person · Dr Eva Dörner Telephone · +49-89-747266-0 Fax · +49-89-776424 Email Address · info@maiwald.eu Internet Website · www.maiwald.eu Social Media · I Q Number of Employees · 220 Founded (year) · 1995 Type of Company · Law Firm Areas of Activity · Sectors: l Pharma & Biotech l Organic Chemistry & Polymers l Inorganic & Construction Materials l Food & Agriculture l Electrical & Mechanical Engineering l Communication & Information Technology l Mobility & Energy l Displays & Light l Measuring & Process Technology l Medical Technology & Imaging Legal Areas: l Patents & Utility Models l Supplementary Protection Certificates l Trademarks & Designs l Copyright l Competition & Antitrust Law l Compliance l Contract Law l Employee Invention Law l Pharmaceutical Law l Data Protection l Plant Variety Protection

As one of Germany’s largest and best-known firms in the field of intellectual property, Maiwald’s foremost aim is to achieve the best possible solution for each client in each particular case. Maiwald employs about 220 people working out of Munich and Düsseldorf. The interdisciplinary teams work closely with each other and with foreign associates, always with an eye to the client’s particular needs, whether start-up, medium-sized firm, or large corporation, across all industrial sectors.

Maiwald’s team does its utmost to ensure that all IP matters are handled with competence and care, irrespective of the client’s physical location, whether in Germany, Europe, or beyond.

Client-oriented solutions and personal consultation are at the heart of Maiwald’s professional approach.

About 80 highly qualified patent attorneys, attorneysat-law, and technical experts, an in-house patent search department, and numerous client-specific teams of paralegals put their extensive range of skills and experience at the clients’ disposal in order to arrive at the best possible customised IP solutions. Client satisfaction is evidenced by the long-standing business relationships with many prestigious corporations.

Main areas of practice Maiwald advises and represents domestic and international clients from all technical fields across the entire spectrum of intellectual property law. When appropriate, an interdisciplinary exchange of information and expertise can take place between various teams, ensuring that the optimal solution is achieved in each particular case.

Maiwald’s patent attorneys Maiwald’s team of patent attorneys combine their expertise across various technical fields and advise and represent clients across a wide range of industries.

Maiwald’s patent attorneys have extensive experience in the management of international patent portfolios.

Services include drafting and filing patent applications

Maiwald

and coordinating worldwide prosecution as well as defending, enforcing, and contesting IP rights. Patent attorneys also prepare freedom-to-operate (FTO) opinions based on thorough research and analysis to establish whether existing IP rights of third parties could potentially stand in the way of a client’s particular product or manufacturing process. Clients also benefit from the exceptional expertise in opposition and appeal proceedings before the German and European Patent Office as well as in infringement and nullity proceedings before the national courts.

Maiwald’s attorneys-at-law Maiwald’s team of attorneys-at-law can boast many years of experience in trademark, design, copyright, and contract law as well as patent infringement litigation, particularly in the conduct and coordination of international litigation proceedings.

Close cooperation between patent attorneys and attorneys-at-law is especially important in patent infringement litigation, since this type of proceedings generally calls for a comprehensive overview of the various national regulations as well as a thorough grasp of the particular technology. The interdisciplinary teams provide a comprehensive package of services to guarantee the successful conduct of legal proceedings in an international arena, also in cases where speed is of the essence, such as in preliminary injunction proceedings or border seizure procedures.

However, Maiwald’s attorneys-at-law would be the first to acknowledge that litigation is not always the best solution. They are skilled advocates in arbitration and mediation proceedings and are trusted experts when it comes to negotiating licensing contracts

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Name · NEUWERK Partnerschaft von Rechtsanwälten mbB Address/P.O. Box Postal Code/City State Contact Person

· · · ·

Telephone Fax Email Address Internet Website Social Media

· · · · ·

Gänsemarkt 35 20354 Hamburg Hamburg Börge Seeger, MLE (Leuven), JSM (Stanford) Partner +49-40-340-57-57-0 +49-40-340-57-57-55 info@neuwerk.legal www.neuwerk.legal

FIQ

Areas of Activity · l Employment Law l Corporate Law/M&A l Real Estate Law l IP/IT l Litigation l Commercial Criminal Law/Compliance

Neuwerk – your legal partner in business Many disciplines – one claim: Neuwerk is a team of experts in different areas of business law. We offer a onestop service for our clients, in particular for complex matters. You can be sure to receive optimum support.

Business life is full of challenges that cannot be clearly assigned to one area of law or another. Therefore, it is important to have an interdisciplinary and highly specialised law firm at your side.

All partners of Neuwerk are experts in their respective area of law. We are able to bring together our knowhow whenever necessary, always for the benefit of our clients. The result: comprehensive interdisciplinary legal advice. Learn more about the areas of law in which we can assist you.

Service with foresight: our focus.

Every case is different. Therefore, legal advice must be tailor-made for every client and for every legal situation.

And this is what Neuwerk can guarantee.

Our focus combines our interdisciplinary know-how and the vast experience of all partners of Neuwerk. We have developed products that offer our clients maximum planning reliability.

There are fixed standards for every product and for all parties in terms of time and resource planning. For each mandate we adjust these standards on an individual basis. In this way we can forecast as early as possible how much time and how many technical and personal resources our advice will require, where and when.

neuwerk

As a team there for you.

Neuwerk’s success formula? Our interdisciplinary team.

How we would describe Neuwerk in one word? Efficient.

Our claim is to achieve optimum results for our clients.

Complex challenges are a daily occurrence in business life. This also applies to legal matters. That is why all approaches to problem solving need to be well thought out. Diversified but clearly oriented – Neuwerk provides services to its clients under this principle.

CONCENTRATED EXPERTISE:

We cover a wide range of legal areas and, at the same time, have developed an efficient and transparent approach to advising our clients. Each of our team members knows the strengths of the others and makes use of their special expertise in related disciplines – literally on demand. We not only share one law firm, we also share the passion for what we do: helping our clients to obtain their lawful rights.

NEUWERK COMBINES EXPERTS IN BUSINESS

Dr Johannes Deiß, Partner

LAW. WE ADVISE AND REPRESENT OUR CLIENTS EFFICIENTLY, TRANSPARENTLY AND

Dr Claudia Jehle, LL.M. (Florence),Partner

INNOVATIVELY. FROM HAMBURG: IN GERMANY

Dr Philipp Jehle, Partner

AND WORLDWIDE.

Dr Sebastian Naber, Partner Dr Matthias Peukert, LL.M. (Canterbury), Partner Börge Seeger, MLE (Leuven), JSM (Stanford), Partner Kirsten Seeger, LL.M., Maîtrise en droit, Partner

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Name · RauCon GmbH & Co. KG

Address/P.O. Box Postal Code/City State Contact Person Telephone Email Address Internet Websites Social Media Number of Employees

· · · · · · · · ·

Rudolf-Diesel-Str. 9 69115 Heidelberg Baden-Wuerttemberg Stefan Hilscher +49-6221-4262960 inform@raucon.com www.raucon.com

I 5

Areas of Activity · Business Development, euroPLX and asiaPLX Marketplaces for Pharma Business Opportunities

A specialist in pharma business development As a top-performing B2B service organisation, RauCon has been facilitating business development partnering of healthcare companies from 86 countries by means of a digital and personal exchange of business opportunities for more than 25 years. RauCon is also the global pioneer of business-only pharma partnering events, which have now evolved into the “Marketplaces for Pharma Business Opportunities”.

First physical partnering event in corona times As one of the few physical events worldwide, the euroPLX 73 Vienna Marketplace for Pharma Business Opportunities held in mid-September 2020 featured two Vienna Meeting Event days followed immediately by 28 Video Meetings Days – not hybrid, but back to back.

Thus it was the first partnering event worldwide to cater to executives who were able to travel as well as to those who were prevented by corona restrictions.

The 2 + 28 formula for a two-tier business meetings strategy Each one of the new Marketplaces for Pharma Business Opportunities combines a two-day Meetings Event with a subsequent 28-days Video Meetings period. This allows the relaxed arrangement of any number of standalone meetings or additional follow-up meetings. The registrants decide which of the 28 days suit them best for the number of meetings they want to arrange. The Video Meetings period offers a wide range of alternative dates in case of scheduling difficulties and enough flexibility should business travel be curtailed.

Unprecedented partnering event flexibility The striking difference between the new Marketplace for Pharma Business Opportunities and mainstream partnering events is its enormous and unprecedented flexibility. Registrants join the Marketplace whenever they want. They determine which business meetings they prefer to have in-person at the venue and which ones by Video Meeting at any convenient date and time during

raucon

the next four weeks. Registrants move from “physical” to “virtual” mode and back as they like, controlling the entire process in their personal online user account.

An almost unlimited number of one-on-one meetings Each Marketplace for Pharma Business Opportunities allows registrants to arrange as many one-on-one meetings as they require, limited only by the number of meeting slots during the two-days Meetings Event and the 28-days Video Meetings period.

Another first: follow-up meetings during the same partnering event Participants who feel that the time allotted for a oneon-one meeting was not enough can fix one or several follow-up meetings during the Video Meetings period right on the spot just by using the meetings tool in their user accounts.

RauCon Marketplaces for Pharma Business Opportunities coming up RauCon is taking bookings for all 2021 events:

2 Meeting Days + 28 Video Days

ioCom_JB2020.indd 1

euroPLX 74 Athens (Greece) Hotel Grande Bretagne, Athens Athens Meetings Event: 23 & 24 November 2020 Video Meetings Period: 25 Nov – 22 Dec 2020 euroPLX 75 Lisbon (Portugal) Hotel Cascais Miragem, Cascais (near Lisbon) Cascais Meetings Event: 15 & 16 March 2021 Video Meetings Period: 17 March – 13 April 2021 euroPLX 76 Noordwijk (Netherlands) Grand Hotel Huis ter Duin, Noordwijk Noordwijk Meetings Event: 14 & 15 June 2021 Video Meetings Period: 16 June – 13 July 2021 euroPLX 77 Brussels (Belgium) Steigenberger The Wiltcher’s Brussels Meetings Event: 22 & 23 November 2021 Video Meetings Period: 24 Nov – 21 Dec 2021

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Name · Technologiepark Heidelberg GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Im Neuenheimer Feld 582 69120 Heidelberg Baden-Wuerttemberg Dr André H.R. Domin +49-6221-50257-00 +49-6221-50257-11 technologiepark@heidelberg.de www.technologiepark-heidelberg.de

Heidelberg Technology Park is one of Germany’s premier sites for innovative high-tech companies. Heidelberg Technology Park offers flexible infrastructure for biotechnology, pharmaceuticals, digital health, medical technology, bioinformatics, organic electronics, environmental technologies, and IT. Researchers, developers, and producers alike find fitting working conditions, an outstanding network, and hands-on support for their activities.

IL

Strong partners at your side

12 1984 S2 standard, GLP, and GMP labs

Since 1984, Heidelberg Technology Park has been offering lab space, clean rooms, and offices to science and technology-driven companies. Today, more than 90 companies and over 2,800 employees share 85,000 sqm across six locations. Tenants leverage the close proximity to Heidelberg University, German Cancer Research Center (DKFZ), European Molecular Biology Lab (EMBL), and twelve university hospitals with more than one million patients per year.

Areas of Activity · l Biotechnology l Pharmaceuticals l Digital health l Medical technology l Bioinformatics l Organic electronics l Environmental technologies l IT / Artificial Intelligence / VR External · l Association of University Research Collaborations

World-renowned life science site

Parks (AURP) l BIO Deutschland e.V. l Biotechnology Innovation Organisation (BIO) l BioRN Network e.V. l Bundesverband Deutscher Innovations-, Technologie- und Gründerzentren e.V. (BVIZ) l Heidelberg Startup Partners e.V. l International Association of Science Parks and Areas of Innovation (IASP) Request for · l Biotechnology Further Collaborations l Pharmaceuticals l Digital health l Medical technology l Bioinformatics l Organic electronics l Environmental technologies l IT

Startup support office Heidelberg Technology Park operates an inter-institutional and inter-disciplinary startup support office. A dedicated team supports entrepreneurs in raising public funding, finding partners and investors, and starting a sustainable business. Various events like startup weekends, hackathons, fireside chats, talks, and seminars enable easy access to a thriving regional startup scene. The startup support office is also headquarters to the Heidelberg Startup Partners network, a joint initiative including Heidelberg’s leading research and educational institutes.

Accelerator programmes Two accelerator programmes at Heidelberg Technology Park offer a fast lane for life science and IT startups: the Life Science Accelerator Baden-Wuerttemberg is an exclusive twelve-month programme consisting of a series of seminars, workshop and mentoring by seasoned entrepreneurs and market experts. The Up2B Accelerator for IT startups with a business-to-business focus includes various programmes for business modelling, product development, and fundraising. Both accelerator programmes are non-diluting and free of charge.

technologiepark heidelberg

International network Heidelberg Technology Park has been the root of BioRN, the regional life science research and industry cluster.

Additional memberships include the Association of University Research Parks (AURP), BIO Deutschland e.V., Biotechnology Innovation Organisation (BIO), Bundesverband Deutscher Innovations-, Technologie- und Gründerzentren e.V. (BVIZ), and the International Association of Science Parks and Areas of Innovation (IASP).

Active participation ensures optimal representation of our tenants and members.

Space to grow A newly built Business Development Centre offers 7,000 sqm of wet lab, cleanroom, and office space.

The new building is part of Heidelberg Innovation Park (HIP), Heidelberg’s latest area of innovation. The Business Development Center (BDC) Heidelberg includes a dedicated conference centre as well as co-working and acceleration areas. BDC Heidelberg ist home of the AI Lab Kurpfalz, a joint initiative of the Heidelberg Technology Park, the Baden-Württemberg Connected Network, as well as the UC Berkeley Data-X Lab. Its aim is to give small and medium-sized enterprises access to the future technology AI.

Park – in brief ·· More than 85,000 sqm wet lab, cleanroom, and office space for startups and growing companies ·· Startup support office and Heidelberg Startup Partners network ·· Accelerator programmes for Life Science and IT / B2B startups ·· Business development support ·· Entrée to an international network ·· Central location ·· Flexible infrastructure ·· Kindergarten ·· Conference Center ·· Bistro/Canteen ·· Car and eBike Sharing station ·· International PartnerPort

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LIFE SCIENCE

Name · TVM Capital Life Science

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media Founded (year)

· · · · · · · · · ·

Ottostraße 4 80333 Munich Bavaria Dr Hubert Birner +49-89-998-992-0 +49-89-998-992-55 info@tvm-capital.com www.tvm-lifescience.com

LI 1984

Areas of Activity · Venture Capital for Life Science Companies in Europe, North America, and Asia

TVM Capital Life Science TVM Capital Life Science is one of the oldest transatlantic Venture Capital funds with teams based in Munich and Montreal. TVM Capital Life Science was founded in Munich in 1984 and has grown to be a truly global VC, with a strong footprint in Germany, Europe, and North America.

During the last 35 years and within eight fund generations, TVM Capital Life Science has invested in entrepreneurial venture-backed companies. Over several fund generations, the investment strategy has included a multi-stage investment approach spanning discovery to market-ready companies, as well as profitable companies searching for growth capital. The investment focus has always been broad and includes investments in therapeutics, technology platforms, medtech, and diagnostics.

No road is long with good company Multiple strategic partnerships with Big Pharma, an innovative investment approach for developing pharmaceutical assets in a capital-efficient fashion, and a global reach have made TVM Capital Life Science the financing partner of choice in many of today’s promising biotechnology segments.

TVM Capital Life Science’s investment professionals draw upon the experience, international approach, and demonstrated success of close to 100 exits from our portfolio. These exits include initial public offerings on the NASDAQ, and the London, Frankfurt, Zurich, and Vienna Stock Exchanges, as well as trade sales and mergers.

Mios

50

250+

50+

Marketed Products

Diseases Currently Targeted

40

Clinical Trials Backed

125+ tvm capital life science

M&A Deals

IPOs

of Patients helped

TVM Capital Life Science TVM Life Science Management GmbH, TVM Capital GmbH, Munich TVM Life Science Management Inc., Montréal

www.tvm-lifescience.com

Benefit from global hands-on experience

LIFE SCIENCE VENTURE CAPITAL

Financing Life Science Innovation

35 Years in Business

150 Life Science Investments

8

1B+

$

Capital Raised

Fund Generations

Mios

50 IPOs

250+ Clinical Trials Backed

500+ Patents Supported

40

50+

With more than three decades of experience in picking promising entrepreneurs, concepts, and products for development, and building successful entrepreneurial companies, TVM Capital Life Science’s team is acutely aware of what it takes to build a category leader in its field, and has gained unrivalled international investment experience with their track record of dedicated board work, extensive global networks in the world of life science research and product development, and a direct knowledge of the local markets. TVM Capital Life Science provides investors, as well as entrepreneurs and innovation-seeking biopharmaceutical companies, access to global life science innovation and paths for successful tech transfer and commercialisation for the benefit of patients, innovators, and investors.

125+ Marketed Products

Diseases Currently Targeted

M&A Deals

of Patients helped

TVM Capital Life Science TVM Life Science Management GmbH, TVM Capital GmbH, Munich TVM Life Science Management Inc., Montréal

www.tvm-lifescience.com

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Name · WOLL MASCHINENBAU GmbH

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Krughütter Straße 93 66128 Saarbrücken Saarland David Seiler +49-681-97024-36 +49-681-97024-24 david.seiler@woll-maschinenbau.de https://woll-maschinenbau.com

F I Q 320 1960

Areas of Activity · l Biotech l Medical l Pharmaceutical industry l Food industry l Water purification Annual turnover · €65m in 2019 Request for · Woll Maschinenbau is looking for Further Collaborations academic and industrial partners to expand into new technology sectors

A strategic partner, focused on your needs Woll Maschinenbau GmbH offers innovative special solutions in the fields of process technology and assembly automation. We develop, manufacture, and assemble complete process-integrated production units and assembly lines for companies in the biotechnology, medical technology, pharmaceutical, and food industries.

Woll Maschinenbau GmbH is an independent family business founded 60 years ago in Saarland, Germany.

Our expertise: Product portfolio ·· Assembly and production lines for dialysis products such as filters and bag systems - WOLL supplies the world market leader ·· Blood hose systems ·· Filter cartridges for the vaccine production process ·· Filtration technology ·· Process units for fibre production ·· Process media technology ·· Process equipment for sterilisation and autoclaving ·· Production units for respirators ·· Packaging lines for medical products, including stainless steel roller belts ·· Spinning machines for the production of fibres for artificial lungs ·· Filling systems for products and substrates of different viscosities ·· Equipment for connector assembly ·· Bioreactors In addition, we are keen to take on your challenges and develop your new projects based on our experience in automation for process optimisation. We can certainly develop the design of your production units in compliance with the FDA or GMP requirements.

Worldwide operations and service Our production units are built worldwide by our highly qualified installation and commissioning teams. You can benefit from our experience in international projects, our committed and customer-oriented performance, and our in-depth know-how.

woll maschinenbau

Our resources: high professional competence and advanced technology

SONDERLÖSUNGEN Maschinenbau

Team Our company works with a strong construction and project team, supported by our own project management, our specialists in control engineering, a CE and documentation department, and our own manufacturing.

We accompany you in all steps of the development and construction of your plant. All processes from the receipt of an inquiry to commissioning are controlled by our own project management; you thus receive the entire service from one source.

Technology Our customised and innovative solutions are created using the latest CAD and simulation software. With an infrastructure based on a comprehensive and modern machine park as well as a highly technological welding centre, we can build production units of the highest quality.

Certifications ·· DIN EN ISO 9001:2015 ·· DIN EN ISO 3834-2 ·· EN 1090-2:2008 ·· EN 1090-3:2008 ·· AD 2000 ·· ASME CERTIFICATION OF AUTHORIZATION ·· NATIONAL BOARD [ASME]

WOLL Maschinenbau GmbH at a glance ·· Production Made in Germany ·· Several decades of expertise in the development and realisation of production units for the manufacturing of pharmaceutical and medical technology products ·· Committed, highly qualified, and customer-oriented specialists ·· Innovative solutions ·· Worldwide project implementation and service.

Together we develop reliable and efficient units for the manufacturing of your products. By doing so we create a future-oriented production environment with a high degree of economic efficiency for your purposes.

WOLL – your strong partner in automation!

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Name · Wuesthoff & Wuesthoff Patentanwälte PartG mbB Address/P.O. Box Postal Code/City State Contact Person Telephone Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · ·

Schweigerstrasse 2 81541 Munich Bavaria Dr Hendrik Wichmann +49-89-621-800-0 wichmann@wuesthoff.de www.wuesthoff.de

I 120 1927

Areas of Activity · l Drafting IP rights l IP prosecution l Challenging IP rights l Defending IP rights l Litigation l IP strategy l Portfolio Management l Plant variety rights

You invent Intellectual Property (IP), especially patents, trademarks, and designs, is usually the most valuable asset of companies in the biotechnology and pharmaceutical industry. For start-ups, IP rights are often the decisive factor in the next round of financing; for large companies, the IP-pipeline guarantees success in the longterm future; and for technology transfer centres, IP is the essential basis for the successful commercialisation of an innovation. Inventions in life sciences often have the potential to change the market or even open up a new market segment. At the same time, inventors may be confronted with challenges such as how to best protect early developments in a highly competitive field or particular exceptions from patentability.

We protect Our Life Sciences team is committed to understanding your invention with all its implications and applications, transforming it into a solid platform for your business, and accompaning you throughout the entire commercialisation process. We support you against your competitors and fight for the best possible outcome with passion. The client’s success is our success.

Our background Our team consists of scientists holding PhDs in the fields of biochemistry, chemistry, and biology. We are particularly happy that each of our patent attorneys completed his/her scientific training in a different life sciences specialisation, including antibody therapeutics, cell biology, DNA repair and organic/inorganic chemistry. In addition to our scientific expertise, we are legally certified as German and/or European Patent Attorneys with many years of experience. This allows us to offer you the best suited expert for your invention, or, if applicable, an efficient and goal-oriented team of experts for your case.

wuesthoff & wuesthoff

Our activities Our activities range from evaluating invention reports, drafting, and prosecuting patent applications before the EPO and the German Patent and Trademark Office to nullity and infringement proceedings before German courts.

Of course, we also provide support regarding FreedomTo-Operate Analyses (FTO) and Supplementary Protection Certificates (SPCs). Our clients include universities and highly recognised research institutes (tech transfer offices), start-ups, SMEs, and global players.

Contact us We are happy to support you with our proven expertise and experience in all phases of the development of your products or services. Just reach out to us for a nonbinding initial consultation with one of our experts.

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Name · Xlife Sciences AG

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Klausstrasse 19 8008 Zürich Switzerland Elena Sachs +41-44-385-84-60 +41-44-385-84-61 info@xlifesciences.ch www.xlifesciences.ch

LI I 10–50 2018

Areas of Activity · l Technology platforms l Biotech/therapies l Medical technology l Artificial intelligence External · l University Hospital Jena Collaborations l University of Jena l European Molecular Biology Laboratory (EMBL) l Enterprise Management Technology Transfer GmbH (EMBLEM) l University Hospital Tübingen

Xlife Sciences AG – where innovation leads to success.

Xlife Sciences AG (Xetra: XLS) is a Swiss company with a focus on investing in promising technologies in the life sciences industry. Xlife Sciences AG is building the bridge from research and development to healthcare markets by supporting researchers and entrepreneurs in positioning, structuring, developing, and implementing their concepts. Together with industrial partners, research institutions, and universities, Xlife Sciences AG leads projects through the proof-of-concept phase after an invention disclosure or start-up. Subsequently, the firm focuses on out-licensing or selling the company, often with a combination of a strategic partnership. Xlife Sciences AG offers its investors direct access to the further development of innovative and future-oriented technologies at a very early stage. Inflamed pharma GmbH and Lysatpharma GmbH are presented in the following as an extract of the portfolio of Xlife Sciences AG. Velabs Therapeutics GmbH, presented on page 202 of this booklet is a project of Xlife Sciences AG as well.

inflamed pharma GmbH inflamed pharma GmbH produces an active pharmaceutical ingredient based on the substance procaine.

Procaine is an active pharmaceutical ingredient used globally in the category of local anaesthetics. It is well-tested, low in side-effects, and can be applied in various instances. For example, it has been tested and affirmed that it can be widely used in neural therapy. A less established application is that it can also be used as a painkiller and anti-inflammatory in conditions such as arthritis and arthrosis. Through the patented manufacturing process, the formerly solely parenterally administered pharmaceutical ingredient is now suitable for oral and dermal application and it is possible to realise synergistic effects in terms of impact. This is possible through an enhanced bioavailability. This technology uses a clustering method where the active pharmaceutical ingredient is integrated in a protective shell, allowing the transfer to other active pharmaceutical ingredients.

This ingredient is currently used as an extemporaneous mixture for the manufacturing of pharmaceuticals

xlife sciences

of inhouse production. inflamed pharma GmbH is a GMP-certified manufacturer of active pharmaceutical ingredients and aims to conduct a clinical study in cooperation with University Hospital Jena, leading to the application for approval.

Lysatpharma GmbH Lysatpharma GmbH is a biotech-startup focusing on regenerative medicine and new biomedical immunotherapies. The company is developing novel immunotherapies for acute as well as chronic, systemic inflammatory diseases. These encompass autoimmune disorders such as rheumatoid arthritis, multiple sclerosis, and certain forms of diabetes, as well as typical lifestyle diseases such as myocardial infarction, stroke, and complex diseases that often occur after transplantation. Currently, four projects are in the company’s R&D programme: LPRA-01, LPMS-02, LPGVHD-03, and LPALS-04.

In LPRA-01, a new immunotherapy for clinical use in the field of rheumatoid arthritis is under development.

LPMS-02 aims at the treatment of multiple sclerosis while LPGVHD-03 targets the severe graft-versus-host disease (GvHD) that is a major complication after allogeneic stem cell transplantation in cancer patients.

LPALS-04 represents a novel treatment option in the fi eld of amyotrophic lateral sclerosis (ALS).

The patented approach of Lysatpharma GmbH is based on the use of defined bioactive components, which are extracted out of surplus production of high-quality tested blood-products. These conserves are provided continuously by blood banks for clinical primary care.

By repurposing unused and otherwise discarded blood products, Lysatpharma processes the precious material and generates a potent future biological. Because inflammatory processes in different diseases share common features and tissue damage is often associated with inflammation and vise versa, a broad biomedical approach is possible, and is pursued in the company’s R&D programmes. So far, Lysatpharma has successful and promising first in vitro as well as preclinical in vivo data in the field of acute and chronic systemic inflammation.

All projects are in the proof-of-concept phase.

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German Biotech Companies

2cureX GmbH, Hamburg 300MICRONS GmbH, Karlsruhe 3a-diagnostics GmbH, Frickenhausen 3B Pharmaceuticals GmbH, Berlin (BIOD) 4 Animals AlsterScience GmbH, Hamburg 4base lab AG, Reutlingen 4basebio AG, Heidelberg 4Gene GmbH, Freising 4HF Biotec GmbH, Freiburg 4SC AG, Martinsried (BIOD) 4TEEN4 Pharmaceuticals GmbH, Hennigsdorf

A

Aachen Proteineers GmbH, Baesweiler AaviGen GmbH, Heidelberg AB Diagnostic Systems GmbH, Berlin AB Enzymes GmbH, Darmstadt (BIOD, VBU) Abalos Therapeutics GmbH, Essen (BIOD) Abbott GmbH & Co. KG, Ludwigshafen Abbott GmbH & Co. KG, Wiesbaden Abbott Rapid Diagnostics Jena GmbH, Jena Abbvie Deutschland GmbH & Co. KG, Ludwigshafen (BIOD) Abbvie Deutschland GmbH & Co. KG, Wiesbaden (BIOD) Abcalis GmbH, Braunschweig ABiTEP GmbH, Berlin ABT Armbruster Biotechnology GmbH, Bensheim Abviris Deutschland GmbH, Ahrensburg Accelero ® Bioanalytics GmbH, Berlin acCELLerate GmbH, Hamburg (BIOD) Ackermann Saatzucht GmbH & Co. KG, Irlbach bei Straubing Acousia Therapeutics GmbH, Tübingen (BIOD) acphis GmbH & Co. KG, Halstenbek Across Barriers GmbH, Saarbrücken Actome GmbH, Freiburg Acus Laboratories GmbH, Köln Adhesys Medical GmbH, Aachen adivo GmbH, Martinsried AdrenoMed AG, Hennigsdorf (BIOD) advanceCOR GmbH, Martinsried AESKU.DIAGNOSTICS, Wendelsheim Aeterna Zentaris GmbH, Frankfurt a. Main (BIOD) Affimed GmbH, Heidelberg (BIOD) AGC Biologics, Heidelberg (BIOD) AGCT GmbH, Lübeck Agrobiogen GmbH, Hilgertshausen-Tandern AgroJector UG, Köln AgroProtect GmbH, Aachen Agrostim Biotechnologieprodukte GmbH, Großolbersdorf AiCuris Anti-infective Cures GmbH, Wuppertal (BIOD) AID Diagnostika GmbH, Strassberg Alacris Theranostics GmbH, Berlin (BIOD) Albutec GmbH, Rostock Aldevron Freiburg GmbH, Freiburg Algiax Pharmaceuticals GmbH, Erkrath (BIOD) Allecra Therapeutics GmbH, Weil am Rhein ALLERGOPHARMA GmbH & Co. KG, Reinbek Almirall Hermal GmbH, Reinbek AlphaScience GmbH, Riedstadt altona Diagnostics GmbH, Hamburg (BIOD) Alvotech Germany GmbH, Jülich Alvotech Hannover GmbH, Hannover alytas therapeutics GmbH, Jena Amal Therapeutics SA, Berlin amcure GmbH, Eggenstein-Leopoldshafen AMGEN GmbH, München Amgen Research (Munich) GmbH, München (BIOD) AMINO GmbH, Frellstedt AMODIA Bioservice GmbH, Braunschweig AmplexDiagnostics GmbH, Gars Bahnhof AmpliVak Immunotherapy GmbH, Berlin AmpTec GmbH, Hamburg AMSilk GmbH, Planegg (BIOD) Analyticon Biotechnologies AG, Lichtenfels AnalytiCon Discovery GmbH, Potsdam (BIOD, VBU) Analytik Jena, Jena Anchor Diagnostics GmbH, Hamburg AngioBiomed GmbH, Hennigsdorf ANiMOX GmbH, Berlin Aokin AG, Berlin APARA BioScience GmbH, Denzlingen Apogenix AG, Heidelberg (BIOD) Aptarion biotech AG, Berlin Aquarray GmbH, Eggenstein-Leopoldshafen ARAXA Biosciences GmbH, Heidelberg Ark-Biodiversity GmbH, Berlin arrows biomedical Deutschland GmbH, Münster ARTCLINE GmbH, Rostock Artemiflow GmbH, Potsdam

ARTES Biotechnology GmbH, Langenfeld (BIOD, VBU) ASA Spezialenzyme GmbH, Wolfenbüttel Asbach Medical Products GmbH, Obrigheim Ascendis Pharma GmbH, Heidelberg Assay.Works GmbH, Regensburg Astaxa GmbH, Ritschenhausen Astra Biotech GmbH, Berlin ATG:biosynthetics GmbH, Merzhausen ATLAS Biolabs GmbH, Berlin Atriva Therapeutics GmbH, Tübingen (BIOD) ATTO-LAB GmbH, Lübeck Attomol GmbH, Bronkow, OT Lipten attyloid GmbH, Düsseldorf Aucteq Biosystems GmbH, Mannheim AudioCure Pharma GmbH, Berlin Auto Tissue Berlin GmbH, Berlin Ava Lifescience GmbH, Denzlingen AVENTRA Gesellschaft für biologische Diagnostik mbH, Osnabrück Avergen Pharmaceuticals GmbH, Martinsried Axolabs GmbH, Kulmbach (BIOD) axxelera UG, Karlsruhe AYOXXA Biosystems GmbH, Köln

B

b.fab GmbH, Dortmund baseclick GmbH, Neuried BASF Metabolome Solutions GmbH, Berlin BASF Personal Care and Nutrition GmbH, Monheim BASF SE, Ludwigshafen BAST GmbH, Heidelberg Baumschulen Oberdorla GmbH, Vogtei OT Oberdorla Bavarian Nordic GmbH, Martinsried Baxter Oncology GmbH, Halle/Westfalen Bayer AG, Leverkusen BAYER CropScience AG, Monheim Bayer CropScience Biologics GmbH, Wismar Bayer Pharma AG, Berlin (VBU) Bayer Pharma AG, Wuppertal (VBU) BBT Biotech GmbH, Baesweiler Beckman Coulter Biomedical GmbH, München Beiersdorf AG, Hamburg BELANO medical AG, Hennigsdorf Belyntic GmbH, Berlin beniag GmbH, Jülich Berlin Cures GmbH, Berlin (BIOD) Bex-Biotech GmbH & Ko.KG, Münster Biaffin GmbH & Co KG, Kassel BianoScience GmbH, Zwickau BIBITEC Gesellschaft für Prozessentwicklung mbH, Bielefeld Bicoll GmbH, Planegg/Martinsried bifa Umweltinstitut GmbH, Augsburg BINOMED GmbH, Ulm Bio-Protect GmbH, Konstanz BioAgilytix Europe GmbH, Hamburg Bioanalytics Gatersleben UG, Gatersleben BioCheck GmbH, Münster BioControl Jena GmbH, Jena BioCopy GmbH, Emmendingen BIOCYC Gesellschaft für Biotechnologie und Recyclingverfahren mbH & Co. Entwicklungs KG, Potsdam-Golm BioEcho Life Sciences GmbH, Köln Bioenergy CellTec GmbH, Lübeck bioeq GmbH, Holzkirchen Biofidus AG, Bielefeld (BIOD) Biofrontera AG, Leverkusen (BIOD) BioGenes GmbH, Berlin (BIOD, VBU) Bioglobe GmbH, Hamburg BioKryo GmbH, Sulzbach (BIOD) Biolog Life Science Institute GmbH & Co. KG, Bremen Biomax Informatics AG, Martinsried (BIOD, VBU) BioMed X GmbH, Heidelberg (BIOD) Biomedro Biomedizinische Forschung & Entwicklung Rostock GmbH, Bad Doberan Biomes NGS GmbH, Wildau biometec GmbH, Greifswald BioNTech AG (BIOD) BioNTech Cell & Gene Therapies GmbH, Mainz BioNTech Delivery Technologies GmbH, Halle BioNTech Diagnostics GmbH, Mainz BioNTech Innovative Manufacturing Services GmbH, Idar-Oberstein (VBU) BioNTech RNA Pharmaceuticals GmbH, Mainz BioNTech Small Molecules GmbH, Martinsried Biontex Laboratories GmbH, München BioNukleo GmbH, Berlin BIOPHARM GmbH, Eppelheim Biophotonics Diagnostics GmbH, Jena Bioplant Biotechnologisches Forschungslabor GmbH, Ebstorf BIOPRACT GmbH, Berlin Bioresources Technology & Engineering GmbH, Gießen

BIOSERV Diagnostics GmbH, Rostock BioSolveIT GmbH, Sankt Augustin BioSpring Gesellschaft für Biotechnologie mbH, Frankfurt a. Main (BIOD) biosyn Arzneimittel GmbH, Fellbach (VBU) biotechrabbit GmbH, Hennigsdorf BIOTECON Diagnostics GmbH, Potsdam (VBU) Biotest AG, Dreieich BioTeSys GmbH, Esslingen BioTeZ Berlin-Buch GmbH, Berlin BioTissue Technologies GmbH, Freiburg biotx.ai GmbH, Potsdam Biotype GmbH, Dresden (BIOD) BioVariance GmbH, Waldsassen (BIOD) BioVersal Deutschland GmbH, Delitzsch Bioviotica Naturstoffe GmbH, Dransfeld Bioworx, Berlin (VBU) bitop AG, Dortmund (BIOD, VBU) bj-diagnostik GmbH, Göttingen Black Drop Biodrucker GmbH, Aachen BluCon Biotech GmbH, Köln (BIOD) Blue Biolabs GmbH, Berlin BlueBioTech GmbH, Büsum BlueLab Wasseranalysesysteme GmbH, Tübingen Bock Bio Science GmbH, Bremen Böhm-Nordkartoffel Agrarproduktion OHG, Hohenbrünzow Boehringer Ingelheim Biopharmaceuticals GmbH, Ingelheim Boehringer Ingelheim Veterinary Research Center GmbH & Co. KG, Hannover botiss biomaterials GmbH, Zossen BRAIN AG, Zwingenberg (BIOD) Brandenburg Antiinfektiva GmbH , Borstel Breakpoint Therapeutics GmbH, Hamburg Breath Therapeutics GmbH, München BromMarin GmbH, Freiberg BSL BIOSERVICE Scientific Laboratories Munich GmbH, Planegg BSV Bioscience GmbH, Baesweiler Burgwedel Biotech GmbH, Burgwedel Byonoy GmbH, Hamburg

C

c-LEcta GmbH, Leipzig (BIOD) CAG GmbH – Center for Animal Genetics, Tübingen Cambrex IEP GmbH, Wiesbaden CAMPTON Diagnostics GmbH, Itzehoe candidum GmbH, Stuttgart CarboCode Germany GmbH, Konstanz Cardior Pharmaceuticals GmbH, Hannover (BIOD) Carpegen GmbH, Münster (BIOD) CASCAT GmbH, Straubing CatalYm GmbH, Martinsried CCRP Therapeutics GmbH, Berlin CE-Immundiagnostika GmbH, Neckargemünd CeCaVa GmbH, Tübingen CeGaT GmbH, Tübingen (BIOD) Celares GmbH, Berlin (BIOD) Cell Concepts GmbH, Umkirch Cell.Copedia GmbH, Leipzig CellAct Pharma GmbH, Dortmund cellasys GmbH, Kronburg (VBU) Cellbricks GmbH, Berlin CellDEG GmbH, Berlin Cellendes GmbH, Reutlingen Celler Pflanzen- und Gewebelabor, Celle Cellex Cell Professionals GmbH, Köln CellGenix GmbH, Freiburg (BIOD, VBU) CELLphenomics GmbH, Berlin CellServe GmbH, Berlin CellSystems Biotechnologie Vertrieb GmbH, Troisdorf CellTrend GmbH, Luckenwalde Cellulosic Technologies UG, Leinfelden-Echterdingen Cellzome GmbH, Heidelberg Celonic Deutschland GmbH & Co. KG, Heidelberg CEMET GmbH, Stuttgart Cenata GmbH, Tübingen Centogene AG, Rostock (BIOD) Cepheid GmbH, Frankfurt Cevec Pharmaceuticals GmbH, Köln (BIOD, VBU) CGS Crop Genetic Systems UG, Hamburg Charles River Discovery Research Services Germany GmbH, Freiburg Charles River Laboratories Germany GmbH, Erkrath Chembiotech – DNA Technologies, Materials and Reagents, Münster Cheplapharm Arzneimittel GmbH, Mesekenhagen Cherry Biolabs, Würzburg Cherrykukess, Düsseldorf chevita Tierarzneimittel GmbH, Pfaffenhofen Chimera Biotec GmbH, Dortmund Chr. Hansen GmbH, Nienburg/Weser Chromatec GmbH, Greifswald ChromoTek GmbH, Martinsried Chronix Biomedical GmbH, Göttingen Chugai Pharma Marketing Ltd., Frankfurt Cilian AG, Münster CIRES cell & immune research services, Bochum Clariant Produkte (Deutschland) GmbH, Planegg (BIOD) CLS Cell Lines Service GmbH, Eppelheim co.don ® AG, Teltow (BIOD) Computomics GmbH, Tübingen Conaris Research Institute AG, Kiel CONGEN Biotechnologie GmbH, Berlin CORAT Therapeutics, Braunschweig Corden BioChem GmbH, Frankfurt a. Main corlife oHG, Hannover Creative-Therapeutics GmbH, Wuppertal Crelux GmbH, Martinsried

CropEnergies AG, Mannheim CSL Behring GmbH, Marburg Cube Biotech GmbH, Monheim Curetis GmbH, Holzgerlingen (BIOD) CureVac AG, Tübingen (BIOD, VBU) Cyano Biotech GmbH, Berlin (BIOD) Cygenia GmbH, Aachen Cysal GmbH, Münster Cytecs GmbH, Münster cytena GmbH, Freiburg Cytobox UG, Konstanz CytoPharma GmbH, Darmstadt Cytophorics GbR, München CytoSwitch, München

D

Danisco Deutschland GmbH, Niebüll Davids Biotechnologie GmbH, Regensburg DECODON GmbH, Greifswald denovoMATRIX GmbH, Dresden Dermagnostix GmbH, Hamburg DermaTools Biotech GmbH, Darmstadt DexLeChem GmbH, Berlin DiaPat GmbH, Hannover Diarect AG, Freiburg Digital Diagnostics AG, Mainz Dispendix GmbH, Stuttgart DMG Deutsche Malaria GmbH , Hamburg Dr. Rölleke Labor für Genetische Analytik GmbH, Potsdam DRG Instruments GmbH, Marburg DSM Nutritional Products GmbH, Grenzach-Wyhlen Dust Biosolutions GmbH, Martinsried DyNAbind GmbH, Dresden Dynamic Biosensors GmbH, Martinsried Dynamic42 GmbH, Jena (BIOD, VBU) Dynavax GmbH, Düsseldorf (VBU)

E

e~nema GmbH, Schwentinental ecSeq Bioinformatics GmbH, Leipzig Eisbach Bio GmbH, Martinsried (BIOD) Electrochaea GmbH, Planegg eleva GmbH, Freiburg (BIOD, VBU) ElexoPharm GmbH, Saarbrücken Ella Biotech Gesellschaft für angewandte Biotechnologie mbH, Martinsried EMC microcollections GmbH, Tübingen Emergence Therapeutics AG, Duisburg (BIOD) EMP Genetech, Ingolstadt Emsland-Stärke GmbH, Emlichheim EnBiotix GmbH, Leipzig EnFin GmbH, Heidelberg Enza Zaden Deutschland GmbH & Co. KG, Dannstadt-Schauernheim Enzymaster Deutschland GmbH, Düsseldorf Enzymicals AG, Greifswald (BIOD) EpiGene GmbH, Freising Epigenomics AG, Berlin (BIOD) Epimune GmbH, Berlin epinamics GmbH, Berlin EpiQMAx GmbH, Martinsried EPITOPIC GmbH, Leipzig Ernst Benary Samenzucht GmbH, Hannover-Münden Eternygen GmbH, Berlin (BIOD) ethris GmbH, Planegg (BIOD) Eupheria Biotech GmbH, Dresden Eurofins BioPharma Product Testing Munich GmbH, Planegg Eurofins GeneScan GmbH, Freiburg Eurofins Genomics Europe Sequencing GmbH, Konstanz (BIOD) Eurofins Genomics Germany GmbH, Ebersberg Eurofins LifeCodexx AG, Konstanz EUROIMMUN Medizinische Labordiagnostika AG, Lübeck Evonik Industries AG, Essen Evonik Industries AG, Hanau Evonik Industries GmbH, Marl Evonik Nutrition & Care GmbH, Halle/Westfalen EVORION Biotechnologies GmbH, Münster (BIOD) Evotec (München) GmbH, Martinsried Evotec International GmbH, Göttingen Evotec SE, Hamburg (BIOD) Evotec, Köln evoxx technologies GmbH, Monheim am Rhein (BIOD) EW Biotech GmbH, Leuna Exosome Diagnostics GmbH, Martinsried Experimentelle Pharmakologie & Onkologie Berlin-Buch GmbH, Berlin

F

F&F LifeScience GmbH, Berlin Fast BT UG, Mannheim FERRING Arzneimittel GmbH, Kiel Filt Lungen- und Thoraxdiagnostik GmbH, Zellingen Formycon AG, Martinsried (BIOD) Formycon Project 203 GmbH, Martinsried Freeline Therapeutics GmbH, Martinsried (BIOD) FRIZ Biochem Gesellschaft für Bioanalytik mbH, Neuried FRUTAROM Savory Solutions GmbH, Stuttgart FundaMental Pharma GmbH, Heidelberg

G

GA Generic Assays GmbH, Dahlewitz GALAB Technologies GmbH, Hamburg GANYMED Pharmaceuticals GmbH, Mainz GEMoaB Monoclonals GmbH, Dresden (BIOD) GEN-IAL GmbH, Troisdorf GenArc (Genome Architecture) GmbH, Dresden

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Genaxxon Bioscience GmbH, Ulm Gene Bridges GmbH, Heidelberg Genedata Bioinformatik GmbH, München GeneQuine Biotherapeutics GmbH, Hamburg (BIOD) GeneSurge GmbH, München Genetek Biopharma GmbH, Berlin Genewerk GmbH, Heidelberg geneXplain GmbH, Wolfenbüttel GenExpress Gesellschaft für Proteindesign mbH, Berlin Genome Biologics UG, Frankfurt Genotype, Biotechnologische und molekularbiologische Forschung GmbH, Wilhelmsfeld GenXPro GmbH, Frankfurt am2016 Main German Seed Alliance GmbH, Köln GewürzMühle Nesse, Loxstedt-Nesse GFE Blut mbH, Frankfurt a. Main GHG Saaten GmbH, Aschersleben GlaxoSmithKline Biologicals, Dresden Global Bioenergies GmbH, Leuna (BIOD) Glycotope GmbH, Berlin (BIOD) GlycoUniverse GmbH & Co.KGaA, Potsdam glyXera GmbH, Magdeburg GNA Biosolutions GmbH, Martinsried (BIOD) GoodMills Innovation GmbH, Hamburg GoSilico GmbH, Karlsruhe Grifols Deutschland GmbH, Frankfurt Grünenthal GmbH, Aachen GSK Vaccines GmbH, Marburg/Lahn GVG Diagnostics GmbH, Leipzig

H

Hain Lifescience GmbH, Nehren HDC GmbH, Konstanz Heidelberg Delivery Technologies GmbH, Heidelberg Heidelberg ImmunoTherapeutics GmbH, Heidelberg Heidelberg Pharma AG, Ladenburg (BIOD) Heidelberg Pharma Research GmbH, Ladenburg (BIOD) Henkel AG & Co. KGaA, Düsseldorf HepaRegeniX GmbH, Konstanz (BIOD) Heppe Medical Chitosan GmbH, Halle Heraeus Precious Metals GmbH & Co. KG, Hanau Herbrand PharmaChemicals GmbH, Gengenbach highQu GmbH, Kraichtal HMNC Brain Health, München Horizon Pharma GmbH, Mannheim HS Diagnomics GmbH, Berlin HTCycle GmbH, Murchin HUMAN Gesellschaft für Biochemica und Diagnostica mbH, Magdeburg Human Gesellschaft für Biochemica und Diagnostica mbH, Wiesbaden Human Tissue and Cell Research-Services (HTCR) GmbH, Planegg/Martinsried humatrix AG, Pfungstadt (BIOD) Hummingbird Diagnostics GmbH, Heidelberg (BIOD) Hybro Saatzucht GmbH & Co. KG, Schenkenberg Hybrotec GmbH, Potsdam HYCOR Europe Bio Crest B.V., Kassel – Lohfelden Hyglos GmbH – a bioMérieux company, Bernried Hypharm GmbH, Bernried

I

IBA GmbH, Göttingen ibidi GmbH, Gräfelfing (BIOD) Ibt – immunological and biochemical testsystems GmbH, Ertingen IcanoMAB GmbH, Polling Icon Genetics GmbH, Halle (BIOD) IdentXX GmbH, Stuttgart IDT Biologika GmbH, Dessau-Roßlau IFM Therapeutics GmbH, Bonn IGV Institut für Getreideverarbeitung GmbH, Nuthetal IIT – Institut für Innovationstransfer an der Universität Bielefeld GmbH, Bielefeld IMAX Discovery GmbH, Dortmund IMD Natural Solutions GmbH, Dortmund ImevaX GmbH, München IMGM Laboratories GmbH, Martinsried immatics NV, Tübingen Immucor Medizinische Diagnostik GmbH, Dreieich Immumed GmbH, München Immundiagnostik AG, Bensheim Immungenetics AG, Rostock Immunic AG, Gräfelfing (BIOD) immunoGlobe Antikörpertechnik GmbH, Himmelstadt Immunolab GmbH, Kassel Immunologik GmbH, Berlin ImmunoQure AG, Düsseldorf Immunservice GmbH, Hamburg (BIOD) Immutep GmbH, Leipzig (BIOD) imusyn GmbH & Co. KG, Hannover in.vent DIAGNOSTICA GmbH, Hennigsdorf (BIOD) Indical Bioscience GmbH, Leipzig INDIVUMED GmbH, Hamburg InfanDx AG, Köln InflaRx GmbH, Jena (BIOD) InnovaPlant GmbH & Co. KG, Gensingen innoVitro GmbH, Jülich InSCREENeX GmbH, Braunschweig Insilico Biotechnology AG, Stuttgart (VBU) Institut für angewandte Zellkultur Dr. Toni Lindl GmbH, München Institut für Bioanalytik, Umwelttoxikologie & Biotechnologie Halle GmbH, Halle Institut für Medizinische Molekulardiagnostik GmbH, Berlin Institut für Pflanzenkultur e.K., Schnega Institut Virion\Serion GmbH, Würzburg Intana Bioscience GmbH, Martinsried Intavis Peptide Services GmbH & Co. KG, Tübingen INVICOL GmbH, Berlin INVIGATE GmbH, Jena

Invitek Molecular GmbH, Berlin InVivo BioTech Services GmbH, Hennigsdorf iOmx Therapeutics AG, Martinsried Ionera Technologies GmbH, Freiburg Ipsen Pharma GmbH, München Iris Biotech GmbH, Marktrewitz (VBU) ISAR Bioscience GmbH, Martinsried Isarna Therapeutics GmbH, München Isoloid GmbH, Düsseldorf IVD Gesellschaft für Innovative Veterinärdiagnostik mbH, Seelze-Letter

J

Jena Bioscience GmbH, Jena JeNaCell GmbH, Jena (BIOD) Jennewein Biotechnologie GmbH, Rheinbreitbach (BIOD) JPT Peptide Technologies GmbH, Berlin

K

Kaesler Animal Nutrition GmbH, Cuxhaven Katairo GmbH, Kusterdingen Kosmas Therapeutics GmbH, Nürnberg KreLo GmbH, Ulm KWS LOCHOW GmbH, Bergen KWS SAAT SE, Einbeck

L

LABOR DR. MERK & KOLLEGEN GmbH, Ochsenhausen LABOR FÜR DNA-ANALYTIK, Freiburg Larova GmbH, Jena Laves-Arzneimittel GmbH, Ronnenberg Lead Discovery Center GmbH, Dortmund (BIOD) LegenDairy Foods GmbH, Berlin LenioBio GmbH, Düsseldorf LEO Pharma GmbH, Neu-Isenburg LEUKOCARE AG, Martinsried LGC Genomics GmbH, Berlin Life & Brain GmbH, Bonn (BIOD) LifeGlimmer GmbH, Berlin lifespin GmbH, Regensburg Ligandis UG, Gülzow-Prüzen Lilly Deutschland GmbH, Bad Homburg Limagrain GmbH, Edemissen LINDIS Biotech GmbH, Martinsried Lindis Bloodcare GmbH, Hennigsdorf Lionex GmbH, Braunschweig Lipocalyx GmbH, Halle (Saale) Lipotype GmbH, Dresden Lipozyt Marker GmbH, Bremen Lisando GmbH, Regensburg Loewe Biochemica GmbH, Sauerlach LOGOPHARM GmbH, March Lohmann Animal Health GmbH, Cuxhaven Lohmann Tierzucht GmbH, Cuxhaven Lonza Cologne GmbH, Köln (VBU) Lophius Biosciences GmbH, Regensburg (BIOD) Lumobiotics GmbH, Karlsruhe LXP Group GmbH, Teltow

M

m2p-labs GmbH, Baesweiler MabTag GmbH, Friesoythe Magna Diagnostics GmbH, Leipzig MalVa GmbH, Heidelberg Matricel GmbH, Herzogenrath MBBL Dr. Bartling GmbH, Bielefeld medac Gesellschaft für klinische Spezialpräparate mbH, Wedel Mediagnost GmbH, Reutlingen Medical Biomaterial GmbH, Neustadt-Glewe Medigene AG, Planegg/Martinsried (BIOD) Medigene Immunotherapies GmbH, Planegg MEDIPAN GMBH, Dahlewitz MEDIWISS Analytik GmbH, Moers Medprin Biotech, Frankfurt am Main Meidrix Biomedicals GmbH, Esslingen MELEMA Pharma GmbH, Hamburg MERCK KGaA, Darmstadt (BIOD) Merlion Pharmaceuticals GmbH, Berlin Merz GmbH & Co. KGaA, Frankfurt a. Main Merz Pharma GmbH & Co. KGaA, Dessau-Roßlau metabion GmbH, Planegg (VBU) Metabolon GmbH, München (BIOD) MetaHeps GmbH, Martinsried MetaSysX GmbH, Potsdam (BIOD) Micro Pro GmbH, Magdeburg microbEnergy GmbH, Schwandorf Microcoat Biotechnologie GmbH, Bernried MicroDiscovery GmbH, Berlin Micromun Privates Institut für Mikrobiologische Forschung GmbH, Greifswald Microsynth Seqlab GmbH, Göttingen Mikrogen GmbH, Neuried (BIOD) Milenia Biotec GmbH, Gießen MILTENYI BIOTEC GmbH, Bergisch Gladbach (BIOD) Miltenyi Biotec GmbH, Teterow Milupa GmbH, Bad Homburg Minaris Regenerative Medicine GmbH, München (BIOD) Minerva Analytix GmbH, Rangsdorf Minerva Biolabs GmbH, Berlin (VBU) MINITÜB GmbH, Tiefenbach miRdetect GmbH, Bremerhaven Mireca Medicines GmbH, Tübingen mk2 Biotechnologies, München MLM Medical Labs GmbH, Mönchengladbach (BIOD) MobiTEC GmbH, Göttingen

MODAG GmbH, Wendelsheim Molecular Health GmbH, Heidelberg (BIOD) moloX GmbH, Berlin Molzym GmbH & Co.KG, Bremen Morphoplant GmbH, Bochum MorphoSys AG, Planegg (BIOD) Mosaiques Diagnostics and Therapeutics AG, Hannover MSD SHARP & DOHME GmbH, Haar Mukocell GmbH, Dortmund (BIOD) multiBIND biotec GmbH, Köln multimmune GmbH, München Multiplexion GmbH, Friedrichshafen Mundipharma GmbH, Frankfurt MyBiotech GmbH, Überherrn Myelo Therapeutics GmbH, Berlin Mylan dura GmbH, Darmstadt myPOLS Biotec GmbH, Konstanz MYR GmbH, Burgwedel Myriad GmbH, Martinsried Myriad International GmbH, Köln myriamed GmbH, Göttingen

N

nadicom Gesellschaft für angewandte Mikrobiologie mbH, Marburg nandatec GmbH, Lübeck Nanion Technologies GmbH, München NanotecMARIN GmbH, Ingelheim am Rhein NanoTemper Technologies GmbH, München nanoTOOLS Antikörpertechnik GmbH & Co. KG, Teningen Naturin Viscofan GmbH, Weinheim Navigo Proteins GmbH, Halle (BIOD, VBU) Navitect Bio GmbH, Heidelberg NEO New Oncology GmbH, Köln Neovii Biotech GmbH, Gräfelfing (BIOD, VBU) Neracare GmbH, Köln NEUREVO, München NeuroProfile GmbH, Regensburg NEUWAY Pharma GmbH, Bonn (BIOD) nextplant UG, Berlin nexttec GmbH, Hilgertshausen-Tandern NH DyeAGNOSTICS GmbH, Halle Nomad Bioscience GmbH, Halle Norbitec GmbH, Uetersen Norddeutsche Pflanzenzucht Hans-Georg Lembke KG, Holtsee Norden Vaccines GmbH, Braunschweig Nordmark Arzneimittel GmbH & Co. KG, Uetersen (BIOD, VBU) Nordsaat Saatzucht GmbH, Langenstein Norika Nordring-Kartoffelzucht- und Vermehrungs-GmbH, Groß-Lüsewitz Northwest Biotherapeutics GmbH, Leipzig Noscendo GmbH, Duisburg (BIOD) NovaBiotec ® Dr. Fechter GmbH, Berlin NOVAgreen GmbH, Vechta-Langförden Novaliq GmbH, Heidelberg (BIOD) NovaTec Immundiagnostica GmbH, Dietzenbach Novo Nordisk Pharma GmbH, Mainz Novozymes Berlin GmbH, Berlin (BIOD, VBU) NOXXON Pharma AG, Berlin (BIOD) NPZ Innovation GmbH, Holtsee NUMAFERM GmbH, Düsseldorf

O

OakLabs GmbH, Hennigsdorf Ocean Pharma GmbH, Reinbek oceanBASIS GmbH, Kiel Octapharma Biopharmaceuticals GmbH, Heidelberg Octapharma GmbH, Langenfeld Ohly GmbH, Hamburg Okmed Biotech GmbH, Halle OMEICOS Therapeutics GmbH, Berlin OmicEra Diagnostics GmbH, Planegg OmicEra Diagnostics GmbH, Planegg OmicScouts GmbH, Freising oncgnostics GmbH, Jena (BIOD) Oncimmune Germany GmbH, Dortmund (BIOD) OncoLead GmbH & Co. KG, Karlsfeld Oncoscience GmbH, Schenefeld Oncoscreen – Ein Unternehmen der synlab MVZ Weiden GmbH, Jena Oncotrition GmbH, Leipzig OneWorld Diagnostics GmbH, Düsseldorf OntoChem GmbH, Halle optiferm GmbH, Oy-Mittelberg ORGENTEC Diagnostika GmbH, Mainz origenis GmbH, Martinsried (BIOD) ORYX GmbH & Co. KG, Baldham Oxacell AG, Potsdam OxProtect GmbH, Münster

P

P. H. Petersen Saatzucht Lundsgaard GmbH & Co. KG, Grundhof PAIA Biotech GmbH, Köln PAION AG, Aachen (BIOD) PAN-Biotech GmbH, Aidenbach Pantherna Therapeutics GmbH, Hennigsdorf (BIOD) PELOBIOTECH GmbH, Martinsried PEPperPRINT GmbH, Heidelberg (BIOD) peptides&elephants GmbH, Hennigsdorf PerioTrap Pharmaceuticals GmbH, Halle PerkinElmer chemagen Technologie GmbH, Baesweiler Pfizer Deutschland GmbH, Berlin (BIOD) Pfizer Manufacturing Deutschland GmbH, Freiburg Pflanzenzucht Oberlimpurg, Schwäbisch Hall Phadia GmbH, Freiburg PHARMA WALDHOF GmbH, Düsseldorf

PharmaInformatic, Emden PHARMAPLANT Arznei- und Gewürzpflanzen Forschungs- und Saatzucht GmbH, Artern PharmaZell GmbH, Raubling Pharmbiotec GmbH, Saarbrücken PharmGenomics GmbH, Mainz Phenex Pharmaceuticals AG, Heidelberg (BIOD) Phenos GmbH, Hannover Phytolinc UG, Köln Phyton Biotech GmbH, Ahrensburg Phytowelt GreenTechnologies GmbH, Nettetal (VBU) Pieris Pharmaceuticals GmbH, Freising (BIOD) Pixelbiotech GmbH, Schriesheim PL BioScience GmbH, Aachen Planton GmbH, Kiel (VBU) PlasmidFactory GmbH & Co. KG, Bielefeld (BIOD, VBU) PLS-Design GmbH, Hamburg pluriSelect Life Science UG, Leipzig Polypharm GmbH, Darmstadt Polyquant GmbH, Bad Abbach (VBU) PortaCellTec biosciences GmbH, Göttingen Precigen Bioinformatics Germany GmbH, München Precision for Medicine GmbH, Berlin PreOmics GmbH, Martinsried Priavoid GmbH, Jülich (BIOD) PRIMACYT Cell Culture Technology GmbH, Schwerin Prime Vector Technologies GmbH, Tübingen ProBioGen AG, Berlin PROGEN Biotechnik GmbH, Heidelberg (BIOD) ProJect Pharmaceutics GmbH, Martinsried Prolytic GmbH, Frankfurt am Main PromoCell GmbH, Heidelberg Protagen Protein Services GmbH, Heilbronn (BIOD) Protagen Protein Services, Dortmund Proteo Biotech AG, Kiel Proteome Factory AG, Berlin Proteome Sciences R&D GmbH & Co. KG, Frankfurt a. Main Proteona Antibody Protection (PAP) GmbH, Köln Proteona GmbH, Köln Proteros Biostructures GmbH, Martinsried (BIOD) PROVIREX Genome Editing Therapies GmbH, Hamburg Provita Supplements GmbH, Pinneberg provitro AG, Berlin PXBioVisioN GmbH, Hannover (VBU)

Q

Q-bios GmbH, Edingen-Neckarhausen QIAGEN, Hilden (BIOD) QITHERA GmbH, Düsseldorf QLi5 Therapeutics GmbH, Dortmund Qualitype GmbH, Dresden Quidel Germany GmbH, Kornwestheim

R

R-Biopharm AG, Darmstadt (BIOD) ravo Diagnostika GmbH, Freiburg Reaction Biology Europe GmbH, Freiburg (BIOD) Recipharm Verwaltung GmbH, Wasserburg ReliaTech GmbH, Wolfenbüttel Rentschler Biopharma SE, Laupheim (BIOD) Repairon GmbH, Göttingen RESprotect GmbH, Dresden RHEACELL GmbH, Heidelberg RHEINCELL Therapeutics GmbH, Langenfeld Ribocon GmbH, Bremen RIBOnomix GmbH, Leipzig Riboxx GmbH, Radebeul Richter-Helm BioLogics GmbH & Co. KG, Hamburg (BIOD, VBU) Ridom GmbH, Münster RIEMSER Pharma GmbH, Greifswald-Insel Riems RLP AgroScience GmbH, Neustadt Roboscreen GmbH, Leipzig Roche Diagnostics GmbH, Penzberg (BIOD) Roche mtm laboratories AG, Mannheim Rodos BioTarget GmbH, Hannover Roquette Klötze GmbH & Co. KG, Klötze

S

Saaten-Union BIOTEC GmbH, Leopoldshöhe (VBU) Saatzucht Josef Breun GdbR, Herzogenaurach Saatzucht Steinach GmbH & Co KG, Steinach Saatzucht Streng-Engelen GmbH & Co. KG, Uffenheim SaKa Pflanzenzucht GmbH & Co. KG, Windeby Salata AG, Ritschenhausen SanguiBioTech GmbH, Hamburg Sanofi-Aventis Deutschland GmbH, Frankfurt (BIOD) SanoLiBio GmbH, München Sartorius Stedim Cellca GmbH, Laupheim (BIOD) ScheBo ® Biotech AG, Gießen (BIOD) SCIENION AG, Berlin (BIOD) Scientific Research and Development GmbH, Oberursel Sciomics GmbH, Neckargemünd (BIOD, VBU) SciRhom GmbH, Martinsried ScobyTec UG, Halle ScreenFect GmbH, Eggenstein-Leopoldshafen Secarna Pharmaceuticals GmbH & Co. KG, Martinsried (BIOD) Selecta Klemm GmbH & Co. KG, Stuttgart selectION Therapeutics GmbH, Martinsried SeNostic Health GmbH, Hannover Senova Gesellschaft für Biowissenschaft und Technik mbH, Weimar SenseUp GmbH, Jülich SensID GmbH, Rostock (BIOD) Senzyme GmbH, Troisdorf

22 nd Guide to german biotech companies 2021

254 | 255

SequentiX – Digital DNA Processing, Klein Raden sequiserve GmbH, Vaterstetten Seracell Stammzelltechnologie GmbH, Rostock Seramun Diagnostica GmbH, Heidesee (BIOD) Seratec Gesellschaft für Biotechnologie mbH, Göttingen Serengen GmbH, Dortmund SeSaM-Biotech GmbH, Aachen (VBU) Sidanis Pharma GmbH, Hamburg Siemens Healthcare Diagnostics Products GmbH, Marburg sifin diagnostics gmbh, Berlin (VBU) Sigma-Aldrich Biochemie GmbH, Hamburg Signatope GmbH, Reutlingen Signature Diagnostics GmbH, Potsdam SILANTES GmbH, München (BIOD) Silence Therapeutics GmbH, Berlin Sirana Pharma GmbH, Plannegg-Martinsried SIRION Biotech GmbH, Martinsried (BIOD) Sirius Fine Chemicals SiChem GmbH, Bremen siTOOLs Biotech GmbH, Martinsried Soluventis GmbH, Bochum SP Sourcon Padena GmbH & Co. KG, Tübingen Sphingotec GmbH, Hennigsdorf SpinDiag GmbH, Freiburg SpinPlant GmbH, Halle Squarix GmbH, Marl Stabizym GmbH, Roßdorf STADA Arzneimittel AG, Bad Vilbel StarSEQ GmbH, Mainz Steffens Biotechnische Analysen GmbH, Ebringen sterna biologicals GmbH & Co. KG, Marburg SternEnzym GmbH & Co. KG, Ahrensburg Strube Research GmbH & Co. KG, Söllingen Subitec GmbH, Stuttgart Südzucker AG, Obrigheim Sumaya Biotech GmbH & Co. KG, Heidelberg Surflay Nanotec GmbH, Berlin SymbioVaccin GmbH, Herborn Symrise AG, Holzminden Synaptic Systems Gesellschaft für neurobiologische Forschung, Entwicklung und Produktion mbH, Göttingen Synbionik GmbH, Frankfurt (VBU) Syngenta Agro GmbH, Maintal Syngenta Seeds GmbH, Bad Salzuflen Synimmune GmbH, Tübingen Synovo GmbH, Tübingen (BIOD) Syntab Therapeutics GmbH, Würselen (BIOD) Sysmex Inostics GmbH, Hamburg Sysmex Partec GmbH, Görlitz Systasy Bioscience GmbH, München

Vaxxinova Diagnostics GmbH, Leipzig Vaxxinova Research & Development GmbH, Münster Velabs Therapeutics GmbH, Heidelberg Velvio GmbH, Regensburg Ventaleon GmbH, Gemünden/Wohra vermicon AG, München VEROVACCiNES GmbH, Halle (BIOD) vertis Biotechnologie AG, Freising Vibalogics GmbH, Cuxhaven (BIOD) ViGeneron GmbH, Starnberg Viramed Biotech AG, Planegg VIROTECH Diagnostics GmbH, Rüsselsheim Vita 34 AG, Leipzig VivaCell Biotechnology GmbH, Denzlingen vivo Science GmbH, Gronau (BIOD) Vivoryon Therapeutics AG, Halle (BIOD) Volition Germany GmbH, Gräfelfing

W

W. von Borries-Eckendorf GmbH & Co. KG, Leopoldshöhe Wacker Biotech GmbH, Halle (VBU) Wacker Biotech GmbH, Jena (VBU) Wacker Chemie AG, München (VBU) WeissBioTech GmbH, Ascheberg

X/Y/Z

XanTec bioanalytics GmbH, Düsseldorf Xell AG, Bielefeld XL-protein GmbH, Freising (BIOD, VBU) Xvir Therapeutics GmbH, München YUMAB GmbH, Braunschweig (BIOD) Zedira GmbH, Darmstadt (BIOD) zell-kontakt GmbH, Nörten-Hardenberg Zellkraftwerk GmbH, Leipzig Zellwerk GmbH, Oberkrämer OT Eichstädt Zentrum für Humangenetik und Laboratoriumsdiagnostik, Martinsried Zimmer BioTech GmbH, Neu-Ulm ZytoVision GmbH, Bremerhaven (VBU)

Abbreviations: BIOD: BIO Deutschland VBU: Vereinigung Deutscher Biotechnologie-Unternehmen

(All data is provided without guarantee.)

T

T-CURX GmbH, Würzburg T-Knife GmbH, Berlin t2cure GmbH, Frankfurt Tacalyx GmbH, Berlin Taconic Biosciences GmbH, Leverkusen (BIOD) Takeda GmbH, Konstanz targenomix GmbH, Potsdam Targos Molecular Pathology GmbH, Kassel (BIOD) Taros Chemicals GmbH & Co. KG, Dortmund (BIOD, VBU) TECNARO GmbH, Ilsfeld Telexos GmbH, Weiden TentaMedix GmbH, Karlsruhe (BIOD) TETEC Tissue Engineering Technologies AG, Reutlingen (BIOD) Teva GmbH, Ulm tgcBIOMICS GmbH, Bingen (VBU) TherapySelect Dr. Frank Kischkel, Heidelberg Therawis Diagnostics GmbH, München Therawis Pharma GmbH, München Thermo Fisher Scientific B.R.A.H.M.S GmbH, Hennigsdorf Thermo Fisher Scientific GENEART GmbH, Regensburg Thermosome GmbH, Martinsried (BIOD) TheryCell GmbH, Berlin Tib Molbiol Syntheselabor GmbH, Berlin TICEBA GmbH, Heidelberg TIGO GmbH, Wiesbaden Tinplant Biotechnik und Pflanzenvermehrung GmbH, Wanzleben TissUse GmbH, Berlin TolerogenixX GmbH, Heidelberg Topas Therapeutics GmbH, Hamburg (BIOD) TOPLAB Gesellschaft für angewandte Biotechnologie mbH, Martinsried TraitGenetics GmbH, Stadt Seeland OT Gatersleben Transimmune AG, Düsseldorf trenzyme GmbH, Konstanz (VBU) TriMedicales GmbH, Dreieich-Götzenhain TRION Research GmbH, Martinsried Tubulis Technologies, Martinsried TunaTech GmbH, Düsseldorf

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U

UCB GmbH, Monheim UGA Biopharma GmbH, Hennigsdorf (BIOD) UGiSense AG, Dortmund upcyte technologies GmbH, Hamburg UROQUANT GmbH, Bad Abbach URSAPHARM Arzneimittel GmbH, Saarbrücken

V

Varicula Biotec GmbH, Wismar vasopharm GmbH, Würzburg (BIOD) VAXIMM GmbH, Mannheim Vaxxilon Deutschland GmbH, Berlin Vaxxinova Autogenous Vaccines GmbH, Cuxhaven

Andreas Macht Sales & Marketing Tel. +49-30-264921-54 a.macht@biocom.de

22nd Guide to German Biotech Companies 2021

22 Guide to German Biotech Companies nd

2021

In cooperation with: BIO Deutschland â&#x20AC;&#x201C; German Biotech Industry Organisation European Biotechnology Network ISBN 978-3-928383-76-9

VBU Association of German Biotechnology Companies