Guide to German Biotech Companies 2024

Page 1

25th Guide to German Biotech Companies 2024

ISBN 978-3-928383-89-9

2024 Jubilee Edition



25th Guide to German Biotech Companies 2024


© BIOCOM Interrelations GmbH, Berlin 2023 25th Guide to German Biotech Companies Published by:

BIOCOM Interrelations GmbH, Jacobsenweg 61, 13509 Berlin, Germany Tel. +49-30-264921-0, Fax +49-30-264921-11, service@biocom.de, www.biocom.de

Publisher: Andreas Mietzsch Executive Producer: Wolfgang Gutowski Production: Martina Willnow Graphic Design: Michaela Reblin Printed at:

Heenemann GmbH & Co. KG, Berlin

This book is protected by copyright. All rights including those regarding translation, reprinting and reproduction reserved. No part of this book covered by the copyright hereon may be processed, reproduced, and proliferated in any form or by any means (graphic, electronic, or mechanical, including photocopying, recording, taping, or via information storage and retrieval systems, and the Internet). ISBN: 978-3-928383-89-9


Editorial

What, 25 years already? Here it is, dear readers, the 25th Guide to German Biotech Companies. Let us celebrate the anniversary with a beautiful and interesting book. When this “international business card” was launched at the end of the last millennium (!) by a small group of biotech entrepreneurs not far from the Brandenburg Gate in Berlin, none of us could see into the future. Today, most of us are already close to well-deserved retirement. But I am sure that if we had put our personal ideas on paper and only brought them out again today, we would be amazed at how ambitious we were back then. Well, we had quite expected that most new medicines today would be biotechnological. We also believed that companies from our sector would one day make it into the highest German stock market league, the DAX®. But we actually expected an industrial revolution - and we are still waiting for it today. Especially in the field of industrial biotechnology, we are clearly behind expectations. Although with the climate catastrophe we should finally have a powerful lever to end the domination of oil, there is no sign of an overall biologisation of industry. The petrochemical industry is proving to be as powerful as it is reactionary. 26 years after the legendary Kyoto Protocol on Climate Change, humanity’s CO2 emissions are still rising. In many industrialised countries, there is widespread discussion about how we can do better. It is depressing when biotechnology solutions are not even mentioned. Instead of adapting the entire industry to the natural cycles of our biosphere, for example, it is suggested in earnest to set up tens of millions of CO2 filter stations, whose incredible energy needs are then to be covered by nuclear power plants. And this after decades of investment in the development of the biotechnology.

Andreas Mietzsch Publisher

Well, neither the Corona pandemic nor the atavistic war in Ukraine were on our radar 25 years ago, but our main wish came true thanks to the tireless work of many: Today, there is a successful biotechnology industry in Germany - see page 7 ff. Despite all the satisfaction about this, we are concerned about the German government and its less than stringent approach to creating good framework conditions. Fortunately, we have smart and dedicated entrepreneurs and managers with well-trained staff who work hard to make their companies successful. A whole range of these successful enterprises present themselves to the international public in this English-language book. The megatrends of an ageing society and climate change continue to call for biotechnological solutions: smart, efficient, environmentally friendly and climateneutral. Let’s just keep going. Hopefully more peaceful and prosperous times will come again. It is something to look forward to. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

2|3


Content

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

3

The German Biotech Sector 2023 . .

7

Profiles of German Biotech Companies. . . . . . . . 4HF Biotec GmbH. . . . . . . . . . . . . . . . . . . . . . . . . Aeterna Zentaris GmbH. . . . . . . . . . . . . . . . . . . . . Affimed GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . AGC Biologics GmbH. . . . . . . . . . . . . . . . . . . . . . Artcline GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . ASKA Biotech GmbH . . . . . . . . . . . . . . . . . . . . . . AvenCell Europe GmbH. . . . . . . . . . . . . . . . . . . . . AxoLabs GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . BAG Health Care GmbH. . . . . . . . . . . . . . . . . . . . Biaffin GmbH & Co. KG. . . . . . . . . . . . . . . . . . . . . BioCopy GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . BioSpring GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . Biotype GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . BRAIN Biotech AG. . . . . . . . . . . . . . . . . . . . . . . . . Cardior Pharmaceuticals GmbH. . . . . . . . . . . . . . CeGaT GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . CLADE GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . Coriolis Pharma Research GmbH. . . . . . . . . . . . . CureVac AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Eppendorf SE . . . . . . . . . . . . . . . . . . . . . . . . . . . . Eurofins BioPharma Product Testing Munich GmbH FGK Clinical Research GmbH. . . . . . . . . . . . . . . . Formycon AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fraunhofer ITEM. . . . . . . . . . . . . . . . . . . . . . . . . . GALAB Laboratories GmbH . . . . . . . . . . . . . . . . . GENEWIZ Germany GmbH. . . . . . . . . . . . . . . . . . Gen-H Genetic Engineering Heidelberg GmbH. . . Gilson International BV Deutschland. . . . . . . . . . . GKM Gesellschaft für Therapieforschung mbH. . . glyXera GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . Heidelberg Pharma AG. . . . . . . . . . . . . . . . . . . . . HS Diagnomics GmbH . . . . . . . . . . . . . . . . . . . . . IBA Lifesciences GmbH. . . . . . . . . . . . . . . . . . . . . ibidi GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IDT Biologika GmbH. . . . . . . . . . . . . . . . . . . . . . . Immunic AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 80 82 84 86 88

Indivumed GmbH . . . . . . . . . . . . . . . . . . . . . . . . . 90 iOmx Therapeutics AG . . . . . . . . . . . . . . . . . . . . . 92 ITM Isotope Technologies Munich SE. . . . . . . . . . 94 KNAUER Wissenschaftliche Geräte GmbH. . . . . . 96 Kupando GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . 98 KyooBe Tech GmbH . . . . . . . . . . . . . . . . . . . . . . . 100 Lonza Cologne GmbH. . . . . . . . . . . . . . . . . . . . . . 102 metabion international AG. . . . . . . . . . . . . . . . . . . 104 Mettler-Toledo GmbH . . . . . . . . . . . . . . . . . . . . . . 106 Microcoat Biotechnologie GmbH . . . . . . . . . . . . . 108 Microsynth Seqlab GmbH. . . . . . . . . . . . . . . . . . . 110 MLM Medical Labs GmbH. . . . . . . . . . . . . . . . . . . 112 Molzym GmbH & Co. KG . . . . . . . . . . . . . . . . . . . . 114 MorphoSys AG . . . . . . . . . . . . . . . . . . . . . . . . . . . 116 Navigo Proteins GmbH . . . . . . . . . . . . . . . . . . . . . 118 Neovii Biotech GmbH . . . . . . . . . . . . . . . . . . . . . . 120 New England Biolabs GmbH . . . . . . . . . . . . . . . . . 122 Nordmark Pharma GmbH . . . . . . . . . . . . . . . . . . . 124 Nova Biomedical GmbH . . . . . . . . . . . . . . . . . . . . 126 Pantherna Therapeutics GmbH . . . . . . . . . . . . . . . 128 Pharmaplan GmbH . . . . . . . . . . . . . . . . . . . . . . . . 130 Phyton Biotech GmbH . . . . . . . . . . . . . . . . . . . . . . 132 PlasmidFactory GmbH . . . . . . . . . . . . . . . . . . . . . 134 ProBioGen AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136 Process Sensing Technologies PST GmbH . . . . . . 138 PROGEN Biotechnik GmbH . . . . . . . . . . . . . . . . . 140 ProJect Pharmaceutics GmbH . . . . . . . . . . . . . . . 142 ProtaGene GmbH . . . . . . . . . . . . . . . . . . . . . . . . . 144 Rentschler Biopharma SE . . . . . . . . . . . . . . . . . . . 146 Richter-Helm BioLogics GmbH & Co. KG . . . . . . . 148 RNATICS GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . 150 Roche Diagnostics GmbH . . . . . . . . . . . . . . . . . . . 152 Sanofi-Aventis Deutschland GmbH . . . . . . . . . . . 154 Sartorius CellGenix GmbH . . . . . . . . . . . . . . . . . . 156 ScheBo® Biotech AG . . . . . . . . . . . . . . . . . . . . . . . 158 SciRhom GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . 160 Secarna Pharmaceuticals GmbH & Co. KG . . . . . 162 SERVA Electrophoresis GmbH . . . . . . . . . . . . . . . 164 SGS Analytics Germany GmbH . . . . . . . . . . . . . . . 166 Sino Biological Europe GmbH . . . . . . . . . . . . . . . . 168 Sirius Fine Chemicals SiChem GmbH . . . . . . . . . . 170 T-CURX GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . . 172 Tentamus Pharma & Med Deutschland GmbH . . . 174 Therycell GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . . 176


Tosoh Bioscience GmbH. . . . . . . . . . . . . . . . . . . . 178 Valicare GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . 180 Vetter Pharma International GmbH. . . . . . . . . . . . 182 Viscofan BioEngineering. . . . . . . . . . . . . . . . . . . . 184 Vivoryon Therapeutics N.V.. . . . . . . . . . . . . . . . . . 186 WuXi Biologics Germany GmbH. . . . . . . . . . . . . . 188 X-act Cologne Clinical Research GmbH. . . . . . . . 190 XL-Protein GmbH . . . . . . . . . . . . . . . . . . . . . . . . . 192 YMC Europe GmbH. . . . . . . . . . . . . . . . . . . . . . . . 194 Yumab GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196 Zedira GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198

Profiles of Service Providers . . . . . . . . . 201 BIO.NRW. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202 BIOCOM Interrelations GmbH. . . . . . . . . . . . . . . . 204 BioM Biotech Cluster Development GmbH. . . . . . 206 Biomindz Standortentwicklungsgesellschaft Mainz mbH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208 BIOPRO Baden-Württemberg GmbH. . . . . . . . . . 210 btS e.V. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212 Carl Roth GmbH & Co. KG . . . . . . . . . . . . . . . . . . 214 HealthCapital Berlin-Brandenburg . . . . . . . . . . . . 216 HOX Life Science GmbH. . . . . . . . . . . . . . . . . . . . 218 IZB - Fördergesellschaft IZB mbH. . . . . . . . . . . . . 220 Life Science Nord Management GmbH. . . . . . . . . 222 LUMIS International GmbH. . . . . . . . . . . . . . . . . . 224 Meissner Bolte Patentanwälte Rechtsanwälte Partnerschaft mbB . . . . . . . . . . . . . . . . . . . . . . . . 226 restracon GmbH & Co. KG . . . . . . . . . . . . . . . . . . 228 Technologiepark Heidelberg GmbH . . . . . . . . . . . 230 Wuesthoff & Wuesthoff Patentanwälte PartG mbB. 232

A fine pen with 5 km writing performance. The body is made from biotechnologically produced biopolymers – fully compostable in the garden. Made in Europe

German Biotech Companies . . . . . . . . . 234

Available for 3 EUR exclusively at the

biospheria.shop/en Advertisements BIOMATEC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 BIOCOM |transkript. . . . . . . . . . . . . . . . . . . . . . . . 6 eurobiotechjobs.net . . . . . . . . . . . . . . . . . . . . . . . 16 BIOCOM European Biotechnology Magazine. . . . 200

BIOMATEC® 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

4|5


A good antidote to alternative truths For all those who are allergic to fake news: |transkript reports on biotechnology and life sciences in German-speaking Europe – competent, networked, never boring. As a printed magazine or daily updated online at transkript.de

Economy. Technology. Life. 2023 in its 29th volume. ISSN 1435-5272

Subscription: transkript.de

transkript.de BIOCOM Interrelations GmbH I Jacobsenweg 61 I 13509 Berlin I Germany Tel. +49 (0)30 264921-54 | info@biocom.de I www.biocom.de


The German Biotechnology Sector 2023

It is a rare case of a collateral gain: The devastating Corona pandemic has cast the German biotechnology industry into the public and capital market spotlight. The mRNA vaccine developed by BioNTech in Mainz proved to be highly effective and paved the way for broad-based vaccination campaigns around the world ­– the only way to overcome the epidemic. The pandemic raised awareness of the importance of biotech research, development and production, which boosted investment and led to accelerated growth in the biotech industry.

despite the difficult economic environment, the start-up momentum remained unbroken. This is shown by the results of the Biotechnology Company Survey 2023 conducted by BIOCOM AG, which collected the most important key figures in spring 2023. BIOCOM has been analysing the development of the biotechnology industry in Europe for 37 years. Since 2005, the key figures of German biotechnology companies, which are collected annually, have been made internationally comparable according to the criteria of the Organisation for Economic Cooperation and Development (OECD). It was only in 2020 that data collection was suspended due to COVID-19. The figures and graphs given below refer to those companies defined by the OECD as “dedicated” biotech companies.

In 2022, investment was significantly lower than in the previous year, and with the pandemic subsiding and thus significantly lower demand for the Covid vaccine Comirnaty, industry sales also slumped, but less sharply than expected.

Although most of the industry is active in the healthcare sector, Germany is also working on biotechnological innovations in other fields. In industrial biotechnology, there are promising approaches to effectively counter the challenges of climate change. Alternative proteins, for example, are gaining in importance because they combine several advantages: they make a significant contribution to supplying food to the world’s growing population, reduce the consumption of resources and

By contrast, research and development spending rose to a new record level. Biotech companies invested a total of €3.33 billion of which three billion alone went towards researching new active ingredients, technologies and products or improving existing innovations in the healthcare sector. These figures speak for the strong self-confidence of the industry. Companies were also able to continue acquiring qualified employees; and

Key figures of the biotech sector in Germany 2014

2015

2016

2017

2018

2020

2021

2022

Number of dedicated biotechnology companies

579

593

615

646

679

736

753

776

Number of employees in dedicated companies

17,930

19,010

20,280

21,860

23,540

27,200

30,280

34,390

Turnover of dedicated biotechnology companies

€3.03bn €3.28bn €3.54bn €4.11bn €4.51bn €6.71bn €26.5bn €25.4bn

R&D expenditures of dedicated biotechnology companies

€0.95bn €1.04bn €1.10bn €1.12bn €1.19bn €2.14bn €2.83bn €3.33bn

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

6|7


Compared to 2021, the turnover of the 776 dedicated biotech companies dropped to €25.4 billion in 2022. However, when comparing the two years excluding BioNTech sales, sales increased from €7.5 billion in 2021 to €8.1billion. This represents growth of more than 8% and shows that many German biotech companies have now reached a high level of maturity and have been able to hold their ground even in the difficult economic and geopolitical environment.

put a halt to animal suffering. Also, work is underway to develop microorganisms that can break down carbon dioxide, thereby helping to reduce CO2 concentrations in the atmosphere. In the field of sustainable packaging and materials, biotechnological applications offer innovative and climate-friendly solutions, just as they do in the field of sustainable textiles or in waste-to-value approaches in a circular economy.

Decline in turnover more moderate than expected

All-time high in expenditure for research & development

The biotech industry in Germany has achieved continuous growth in recent years. As expected, however, turnover in 2022 did not increase further. The subsiding of the pandemic and the resulting lower demand for the COVID-19 vaccine had already led to forecasts of a significant drop in sales. In fact, BioNTech suffered a €1.5 billion drop in sales. The industry’s turnover curve thus fell slightly (-4%) for the first time since 2013.

After exceeding the two billion mark for the first time in 2020, research and development (R&D) expenditure in biotechnology was able to break through the three billion mark in 2023. A total of €3.33 billion was invested in R&D, an increase of 17.6% compared to 2021. R&D spending by “red” biotech companies accounted for more than 90% of the industry’s total research expenditure.

Fig. 1: Turnover and R&D expenditure of dedicated biotech companies in EUR million 7.500 7.000

Turnover

6.500

R&D Expenditure

6.000 5.500 5.000 4.500 4.000 3.500 3.000

2,374

2.500

2,619 +10.5%

2,903 +10.9%

-1.4%

2,864

+5.9%

3,031

3,284 +8.3%

2.000 1,015

1.500 1.000 500

975

937

954

899

-3%

-4%

-4%

−3.7%

+6.2%

2010

2011

2012

2013

2014

+8.8%

0 2015


However, about half of the research expenditure (51%) in this sector were borne by the Mainz-based vaccine specialist BioNTech. BioNTech invested €1.54 billion in 2022, 62% more than in 2021 (€957 million), in the development and production of the bivalent COVID-19 vaccines adapted to Omikron and in the development of further pipeline candidates. CureVac, however, another pioneer in the field of mRNA-based technologies, has seen a completely opposite trend in research spending, with its vaccine failing to meet the desired outcome. While CureVac still invested €853 million in research in 2021, the figure was just under €63 million in 2022.

26,485 25,426 -4.0% +295%

But the remaining 393 companies also spent €1.42 billion on R&D, compared to only €742 million in 2021. The research budget in the field of medical biotechnology has thus almost doubled, which shows that the companies still have sufficient financial resources.

6,709 +48.7% 4,510 4,105 +9.9% +8.0%

3,545

+15.8%

3,332 2,830 +17.6%

2,140 +32% 1,117

1,104

1,038

1,195 +79.1%

+6.3%

+1.2%

+7%

2016

2017

2018

2020

2021

2022 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

8|9


R&D spending has also increased in almost all other biotech segments despite the difficult economic environment. In industrial biotechnology, research spending increased by almost 14% to €81.5 million. Biotechnology service providers and bioinformatics companies, respectively, increased by 5.4% and 6.1% (€194 million and €17.3 million). Only at the agrobiotech companies did R&D expenditure stagnate (€ 15.5 million).

employees in the agrobiotechnology sector remained unchanged at 400.

Number of start-ups at record high Shrinking economy, high inflation rates - this apparently did not faze those willing to found biotechnology companies. Last year, there was a veritable boom in the number of start-ups. At the end of the first quarter of 2023, 30 new start-ups were already reported for the year 2022. This high number has not been matched in the past ten years. Last year, only 21 start-ups could be listed at the same time.

More employees than ever The number of employees in dedicated biotech companies increased by 13.6% to 34,390 in 2022. The highest increase of almost 30% was in bioinformatics companies, with 700 employees in this area in 2022. Industrial biotechnology companies saw an increase of almost 19%. Companies in the non-specific biotechnology applications sector increased by just over 13% (11,200 employees), followed by almost 13% in the healthcare sector (19,540 employees). The number of

As in previous years, start-ups from the medical sector (13) again made up the majority of the start-ups, closely followed by companies from the field of industrial biotechnology (10). The demand for sustainable solutions in the fight against world hunger and climate change triggered a veritable wave of start-ups in this

Fig. 2: Sources of financing for dedicated biotech companies Mio.Mio. € Euro 2500

2500 2500 2500

IPOs  VentureVenture capital   Capital   IPOs   Investments Investments in Public in public Equityequity 2000

1500

1000

2000 2000 2000

1500 1500 1500

1000 1000 1000

656 500

500 500

500 335

656 485 126 101

−79% +1% −76%

00

127 24

335 −26%

+26% −100%

321 258 −77% 0

142 297 70 72

2006 2006 2010 20102006

2007 2007 2007 2011 2011

+15%

0

448

+185% −32%

296 300 9495

+30%

202 205

−20%

2008 2008 2008 2012 2012

264

355+175%−30%

+128% 122 218

+100%

−33% 142 137

+26%

+126%

2009 2009 20092013 2013

321

−79%

550

+5%

401

+61%

152 77 −77% 172

−42% 142

44 +26%

−29% 95

+52% 70

+185% 260

−17% 205

2010 2010 2010 2014

72

246

2011 2011 2011

2015 2015

300

2012 2012


Focus on medical biotechnology

field. Newcomers are primarily companies active in so-called cellular agriculture. They grow animal products directly from cells or with the help of microorganisms and also rely heavily on the capabilities of precision fermentation. In the future, fish, meat and dairy products can be produced in the laboratory instead of raising and slaughtering farm animals. This will not only produce new foods and reduce the burden on the climate, but also defuse land-use conflicts. Pasture land and the areas used to grow fodder could be developed to produce food for a growing world population, and further “consumption” of the remaining natural areas would be avoided in favor of biodiversity.

The development of therapeutic agents, vaccines and new diagnostic methods is the focus of most biotech companies –­ and not only in Germany. A total of 395 companies (51%) belong to the field of “red” biotechnology. They focus on the development of drugs, vaccines, new diagnostic methods and personalized medicine. There are 19,540 employees in the medical biotechnology sector and total sales of €22.6 billion (-6.2%). Expenditure on research and development amounted to €3.02 billion (+18.8%).

Therapeutics development takes time and money A total of 70 companies in Germany already had one or more phase I or higher products in their pipeline in 2022. This number is growing slowly but steadily – which is not surprising, because drug development is a lengthy, expensive process and thus difficult for small

Four start-ups came from the field of bioinformatics, two are dedicated to non-specific biotechnology services and one company was founded in the field of agrobiotechnology.

2,211

2,162 -18%

1,118

1,320

+25%

+155%

207 898

+33%

352

+110%

258 32

+172%

86

−100%

216

+9%

235

+79%

2016 2016

2017 2017

+102%

418

-7%

673 506

919

886

482 825 475

442

2018 2018

957

2020 2020

2021 2021

2022 2022 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

10 | 11


Technology platforms and preclinical development

Fig. 3: Number of annual new biotech start-ups over the time 2022

Most medically oriented biotechnology companies (219) are either still in the preclinical stage of therapeutics research or offer a technology platform as a service in the field of healthcare. The number of companies with technology platforms has risen steadily in recent years, underscoring the growing importance of broadly applicable technology platforms – either related to drug classes or to indications – in drug development.

30

2021

36

19

2020

34

25

2019

44

18

2018

33

25

2017

21

2016

20

2015 2014

14

2013

13 10

Importance of diagnostics

34 28

10

0

30

35 19 20

30

40

50

As reported in Q1 of the following year As of Q4 of the following year

to medium-sized biotech companies to undertake. The potential of a technology or research approach and the degree of maturity of a medical biotechnology company is commonly indicated by the number of drug candidates and the stage of their clinical development. Each step and phase comes with its own particular hurdles, and each further development is often associated with greater investment and higher risk. After all, in Germany or elsewhere, experts estimate that the development of a new drug now costs one to three billion euros and takes ten to fifteen years. Moreover, only one in 10,000 active ingredients ever makes it from discovery to the market. Against this background, a look at the current pipeline of German drug candidates invariably gives some indication of the maturity and innovative capacity of the industry. A total of 70 biotechnology companies had one or more candidates in clinical development in 2022. In total, 127 biologically active substances were in one of the clinical phases, 92 biologicals (+7) and 35 small molecules (+1).

The past few years have shown that also in the field of diagnostics, speed is a key factor in successfully combating diseases. Only the rapid development of specific reagents and methods, for example for established PCR-based methods, will make it possible to develop and approve new in vitro diagnostics. Experts predict that the trend towards stratified and individualised medicine will increase the importance of diagnostics in the future, because tailoring medical diagnostics and therapy to individual patients allows for more precise and personalised treatment. Personalised medicine can lead to better treatment outcomes while reducing costs for the healthcare system. In addition, adverse drug reactions can be minimised as medicines are selected based on individual characteristics and tolerability.

Non-specific services as growth driver With 218 companies and more than 11,000 employees, the non-specific biotech services segment is the second largest pillar of the German biotech industry. This segment includes all companies offering equipment and reagents or services that are predominantly based on biotechnological principles. However, this also includes contract researchers and biomanufacturing experts. In 2022, these companies were again able to increase their revenue strongly. More than two billion euros in sales (€2.27 billion) were generated in this segment, an increase of 23% compared to 2021 (€1.84 billion). R&D expenditure (€194 million) also increased by another 5.4% compared to 2021. Just under a third


(32.5%) of all employees in the biotech sector worked in this area. The number of employees rose by 13% to 11,200 in 2022 (2021: 9,890 employees).

Potential of industrial biotechnology Industrial applications for various industries are being developed by 96 biotechnology companies (2021: 77 companies) in Germany. This segment recorded the largest increase in new companies in 2022. This is hardly surprising in times of climate change - after all, industrial biotechnology holds enormous potential for transformation. For example, it can replace or optimise conventional production processes. By using microorganisms, enzymes or biotechnologically produced materials, more environmentally friendly and sustainable processes can be developed. Biotechnology enables the use of bio-based raw materials instead of fossil fuels and non-renewable resources. By using microorganisms, pollutants can be degraded, biological wastewater can be purified, and contaminated soil or water can be restored. Biotechnological processes also enable more efficient waste treatment and disposal. In addition, industrial biotechnology can help increase food production and improve food security. Precision fermentation, for example, offers innovative solutions to nutrition-related challenges and sustainability problems. Several products are already being developed using precision fermentation, including dairy substitutes, functional ingredients, and other innovative foods. Not only did the number of companies in industrial biotechnology grow by 25% in 2022, but their workforce also increased by nearly 19% to 2,550 (2020: 2,150 employees).The sales curve does not point quite as sharply upwards, but an increase in sales (€433 million, +8.6%) was nevertheless recorded - research and development expenditure rose more significantly, by almost 14% to €81.5 million.

Agrobiotechnology stable at low level The use of biotechnology in plant breeding and agriculture has declined over the years due to strict regulations and general scepticism, especially towards green genetic engineering. Since 2015, the sector has stabilized

Fig. 4: Main areas of activity of dedicated biotech firms 6.3%

50.9%

28.1%

12.4%

2.3%

Health Agrobiotechnology Industrial biotechnology

Non specific services Bioinfomatics

at a low level. In 2022, 18 companies were active in this segment, one more than in 2021. The number of employees also varied only slightly, remaining unchanged at 400 employees. Turnover and R&D expenditure, on the other hand, fell slightly (turnover: €37, 9 million, -3.1%; R&D: €15.5 million, -4.9%). A turnaround could be achieved if the European Union revises its classification of new molecular breeding methods (e.g. CRISPR/ Cas) as genetic engineering in early summer 2023.

Bioinformatics gain in importance A steadily growing number of companies (2022: 49 companies, +16.7%) are primarily involved in bioinformatics: a multidisciplinary field of research combining methods from computer science, statistics and biology. Modern high-throughput procedures require the systematic acquisition and analysis of ever larger, medically relevant volumes of data. Information sciences provide the leverage to harness the potential of these data for prognostic, diagnostic and therapeutic applications. But in other areas, too, such as phenotyping or precision breeding, the latest techniques require ever more comprehensive analysis of data. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

12 | 13


The 49 companies employed 700 staff, almost 30% more than in 2021. Their turnover rose by 5.1% to €2.27 million; research and development expenditure climbed to €17.3 million (+6.1%).

Financing sources at a glance Following the high investment levels of the pandemic years, the volume of investment in 2022 flattened out again to the level of the years before the pandemic. On the one hand, many companies still had sufficient funds, and on the other, the willingness to invest also declined. The restraint of investors was certainly also due to the generally difficult economic situation. In 2022, German biotech companies raised a total of €957 million - only 44% of the previous year’s total. However, measured against pre-Corona investments between 2006 and 2019, it only came second to 2018, when companies were able to raise more than €1 billion. Listed companies raised €482 million in ten rounds of capital increases. Private companies raised a similar amount, €475 million. However, as the investment amounts, including some seed and pre-seed rounds, were significantly lower on average, 32 companies benefited.

Top financing via the stock exchange In April 2022, Nasdaq-listed Affimed NV, headquartered in Heidelberg, Germany, announced the completion of a €95 million capital increase; the company was

Top 3 financing rounds of listed companies in 2022 Capital raised immatics NV

€113.0m

Affimed NV

€95.3m

Heidelberg Pharma AG

€80.0m

already able to announce a similar sum in 2021. Affimed develops innovative therapeutic antibodies in immuno-oncology. They are intended to fight cancer cells by reactivating the body’s own defense mechanisms. Two drug candidates are being tested in a series of studies targeting different types of cancer. Heidelberg Pharma AG, which is also based in the Rhine-Neckar region and listed on the Frankfurt Stock Exchange, successfully placed a capital increase of around €80 million in August. The proceeds will mainly be used to conduct the ongoing Phase I trial with HDP-101 and to further develop the followup projects HDP-102 and HDP-103 and the proprietary ATAC® technology. A further €113 million went to Baden-Württemberg. A capital increase by Immatics NV in October 2022 flushed €113 million into the company’s coffers. This was the largest round of 2022. Immatics is a Nasdaqlisted biotechnology company headquartered in Tübingen, Germany. The company works on targeted immunotherapies against cancer. For this purpose, it identifies tumor-specific targets and develops matching T-cell receptors (TCRs) that can be used specifically against the respective tumor.

Top private biotech companies financings In the summer of 2021, U.S. investor Blackstone Life Sciences expressed interest in investing in Dresden-based GEMoab, which which is developing a universal switchable platform to improve CAR T-cell therapies. Blackstone, however, wanted to expand research into allogeneic therapies and brought gene shearing specialist Intellia on board. Intellia’s CRISPR-Cas technology will be used in the future to modify donor cells to make them suitable for as many recipients as possible. Blackstone invested €210m in the founding of the new company AvenCell (see p. 36), which is based in Cambridge, Massachusetts, with research continuing in Dresden. Last year, Berlin-based T-knife - which is also active in the field of T-cell therapies - already caused a stir


with a Series A financing of €66m. Almost exactly one year later, in August 2021, another €93m was added. Emergence Therapeutics, which was only founded in 2019, raised €87m at the end of the year, the secondhighest Series A round in the German biotech sector. The Duisburg-based company is developing novel antibody-drug conjugates (ADCs) against cancers that currently have little or no treatment.

Methodology and background The data and facts used here are taken from the biotechnology company survey carried out annually by BIOCOM AG. It is based on the guidelines of the Organisation for Economic Cooperation and Development (OCED). In December 2004 the OECD harmonised the large number of existing definitions for biotechnology. Since then, all OECD countries have been called upon to base their biotechnology surveys on the so-called “Framework for Biotechnology Statistics” (www.oecd. org). The OECD differentiates between two different categories of companies within the biotech sector: “Dedicated biotechnology companies” on the one hand and “other biotechnologically active companies” on the other. According to the OECD definition, the former are biotechnologically active companies whose main corporate objectives are the use of biotechnological processes for the manufacturing of products or the provision of services or the implementation of biotechnological research and development. In contrast to this type of dedicated biotech company, the main corporate objective of an “other biotechnologically active company” is not exclusively the application of biotechnological processes. The OECD describes those companies as the ones using biotechnology only as part of their

Top 3 financing rounds of private companies in 2022 Capital raised Resolve BioSciences GmbH

€68.7m

Tubulis GmbH

€60.0m

CatalYm GmbH

€51.3m

business and field of activity, such as pharmaceutical and chemical companies or seed manufacturers. For the purposes of biotech statistics, BIOCOM has drawn up a questionnaire based on the OECD definitions explained above. A total of 922 companies were contacted between January and March 2023. The selection of the companies contacted for the survey took into account the OECD definition in comparison with the company database of BIOCOM AG. 562 of the companies surveyed answered either by questionnaire or after a telephone call. The response rate or verification rate is 45%. In accordance with the OECD guidelines, when selecting companies, care was taken to include all companies that deal with biotechnology in Germany and are based in Germany. For this reason, companies that are majority owned by a non-German parent company but have R&D activities in Germany were also taken into account. When recording jobs, business figures and business areas, the survey was only carried out for the German locations of a company. If a company has more than one location in Germany, it is counted once with the corresponding cumulative values. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

14 | 15


stock.adobe.com/annette shaff

New job? Need help hunting?

eurobiotechjobs.net


Profiles of German Biotech Companies

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

16 | 17


Name › 4HF Biotec GmbH Address/P.O. Box › Am Flughafen 14 Postal Code/City › 79108 Freiburg im Breisgau State › Baden-Wuerttemberg Contact Person › Prof. Dr Heinz-Herbert Fiebig (CEO) Dr Vincent Vuaroqueaux (CSO) Telephone › +49-761-7088-93-10 Fax › +49-761-7088-93-99 Email › Fiebig@4HF.eu Website › www.4hfbiotec.com Social Media › I Number of Employees › 5–10 Founded (year) › 2015 Type of Laboratory › Bioinformatics platform/Dry Lab Areas of Activity › Anticancer Drug Discovery, Molecular Oncology, In Silico Research External › German Consortium for Translational Collaborations Cancer Research (DKTK), Freiburg Site; Clinic for Nuclear Medicine, University Hospital Freiburg Request for › 4HF Biotec is interested in strategic Further Collaborations collaborations in the fields of linker chemistry, cytotoxic payloads, virtual screening/cheminformatics, DNAencoded libraries, lead optimisation, antibody discovery, bispecific antibodies, bioinformatics-based projects involving cancer data

4HF was founded by Prof. Heinz-Herbert Fiebig in Freiburg in 2015 after he had sold his former company Oncotest GmbH. 4HF consists of an experienced multidisciplinary team of scientists covering all facets of cancer research, including clinical and molecular oncology, drug discovery, pharmacological profiling, and in silico research. 4HF focuses on next generation drug conjugates to give cancer patients new treatment options. Since its foundation it has been 4HF’s ambition to utilise cancer-associated proteins as molecular targets for drug conjugates consisting of a tumour-targeting moiety and an effector component. Such conjugates can display substantially wider therapeutic windows than conventional cytotoxic drugs. To achieve this goal, 4HF has built a dedicated in silico platform (the CANCER DATA MINER), integrating molecular (OMICS) data from thousands of patient tumours and normal tissues and from preclinical tumour models plus more than a million drug sensitivity data points for ~2000 compounds. Specific bioinformatics pipelines have been developed to support the early phases of anti-cancer drug discovery by detecting tumourassociated molecular targets, providing insights into the mechanism of action of anti-cancer agents, identifying predictive biomarkers of tumour response, and enabling estimates of compounds’ clinical potential. To make our expertise available to the research community, we also offer data analysis and bioinformatics capabilities on a fee-for-service basis. To date, 4HF has identified a set of cancer-associated proteins as potential targets for new anti-cancer agents. For some of them we found the first small molecule ligands that, as components of small molecule drug conjugates (SMDCs), could help to target a wide range of cancers with high medical need, including cancers of the prostate and lung.


4HF BIOTEC

The advent of immune oncology drugs that activate a patient’s immune system to fight cancer and of conjugates that direct cytotoxics specifically to cancer cells have arguably been among the greatest achievements in cancer research over the last two decades. 4HF is well positioned to contribute to the latter of these developments by utilising its collection of tumour-associated molecular targets to develop SMDCs and also, if appropriate, radiotherapeutics and ADCs.

4HF Biotec’s Goals Discovery and development of novel targeted anti-cancer agents › Compilation of a comprehensive catalogue of cancer­ associated proteins as potential targets, target prioritisation for various drug formats (SMDCs, ADCs, radiopharmaceuticals, etc.) › Early-stage projects: identification of small molecule ligands that bind to cancer-associated proteins, also based on advanced virtual screening approaches › More advanced projects: design and synthesis of linker-payload conjugates; profiling candidate SMDCs regarding binding specificity, stability, target-specific cytotoxic activity, pharmacokinetics, efficacy, etc.; identification of a clinical candidate In silico research/ bioinformatics services portfolio › Broaden our consulting services dedicated to the preclinical characterisation of anticancer agents and their associated targets. Highlights: expansion of our database, digitalisation of our processes (e.g. enab­ ling client interaction via an interactive interface), new tools (e.g. multi-dimensional data analyses integrating pathway investigation) › Develop computer-aided services for cancer target investigations and lead generation

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

18 | 19


Name › Aeterna Zentaris GmbH Address/P.O. Box › Weismuellerstr. 50 Postal Code/City › 60314 Frankfurt am Main State › Hesse Contact Person › Dr Eckhard Guenther Telephone › +49-69-42602-0 Email › info@aezsinc.com Website › www.zentaris.com Social Media › F I Number of Employees › 17 Founded (year) › 2001

In pursuit of medical innovations Aeterna Zentaris (NASDAQ and TSX: AEZS) is a publicly listed, specialty biopharmaceutical company commercializing 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 the Aeterna Zentaris Inc. Aeterna Zentaris GmbH is the wholly owned German subsidiary located in Frankfurt am Main. The GmbH is the operations center of the group, whereas the legal headquarter is in Toronto, Canada.

Areas of Activity › Endocrinology, autoimmune diseases, neuromyelitis optica spectrum disorder (NMOSD), Parkinson’s disease (PD), amyotrophic lateral sclerosis (ALS), hypoparathyroidism, rare and orphan diseases, diagnosis of growth hormone deficiency

Aeterna Zentaris has successfully developed Cetrotide® for in-vitro fertilization, Impavido® for the treatment of Leishmaniasis, and Lobaplatin for the treatment of solid tumors. All three products are commercially available through global and local pharmaceutical companies since many years and have improved the lives of patients around the world.

Biological Patents › Several patents and patent applications covering our products and projects filed or licensed

Our current lead product macimorelin, a ghrelin receptor agonist, is the first and only approved drug indicated for diagnosis of adult growth hormone deficiency (AGHD) in the U.S. and EU. Macimorelin is a small peptidomimetic administered orally, which stimulates the secretion of growth hormone from the pituitary gland into the circulatory system. Macimorelin has the potential to displace current testing procedures as the diagnostic standard for growth hormone deficiency.

External › Big and medium size pharmaceutical Collaborations companies as well as academic institutions Request for › We are interested to find development Further Collaborations and/or commercial partners for our preclinical projects after proof-ofconcept

Macimorelin is marketed under the trademark Ghryvelin™ in the European Economic Area (EEA) and UK. Outside Europe the international trademark is Macrilen®. In the last few years, we were able to execute several license and distribution agreements. These include contracts with Pharmanovia for EEA and UK, with Er-Kim Pharmaceuticals for Turkey and some Balkan countries, with Megapharm for Israel and Palestine, and with NK Meditech for Korea. In our business development efforts we are attracting and negotiating with further partners for the commercialization of macimorelin in the U.S. and other new regions.


AETERNA ZENTARIS

AEZS-150 (DC-PTH)

AEZS-130 (Macimorelin)

AIM Biologicals

We are leveraging the clinical success of macimorelin by developing it also for the diagnosis of childhood-onset growth hormone deficiency (CGHD). The multinational pivotal Phase 3 safety and efficacy study “DETECT” is expected to complete enrolment in Q4 2023.

Our expertise AEZS has a strong scientific R&D expertise in endocrinology, autoimmune diseases, and CNS disorders, with focus on proteins, small molecules, and peptides.

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 have established license-, and R&D agreements with the University of Würzburg, The University of Sheffield, and the University of Queensland. 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 continue to leverage moving forward. Apart from investigating opportunities for new therapeutic applications of macimorelin, we have licensed in a range of innovative early-stage development projects addressing high unmet medical need in also economically highly interesting indications. With financial strength, our capabilities, and specific knowhow, we believe we are well-positioned to rapidly move promising projects into clinical development.” Management Dr Klaus Paulini President & CEO Aeterna Zentaris Inc. and Managing Director Aeterna Zentaris GmbH Dr Eckhard Günther Senior Vice President Business Develoment and Managing Director Aeterna Zentaris GmbH Giuliano La Fratta Senior Vice President, Chief Financial Officer Dr Nicola Ammer Senior Vice President, Chief Medical Officer D. Michael Teifel Senior Vice President, Chief Scientific Officer 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

20 | 21


Name › Affimed Address/P.O. Box › Gottlieb-Daimler Straße 2 Postal Code/City › 68165 Mannheim State › Baden-Wuerttemberg Additional office › Philadelphia, US Contact Person › Dr Angela Sickmann Telephone › +49-621-56003672 Email › A.Sickmann@affimed.com Website › www.affimed.com Social Media › I Number of Employees › 151 Founded (year) › 2000 Areas of Activity › Immuno-Oncology External › | AbCheck Collaborations | Artiva | Genentech | Leukemia and Lymphoma Society | MSD (Merck & Co.) | NKGen Biotech | Roche | Roivant | The University of Texas, MD Anderson Cancer Center

Affimed – engaging innate immune cells to fight cancer Affimed (Nasdaq: AFMD) engineers targeted innate immunotherapies, seeking to cure patients by giving them back their innate ability to fight cancer. We are developing mono- 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® molecules) 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 halflife, tissue distribution, and optimal tumour and immune cell targeting. This allows us to tailor our immune cell engagers to specific indications and patient settings.


AFFIMED

Targeted tumour cell killing via innate immune cell engagement

innate cell

Tumour

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 CD30positive malignancies including Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). A phase 1/2 study with AFM13 in combination with cord bloodderived autologous NK cells showed unprecedented efficacy results. In addiiton, a phase 2 study (LuminICE-203) with AFM13 and allogeneic NK cells is planned to be initiated in 2023.

Engager Therapy

AFM24 Innate cell target: CD16A Tumour target:   EGFR AFM24 binds to EGFR, which is constitutively active in many solid tumors. AFM24 has demonstrated the killing of tumour cells independent of their mutational status (e.g. Ras) and has gained clinical proof-of-concept in a phase 1/2a monotherapy study. A combination study with the checkpoint inhibitor atezolizumab is ongoing.

Release of Perforins and Granzymes

Tumour Cell Lysis

AFM28 Innate cell target: CD16A Tumour target:   CD123 AFM28 binds to natural killer (NK) cells and CD123positive tumor cells and demonstrated the eradication of CD123-positive leukemic blasts and leukemic stem cells (LSCs). Inhibition of tumour outgrowth as well as a good tolerability was demonstrated in vivo. A first-inhuman phase 1 clinical study with patients with AML is ongoing. Additionally, a combination approach with NK cells is planned.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

22 | 23


Name › AGC Biologics Address/P.O. Box › Czernyring 22 Postal Code/City › 69115 Heidelberg State › Baden-Wuerttemberg Contact Person › Ben Clauberg Telephone › +49-1515-7528832 Email › bclauberg@agcbio.com Website › www.agcbio.com Social Media › F I Number of Employees › 2,500+ Founded (year) › 2018 Type of Laboratory › Technology Transfer, Process Development, Analytical Development, cGMP Manufacturing, Quality Control and Quality Assurance, and Process Validation Areas of Activity › Mammalian and Microbial-based Therapeutic Proteins, Recombinant DNA, Plasmid DNA (pDNA), Messenger RNA (mRNA), Viral Vectors, and Genetically Engineered Cells. Request for › We are currently seeking additional Further Collaborations collaborations and have capacity available at all of our sites in Europe.

AGC Biologics is a global CDMO (Contract Development and Manufacturing Organisation) providing pharmaceutical development and manufacturing services for protein-based biologics and cell and gene therapies. With seven facilities and teams of scientists across three continents, we have the resources and available capacity you need to bring your next project to life. From development to clinical trials to full-scale commercialisation, we can help you reach your goals at any stage in your drug product’s journey. We specialise in the following modalities and substances: mammalian and microbial-based therapeutic proteins, recombinant DNA, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our sites offer services you need at any stage of product development and manufacturing, including Technology Transfer, Process Development, Analytical Development, cGMP Manufacturing, Formulation Development, Quality Control and Quality Assurance, and Process Validation. We have several sites near Germany that can service small, medium, and large biotech companies, global pharmaceutical organisations, and emerging advanced therapies organisations working on cell and gene therapies.

European Facilities Heidelberg, Germany The Heidelberg facility serves as a hub for microbial systems and services for our global customers. The site has scientists with several decades of protein expression experience, which has enabled AGC Biologics to establish a centre for custom pDNA and mRNA service lines at this site. We have just completed an expansion in 2023, adding a new line to offer more pDNA and mRNA projects, at a faster pace. The facility’s segregated line design allows for capacity and technological flexibility while ensuring compliance with the current global guidelines required for cGMP compliance.


AGC BIOLOGICS

Copenhagen, Denmark The Copenhagen site is one of the most active biologics facilities in the AGC Biologics network. Onsite, we operate multiple mammalian and microbial cGMP manufacturing lines at a variety of scales, and the facility also offers a great depth of technological flexibility. The core teams of scientists have been working together to develop and manufacture biologics for two decades. This expertise and experience mean that your product is managed by some of the best in the business. This site is finalising an expansion to extend its capabilities and more than double its single-use bioreactor mammalian cell-culture capacity. We are in active discussions to fill this space now before it opens in mid-2024. Milan, Italy AGC Biologics Milan specialises in cell therapy and viral vector development and manufacturing. The site works with any cell type and lentiviral, retroviral, and adeno-associated viral vectors. This site expanded in 2023 to offer more more vector manufacturing capacity for clinical and commercial projects. The facility was the first cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies. The core scientific team has 25 years of expertise in the field and unique knowledge you will not find anywhere else. The Milan team has developed 3 commercial products including, before joining the AGC network, bringing its own product to market (Zalmoxis ®). This experience means they understand the processes, procedures, and painstaking work involved in developing and bringing these treatments to market.

Sites in Japan and U.S.A. With one site in Japan and three in the U.S., one of the unique things about AGC Biologics is we can produce products on three continents. If you need something done outside of Europe, we have the network and global supply chain to meet your needs. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

24 | 25


Name › ARTCLINE GmbH Address/P.O. Box › Schillingallee 68 Postal Code/City › 18057 Rostock State › Mecklenburg-Western Pomerania Contact Person › Jens Altrichter, MD Telephone › +49-381-440-703 0 Email › info@artcline.de Website › www.artcline.de Social Media › I Number of Employees › 15 Founded (year) › 2007 Areas of Activity › Treatment of severe infections (Sepsis) with purified human immune cells

ARTCLINE – We fight sepsis! ARTCLINE is at the forefront of sepsis treatment innovation, introducing ARTICE®, an immune cell-based therapy to revolutionise the way we combat this deadly condition. ARTICE® is targeting the underlying cause of sepsis. the immune dysfunction. Immune cells of healthy donors are used to treat the patient by an adapted immune response. Therefore, the ARTICE® cells provide kind of a personalised medicine for septic shock patients.

Technology The ARTICE® Technology: Sepsis remains a formidable challenge in medicine due to its complex immune system dysfunction and high mortality rate. The ARTICE® Technology utilises immune cells from healthy donors, employing purified granulocyte concentrates in an extracorporeal procedure. This innovative process unfolds in two pivotal parts: › Remove Inflammatory Substances: donor immune cells remove inflammatory substances from the patient’s plasma. This action curtails the destructive inflammation associated with sepsis. › Reactivation of the Patients’ Immune System: simultaneously, our therapy triggers the production of immunological messenger substances, known as cytokines. These cytokines are administered by the healthy donor immune cells directly into the patient’s blood to support the reactivation of the patients’ immune system from immune dysfunction.


ARTCLINE

Clinical breakthrough In our relentless pursuit of excellence, we are currently conducting a third clinical trial involving 142 septic shock patients. Building on the success of two prior trials, each with ten patients, our results have been very positive. We’ve witnessed significant reductions in shock symptoms, immune system reactivation, and better survival than expected from the clinical scores at inclusion. All our findings have been published.

Looking forward Our commitment extends to a planned 2024 market launch in Germany. This milestone signifies the culmination of extensive research and development, heralding a new era in sepsis treatment. We are driven by the vision of a world where sepsis no longer claims as many lives.

Together, let’s fight sepsis!

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

26 | 27


Name › ASKA Biotech GmbH Address/P.O. Box › Veltener Str. 12 Postal Code/City › 16761 Hennigsdorf State › Brandenburg Contact Person › Anke Holzinger Telephone › +49-3302-4941-430 Email › info@aska-biotech.de Website › https://www.aska-biotech.de Social Media › F I Q Number of Employees › 15 Founded (year) › 2018 Type of Laboratory › S1; ISO 9001:2015; ISO 13485:2016 Areas of Activity › Contract manufacturing and development of | recombinant antibodies and proteins | monoclonal antibodies | Immunoassay-Kits: ELISA and Lateral Flow | sample analysis of human sera and plasmas Request for › | R&D units Further Collaborations | IVD-, pharma- and biotechcompanies

ASKA Biotech GmbH is an independent and trusted contract manufacturing organisation for the development and production of recombinant proteins, monoclonal antibodies and immunoassay kits. Customers from universities, research & development, in vitro diagnostic (IVD) and preclinical fields benefit from our expertise. ASKA provides individual and flexible solutions for each customer requirement.

Our mission We support our customers in their success. Our goal is to provide reliable services at competitive prices, to fulfill the specific requirements of our customers. With over 20 years of experience in cell culture, hybridoma development, downstream processing and immunoassay production, we are able to provide an excellent service in constant quality. All employees are specialists in their field, which enables ASKA Biotech to answer every inquiry in a short time with customised solutions. For this, we do not stop at the actual order, but think further and also advise our customers for the further process. Thus, every customer, regardless of the size of the company, benefits from our expertise.

Services As an ISO 9001:2015 and ISO 13485:2016 certified company, ASKA focuses on quality from the very beginning, ensuring the consistent delivery of high-quality services and customer satisfaction. Our services include, but are not limited to, the following areas:

ASKA’s rePro-Services: ASKA expresses recombinant proteins and antibodies in mammalian cells. This can be realised transiently in HEK cells within weeks or via stable cell line development in CHO cells. Thanks to our optimised system for transient gene expression, we can perform several small-scale productions in parallel or produce up to several grams of recombinant antibodies in a few weeks.


ASK A BIOTECH

ASKA’s monA-Services: ASKA Biotech produces monoclonal antibodies in small and large scale under serum-free conditions. We offer the option to dedicate the development and production of each antibody to our well-trained team with many years of experience. Alternatively, there is also the possibility to comply with customers’ protocol and specific needs for purification strategy, buffer, concentration, etc.

ASKA’s Immuno-Services: Our protein services are complemented by our sample analysis of human sera and plasmas and immunoassaykit production services. ASKA Biotech offers you the entire range of services for development and production of immunoassays in ELISA as well as Lateral Flow Format.

Additional Services: In addition, we offer several supplementary services such as cell line storage, aliquotation, protein polishing, diverse analytic methods, activity testing, lyophilisation and many more. Methods which are not yet part of our portfolio can be established upon request.

From the bench to market ASKA Biotech supports its customers in the market launch of their product. Starting with antigen and antibody production, feasibility testing of the immunoassay kit up to development and production. Thanks to its extensive experience in all service areas, ASKA Biotech is the optimal partner for all important projects.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

28 | 29


Name › AvenCell Europe GmbH Address/P.O. Box › Tatzberg 47 Postal Code/City › 01307 Dresden State › Saxony Contact Persons › Armin Ehninger (CSO) Constanze Medack (Executive Assistant) Telephone › +49-351-446645027 Fax › +49-351-446645099 Email › armin.ehninger@avencell.com constanze.medack@avencell.com Website › www.avencell.com Number of Employees › 86 Founded (year) › 2011 Areas of Activity › | Immunotherapy | Oncology External › | Intellia Therapeutics Collaborations | Cellex Cell Professionals | Blackstone Life Sciences

Company overview AvenCell Europe GmbH, located in Dresden, is a clinical-stage biopharmaceutical company developing next-generation immunotherapies to treat cancer and autoimmune disease patients with high unmet medical needs. AvenCell’s mission is to overcome the limitations of current-generation chimeric antigen receptor (CAR) T cell therapies with an improved therapeutic window and substantially expand the types of cancer treatable with adoptive cell therapy, including solid tumours. AvenCell’s deep pipeline of immunotherapies includes three in clinical trials for solid tumours and haematological malignancies and several preclinical candidates. AvenCell’s Universal Switchable CAR platform combines the best of two worlds – the powerful anti-tumour response of CAR-T and flexible soluble adaptors termed targeting modules (TM) allowing flexible targeting of multiple antigens to overcome tumour escape and deepen responses. AvenCell’s Allogeneic platform is engineered to overcome graft-versus-host disease as well as graft rejection by host T and NK cells and aims to provide highly effective “off-the-shelf” cell therapies at significantly reduced costs.

Technology The Universal Switchable CAR-T platform consists of two components and can be rapidly switched on and off. It comprises genetically modified T cells with a chimeric antigen receptor and targeting modules (TM). TMs act as soluble adaptors that mediate a reversible, specific binding to the universal CAR and additionally realize directed targeting of cancer cells via a highly flexible antigen-binding moiety. TMs efficiently penetrate and accumulate in bone marrow and solid tumour tissue. Their simultaneous binding to the universal CAR and the target antigen acts as a switch leading to activation and expansion of universal CAR-bearing effector T cells and subsequent cancer cell lysis. Crucially, the switch-off mechanism (removal of TM) avoids acute and long-term toxicity and T effector cell exhaustion seen in conventional CAR-T cell strategies.


AVENCELL

The Allogeneic platform allows AvenCell’s pipeline candidates to benefit from world-leading CRISPR cell engineering, enabling large-scale batch manufacturing of allogeneic products from healthy donors and compelling cost reductions. Through the combination of both differentiated platforms, AvenCell now aims for CAR-T cell therapies with an improved therapeutic window and to provide persistent, safe, and versatile ‘off-the-shelf’ cell products that enter new dimensions in cellular immunotherapy.

Clinical progress AVC-101, AvenCell’s lead clinical autologous cell therapy program, is directed against the CD123 antigen and designed for the treatment of patients with haematologic and lymphatic malignancies positive for CD123. The phase I study using a Universal Switchable CAR with a CD123-directed TM is currently in completion and has provided platform validation. A second phase I trial with the autologous cell therapy AVC-102 is ongoing and employs the technology with a TM targeting prostatespecific membrane antigen (PSMA) for the treatment of metastatic prostate cancer. AvenCell’s lead allogeneic cell therapy program AVC201, combining the Universal Switchable CAR technology with the Allogeneic platform to provide an “off-theshelf” product for the treatment of relapsed/refractory AML has recently been granted permission for a phase I clinical trial including up to 35 patients at multiple sites in Germany.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

30 | 31


Name › Axolabs GmbH Address/P.O. Box › Fritz-Hornschuch-Str. 9 Postal Code/City › 95326 Kulmbach State › Bavaria Contact Person › Dr Ingo Röhl Telephone › +49-9221-82762-0 Fax › +49-9221-82762-99 Email › info@axolabs.com Website › www.axolabs.com Number of Employees › ~220 Founded (year) › 2000 (as Ribopharma; acquired by LGC in 2017) Type of Laboratory › S1, S2

Axolabs is the leading custom research organisation focused on the discovery, development and manufacture of oligonucleotide and nucleic acid therapeutics. Founded firmly on our world-leading know-how and more than 20 years of experience, we provide high-end preclinical and clinical development solutions tailored to our clients’ needs. At our branches in Petaluma, California, and Berlin we have manufacturing and purification capabilities for oligonucleotide drug substance under the standards of GMP.

Services and Products Manufacturing

Areas of Activity › Research solutions for preclinical and clinical development with a focus on nucleic acid therapeutics (NAT), including bioinformatics-guided sequence selection, high quality oligonucleotide manufacturing, analytics (GMP), bioanalytics (GLP, GCP), lead molecule identification, and in vitro and in vivo pharmacology Intellectual Property › Proprietary bioanalytical assay for the detection and quantification of oligonucleotides in blood and tissue; proprietary lipid platform for LNPmediated cellular delivery of nucleic acids External › Axolabs collaborates with research Collaborations groups around the world in the field of oligonucleotide therapeutics, including > 15 Big Pharma enterprises, > 200 biotech companies, and > 30 academic research institutes

› High-quality non-GMP oligonucleotide synthesis in quantities of up to several 100 g › GMP production of oligonucleotides (in Berlin and Petaluma) › Custom-tailored process optimisation › Chemical synthesis of long RNA/DNA sequences › Wide range of chemically modified oligonucleotides and conjugates › Potency and stability improvement › Process-related impurity marker synthesis and reference standards › Lipid synthesis

Analytics › Broad capabilities for CMC analytical method development › Physicochemical and thermodynamic characterisation › Stability determination in biological matrices › Identification of impurities and metabolites by LC/MS

GMP-compliant analysis of oligonucleotide APIs › Release testing for Drug Substances and Drug Products › ICH-compliant stability studies


A XOL ABS

Analyses specific to mRNA therapeutics › Cap structure by uHPLC with ESI-MS › Poly-A tail by uHPLC with ESI-MS › Purity by uHPLC with UV › Release testing of mRNA-LNP Drug Products

PK and biodistribution › GLP-and GCP-certified test site › Proprietary assay system for sensitive detection of oligonucleotides › Quantification of mRNA

Oligonucleotide lead identification › Bioinformatics assessment for sequence pre-selection › Oligonucleotide design and synthesis › High-throughput in vitro screening › Lead characterisation and optimisation › 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

Platform for functional cell type-specific delivery of oligonucleotides and mRNAs › In vitro functional analysis and in vivo models › Rational oligonucleotide designs tailored for specific delivery systems › Proprietary lipid nanoparticle formulations

Gene-editing therapeutics › Unprecedented purity of therapeutic sgRNAs for CRISPR Cas and prime editing applications › Superior biological editing efficiency

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

32 | 33


Name › BAG Health Care GmbH Address/P.O. Box › Amtsgerichtsstrasse 1-5 Postal Code/City › 35423 Lich State › Hesse Contact Person › Dr Melanie Berger Telephone › +49-6404-925-0 Email › contact@bag-healthcare.com Website › www.bag-healthcare.com Social Media › I Number of Employees › 135 Founded (year) › 1947 Areas of Activity › | Contract manufacturing organisation (CMO) for biopharmaceuticals and small molecules | Aseptic filling and lyophilisation in vials from small to mid-size batches | Analytical services for drug substance, drug product, and stability programmes | Packaging, labelling, and serialisation | QP-release

Leading to success – wholeheartedly committed to the success of our customers As a traditional company, we have been equally committed to our customers and to our employees for more than 75 years. This has decisively shaped our value culture. Our credo: Consistently ensuring top quality with real customer and employee satisfaction. With our project team, you have people at your side who take the decisive step ahead and lead your project safely to success. We set everything in motion for you when you make an enquiry: › A personal companion: within 24 hours, your personal contact will get in touch with you and clarify your individual needs. A partner who is available to you throughout the entire process. › A concrete reply: within 72 hours you will receive reliable statements regarding feasibility, requirements, costs, and timelines. › An individualised approach: we provide a detailed offer, in which all requirements are taken into account – even those you may not (yet) have thought of. And all of that within five working days. › A firm eye on your timeline: no later than two months after all relevant points have been clarified, we will guarantee a fixed production slot for your project. Realistically calculated deadlines you can rely on. › A safe pair of hands for your project: thanks to our well-engineered project management, we produce and deliver your desired batch with an OTIF effectiveness of >95%. At BAG, we have grown together to form an interdisciplinary team, a family that stands up for each other. We feel flexible enough to be able to react quickly to your requirements. At the same time, with our experience and desire for perfectionism, we bring the necessary professionalism that makes it possible to constructively master even extraordinary situations. As a BAG family, we solve every challenge together.


BAG HEALTH CARE

A visionary portfolio Our combination of analytical understanding and a great deal of experience paired with empathy and passion delivers outstanding results. Our portfolio › Sterile filling › Freeze-drying › Analytical service › Stability studies › Labelling and packaging › QP-release As a reliable fill & finish partner, we provide on standardised processes in the filling and freeze-drying of parenterals, covered by a sophisticated quality management system. Thanks to our eager team, we flexibly adapt our production to your requirements. Take advantage of on-demand batch production thanks to small-format freeze dryers and flexible filling lines. We ensure a highly attractive price/performance ratio. Get your clinical trials off to a great start! When it comes to the manufacturing of your clinical trial products, we inspire with short delivery times and process support from our experts. For phases I–III of your clinical trial, we provide the data required for IMPD/IND submission and release it within the EU. Of course, all premises and equipment as well as the production sequence are regularly re-qualified according to GMP.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

34 | 35


Name › Biaffin GmbH & Co KG Address/P.O. Box › AVZ 2, Heinrich-Plett-Str. 40 Postal Code/City › 34132 Kassel State › Hesse Contact Person › Dr Bastian Zimmermann Telephone › +49-561-8044668 Fax › +49-561-8044665 Email › info@biaffin.com Website › www.biaffin.com www.proteinkinase.biz Social Media › F I Q Number of Employees › 8 Founded (year) › 2001 Type of Laboratory › Analytical, ISO 9001:2015 certified Areas of Activity › Service provider for biomolecular interaction analysis using SPR Biacore technology; supplier of recombinant proteins and reagents for kinase research and signal transduction External › Collaborations with academic research Collaborations groups and industrial partners Request for › Biaffin is looking for strategic partners Further Collaborations interested in complementing their analytical portfolio with SPR Biacore technology.

Company overview Biaffin GmbH & Co KG is an ISO 9001:2015 certified bioanalytical service provider specialised in the application of biosensors based on surface plasmon resonance (SPR) for biomolecular interaction analysis (BIA). BIA technology is ideally suited for highly accurate kinetic characterisation of any interacting molecules in real time in a label-free state. Biaffin has extensive knowledge and many years of experience in various application areas and supports biopharmaceutical drug development programme of pharma, biotech, and generic drug companies as well as scientific institutions worldwide as a competent partner. Our services are performed by a highly specialised team (PhD level scientists) in a laboratory well equipped with several state-of-the art SPR instruments (5x Biacore T200, 1x Biacore 8K+). Sufficient capacity of SPR instruments allows Biaffin to start interaction studies on short notice, quickly run multiple projects in parallel, and receive results in a timely manner. A qualified Biacore T200 instrument is available for SPR assay validation and GMP-like SPR analysis. The company’s expertise is documented by many peerreviewed publications in renowned scientific journals.

Analytical services for biopharmaceutical development For the development of therapeutic antibodies, bio­ pharmaceuticals, and biosimilars, Biaffin offers reliable SPR services for a highly accurate, quantitative kinetic characterisation, semi-quantitative kinetic ranking, or rapid qualitative screening of drug candidates. SPR assays have already been established for many target proteins and can be developed quickly by application of established protocols for reversible and site-directed coupling of biomolecules using specific capture surfaces. These assays can be applied for comparability and stability studies and batch-to-batch comparison during process optimisation. Available assay formats include dual-potency assays, pair-wise epitope mapping, and determination of active concentration based on binding activity (calibration-free methods). Assays can be validated and conducted under GMP-like conditions on a qualified Biacore instrument.


BIAFFIN

ADCC SPR assays ADCC SPR assays are established for interaction analysis of antibodies with Fc gamma receptors (CD16, CD32, CD64) including receptor variants and different species, neonatal Fc receptor (FcRn), and complement C1q binding.

Small molecule drug development Biaffin’s services in small molecule drug development comprise customised SPR assay development for defined target proteins, fragment screening, hit validation, secondary screening, kinetic profiling, competition analy­sis, and lead optimisation of compounds to improve specificity, selectivity, and potency. Early ADME studies (serum protein binding) and studies on mode of action, cofactor requirements, and thermodynamic binding analysis further support the drug development process.

Catalogue products Apart from analytical services, Biaffin offers a range of products serving customers’ needs in kinase research and exploring cellular signal transduction pathways. Biaffin’s product portfolio, available from the online shop www.Proteinkinase.biz, comprises recombinant proteins (kinases, cytokines, receptors, CD antigens), peptide substrates, specific inhibitors, and a biochemical ATP determination assay for customers’ in-house research.

Quality statement Biaffin has successfully implemented and maintains a Quality Management System certified according to the ISO 9001:2015 international standard, enhancing our ability to supply high-quality products and provide reliable, innovative services according to the highest quality standards, which consistently meet the needs and expectations of our clients.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

36 | 37


Name › BioCopy GmbH Address/P.O. Box › Elzstrasse 27 Postal Code/City › 79312 Emmendingen State › Baden-Wuerttemberg Contact Persons › Dr Matthias Wiedenfels, Dr Günter Roth Telephone › +49-7641-9377870 Email › info@biocopy.de Website › www.biocopy.de Social media › I Number of Employees › 30 Founded (year) › 2019 Areas of Activity › l Immuno-oncology l Drug Discovery and Development l T-cell therapeutics l TCR(m)-based drugs Request for › We are looking for partners for the Further Collaborations discovery and development of TCR(m)-based immuno-oncology drugs.

BioCopy BioCopy is a multinational company. Our German branch, including a state-of-the-art research and development facility, is situated in Emmendingen, north of Freiburg i. Br. Our company is part of the BioCopy group, headquartered in Switzerland and focuses on TCR(m)-based immuno-oncology drug development. We are successfully using our unique platform technology based on extensive expertise in microarray customization, binding kinetics and bioinformatics. Our team of experts is continuously working on improving the proprietary inhouse technologies for the fast, ­efficient and accurate characterization and development of TCR(m)-based immuno-oncology drugs.

Targeting complex molecules At BioCopy, we use our proprietary microarray technology for efficient immune profiling and lead screening, which allows us to establish our own pipeline for nextgeneration drug development. Currently, we are looking for partners for the joint development of novel TCR(m)-based immuno-oncology drugs with which to destroy cancer cells as precisely and accurately as possible without affecting healthy tissue.

BioCopy technology The BioCopy technology is based on three pillars: expertise in fabricating complex microarrays, label-free binding kinetics measured through the proprietary SCORE device and extensive know-how in bioinformatics. BioCopy’s patented complex microarrays are tailored to assay-specific requirements. They comprise thousands of complex biological molecules such as pHLAs and are used for efficacy screening of immuno-oncology drug candidates - in particular TCR(m).


BIOCOPY

BioCopy’s Single COlor REflectometry (SCORE) works seamlessly with these customized microarrays. By combining the two technologies, molecular binding interactions can be analysed in ultra-high throughput, label-free, at high quality and with great data depth. The BioCopy bioinformatics team works hand in glove with bench science creating many synergy effects for the improvement of the platform technology as well as fine-tuning the e ­ fficacy and specificity of antibody candidates.

TCR(m) Drugd Discovery with BioCopy BioCopy facilitates the development of effective immuno-oncology drugs that are less prone to harmful side effects. The BioCopy proprietary workflow builds on the company’s core competences: validating TCR(m) binding profiles with high data depth and implementing highquality specificity and safety measurements into the TCR(m) drug discovery and development process. BioCopy stands for exploring and sharing novel technologies for the development of safe and effective immune therapeutics. Consequently, we are ready to share our expertise with selected partners to advance TCR(m) drug discovery and pave the way for safer cancer therapeutics.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

38 | 39


Name › BioSpring GmbH Address/P.O. Box › Alt-Fechenheim 34 Postal Code/City › 60386 Frankfurt on the Main State › Hesse Contact Person › Dr Martin Schink Telephone › +49-69-660-5500-0 Email › info@biospring.de Website › www.biospring.de Social Media › I Number of Employees › > 585 Founded (year) › 1997 Type of Laboratory › CDMO Areas of Activity › CDMO for therapeutic nucleic acid manufacturing and analysis (GMP certified, FDA inspected)

BioSpring is your comprehensive source for synthetic nucleic acid solutions, providing expertise across all stages of drug development. With a steadfast commitment to excellence and innovation, we offer a wide range of services tailored to meet the diverse needs of our biotech and pharma clients.

Oligonucleotides at All Scales from One Source In the field of oligonucleotides, we are your one-stop destination, offering a wide spectrum of services that support our clients in every phase of drug development, from early-stage development to commercial supply: › Commercial manufacturing and process validation › cGMP manufacturing for clinical Phase I – III › Pre-clinical non-GMP batch manufacture › Manufacturing of oligonucleotides for R&D, lead screening and lead optimization › Process development – more than 140 successful programs each year › Scale-up, scale-down and process transfer

Preclinical & Diagnostic Manufacturing Our specialized and ISO 13485-certified department for customized and diagnostic manufacturing (CDM) has high-throughput capabilities and deep experience in handling diverse synthetic nucleic acids: › Strong expertise with highly modified, complex oligonucleotides › Commercial diagnostic manufacturing experience › Cutting-Edge Technology · Simultaneous manufacturing of > 400 sequences · Conjugation/liquid chemistry · Post-synthesis modifications › Aliquoting services (dry, liquid, lyophilized) › Utilization of custom amidites and solid supports on request › Diagnostic production (ISO 9001 & ISO 13485) › Analytical services (e.g., LC-MS) › Cleaning in place (CIP) › Scales available from nmol/µg up to several grams › Interdivisional cooperation allowing for seamless upscaling up to kg scale.


BIOSPRING

FDA-inspected Oligonucleotide Analytics and Quality Control We excel in tailor-fit solutions for release testing, stability studies, and characterization of oligonucleotides, following Analytical Quality by Design (AQbD) principles and meeting ICH Q14 requirements. We employ stateof-the-art methods, including high-resolution LC-MS, MS/MS sequencing, and NGS. BioSpring’s (bio-)analytical services support the entire drug development process: › Raw material method transfer, development, and validation › Impurity marker synthesis › Analytical method development and validation › Stress and forced degradation studies › Reference standard characterization We handle release and stability testing for both drug substance and drug product. Our expertise extends to the extraction of oligonucleotides from various biofluids and tissues, data support and pharmacokinetic investigations.

Guide and mRNA Manufacturing, R&D-Grade to cGMP BioSpring is the industry’s leading partner for R&D, preclinical, and cGMP RNAs. With a new, dedicated production building, we have now increased guide and mRNA capacity threefold in 2023, to support even more RNA projects from early-stage research to commercialization. Our FDA-inspected and GMP-certified facilities meet the highest quality standards. BioSpring has established cGMP manufacturing processes and analytical methods for > 175 guide RNAs. We employ a platform approach to streamline the onboarding process for therapeutic programs. BioSpring offers process validation and commercialization support, along with regulatory assistance. With a commitment to quality and cutting-edge technology, we are poised to help you succeed at every stage of your journey. Want to know more? Visit www.biospring.de 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

40 | 41


Name › Biotype GmbH Address/P.O. Box › Moritzburger Weg 67 Postal Code/City › 01109 Dresden State › Saxony Contact Person › Dr Norman Gerstner Telephone › +49-351-8838-400 Fax › +49-351-8838-403 Email › info@biotype.de Website › www.biotype.de www.modaplex.biotype.de www.custom-solutions.biotype.de Social Media › IQ Number of Employees › 90 Founded (year) › 1999 Type of Laboratory › S1, BSL-2 ISO 13485 & ISO 9001 certified Areas of Activity › In-vitro diagnostics Molecular diagnostics Contract development Contract manufacturing External › Strong network with numerous Collaborations industry and academic partners Member of the Molecular Diagnostics Group (MDG); contributing solutions for healthcare, personalised medicine & data management

Company Profile BIOTYPE is an innovative solution provider for molecular precision diagnostics, headquartered in Dresden, Germany. We are committed to advancing precision medicine through our products and services for robust analysis and interpretation of biomarker signatures. BIOTYPE offers a strong portfolio in molecular cancer diagnostics for applications in hemato-oncology, liquid biopsy, and molecular profiling of solid tumors. The portfolio includes in vitro diagnostic (IVD) assays for clinical diagnostics and research use only (RUO) assays for translational and clinical research. In addition, BIOTYPE offers high-quality and IVD compliant contract development and manufacturing services. Our proprietary MODAPLEX platform is a benchtop system for automated molecular profiling and modular multi-gene testing. Founded in 1999 and privately owned since then, BIOTYPE’s core business for many years has been PCR multiplex applications for forensic and professional laboratories in various industries. Since then, BIOTYPE has gained extensive expertise in providing high-quality molecular diagnostic products and services to professional laboratories, diagnostic, pharmaceutical and biotech companies, and research institutions worldwide. Today, BIOTYPE is a molecular diagnostics company providing the highest quality molecular testing systems, including assays, proprietary biochemistry, instrumentation and software. BIOTYPE‘s quality management system is certified according to ISO 9001:2015 & ISO 13485:2016.


BIOT YPE

Molecular Diagnostic Assays BIOTYPE provides a robust portfolio of molecular cancer diagnostics to support hemato-oncology, liquid biopsy, and molecular profiling of solid tumors. The portfolio comprises IVD assays for clinical diagnostics, RUO assays for translational and clinical research, and a benchtop system for automated molecular profiling. Professional laboratories use the molecular test systems to diagnose cancer patients accurately, determine the best treatment option, and timely identify actionable biomarkers for molecular-guided therapy.

MODAPLEX Platform BIOTYPE offers a unique system for molecular profiling. The MODAPLEX platform merges Polymerase Chain Reaction (PCR) and Capillary Electrophoresis (CE) into one automated workflow. Thus detection, differentiation, and quantification of all clinically relevant molecular markers and all known genetic alterations can be consolidated onto one platform.

Custom Solutions Focus on your core business and get things done. Our contract development & manufacturing services cover all challenges from the idea up to the realisation of a commercial product. This allows companies to outsource defined tasks or projects, thus improving efficiency, success rate, and scalability. We are committed to high-quality standards and accommodate individualised product specifications for our international customers. › Contract development › Contract manufacturing › Custom Packaging › Multiplex Assay development › Regulatory consultancy

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

42 | 43


Name › BRAIN Biotech AG Address/P.O. Box › Darmstädter Str. 34–36 Postal Code/City › 64673 Zwingenberg State › Hesse Telephone › +49-6251-9331-0 Fax › +49-6251-9331-11 Email › public@brain-biotech.com Website › www.brain-biotech.com Social Media › I Number of Employees › ~ 330 (BRAIN Biotech Group; around 120 at headquarter in Zwingenberg, Germany) Founded (year) › 1993 Type of Laboratory › S1, S2, L1, L2 Areas of Activity › l Speciality Enzymes l Bioactive natural products / small molecules l Microbial strain development l Bioprocess Development l Biomanufacturing External › Collaborations with global players as Collaborations well as with renowned universities. Request for › We’re looking for partners in the food, Further Collaborations feed, chemicals and cosmetics ­industries to work with us to develop ­innovative bio-based solutions.

Creating a #BiobasedFuture BRAIN Biotech AG is a leading provider of biobased products and solutions for sustainable industrial processes. BRAIN Biotech AG is the parent company of the international BRAIN Biotech Group, which is active in these fields: › Research-intensive custom solutions based on enzyme technology, strain development, bioprocess development and natural bioactive substances screening. › Production of speciality enzymes and proteins in industrial scale, with fermentation facilities in the UK and production facilities in continental Europe and the USA. › Bioincubator with own or partner-initiated R&D projects with high value-added potential. BRAIN Biotech’s focus areas are nutrition, health and the environment.

Technology services › Enzymes and Proteins: Function & sequence-driven discovery (proprietary database for rapid discovery) / Rational enzyme engineering / Bioinformatics ·  Designed and tailored for application › Microbial Strain Development – Microorganism discovery / Genetic & metabolic engineering /Production strains ·  Development of powerful protein & enzyme producers › Bioprocess Development: Process development & optimisation / Process transfer & scale-up / Analytics ·  Designed for production


BRAIN

R&D Services Genome Editing tools and services We use a proprietary CRISPR/Cas genome editing platform with a toolbox of several nucleases to perform custom genome editing services (“We CRISPR for you”) in a variety of applications. These genome editing tools have been identified and developed in-house, and are independent of common nucleases like e.g. Cas9 or Cas12a. We also provide and license these tools to our partners.

Enzymes optimization and search for new Enzymes If a particular enzyme product is not found in the BRAIN Biotech Group´s enzyme portfolio, our metagenome ­libraries are the basis for our sequence- or activitybased search for new enzyme product candidates. We further optimize enzymes already used by our customers so that complex process and application requirements can be met even better.

Process development and optimiziation We develop bioprocesses at lab-scale and to scale-up (200L) for process validation and sample generation. Our engineers within the BRAIN Biotech Group are experts for the tech and process transfer to enable a production at an industrial scale (up to 2 x 10,000L).

Applied technologies › Protein engineering › Eucaryotic cell expertise › Natural compound libraries › Genome editing / independent CRISPR nucleases › BRAIN BioArchive with access to nature‘s biodiversity › Metagenome technologies › Next generation sequencing › Precision fermentation & bio-processing › Applied bioinformatics › 3D modelling › Analytics

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

44 | 45


Name › Cardior Pharmaceuticals GmbH Address/P.O. Box › Hollerithallee 20 Postal Code/City › 30419 Hannover State › Lower Saxony Contact Person › Dr Claudia Ulbrich, CEO Telephone › +49-511-338599-30 Fax › +49-511-338599-39 Email › info@cardior.de Website › www.cardior.de Social Media › I Number of Employees › 30 Founded (year) › 2016 Type of Laboratory › S1 Areas of Activity › Research & development of RNA-based therapeutics and diagnostics for cardiac diseases External › l MHH Collaborations l IMTTS l Fraunhofer ITEM l CRC l WCN NL l Jade Klinik

Cardior Pharmaceuticals is a leading clinical-stage biopharmaceutical company pioneering the discovery and development of RNA-based therapeutics designed to prevent, repair, and reverse diseases of the heart. Cardior’s therapeutic approach uses distinctive noncoding RNAs as an innovative platform to address the root causes of cardiac dysfunctions. The company aspires to bring transformative therapeutics and diagnostics to patients, thereby making a lasting impact on the treatment of cardiac diseases worldwide. The company is led by Dr Claudia Ulbrich (CEO and cofounder), who brings more than 25 years of corporate leadership experience and co-founded the company with Prof. Dr Dr Thomas Thum (CSO/CMO and founder), a leading cardiologist and pioneer in the development of RNA therapeutics for heart diseases. They are joined by Axel-Sven Malkomes (CFO) who brings in three decades of experience and a proven track record in banking and finance. To advance Cardior’s pioneering work and the tremendous opportunity to impact the significant global population with heart disease, the company raised a Series B round of 64 million euros in 2021 from leading international biotechnology investors including BioMedPartners, COPARION, EQT Life Sciences, Fund+, Hadean Ventures, High-Tech Gründerfonds, Inkef Capital, Sunstone, as well as pharma company Bristol Myers Squibb.

Technology Cardior’s approach is rooted in a deep understanding of RNA biology. As non-coding RNAs (ncRNAs) are important regulators for many cellular processes, their ­dysregulation can lead to detrimental remodeling of heart cells, impairing their overall function. The ­c ompany has identified microRNA-132 as the main cause of this process, and by blocking the abnormal levels of this microRNA a concerted therapeutic effect against key hallmarks of heart disease is triggered.


CARDIOR

Pipeline addressing a major unmet medical need Heart diseases represent an increasing burden for families and the healthcare system globally, with prevalence, hospitalisation, and mortality rates far exceeding those of other diseases. Current treatment options primarily alleviate the symptoms and do not address the underlying root causes, despite decades of research and development in all areas related to cardiac diseases and heart failure. Cardior is advancing a novel class of cardiac therapeutics with a revolutionary mode of action. By modulating disease pathways at the cellular level, the company is pioneering a transformative approach applicable to a broad range of heart diseases as ­represented in its development pipeline, which addresses major cardiac indications as well as rare diseases such as hypertrophic and dilated cardiomyopathies.

Lead candidate

Thomas Thum

Claudia Ulbrich

Axel-Sven Malkomes

CDR132L is a synthetic antisense oligonucleotide-based inhibitor directed against microRNA-132 (­miR-132), which is up-regulated in cardiac tissue of heart failure patients and drives abnormal expression of genes crucially involved in cardiac function, leading to pathological remodeling. By blocking miR-132, healthy levels of miR-132 are restored and trigger a concerted therapeutic effect against key hallmarks of heart disease including pathological remodeling processes, impaired contractility, and fibrosis. CDR132L is currently being evaluated in the multicentre, randomised, placebocontrolled Phase II HF-REVERT trial in heart failure patients following a heart attack. The drug candidate has the potential to restore normal heart function, thereby prolonging the patient’s life span as well as improving quality of life.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

46 | 47


Name › CeGaT GmbH Address/P.O. Box › Paul-Ehrlich-Strasse 23 Postal Code/City › 72076 Tübingen State › Baden-Wuerttemberg Telephone › +49-7071-565-44-55 Fax › +49-7071-565-44-56 Email› info@cegat.com Website › www.cegat.de Social Media › I F  Number of Employees › ~ 200 Founded (year) › 2009 Areas of Activity › Genetic analysis, next-generation sequencing (NGS)

About CeGaT CeGaT is a global provider of genetic analyses for a wide range of medical, research, and pharmaceutical applications. Founded in 2009 in Tübingen, Germany, the company combines state-of-the-art sequencing technology with medical expertise – with the aim of identifying the genetic causes of diseases and supporting patient care. For researchers and pharmaceutical companies, CeGaT offers a broad portfolio of sequencing services and tumour analyses. CeGaT generates the data basis for clinical studies and medical innovations and drives science forward with its own insights. The owner-managed company stands for independence, comprehensive personal customer service, and outstanding quality. CeGaT’s laboratory is accredited according to CAP/CLIA, DIN EN ISO 15189, and DIN EN ISO/IEC 17025 and thus meets the highest international standards.

Your true partner for next-generation sequencing (NGS) Our vision is to make next-generation sequencing available to all life scientists and bring diagnostic knowledge into sequencing service. We are your true partner for next-generation sequencing. Being pioneers in NGS-based genetic diagnostics, we have a profound understanding of the underlying technology. Based on this, we offer practical applications for research and medicine. Consistently high quality is our maxim: We perform all projects in-house and automate processes whenever possible. We strongly believe that teamwork is key. Our interdisciplinary team is composed of specialists of various disciplines contributing their specific know-how. A dedicated project manager supports you from beginning to completion and will be your individual contact. Together, we realise smart sequencing solutions to address your research questions.


CEGAT

A comprehensive product portfolio to match your project’s requirements To support scientists in accomplishing projects of any scope, we offer a broad product portfolio. You can choose from a wide range of sequencing services, such as: › Whole Genome Sequencing › Whole Exome Sequencing › Transcriptome Sequencing › Ready to Load Sequencing The portfolio is complemented by analyses suited for microbiome, immunology, and translational oncology studies. All our services can be tailored to your requirements, be it the isolation of nucleic acids, data output format, or further bioinformatic analyses.

High throughput technology meets outstanding scientific expertise The rapid advancement of technology is constantly increasing the potential of genetic analyses. Therefore, CeGaT continuously invests in the latest equipment. We constantly improve sequencing quality and data analysis by using the most advanced technologies and pipelines available. With the in-house NovaSeq™ X Plus, six NovaSeq™ 6000, and a PacBio Sequel IIe system, we sequence large quantities of genetic material within a very short time. For consistently high quality as well as time and cost savings, we rely on the automation of processes. At the same time, human expertise is indispensable to us and an essential pillar of our company. The entire process is supervised by a dedicated project manager who provides advice and support from project design to the final report. We adopt the strict requirements of genetic diagnostics also for research projects.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

48 | 49


Name › CLADE GmbH Address/P.O. Box › Schelztorstraße 54-56 Postal Code/City › 73728 Esslingen on the Neckar State › Baden-Wuerttemberg Contact Person › Gürkan Korkmaz Telephone › +49-176-12667004 Email › info@clade.io Website › clade.io Social Media › I I Number of Employees › 60 Founded (year) › 2001 Areas of Activity › | Manufacturing Quality Control | Protein Characterization | Quality-by-Design | Fast Batch Release | Fermentation | Galenics | Process Control | Waste Water Analysis

CLADE - We bring efficiency to your quality control CLADE, a pioneer in the field since its establishment in 2001. With over two decades of dedicated experience in crafting innovative spectroscopy-based solutions. We stand as a testament to unwavering commitment in the face of evolving challenges. Our guiding principle remains unchanged: the pursuit of enhancing analytical efficiency. In the realm of life sciences, especially biopharma, the role of effective analytics cannot be overstated. It serves as the cornerstone for upholding quality standards across a spectrum of applications. Speed, precision, and reproducibility remain priorities in every domain we touch. That’s precisely why we’ve embarked on a journey of redefining analytics, seamlessly weaving together the art of chemometrics with cutting-edge spectroscopic technology. In essence, our mission boils down to delivering outcomes of superior quality, at an accelerated pace. Amidst the intricacies of bioanalytics, we’ve taken it upon ourselves to simplify the path. We’re making bioanalytics a journey that’s as streamlined as it is profound.

PRODUCT MIRA Analyzer Our MIRA Analyzer generates the chemical fingerprint of a liquid sample using superior FTIR technology. Resulting in a true digital twin of aqueous samples. All thanks to MIRA, our proprietary hardware with AquaSpec™ technology. MIRA has been designed from the ground up to generate fast, accurate, and reproducible data without the need of time-consuming sample preparation. It’s the only mid infrared (MIR) spectroscopy solution that allows the highly reproducible acquisition of spectra from aqueous samples. GMP compliance enables our partners to elevate their biopharmaceutical production and development to the next level.


CL ADE

Sphere Sphere is our software collection that enables the rapid analysis, identification, and evaluation of mid infrared spectra generated by the MIRA Analyzer. Within Sphere we provide tools that enables non chemometric experts to build spectroscopic models. This includes database driven approaches that tab into our unique spectral database, PLS models as well as qualitative models based on SIMCA statistical methods.

QA Scan QA Scan, a unique tool within Sphere. QA Scan will revolutionize data analytics and how chemometric models are applied. Moving away from cumbersome Design of Experiments. With just a simple click, our partners can now create accurate and reliable chemometric models using a simple two-point calibration. Designed from the beginning for the biopharmaceutical industry, QA Scan is tailored to meet biopharma specific needs in release testing, formulation testing and stability testing. The QA Scan empowers its users to measure an extensive range of quality attributes, including pH, protein concentration, excipients, protein secondary structure, polysorbate concentration, and protein identification – all at once without sample prep, all in four minutes.

Together Stronger MIRA and Sphere are purpose-designed to work together as a unified platform. Together, they enable the consistent, reproducible generation of standardized data, independent of device, user, or location. By combining MIRA and Sphere: we create the global standard for bioanalytics by revolutionizing the way we obtain, translate, interpret, and compare information derived from all chemicals and biologics.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

50 | 51


Name › Coriolis Pharma Research GmbH

Coriolis – Your partner for formulation, analytics, and manufacturing

Address/P.O. Box › Fraunhofer Straße 18b Postal Code/City › 82152 Martinsried/Munich State › Bavaria Contact Person › Bettina von Klitzing-Stückle Email › Bettina.klitzing@coriolis-pharma.com Website › www.coriolis-pharma.com Social Media › I Number of Employees › 200+ Founded (year) › 2008 Type of Laboratory › Contract research and development

Coriolis Pharma is a global contract research organisation and one of the world leaders in formulation research and development of (bio)pharmaceutical drugs, including cell and gene therapy products and vaccines. The company’s offerings include liquid and lyophilised drug formulation development from early stage to market approval and beyond, lyophilisation process development, and analytical development under R&D and GMP. Non-GMP manufacturing services for a wide range of products complete the service offering.

Areas of Activity › Formulation excellence for biopharmaceuticals, incl.: | Liquid and lyophilised formulations | Lyophilisation process development | Analytical services for biologics | Aggregate & particle analysis | Particle identification | Higher-order structure analysis | Forced-degradation studies | Long-term and in-use stability | Pre-formulation screening | Developability assessment | Supply of TOX-material | Level: R&D, GMP, S1 (BSL1), S2 (BSL2)

More than 725 clients – from start-ups to big pharma – already rely on Coriolis’s scientific expertise. For each and every project, our highly skilled scientists develop customised study designs that align with our customers’ drug development strategies.

Our service portfolio › Formulation development services for liquid and lyophilised products including biosafety level S1 and S2 · Pre-formulation and candidate selection · Early-stage formulation development · Late-phase formulation development · Lyophilisation process development and 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 › Analytical testing of S1 and S2 GMO material › Polysorbate analytics › Biosimilarity studies › Supply of preclinical Tox-material


CORIOLIS PHARMA RESEARCH

Our mission: Formulating innovation Following our mission of “formulating innovation”, we combine technologies, knowledge, and experience to add significant financial value to projects by generating IP for the clients’ pharmaceutical compound and managing the patent lifecycle in later stages.

Our analytical techniques 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 size range) › Particle identification › Aggregate analytics › Physico-chemical characterisation of lyophilisates › Surfactant characterisation › Higher order structure analysis › Chemical changes

Our scientific expertise We provide cutting-edge services and tailor-made solutions for our clients, conducted by our interdisciplinary team of highly skilled scientists and an international expert scientific advisory board. This scientific advisory board contains some of the most renowned specialists in biopharmaceutical formulation development and particle characterisation, who are actively involved throughout each client project and contribute with independent advice to a successful outcome. 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. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

52 | 53


Name › CureVac Address/P.O. Box › Friedrich-Miescher-Strasse 15 Postal Code/City › 72076 Tuebingen State › Baden-Wuerttemberg Contact Person › Dr Sarah Fakih, Vice President Corporate Communications & Investor Relations Telephone › +49-7071-9883-0 Fax › +49-7071-9883-1101 Email › communications@curevac.com Website › https://www.curevac.com/en/ Social Media › I Number of Employees › More than 1,100 Founded (year) › 2000 Areas of Activity › Research, development, and manufacturing of transformative medicines based on messenger RNA (mRNA) External › Selected CureVac collaborations: Collaborations | GlaxoSmithKline (GSK) | Bill and Melinda Gates Foundation | myNEO | CRISPR Therapeutics | Harvard Medical School | Genmab

CureVac’s profile CureVac is a global biotech company and pioneer in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in this versatile biological molecule for medical purposes. As a central mRNA player, CureVac holds one of the broadest and most diverse patent portfolios in the field, based on its endto-end competencies, which span a broad technology platform, a solid product development pipeline and large GMP manufacturing capacities. The principle of CureVac’s proprietary technology is the use of optimized mRNA as a data carrier to instruct the human body to produce its own medicine. Based on this technology, CureVac has built a clinical pipeline across the areas of prophylactic vaccines, oncology, and molecular therapies. Broad internal manufacturing capabilities and expertise allow for the rapid, efficient and cost-effective production of mRNA-based medicines. CureVac is headquartered in Tübingen, Germany, and has more than 1,100 employees across its sites in Germany, the Netherlands, Belgium, Switzerland and the U.S.

CureVac’s pipeline CureVac is the pioneer in successfully harnessing mRNA as the universal template for protein synthesis to prevent infections or to treat diseases by mimicking human biology to synthesize the desired proteins. CureVac’s clinical development pipeline spans the therapeutic areas of prophylactic vaccines, oncology, and molecular therapy. In prophylactic vaccines, CureVac is advancing mRNA vaccine candidates against a broad range of infectious diseases including COVID-19 and seasonal influenza in partnership with GSK. All vaccine candidates are based on CureVac’s proprietary secondgeneration mRNA backbone, targeting improved intra-


CUREVAC

cellular mRNA translation for early and strong immune responses. The second-generation mRNA backbone is expected to enable protection against one or more emerging COVID-19 variants or multiple influenza strains, with potential for combination vaccines against multiple different viruses as well. Progress in prophylactic vaccines has been expanded into the area of oncology for development of novel therapeutic cancer vaccines. CureVac is building a meaningful portfolio of cancer vaccine candidates and has added advanced genomics and bioinformatics expertise to identify both shared and unique neoantigens across different cancer types.

mRNA-based medicines The CureVac technology platform is based on a targeted approach to create and optimize mRNA constructs that encode functional proteins that either induce a desired immune response or replace defective or missing proteins. These new mRNA constructs represent a novel class of medicine that have the potential to address limitations of conventional treatment modalities. The highly flexible nature of mRNA has the potential for higher efficacy, greater speed and lower cost of production as compared to conventional treatments. In early 2023, CureVac reported positive preliminary data from ongoing Phase 1 clinical programs in COVID-19 and seasonal flu, validating CureVac’s technology platform, led by its second-generation mRNA backbone. Since then, both programs have successfully advanced to a Phase 2 clinical development. Fuelled by the advancements in prophylactic vaccines, CureVac also initiated a Phase 1 study in oncology, ­a ssessing the first therapeutic cancer vaccine based on its second-generation mRNA backbone in patients with resected glioblastoma.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

54 | 55


Name › Eppendorf SE Address/P.O. Box › Rudolf-Schulten-Str. 5 Postal Code/City › 52428 Jülich State › North Rhine-Westphalia Email › bioprocess-info@eppendorf.de Website › www.eppendorf.com Social Media › F I Number of Employees › 5,000 Founded (year) › 1945

We help bring life-saving treatments to the world – your expert partner in bioprocessing Since 1945, the Eppendorf brand is synonymous with customer-oriented processes and innovative products, such as laboratory devices and consumables for liquid handling, cell handling and sample handling. Today, Eppendorf and its more than 5,000 employees serve as experts and advisors, using their broad knowledge and experience to support laboratories and research institutions around the world. This is also true for the world of bioprocessing, an important field which already improves human living conditions today and will continue to do so in the future.

Bioprocessing – important today and tomorrow One might not notice but bioprocessing is already touching many aspects of our daily life. For instance, the COVID-19 pandemic had shown once more the importance of vaccination strategies to decrease the risk of fatal diseases. Vaccine development is highly dependent on bioprocessing where process development and production of vaccine components by specific cell lines are carried out in bioreactors. The same is valid for the production of antibodies, which serve important roles as diagnostic and therapeutic tools alike.

Improving human living conditions Bioprocessing is also important for the establishment of approaches that will gain more and more momentum in the future. One such example is the use of stem cells for various applications, including cell therapy as well as modern food. Cell and gene therapies offer new opportunities for the development of life-saving treatments for previously incurable diseases. As the name suggests, they use cells or gene-modifying tools, such as stem cells, T cells or viral vectors to revolutionize the treatment of diseases such as cancer. Modern food is an innovative way to tackle the negative impact of livestock husbandry on animal welfare and environment. Here, muscle stem cells are utilized to grow meat in a bioreactor.


EPPENDORF

We Help Bring Life-Saving Treatments to the World Your expert partner in bioprocessing

Bioprocess equipment to meet the challenges As these fields evolve, they bring more challenges as the processes need to be standardized and scalable to cultivate enough cells. Bioreactor technology from Eppendorf helps to meet these challenges. › From research to pilot production: Our bioprocessing solutions support the upstream bioprocessing cycle from early development to scale-up to pilot-scale production, with working volumes ranging from 60 mL to 2,400 L. › For optimal cell growth: Powerful hardware and software tools for process monitoring, control, and analytics facilitate standardized process control. › Time saving and risk mitigation: The BioBLU® SingleUse Bioreactors from Eppendorf eliminate the need for time-consuming and costly cleaning and sterilisation processes associated with reusable stirred-tank bioreactors. This streamlines the workflow, reduces downtime between batches, and enables faster turnaround times. › Service and support: With worldwide technical and application services, clear technical documentation, and preventive maintenance services, Eppendorf ensures reliable system operation. The need for solutions is constantly increasing. With more than 70 years of expertise in bioprocessing we are helping you to find solutions tailored to your challenge.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

56 | 57


Name › Eurofins BioPharma Product Testing Munich GmbH Address/P.O. Box › Behringstraße 6–8 Postal Code/City › 82152 Planegg near Munich State › Bavaria Contact Person › Dr Bettina Katterle Telephone › +49-89-899-650-0 Email › PharmaTesting@eurofins.com Website › www.eurofins.de/biopharma-producttesting-dach-en/ Social Media › I Number of Employees › around 1,000 in the DACH region Founded (year) › 1984 Type of Laboratory › GMP/GLP Facilities, ISO 17025 and FDA accreditations Areas of Activity › External testing services for bio-/ pharmaceutical and medical device companies External › Global Eurofins BioPharma Product Collaborations Testing Network of Laboratories (over 40 GMP- certified partner labs) and BSL BIOSERVICE Scientific Laboratories Munich GmbH

Global BioPharma Product Testing within your reach Welcome to the site of the Eurofins BioPharma Product Testing (BPT) laboratories in the D-A-CH region, which can look back on up to 90 years of experience. We are part of the world’s largest network of GMP-certified laboratories and offer comprehensive laboratory services for (bio-)pharmaceutical and medical device companies. In Germany, Austria, and Switzerland, we are at your disposal at seven locations, in Birkenfeld, Hamburg, Homburg, Constance, Munich, Linz (AT), and Schoenenwerd (CH).

Our services at a glance We support customers in the following areas: › (Bio)-chemical and microbiological testing of raw materials › Water testing › APIs and finished drugs (small & large molecules), biologics, batch release (also by a Qualified Person, QP) › ICH stability studies (including controlled storage and licences for narcotics) › Bioassays, ATMP testing › Medical device testing › In vitro toxicology / pharmacology biocompatibility, chemical characterisation These services help you bring safe human and veterinary medicines to market. In addition to the pharmaceutical industry, we work for customers from the medical device, chemical, and cosmetics industries.


EUROFINS BIOPHARMA PRODUCT TESTING

Experience our expertise With over 27,000 m² of laboratory and office space, we offer customers in the DACH region the most comprehensive laboratory services and the greatest possible capacities using state-of-the-art equipment and software solutions. Our locations are predominantly GMP and GLP certified. Several locations are additionally accredited according to DIN EN ISO 17025 for the testing of medical devices. The BPT sites in Munich, Hamburg, and Homburg have been successfully audited several times by the US Food and Drug Administration (FDA), which is an additional confirmation of our consistently highest level of quality.

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.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

58 | 59


Name › FGK Clinical Research GmbH Address/P.O. Box › Heimeranstr. 35 Postal Code/City › 80339 Munich State › Bavaria Contact Persons › Martin Krauss, Dr Edgar Fenzl Telephone › +49-89-893-119-0 Email › martin.krauss@fgk-cro.com edgar.fenzl@fgk-cro.com Website › www.fgk-cro.com www.fgk-pv.com www.fgk-rs.com Social Media › I Number of Employees › 230 Founded (year) › 2002 Areas of Activity › Full service CRO (contract research organisation) offering a complete range of clinical development and consulting services all over Europe and the US: 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. External › BVMA - Federal Association of Collaborations Contract Research Organisations

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 230employees – most of them located in our headquarters in Munich and our branch office in Berlin, 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 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 Regulatory Affairs › Consulting on regulatory topics › Review of study documents (e.g. protocol, informed consent form, labels) › CTA with submission to authorities and ECs

Clinical Operations › Project management, primary liaison for sponsor communication, status reports, etc. › Feasibility, contract negotiations, site management, monitoring, etc.

Medical Safety/Pharmacovigilance › Adverse Event Management and assessment/reporting › Drug safety, medical monitoring and coding of medical terms › Pharmacovigilance – also visit www.fgk-pv.com

Medical Writing › Investigator’s brochures, study protocols, ICF and subject information › Clinical expert reports, clinical publications, IMP and submission dossiers

Data Management › CRF design and review, clinical trial databases › Data validation, processing and cleaning, external data handling, CDISC SDTM

Biostatistics and Programming › Study design, sample size calculations › Statistical consultancy, analysis plan, programming and reporting › CDISC ADaM

Quality Assurance › Audits of investigator site, database and system audits, internal audits › SOP composition and implementation

eSolutions › eCRF, IWRS/Drug supply, eTMF, CTMS

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

60 | 61


Name › Formycon AG Address/P.O. Box › Fraunhoferstr. 15 Postal Code/City › 82152 Martinsried/Planegg State › Bavaria Contact Person › Sabrina Müller Telephone › +49-89-864-667-149 Fax › +49-89-864-667-110 Email › sabrina.mueller@formycon.com Website › www.formycon.com Social Media › IQ Number of Employees › 230 Founded (year) › 2012 Areas of Activity › Biosimilar Development External › Formycon aims to develop its Collaborations biosimilar candidates to near-market development stages before transferring them fully or partially into partnerships for global commercialisation. Project and marketing rights for FYB206, FYB208, and FYB209 are fully owned by Formycon. For FYB202, Formycon entered into a global commercialisation partnership with Fresenius Kabi. FYB203 is in a licensing partnership with Klinge Biopharma GmbH. Formycon owns a 50% stake in the already approved biosimilar FYB201, which is marketed by Coherus BioSciences, Inc. in the US and by Teva Pharmaceutical Industries Ltd. in the EU and other territories.

Who we are: Formycon is an expert company for the development of Biosimilar Medicines. The company’s pipeline includes FYB201 (reference medicine Lucentis®), which has already been approved in the US, the EU, and the UK, the late­stage biosimilar candidates FYB202 (reference medi­ ylea®), cine Stelara®) and FYB203 (reference medicine E as well as FYB206 (reference medicine Keytruda®), a biosimilar candidate in an advanced preclinical development phase. The two preclinical biosimilar candidates FYB208 and FYB209 complete Formycon’s biosimilar pipeline.

Biosimilars – Medicines for the Future A Biosimilar Medicine is a biological medicine highly similar to another already approved biological medicine (the “reference medicine”). Biosimilars are approved according to the same standards of pharmaceutical quality, safety, and efficacy that apply to all biological medicines. 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. Thus Biosimilars help patients around the world and while helping to ease the financial strains on the world’s healthcare systems


FORMYCON

What we do: Formycon develops Biosimilars for the rapidly growing disease areas of ophthalmology, immunology, and immuno-oncology, as well as for other key chronic diseases. Formycon covers all stages of biopharmaceutical development from analytics and cell line development to preclinical and clinical studies, all the way to the preparation of regulatory submission documents. We develop Biosimilar Medicines to meet the high stan­ dards of the world’s most regulated markets: Europe, United States, Canada, Japan, and Australia.

Our Expertise: Our unique advantage lies in the vast expertise of our international 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 Biosimilars to market and thus 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.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

62 | 63


Name › Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Division of Pharmaceutical Biotechnology Address/P.O. Box › Inhoffenstr. 7 Postal Code/City › 38124 Braunschweig State › Lower Saxony Contact Person › Prof. Dr Holger Ziehr Telephone › +49-531-6181-6000 Fax › +49-531-6181-6099 Email › biopharmaceutical-services@item. fraunhofer.de Number of Employees › Institute: 463 (2022) Pharmaceutical Biotechnology: 62 Founded (year) › 1981 Type of Laboratory › S1, S2, clean rooms of grades D, C, and B Areas of Activity › Biopharmaceutical consultancy, cell line development (CLD), GMP-contract manufacture of cell banks and investigational biopharmaceuticals, bioprocess development, analytical development and bioanalytical service, aseptic fill and finish of investigational medicinal products (IMPs)

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 › €38.0 million (2022) Request for › l Collaborations concerning GMP Further Collaborations manufacture of biological active pharmaceutical ingredients for clinical trials and analytical development l Manufacture of investigational medicinal products (IMPs)

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

The core elements of the GMP cleanroom facilities are Class B (Iso 6) cleanroom suites with laminar flow hoods providing Class Iso 5 (cleanroom class A) working environments for manual aseptic fill and finish operations or as a Restricted Access Barrier System (RABS) equipped with an automated filling line for vials and ampoules with volumes between 1 and 13.3 milliliters and batch sizes up to 9000 units.

Services › Development 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 bio­­­­ pharmaceutical active ingredients › Aseptic manufacture of final dosage forms as IMPs for clinical trials › GCP labelling and release of IMPs for clinical trials

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

64 | 65


Name › GALAB Laboratories GmbH Address/P.O. Box › Am Schleusengraben 7 Postal Code/City › 21029 Hamburg State › Hamburg Contact Person › Dr Jürgen Kuballa Telephone › +49-40-36-80-77-0 Fax › +49-40-36-80-77-401 Email › info@galab.com Website › www.galab.com/biotechnology/ Social Media › F I  I Number of Employees › 250 Founded (year) › 1992 Type of Laboratory › Biotechnology laboratory of class S1 according to GenTSV and S2 according to BioStoffV Areas of Activity › Biocatalysis of valuable poly- and oligosaccharides for a broad range of applications in the food and pharmaceutical industries HMO production processes In vitro multi-enzyme cascades Complex whole cell biocatalysts Modular nucleotide cofactor regeneration technology

GALAB Biotechnology specialises in the biocatalysis of valuable poly- and oligosaccharides for a broad range of applications in the food and pharmaceutical industries. With our proprietary Glycokat® technology we provide innovative, high-quality products and services for the benefit and added value of our customers. We are a privately owned, internationally operating company with an annual average growth of 10%, and we consistently invest our profits in R&D as a foundation for further growth.

Patented HMO production strains – biocatalysis for a better life The oligosaccharides of human breast milk (HMOs) stimulate the immune system and digestive tract of newborns and infants, protecting them against diseases and contributing to healthy development. Our patented E. coli and C. glutamicum strains provide two of these valuable HMOs, fucosyllactose and sialyllactose, along with their beneficial effects for a growing global market. We are passionate about developing HMO processes and are seeking long-term strategic partnerships with institutions that plan to invest in HMO research and scale up production.

Glycokat® nucleotide cofactor regeneration takes glycosylation to a whole new level Many valuable compounds relevant to the food or pharmaceutical industry obtain their functionality through enzymatic glycosylation. However, once your biocatalysis works, it becomes evident: glycosylation requires extremely costly nucleoside triphosphates. GALAB Biotechnology’s Glycokat® technology makes it possible to recycle these crucial energy-rich cofactors based on cheap and renewable substrates. It can be used at line in a plug and play fashion in various complex biocatalytic cascades. With our modular Glycokat® technology, cost-effective enzymatic glycosylation processes become within reach for our customers.


GAL AB

Customer-centric development of new production processes for polyand oligosaccharides If you require a new production process for poly- and oligosaccharide structures, Glycokat® is the right choice for you! We identify and evaluate potential biocatalytic synthesis routes for you and select the most promising approach to follow. Our Glycokat ® technology covers the whole biotechnological research and development portfolio to reach your goal: ranging from strain development to a scalable bio- and downstream process up to final product quality control. The Glycokat® technology allows for multistep biosynthesis so you can pick the best tool of the trade according to your envisioned application, either in vitro enzyme cascades or whole cell biocatalysis. The scalable Glycokat ® technology achieves high space-time yields with high product quality. It is equally suitable for obtaining products for experimental research or to purifying them on an industrial production scale. Our core competencies: › Process development and analytics for poly- and oligosaccharide production, such as HMOs › Assay and chromatography methods for biocatalysis › Metabolic engineering to create efficient production strains of E. coli and C. glutamicum › Production of pure, active, and stable recombinant enzymes with up to two-digit gram per litre titre › Cofactor regeneration and immobilisation to optimise biocatalysis › Solving catalytic bottlenecks within whole cell biocatalysts and enzyme cascades › Model-assisted optimisation of fermentation processes and enzyme cascades

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

66 | 67


Name › GENEWIZ Germany GmbH Address/P.O. Box › Bahnhofstrasse 86 Postal Code/City › 04158 Leipzig State › Saxony Telephone › +49-341-520-122-41 Email › Genomics.Service.Europe@azenta.com Website › www.genewiz.com Social Media › I Number of Employees › ~100 Founded (year) › 2017 Areas of Activity › | Next generation sequencing (NGS) | Plasmid sequencing and PCR Services | Gene synthesis and gene editing | Full-length plasmid sequencing | RNA / transcriptome sequencing | Whole genome sequencing | Microbiome and metagenomics | Proteomics and spatial biology | Oligo synthesis | Plasmid preparation services | Custom antibodies | Viral packaging | Pre-clinical and clinical services

GENEWIZ Germany GmbH, located in Leipzig, is a leading service provider offering superior data quality for Next Generation Sequencing (NGS), Sanger Sequencing and Gene Synthesis. Our goal is to support scientists with high quality services, offered at competitive pricing. GENEWIZ Germany GmbH offers all standard DNA and RNA sequencing services, with a focus on enabling researchers around the world to advance their scientific discoveries. Our international team supports researchers in their project management and implementation as well as analysis of results. Our Leipzig facility employs the latest sequencing technologies providing end-to-end NGS workflows. We can assist at any stage of the workflow, including sample extraction, library preparation, sequencing and bioinformatics analysis. Strongly supported by individual logistics solutions, our laboratory in Leipzig features an automated production, capable of implementing even complex projects within very short periods of time. We offer scalable project solutions from individual samples to large studies with several thousand samples.

Plasmid sequencing and PCR services GENEWIZ Germany GmbH offers cost-efficient plasmid and PCR sequencing services with Sanger sequencing, including overnight services. Sample pick-up can be organized all over Europe with a focus on individual solutions. Additionally, applying the newest long-read NGS technology, complete plasmid sequencing services are offered, without the need of designing or providing a sequencing primer. All samples are processed in a highly automated lab environment, including precise sample tracking via barcodes. For all plasmid sequencing services, results are available within one business day in Europe.


GENEWIZ

Next generation sequencing services Our service offerings in Transcriptomic (RNA) and genome sequencing is not limited to human samples, but also animal and plant samples, as well as microbiological samples, including bacterial, fungal and viral. The laboratory in Leipzig has a large extraction capacity from all common starting materials and is accredited to process infectious and genetically modified organisms. We can also offer specialized services such as SingleCell Sequencing (10x Genomics), Spatial transcriptomics (Nanostring) and Olink proteomics to enable multiomic insights in complex samples. Pre-clinical and clinical services can be also performed in a highly regulated environment, based on Good Laboratory Practice (GLP), Clinical Laboratory Improvement Amendments (CLIA) regulations, and College of American Pathologist (CAP) standards.

Part of Azenta Life Sciences GENEWIZ Germany GmbH is part of Azenta Life Sciences, a leading provider of life sciences solutions worldwide, enabling impactful breakthroughs and therapies to market faster. Azenta provides a full suite of reliable cold-chain sample management solutions and multiomics services across areas such as drug development, clinical research and advanced cell therapies for the industry’s top pharmaceutical, biotech, academic and healthcare institutions globally. For additional information, please visit www.genewiz.com.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

68 | 69


Name › Gen-H Genetic Engineering Heidelberg GmbH Address/P.O. Box › Im Neuenheimer Feld 584 Postal Code/City › 69120 Heidelberg State › Baden-Wuerttemberg Contact Person › Dr Marlen Schmidt, Dr Katherine Brechun Telephone › +49-6221-1370811 Email › contact@gen-h.de Website › www.gen-h.de Social Media › I Number of Employees › 10 Founded (year) › 2019 Type of Laboratory › S1 Areas of Activity › DNA engineering; transgenics; E. coli strain optimization Patents › patent applications related to antibiotic free fermentation: EP22160310 and EP21174990 External › Ozgene Pty Ltd Collaborations Request for › contact@gen-h.de Further Collaborations

Gen-H is a Genetic Engineering company with more than 20 years of experience in “Recombineering”. This technology, originally developed at the EMBL in Heidelberg, enables custom, scarless modification of DNA.

Services We offer our expertise to academic and industrial customers on a fee-for-service basis or as a scientific partner in larger collaborations. Our portfolio encompasses assembly of all types of targeting constructs for animal models and direct modification of bacterial genomes, primarily in E. coli. In addition, we offer a new technology for antibiotic-free plasmid maintenance.

Humanizations We assemble custom targeting constructs for transgenics, actualising complex designs with a size range of approximately 25 – 200 kb. Such large, BAC-based targeting constructs are typically commissioned to create transgenic mice with genomic humanizations. Transgenic mice are valuable tools for research in basic science and human disease and are a critical component in the drug discovery and development pipeline. We have formed a successful partnership with Ozgene, one of the leading companies developing genetically modified mice. With our combined expertise, we have successfully completed more than twenty joint projects in the past two years, creating transgenic mice with large humanizations for clients worldwide. Importantly, the entire workflow is independent of exogenous nucleases, such as CRISPR/Cas9, thereby reducing costs and eliminating the need to analyse for off-target effects.


GEN-H

Strain optimizations Genetically modified microbial strains are used in large-scale fermentations to manufacture products, such as proteins (including enzymes) or fine chemicals. Optimization of these fermentation strains through metabolic engineering provides the means to improve processes and meet environmental as well as commercial objectives. E. coli is one of the most important production hosts in industrial biotechnology. In recent years, scientists at Gen-H have performed hundreds of strain modifications, primarily in E. coli, for numerous academic and industrial partners, including some of the leading European chemical companies. At Gen-H, we have extensive knowledge and experience in challenging genome modifications, including for example genome integration of large expression cassettes and insertion of targeted mutations in essential genes. In addition to performing custom strain modifications, Gen-H distributes optimized strains developed in-house, including our popular E. coli T7E2 strain, an optimized BL21(DE3)-derivative devoid of the DE3 phage.

Antibiotic-free fermentation Gen-H offers a robust and simple method for plasmid maintenance that is independent of antibiotics and free from antibiotic resistance genes. This proprietary and IP-protected technology is highly flexible and has no restrictions regarding culture medium or temperature. Importantly, the method has a simple solution to propagate the empty strain, allowing transformation without repetitive strain modifications or helper plasmids. With this technology, costly antibiotic-supplementation can be eliminated without compromising plasmid stability and fermentation yield. Furthermore, antibiotic-free fermentation improves the product safety profile and simplifies meeting regulatory requirements, potentially facilitating market entry. This antibiotic-free fermentation technology offers a future-oriented solution for more sustainable biomanufacturing.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

70 | 71


Name › Gilson International BV Deutschland Address/P.O. Box › Innovationspark Wuhlheide, Haus 41, Eingang B Köpenicker Str. 325 Postal Code/City › 12555 Berlin State › Berlin Contact Person › Dr David Rooks Telephone › +44-845-5196-872 Email › sales-de@gilson.com Website › www.gilson.com Social Media › F I  Number of Employees › 700+ Founded (year) › 1957 Areas of Activity › Manual and automated liquid handling solutions Purification solutions Extraction solutions Consumables and service support Biological patent › 750+

Meet Gilson We are Gilson, a third-generation family-owned ­company developing liquid handling, purification, and extraction solutions for the life sciences industry. Since 1957, we have developed innovative products designed to improve the reproducibility and traceability of data, connecting with the scientific community to help researchers achieve verifiable results. Since the introduction of the high-precision PIPETMAN®, Gilson has revolutionised laboratories, providing a range of quality and innovative solutions including systems and modules for HPLC, ­a utomated Solid Phase Extraction, liquid handling ­systems, pipettes, and accessories.

Sustainability and Giving Back From carefully designing our products to be greener, to protecting our environment through small changes in our daily work, sustainability is at the core of what we do. We also maintain a number of initiatives that help us to give back to the amazing scientists in the field and support access to science for all.

Expertise for your Applications Whether you need pipettes, instrument service, or a large process-scale system configured to your specific application, we offer the highest quality life sciences products and services, which can be personalised to your workflow or industry.

Trusted Results Begin with Trusted Liquid Handling Tools Gilson liquid handling tools deliver the precise control you need for sample and reagent volume transfers, ensuring reproducible results, while making life in the lab easier. Beginning with the legendary PIPETMAN® technology, our liquid handling tools have evolved with your needs. Ergonomically designed with scientists like you in mind, we offer durable solutions from manual, single channel units to completely automated liquid handling systems.


GILSON

Verifiable Scientific Results Require Reliable Purification Systems Whether you isolate large or small molecules or need milli­ gram to kilogram purifications, our VERITY® ­purification systems offer you a wide array of components to build the perfect system to meet your specific needs. All systems are easily controlled by intuitive software, ­letting you focus on the science. Backed by Gilson’s long history in chromatography, you can be confident that VERITY ­solutions, backed by Gilson’s long history in chromatography, are built to last and will make your life in the lab easier.

Trusted Solutions for Reliable Extraction From compound isolation in biological, food, or environmental matrices to protein-protein interaction studies, we have the extraction solution you need for consistent, reliable results. From manual to automated solutions, choose from the most comprehensive range of instruments and consumables in the market, that have unmatched reliability. Whether your priority is flexibility, throughput, or footprint, we have a system to fit your solid phase extraction (SPE) workflow. Our ­A SPEC ® systems deliver better yields, reproducibility, and ­accuracy so you can have confidence in your results. For protein-protein interaction studies, the EXTRACTMAN® Magnetic Bead Platform offers a fast and gentle method to isolate protein complexes.

Services that Support You Our dedicated global service, support, and training teams are there to help you maintain the maximum performance of your instruments, make your lab life easier, and ensure the reliability of your data. We ­offer both onsite and mail-in service with fast, efficient turnaround times.

Contact Us Please contact the team at Gilson to discuss your individual requirements at sales-de@gilson.com

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

72 | 73


Name › GKM Gesellschaft für Therapieforschung mbH Address/P.O. Box › Lessingstraße 14 Postal Code/City › 80336 Munich State › Bavaria Contact Person › Daniela Seidl Telephone › +49-89-209120-884 Email › d.seidl@gkm-therapieforschung.de Website › www.gkm-therapieforschung.de Social Media › I Q Number of Employees › 100 Founded (year) › 1981 Areas of Activity › Full-service CRO providing a comprehensive portfolio of CRO services for | Clinical trials and non-interventional studies with pharmaceuticals | Clinical and PMCF studies with medical devices | Value dossier writing and consulting, health economic & outcome research

GKM – your full-service CRO GKM is an independent, family-owned full-service CRO providing a comprehensive portfolio of CRO services since 1981. Our core competencies include studies with medicinal products, medical devices as well as early benefit assessment in the context of AMNOG. With over 1,100 clinical research projects completed and approximately 1.6 million patients across various indications involved, our highly experienced team consults and supports our clients throughout their national or international clinical projects deploying state-of-the-art technology and complying with the very latest standards. As a mid-sized CRO, we are able to respond rapidly, efficiently and flexibly to your unique needs at every stage of your project. We are your strategic partner for the whole clinical development.

Key facts: › Over 1,100 clinical projects › Wealth of experience in a broad range of indications › 100 in-house professionals › Outstanding personnel continuity › High rate of academics and MDs › Your strategic partner for the whole clinical development

International coverage: › DACH: 90 freelance CRAs › World-wide: long term co-operations with our partner CROs

Competence: › Clinical trials and non-interventional studies with pharmaceuticals › Value dossier writing and consulting, health economic & outcome research › Clinical and PMCF studies with medical devices

Services › Concept & Design · Medical & statistical consulting · Feasibility analyses, sample size estimation


GKM

· Study design · Definition of enrolment criteria, selection of ­adequate methods of measurement, patientrelevant endpoints · Literature research, register searches › Preparation & Material · Study protocol / observational plan · (e)CRF concept, patient information, informed consent form · Questionnaires and PROs (electronic or paperbased) · Regulatory & ethics · Site recruitment, selection & contracts › Realization & Support · Data management & cleaning, query management · EDC helpdesk · Coding (performed by MDs) · Interim analyses · Clinical safety & medical surveillance (supervised by MDs) · Monitoring, study-specific trainings · Reimbursement management · Vendor management · Project & budget management · TMF handling › Completion & Publishing · Statistical analysis · Clinical study report and layman summaries · Abstract, poster, presentation · Peer-reviewed publication, publication management · Study registries publishing › AMNOG Services · Dossier strategy · Development of consultation request · Planning and writing of all modules · Training/consulting for and participation in oral hearings

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

74 | 75


Name › glyXera GmbH Address/P.O. Box › Brenneckestraße 20 – ZENIT Postal Code/City › 39120 Magdeburg State › Saxony-Anhalt Contact Person › Dr Erdmann Rapp (CEO & CSO) Telephone › +49-391-6117-251 Fax › +49-391-6117-255 Email › info@glyxera.com Website › www.glyxera.com Founded (year) › 2011 Type of Laboratory › | 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) › glyXprep: Sample preparation kit for glycoanalysis › Tailored standards & kits for glycoanalysis

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

76 | 77


Name › Heidelberg Pharma AG Address/P.O. Box › Gregor-Mendel-Str. 22 Postal Code/City › 68526 Ladenburg State › Baden-Wuerttemberg Contact Person › George Badescu, CBO Telephone › +49-6203-1009-0 Fax › +49-6203-1009-19 Email › bd@hdpharma.com Website › www.heidelberg-pharma.com Social Media › I Number of Employees › 113 Founded (year) › 1997 Areas of Activity › ADC technology External › | Takeda collaborations | Chiome Bioscience | Binghamton University

Novel Therapeutic Approach Heidelberg Pharma is a publicly listed biopharmaceutical company specialised in oncology. The company is the first to use the compound Amanitin found in the death cap mushroom as a novel therapeutic principle for cancer therapies in its Antibody Drug Conjugates (ADCs). These proprietary Antibody Targeted Amanitin Conjugates combine the high affinity and specificity of antibodies with the potency of the cytotoxic small molecule Amanitin for the treatment of cancer.

ATAC technology With its patented proprietar y ATAC technology, ­Heidelberg Pharma is able to use the toxin Amanitin as a payload in ADCs. Amanitin is cross-linked to different antibodies designed to target it to the cancer cell, where it is taken up. There, the Amanitin is released and inhibits RNA polymerase II, which results in programmed cell death, or apoptosis.

Toxin Amanitin with Unique Properties Amanitin has a range of unique properties that can be harnessed to develop highly effective, innovative drugs for cancer therapy: › Novel mode of action with ability to overcome drug resistance › Works in a cell-cycle independent manner: kills dividing and quiescent tumour cells; these dormant cells are associated with metastasis and relapse › Shows high efficacy in high-risk del(17p) tumours › Favourable physicochemical properties – hydrophilic payload

First ATAC candidate in clinical trial Heidelberg Pharma’s first and most advanced development candidate HDP-101 is based on an antibody tar-


HEIDELBERG PHARMA

geting the molecule BCMA on myeloma cells. HDP-101 is currently being tested in a clinical Phase I/IIa trial for the treatment of relapsed or refractory multiple myeloma.

Creating inspired medicines to provide tailor-made and highly effective cancer treatments

Further ATAC candidates are being developed against different targets such as CD37, PSMA or GCC each in the indications non-Hodgkin’s lymphoma, metastatic castration-resistant prostate cancer or gastrointestinal tumours such as colorectal cancer. For the Greater China region, HDP-101 and HDP-103 have been outlicensed to Huadong Medicine as part of a strategic investment agreement.

ATAC collaborations In addition to the development of proprietary therapeutic ATACs, the technology platform is also being applied in research collaborations with partners to create a v­ ariety of new ATAC candidates. Under a licensing agreement, the partners use the ATAC technology to pair the ­antibodies they develop with the new mode of action of Amanitin. Preclinical and clinical development of these ATACs is carried out by the partner. Heidelberg Pharma provides its partners technological support in the manufacture and purification of the conjugates, production and delivery of the compound, as well as the necessary preclinical research related to designing, optimising, profiling, and manufacturing new ATACs for exclusive targets. Furthermore, the company is able to supply the Amanitin-linker material on an industrial scale.

Mission Heidelberg Pharma’s mission is to develop drugs for targeted, tailor-made and highly effective cancer treatments.

heidelberg-pharma.com

Strong partnerships with international pharmaceutical and biotech companies as well as renowned scientific research institutes and medical institutions support this mission and the long-term goal of increasing the company’s success even further. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

78 | 79


Name › HS Diagnomics GmbH Address/P.O. Box › Schlossstrasse 110 Postal Code/City › 12163 Berlin State › Berlin Contact Person › Dr Steffen Hennig Telephone › +49-30-70014-5330 Fax › +49-30-54611-698 Email › hennig@hsdiagnomics.de Website › www.hsdiagnomics.de Number of Employees › 6 Founded (year) › 2012 Type of Laboratory › Molecular Biology Lab Areas of Activity › | Immuno-Oncology | T cell profiling | Immune system | Tumour-reactive T-cells | Tumour antigens Biological Patents › | EP2746405 ‘Methods and primer sets for high throughput PCR sequencing’ | EP3180433 ‘Method for providing tumour-specific T-cells’ | EP3372683 ‘METHOD FOR PROVIDING TUMOR-SPECIFIC T CELLS AND USE THEREOF’ External › | Berlin: Vivantes Clinics, Charité, Collaborations Technical University, MDC | Technical University Wien, Fraunhofer IZI Leipzig, NMI Reutlingen Request for › l Pharmacompanies R&D Further Collaborations l Immunotherapies

Background T lymphocytes play a pivotal role in the control of infections and cancer but also in the pathogenesis of autoimmune diseases. T cell receptors (TCRs) recognise antigenic peptides from any subcellular compartment, presented by HLA-molecules on the surfaces of healthy and diseased cells of virtually all organs. Deep profiles about disease associated TCR repertoires of individual patients are an essential factor for the development of novel diagnostic and therapeutic options. We derive TCR repertoires from fresh specimens, such as blood, inflamed, malignant and healthy tissues as well as from archival samples like cryosections and FFPE-tissues. Our TCR repertoire analyses at population level help to understand mechanisms of disease origin and evolution, at single cell resolution they identify disease related TCRs and make them available for therapeutic interventions, e.g., genetic engineering of TCR-T cells against cancer.

HSDiagnomics is a Berlin-based company founded in 2012. As top expert in T-cell receptor profiling by ultra-deep sequencing, HSDiagnomics provides all tools and services along the complete value chain of advanced immunotherapeutic interventions. Starting from preparation of fresh or archival tissue samples, our TCRsafe® technology produces deep profiles of disease associated TCR repertoires. We use and provide tailored tools for analysis of TCR repertoires at population level and for single T cell clonotype identification. The complete decoding of both TCR chains enables synthesis and cloning of disease related TCRs which can be used for identification of cognate antigens or generation of therapeutic TCR-T cells. In addition to biobanking of tumour material and tissue-infiltrating T cells, we generate and maintain disease-associated TCR-databases and supply all tools and services for analysis. As an example, an in-house developed clustering algorithm applied to the analysis of >100 NSCLC samples has resulted in the identification of tumourspecific TCRs shared between HLA-matched patients. These common TCRs are exciting candidates for an off-the-shelf engineering of TCR-T cells against cancer.


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 mission and portfolio We provide robust and integrated services to explore TCR profiles in yet unprecedented resolution. Customers may send us their samples, or we help to find samples within our clinical networks – the rest of the procedure is with us. Our team of molecular biologists, immunologists, and bioinformaticians delivers TCR profiles comprising thousands of clonotypes characterized base by base. All results are displayed in compact easy to manage tables. TCR repertoires can be compared among intra-project samples or between projects and public databases. We are also well prepared to evaluate the therapeutic value of de-novo identified TCR clonotypes or clusters of common TCRs in contract research projects with industry partners.

Our patented technologies TCRsafe ® is available for human and murine analyses and based on a multistep PCR with proprietary primer sets, which amplify TCR-specific regions directly from genomic DNA or cDNA from fresh or FFPE tissues. TCRsafe® is superior to other technologies since it has an inbuilt contamination protection. We use in-house developed bioinformatics tools for population-based and single clonotype analyses from NGS data. The antigen-agnostic identification of tumour-specific TCRs is our second patent-protected and unique technology. It enables the development of personalized therapies with tumour-reactive TCR-T cells.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

80 | 81


Name › IBA Lifesciences GmbH Address/P.O. Box › Rudolf-Wissell-Str. 28 Postal Code/City › 37079 Göttingen State › Lower Saxony Contact Person › Dr Mike Rothe Telephone › +49-551-50672-0 Fax › +49-551-50672-181 Email › info@iba-lifesciences.com Website › www.iba-lifesciences.com Social Media › I Number of Employees › ~50 Founded (year) › 1996 Type of Laboratory › S1 Areas of Activity › l Protein Production & Assays Biological Patents › l Strep-Tactin®XT l Twin-Strep-tag® External › Numerous in- and out-licensing Collaborations contracts

Strep-tag® – the leading affinity tag in recombinant protein production IBA Lifesciences GmbH is a biotechnology company providing products for life science research in academia and industry. Our proprietary Strep-tag® system enables cloning, expression, detection, purification, as well as further analysis of recombinant proteins. 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 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 ­Strep-Tactin®XT. The range of selectable affinities as well as the reversibility of the binding interaction makes the Strep-tag® the leading affinity chromatography system. 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 lysates of 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. The Strep-tag® technology is compatible with numerous protein classes, e.g. metalloproteins, membrane proteins, and fragile protein complexes with multiple subunits. Additionally, its high tolerance to different buffers and additives promotes its universal applicability.


IBA

The 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. surface plasmon resonance (SPR) analysis or bio-layer interferometry (BLI).

Key features › Highly selective binding properties leading to unparalleled protein purity (> 95 %) › Bioactive target proteins due to rapid one-step purification under target specific conditions › Variability in buffer conditions, e.g. high salts, detergents, metal ions, chelators or reducing agents › Peptide tag with balanced/inert amino acid composition, so the protein structure or activity is not influenced, and removal of tag is not required › Favourable for protein: protein interaction studies due to mild elution conditions and low washing volumes › Universal toolbox including products for cloning, purification, and analytical applications (ELISA, FACS, SPR, Microscopy, Western Blot, etc.)

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

82 | 83


Name › ibidi GmbH Address/P.O. Box › Lochhamer Schlag 11 Postal Code/City › 82166 Gräfelfing State › Bavaria Contact Person › Dr Susanne Seifert Telephone › +49-89-520-46-17-0 Fax › +49-89-520-46-17-59 Email › info@ibidi.de Website › ibidi.com Social Media › F I I  Number of Employees › 115 Founded (year) › 2001 Type of Laboratory › S1 Areas of Activity › Functional (phenotypic) cell-based assays Systems that simulate the native environment for analyzing living cells Cell biochips, reagents, and equipment for analyzing living cells Biological patent › More than 25 patent families (around 110 documents)

ibidi ® GmbH is a leading supplier of functional cellbased assays and advanced products for cell microscopy. Based in Gräfelfing, near Munich, ibidi develops cutting-edge solutions for classic cell culture, as well as complex assays. The ibidi products, sold worldwide to customers in scientific institutions, industrial pharmacology, and biotechnology, help researchers understand the mechanisms behind various diseases, leading to the development of novel therapies. In 2001, ibidi GmbH was founded as a spin-off from the Technical University Munich and the Center for Nanoscience at the Ludwig-Maximilians-University Munich. The primary business idea was to produce microfluidic cell chambers for microscopy. With unique cell biochips made from high-performance polymers, ibidi has pioneered the use of plastic as a material for bio-slides to simulate an organ-like environment. Over the past 22 years, ibidi has managed to become the leading international provider of disposables for cell-based microscopy assays – a fact that has been acknowledged in more than 30,000 publications. Among many other awards, ibidi received the Export Award Bavaria 2021 for its excellent crisis strategy during the Corona pandemic. ibidi puts great importance on regionality. Their entire value chain takes place at one location – from research, invention, product development and production, to sales, marketing, and administration. ibidi is ultimately dedicated to maintaining health and improving the quality of life. The company also takes its employees’ well-being seriously. In 2023, they won the German bAV Award for their innovative retirement plan. The ibidi R&D team is comprised of physicists, chemists, and biologists with extensive experience in cell biology, surface chemistry, and fluidics. Their collective knowledge enables them to work together to create a variety of specialized slides and instruments, along with integrated systems.


IBIDI

Products and applications ibidi puts a special emphasis on simulating physiological processes of endothelial cells in blood vessels for studying arteriosclerosis and hypertension. Additionally, ibidi focuses on investigating anti-angiogenic effects of drugs that combat solid tumours. The ibidi product lines include various µ-Dishes, µ-Slides, and µ-Plates for the culture and high-resolution microscopy of cells, as well as solutions for functional cell-based assays for analysing angiogenesis, chemotaxis, wound healing, and cells under flow. The high optical quality of the ibidi labware enables the use of high-end imaging techniques, such as phase contrast, DIC, confocal, and super-resolution microscopy. Additionally, ibidi develops and produces instruments, including stage top incubators for live cell imaging under physiological conditions, and a unique perfusion system that provides continuous flow for blood vessel simulation. ibidi has always been on the forefront of technology, and their specialized slides combined with Collagen I create solutions for 3D cell culture applications. Micropatterning – the latest ibidi technology innovation – allows for spatially defined cell adhesion in 2D and 3D. Finally, ibidi offers reagents for cell microscopy and software for manual and AI-based automated image analysis.

Intellectual property ibidi currently holds more than 25 patent families (23 patents granted in the EU, 16 granted in the USA, and 3 granted in other countries). Over 15 applications are currently pending.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

84 | 85


Name › IDT Biologika Address/P.O. Box › Am Pharmapark Postal Code/City › 06861 Dessau-Rosslau State › Saxony-Anhalt Contact Person › Antje Seidler Telephone › +49-34901-8850 Email › info@idt-biologika.com Website › www.idt-biologika.com Social Media › F I  Number of Employees › 1,800+ Founded (year) › 1921 Areas of Activity › Contract Development and Manufacturing of Innovative Vaccines, Cell & Gene Therapeutics, and Sterile Injectables

About IDT Biologika IDT Biologika is a global contract development and manufacturing organisation that specialises in the production of innovative vaccines, cell & gene therapeutics, oncolytic viruses, and viral vectors for sterile liquid and lyophilised products. The company combines a more than 100-year-old tradition in vaccine research and production with maximum expertise and state-of-theart technology.

Our services We offer our clients a one-stop shop, with seamless end-to-end solutions and the ability to nimbly scale projects from development through to commercialisation. This includes process development and validation, drug substance manufacturing up to BSL-2, fill-finish, labelling & packaging, quality control & analytics for clinical and commercial batches. At our clients’ request we supply their products in vials, pre-filled syringes (with and without safety devices), autoinjectors, or as combination products.

Our sites At our headquarters in Germany, IDT Biologika operates one of Europe’s premiere integrated facilities for end-to end services from process development through clinical Phases I–III to commercial contract manufacturing. In Rockville, MD, USA we utilise broad capabilities and a depth of technologies for process development and manufacturing of clinical trial material for vaccines and cell & gene therapeutics for Phases I-II.

Our expertise Our fully integrated services are underscored by our commitment to quality and the operational excellence that flows through our best-in-class process and cGMP (up to BSL-2) manufacturing capabilities, meeting FDA, EMA, and ANVISA standards.


IDT BIOLOGIK A

Many human vaccines developed by IDT Biologika, together with international partners, are already in use, fighting infectious diseases such as COVID-19, tuberculosis, AIDS, malaria, dengue, and ebola. Our mission is to accelerate the development and flexible manufacturing of vaccines and cell & gene therapeutics, supporting our global healthcare partners and benefiting patients worldwide.

Our Technology Excellence Building on our industry leading knowledge of virus and viral vectors, IDT Biologikas next generation platforms expand on successful partnerships with clients. Having produced one of the first commercial cell & gene products approved by EMA and FDA, we strive to bring the next generation of therapeutics to market. With our cutting-edge technolgy, we are also a sustainable partner in commercial manufacturing of our clients sterile injectable products.

Own seed cell banks › Development and qualification of own seed cell banks for Vaccine & Gene Therapy manufacturing › GMP-compliant cell lines to accelerate process timelines and project start · HEK293 cell line · VERO cell line · DF-1 cell line

Viral Vector Expertise › MVA Know-How IDT Biologika is considered the global leader in MVA (Modified Vaccinia Ankara) and recombinant and non-recombinant poxvirus technologies and aseptic processing. › AAV- and Lentivirus Platform Our Adeno-associated virus and Lentivirus platforms allows us to produce cell & gene therapeutics of our clients, unlocking healing capabilities and offering hope to patients with previously untreatable conditions. Please contact us for further information. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

86 | 87


Name › Immunic Therapeutics Address/P.O. Box › Lochhamer Schlag 21 Postal Code/City › 82166 Gräfelfing State › Bavaria Headquarter › New York City, USA Contact Person › Jessica Breu (Head of IR and Communications) Telephone › +49-89-2080477-09 Email › info@imux.com Website › www.imux.com Social Media › F I Q  Number of Employees › 80 Founded (year) › 2016 Areas of Activity › l Immunology l Chronic inflammatory and

Immunic (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered small molecule therapies for chronic inflammatory and autoimmune diseases. Vidofludimus calcium (IMU-838) is being developed as a next generation treatment option for patients with multiple sclerosis (MS) and other chronic inflammatory and autoimmune diseases. IMU-856 has recently demonstrated clinical proof-of-concept in celiac disease patients and may represent a completely new treatment approach, as the mechanism of action targets the regeneration of bowel wall architecture and restoration of intestinal barrier function, while maintaining full immunocompetency, in patients suffering from gastrointestinal diseases. IMU-381, currently in preclinical testing, is a next generation molecule specifically addressing the needs of gastrointestinal diseases.

autoimmune diseases

Vidofludimus calcium addresses multiple drivers of neurodegeneration in MS

External › l Ludwig-Maximilians-University (LMU) Munich, Germany: Department Collaborations of Pharmacy: Prof. Dr Daniel Merk l City of Hope Duarte, California, USA: Department of Molecular Imaging & Therapy, Research in Cancer and Immunity, Mechanisms Controlling T-cells: Prof. Zuoming Sun, Ph.D. l Universitätsklinikum Erlangen, Germany: Institute of Clinical and Molecular Virology: Prof. Dr Manfred Marschall

Immunic’s lead development programme, vidofludimus calcium, is an orally available, next-generation selective immune modulator that acts as a potent, first-in-class nuclear receptor related 1 (Nurr1) activator, in addition to its known mode of action as a dihydroorotate dehydrogenase (DHODH) inhibitor. Nurr1 is a neuroprotective transcription factor and an emerging target in neurodegenerative diseases. Vidofludimus calcium is currently being investigated in the twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS) and in the supportive Phase 2 CALLIPER trial in progressive multiple sclerosis (PMS), which is designed to corroborate the drug’s neuroprotective potential. Data from an interim analysis of the ENSURE programme is expected in late 2024; the read-out of the first ENSURE trial by the end of 2025. Interim biomarker data for the CALLIPER trial is expected for the fall of 2023, while the top-line data is expected for April of 2025.

Triple effect: Anti-inflammatory, anti-viral and neuroprotective Immunic believes that vidofludimus calcium has the potential to demonstrate medically important advantages versus currently approved MS treatments, due to its


IMMUNIC THERAPEUTICS

combined anti-inflammatory, anti-viral and neuroprotective properties as well as its favourable safety and tolerability profile. The molecule has a targeted effect on hyperactive immune cells without suppressing the normal immune function. It also showed a robust MRI lesion suppression and initial signals for improved rates of confirmed disability worsening in Phase 2 clinical testing, while also decreasing serum neurofilament light chain (NfL), a biomarker for axonal damage. The broad-spectrum antiviral effect of vidofludimus calcium may support lowering the rate of viral infections and reactivations, including Epstein-Barr virus (EBV) reactivation, potentially resulting in slowing EBV-related neurodegenerative processes. In clinical testing, so far, vidofludimus calcium-treated MS patients also showed low discontinuation rates, which indicates an encouraging combination of tolerability and efficacy as well as maintenance of normal quality-of-life. Based on exposure in more than 1,400 humans and with treatment durations of up 4 years, the absence of any hepatotoxicity signals and other relevant adverse events underlines the promising safety and tolerability profile.

IMU-856: Restoring a healthy gut by renewal of the gut wall IMU-856 is an orally available and systemically acting small molecule modulator that targets Sirtuin 6 (SIRT6), a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium. In 2023, Immunic announced positive results from the part C portion of a Phase 1 clinical trial in patients with celiac disease. IMU-856 demonstrated positive results in four key dimensions of the disease’s pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption. IMU-856 was also observed to be safe and well-tolerated in this trial. Immunic believes that this data set provides initial clinical proof-of-concept for an entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of bowel architecture.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

88 | 89


Name › Indivumed GmbH Address/P.O. Box › Falkenried 88 – Bldg. D Postal Code/City › 20251 Hamburg Country › Hamburg Contact Persons › Prof. Dr med Hartmut Juhl (CEO) Telephone › +49-40-4133-83-0 Fax › +49-40-4133-83-14 Email › info@indivumed.com Website › www.indivumed-therapeutics.com Social Media › I Number of Employees › ~100 Founded (year) › 2002 Type of Laboratory › S2, S1 Areas of Activity › Service and partnering in the field of personalised cancer medicine; international standardisation of tissue, blood and clinical data collection in a network of cancer clinics in Europe, North ­America and Asia; multi-omics analysis of cancer tissue combining WGS with ­proteomics, phospho-proteomics, whole transcriptomics and immunophenotyping; data analysis using bioinformatics, artificial intelligence and ­disease models. Target and biomarker discovery and development. External › Indivumed has developed a unique Collaborations collaborative network with leading cancer clinics in Europe, Asia, North and 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 A*STAR 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.

Moving precision oncology forward Indivumed Therapeutics is a global oncology company with a focus on bioinformatics and multi-omics data driven R&D. Our vision is a world in which individual therapeutic treatments exist for every cancer patient. With this goal in mind, we enhance R&D activities and launch new discovery programmes, providing expertise, capabilities and insight knowledge throughout the cancer drug development process. Through a global network of selected partner clinics, we have created and maintain a unique database of proprietary multiomics and clinical data sets that reflect the molecular reality of cancer at an unparalleled level. By combining these proprietary data sets with AI-assisted analytics, we drive cancer biomarker discovery as well as target identification and validation for novel therapies.

Highest quality biospecimens make all the difference The basis of our activity is a strict clinical standard, to which we adhere for the past 20 years. Biospecimen and associated data quality is crucial to making all relevant details of a cancer disease transparent. To ensure this, our global clinical partners apply numerous detailed standard operating procedures (SOPs) to the collection and processing of biospecimen and corresponding clinical data, achieving an ischemia time for tissue of ≤10 minutes and covering around 320 individual data points. We have developed and refined these procedures through years of experience working alongside surgeons and pathologists in our network.


INDIVUMED

Unravelling cancer with AI-powered advanced analytics The high quality of our biospecimens allows us to use a full multi-omics approach. Using next-generation sequencing and mass spectrometry technologies, we extract the deepest possible molecular information from tissue samples to feed our comprehensive cancer database. This is where our powerful discovery and validation platform nRavel ® comes into play. Via this platform, we utilise the power of artificial intelligence to unravel the complexity of cancer and identify useful correlations within the vast amounts of data.

Matched patient cases and cancer models across the drug development pipeline Our expertise benefits pharmaceutical and biotech companies with whom we partner in various areas. We cover the entire drug development pipeline, ranging from target identification and validation to the support of the optimisation of clinical study designs. In order to achieve end-to-end comparability and thus the most accurate results possible, we use matched cases throughout all our in silico and in vitro workflows. As an example, we perform target validation with 2D and 3D cell models derived from similar tissue used in the target identification process. It is this level of comparability, combined with the superior quality of our data, that makes our approach unique in the industry.

‘At Indivumed, we are united by a shared responsibility – using our unique expertise and skill sets to work towards individualised cancer diagnosis and treatment for every patient.’ Prof. Dr Hartmut Juhl, Founder and CEO

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

90 | 91


Name › iOmx Therapeutics AG Address/P.O. Box › Fraunhoferstr. 22 Postal Code/City › 82152 Martinsried State › Bavaria Contact Person › Dr Apollon Papadimitriou Telephone › +49-89-8999-7090-0 Email › info@iomx.com Website › www.iomx.com Social Media › I Number of Employees › 49 Founded (year) › 2016 Areas of Activity › | Next-generation cancer immunotherapies | Drug development | Immuno-oncology

First-in-class drugs targeting cancer immune evasion iOmx Therapeutics AG is a clinical stage company founded in 2016, with the goal of developing first-inclass, next-generation cancer immunotherapy drugs against novel tumour or tumour-associated myeloid cell-expressed immune checkpoints. Currently, immune checkpoint inhibitory drugs targeting the CTLA-4, PD-1 or PD-L1 pathways have emerged as the treatment of choice in many tumour indications. However, they still fall short of meeting the needs of most cancer patients, primarily due to inherent, nonredundant resistance mechanisms of tumours against immune cell attack.

Identifying next-generation immune checkpoints with iOTarg™ iOmx uses its proprietary iOTarg™ target screening platform, a systematic approach, to identify disease relevant and novel immune checkpoint targets in cancer models, refractory to PD-L1 inhibition. iOTarg™ already has been applied to pairs of tumour samples and tumour-infiltrating lymphocytes, resulting in the identification of a variety of novel targets, which show stronger inhibition of T cell-mediated killing compared to classical PD-L1. Additionally, the platform has been expanded to a complex three-cell type screening system and includes now also myeloid cells leading to the identification of myeloid-expressed immune checkpoints, the neutralisation of which restores T-cell function and ultimately could lead to immune rejection of tumours.

Pipeline of novel cancer immune-checkpoint inhibitors iOmx is advancing a clinical stage pipeline of immuno­ therapy candidates to potentially treat patients with tumours resistant to conventional immunotherapies.


IOMX

The company’s lead candidate OMX-0407 is an oral SIK inhibitor that sensitises tumour cells to the effects of immune-derived tumour necrosis factor. In preclinical studies, the kinase inhibitor potentiates death receptormediated apoptosis and shows strong tumour inhibition along with re-polarisation of the tumour microenvironment towards an anti-tumour phenotype. OMX-0407 has shown single-agent activity in cancer models and is currently being investigated also in combination treatment. A clinical trial is currently underway to evaluate OMX0407 as a monotherapy in patients with advanced solid tumours. The trial will characterise the safety, tolerability, pharmacokinetics and pharmacodynamic activity of OMX-0407 in a dose-escalation arm, transitioning rapidly and seamlessly into dose expansion cohorts in selected tumour indications. Key focus is on establishing clinical proof-of-concept and finding a biomarker gene signature. The most advanced antibody programme, IMT-26/27, targets two key immune-suppressive receptors expressed on myeloid cells and other immune cells. Both targets share high structural homology in their ligand-interacting domains and are members of a family that includes both immune-inhibitory and immune-activating receptors. In a dual-targeted approach, iOmx has generated a fully human, cross-specific, high-affinity, ligand-blocking anti­ body that simultaneously neutralises both IMT-26 and IMT-27, while sparing other related immune-activating family members. The dual-targeting of IMT-26 and IMT-27 results in a broad anti-tumour immune response involving recovery of the tumour microenvironment and activation of T cells. The IMT-26/27 programme is on a fast track to IND/CTA, enabling initiation of clinical development.

Summary iOmx Therapeutics focuses on developing next-generation immunotherapies with monotherapy potential for cancer patients currently failing to benefit from existing therapies. With its systematic screening approach, ­iOTargTM, the company uncovers novel immune evasion pathways in tumour and tumour-associated myeloid cells and drives a clinical-stage pipeline of drug candidates. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

92 | 93


Name › ITM Isotope Technologies Munich SE Address/P.O. Box › Lichtenbergstrasse 1 Postal Code/City › 85748 Garching / Munich State › Bavaria Contact Person › Dr Konstantin Zhernosekov Telephone › +49-89-329-8986-6000 Fax › +49-89-329-8986-6061 Email › businessdevelopment@ itm-radiopharma.com Website › www.itm-radiopharma.com Social Media › I Number of Employees › more than 550 Founded (year) › 2004 Type of Laboratory › Radiopharmaceutical biotech company Areas of Activity › | Oncology | Precision Medicine | Targeted Radionuclide Therapy | Nuclear Medicine

Targeted radiodiagnostics and therapeutics for cancer treatment ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiomolecular precision therapeutics and diagnostics for hardto-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including two phase III studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. Targeted Radionuclide Therapy or Radiopharmaceutical Therapy (RPT) is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. In contrast to conventional external radiotherapy, Targeted Radionuclide Therapy is defined by the intravenous infusion of a radiopharmaceutical. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics, like receptors on the tumor cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, thereby destroying the tumor. The highly precise localization enables targeted treatment with minimal impact to healthy surrounding tissue. Often, the targeting molecule can be used in a “theranostic” approach for both therapeutics and diagnostics. For diagnosis, the targeting molecule is linked with a diagnostic radioisotope, for therapy with a therapeutic radioisotope. This allows tumors and metastases to be both precisely localized at an early stage, and subsequently treated following the same mechanism.


ITM

ITM is developing a proprietary portfolio and 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, prostate cancer, as well as folate receptor α positive tumors like lung, ovarian or breast cancer. To validate the Targeted Radionuclide Therapy approach, efficacy and safety of the lead candidate n.c.a. 177Lu-edotreotide is currently being compared to standard treatments for patients with neuroendocrine tumors of gastroenteric or p ­ ancreatic origin in two Phase III clinical trials, ­COMPETE & ­COMPOSE. The unique combination of ITM’s longstanding expertise, high-quality radioisotopes and global supply network enables ITM to develop new Targeted Radionuclide Therapy based treatment options for hard-to-treat cancer indications. ITM strives to positively impact the treatment algorithm currently in place for solid tumors and make a tangible impact in improving the treatment outcomes and lives of cancer patients. For more information about ITM, please visit: www.itm-radiopharma.com

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

94 | 95


Name › KNAUER Wissenschaftliche Geräte GmbH Address/P.O. Box › Hegauer Weg 38 Postal Code/City › 14163 Berlin State › Berlin Contact Person › Dr Markus Fuchs Telephone › +49-30-8097270 Fax › +49-30-8015010 Email › sales@knauer.net Website › www.knauer.net Social Media › F I I  Number of Employees › 190 Founded (year) › 1962 Type of Laboratory › Research & Development; Applications Lab Areas of Activity › | Lipid nanoparticle production systems | Fast Protein Liquid Chromatography (FPLC) | Multi-column chromatography continuous simulated moving bed (SMB) chromatography | Analytical HPLC and UHPLC | Preparative HPLC | High pressure dosing | Osmometry

The Berlin-based company KNAUER has been serving the sciences since 1962. With 190 highly qualified employees, 40% of whom are women, the company develops and produces high-tech laboratory instruments of the highest precision and quality, focusing on liquid chromatography (LC) systems and their components. HPLC and UHPLC systems can be used, for example, to analyse samples for ingredients and impurities and to determine their quantities. LC systems are also applied for the purification of active pharmaceutical ingredients (preparative HPLC) and proteins (FPLC). KNAUER’s valves, pumps, detectors and other components are also used for various tasks such as high-pressure dosing and various flow-through detection tasks. Engineering services in laboratory equipment design are a mainstay of growing importance for KNAUER: The latest development - production equipment for the manufacture of drug-loaded lipid nanoparticles (LNP) - has been successfully used for the global production of mRNA corona vaccines. We support technological progress today and in the future. “Science with Passion”

Main areas of expertise: › Lipid nanoparticle production systems › Fast Protein Liquid Chromatography (FPLC) › Preparative HPLC › Analytical HPLC and UHPLC › Multi-column chromatography – simulated moving bed (SMB) chromatography › High-pressure dosing › Osmometry


KNAUER

Markets KNAUER laboratory instruments and components are used worldwide in laboratories for research and development, quality control and production. Customers include government institutions, industrial companies and numerous universities. The main areas of application are in chemical, pharmaceutical, life science and food research (analysis and purification) as well as in the environmental sector. With its lipid nanoparticle production systems, KNAUER is supplying the field of pharmaceutical production and research.

Responsibility KNAUER develops and produces almost the complete range of measuring instruments at its headquarters in Berlin. The products are distributed to more than 60 countries via a worldwide dealer network, whose members are regularly trained in Berlin. Alexandra Knauer, who runs the company together with Carsten Losch, attaches great importance to sustainability and corporate responsibility both towards employees and towards the environment and society. Environmental management according to ISO 14001, efficient products, green electricity and its own solar power plant are just a few examples. KNAUER is certified according to ISO 9001 and ISO 13485 and ensures the highest quality “Made in Germany” with strict manufacturing and process control.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

96 | 97


Name › KUPANDO GmbH Address/P.O. Box › Willy-Brandt-Platz 2 Postal Code/City › 12529 Schönefeld State › Brandenburg Contact Person › Dr Johanna Holldack (CEO), Angelika Leppert (CFO) Telephone › +49-30-5200586020 Email › contact@kupando.com Website › www.kupando.com Social Media › I Number of Employees › 3, plus extended team of experts Founded (year) › 2018 Areas of Activity › Fighting Cancer and Infectious Diseases

KUPANDO is a pioneering Berlin-based biopharmaceutical company developing TLR 4/7 agonists that stimulate innate immunity.

Our Mission is … › to provide not only a safe but also affordable immuno­ therapy for cancer patients, and › to develop immunostimulatory agents with the means to prevent infectious diseases.

Drug candidates Kupando develops innovative drug candidates – TLR 4/7 agonists – that target Toll-Like Receptors (TLRs), which are responsible for the detection of cancer and infection signature molecules and for the subsequent activation of the innate immune system. The TLR 4 and TLR7 ligands, which can be produced in a cost-effective fashion, provide a variety of options for administration routes and applications.

A multitude of possiblities The proprietary drug candidates are ideally suited for the systemic treatment of solid tumours (tissue agnostic), the prevention of infectious diseases, and as vaccine adjuvants.

Single agent or combinations In oncology, Kupando’s lead candidate KUP101 has the potential to be used as a stand-alone treatment for solid tumours or in combination with other drugs. In vivo studies have demonstrated a synergistic/additive effect with checkpoint inhibitors.

Advantageous features › High specificity for target › No relevant off-targets › High potency and therefore low dose › Antigen-sparing effect › Fast intracellular uptake and therefore improved safety

First-in-class encapsulated small molecules Kupando’s drug candidates are the only TLR 4/7 agonists in development. Proof-of-concept data have been


KUPANDO

confirmed in vitro and in multiple animal experiments, as well as in independent research units. IND-enabling work is ongoing for the treatment of solid tumours and the prevention of infectious diseases.

The purpose of an innate immune stimulator is to initiate an adaptive immune response If a tumour has few infiltrating dendritic cells and B cells, however, a TLR 7 agonist alone may not be a sufficient stimulant. KUP101’s co-encapsulated formulation, which provides additional co-localised TLR 4 agonists, causes local cytokine and chemokine release, especially from the endothelial cells that line the abundant micro vessels that penetrate tumours. In turn, this leads to the recruitment of more dendritic cells and B cells from the blood stream to the tumour, thereby initiating a CD8 cytotoxic immune response.

Both TLR 4 and TLR 7 are validated targets TLR 4 is the target of MPLA, a vaccine adjuvant. TLR 7 is the target of Imiquimod, a drug used to treat bladder cancer, actinic keratosis, basal cell carcinoma, and HPV-induced epithelial lesions.

Management Kupando is led by a management team with a wealth of international biotech and pharma experience gained in both Europe and the US in the fields of immunology, infectious diseases, and oncology. With over 100 drug development projects and a huge variety of transactions under its belt, our team brings extensive expertise in business and drug development, including manufacturing, non-clinical and clinical development of vaccines and drugs, as well as regulatory pathways in Europe, the US, and Asia.

Investors Kupando raised €13 million in a Series A funding round in 2022. The investment was led by Remiges Ventures and co-led by Life Care Partners, with an additional investment by Brandenburg Kapital, High-Tech Gründerfonds, Ventura Biomed Investors, and undisclosed family offices. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024

98 | 99


Name › KyooBe Tech GmbH Address/P.O. Box › Max-Lang-Straße 56/1 Postal Code/City › 70771 Leinfelden State › Baden-Wuerttemberg Contact Person › Dr Andrea Traube Telephone › +49-711-252-785-01 Email › andrea.traube@kyoobe.tech Website › www.kyoobe.tech Social Media › I Number of Employees › 20+ Founded (year) › 2019 Areas of Activity › Special Engineering and Biotechnology External › Strongly cooperating with Bausch + collaborations Ströbel and the Fraunhofer Society Request for › We are open to further collaborations! Further Collaborations

KyooBe Tech is a special mechanical engineering company focusing on biotechnological applications. Founded in 2019 as a corporate start-up of the Bausch+Ströbel group, KyooBe Tech develops and commercialises innovative pharmaceutical production technologies, such as pathogen inactivation and cell and gene therapy manufacturing. Our first product line, INACTIVATE, aims to inactivate pathogens with low-energy electron irradiation. The main applications of INACTIVATE are in vaccine production and for processes ranging from selective degradation to the complete inactivation of infectious pathogens. Other potential applications include media preparation, sterilisation of pharmaceutical effluents, sample processing, and even cell therapeutics. Since 2022, KyooBe Tech has successfully been operating a test platform in the Stuttgart metropolitan region. On this basis, further research is now being carried out to optimise the process parameters for individual product irradiation applications. The first systems for lab-scale applications will be available on the market in 2024. In the second product line, MOSAIC, the mission is to revolutionise personalised cell and gene therapy manufacturing approaches. The goal is to make these therapies more rapidly available and easier to manufacture, and also to drastically reduce costs. Using state-of-the-art robotics and parallel process flows, MOSAIC generates new ways of serving individual patients. The core of this innovative system is a modular machine concept, which can perform all the process steps of cell therapy manufacturing in small, enclosed units. This includes cultivation and manipulation steps that require a sterile environment. Cell cultures can be processed in parallel, which makes the system highly scalable and efficient for the industrial production of small-batch-sized products.


K YOOBE TECH

Both key product lines use a platform-based approach that can be adapted flexibly and serve different uses. KyooBe Tech embodies a customer-centered culture fuelled by a young, interdisciplinary team. We have a strong vision for the future, and our first step is to get key customers on board. Currently, we are actively looking for interested project partners to target relevant ­challenges in the pharmaceutical industry. With both of our future-oriented projects, KyooBe Tech will open up new business fields and shape the future of pharmaceutical manufacturing.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 100

| 101


Name › Lonza Cologne GmbH Address/P.O. Box › Nattermannallee 1 Postal Code/City › 50829 Cologne State › North Rhine-Westphalia Contact Persons › Dr Karl Clasen Gerhard Muster Telephone › +49-221-99199-0 Fax › +49-221-99199-111 Email Address › Info.cologne@lonza.com Internet Website › https://bioscience.lonza.com Social Media › F I  Number of Employees › 125 Founded (year) › 1998 Type of Laboratory › S1/S2 Areas of Activity › | BioAssay Products and Services | Electrophoresis and Analysis | Mycoplasma Detection and Prevention | Pluripotent Stem Cells | Primary Cells and Media | Transfection | QC Testing Solutions

Lonza is a preferred global partner to the pharmaceutical, biotech, and nutrition markets. Our business provides a wide range of products and services spanning early-phase discovery to custom development and manufacturing of active pharmaceutical ingredients and innovative dosage forms. With our scale and resources, we offer a one-stop solution to our customers so they can help people get well, feel well, and stay well. Founded in 1897 in the Swiss Alps, Lonza is now a global company with more than 30 sites and approximately 17,500 full-time employees. One of our four Divisions, the Lonza Cell & Gene Division, provides the biotech market with CDMO services as well as tools for life sciences researchers to develop, test, and manufacture therapies. Lonza’s Bioscience portfolio ranges from cell culture and discovery technologies for research to quality control tests and software for biomanufacturing.

Research tools for biologically relevant results Lonza provides a range of solutions for working with human and animal primary cells. Primary cells more accurately reflect the condition and behaviour of cells within an organism compared to commonly used laboratory cell lines, making them important model systems for both basic and clinical research. At the BioCampus in Cologne, Lonza Bioscience develops and markets the Nucleofector ® Technology, a non-viral gene transfer solution for primary cells and hard-to-transfect cell lines. Introduced in 2001, the Nucleofector ® Technology has continually evolved through innovation. Our current portfolio comprises the 4D-Nucleofector ® Platform and the HT Nucleofector ® System, which enable transfection of hard-to-transfect cells in various formats and scales, with cell numbers ranging from 2 x 104 to 1 x 10 9 cells per reaction, and throughput ranging from a single reaction up to 384 reactions per experiment.


LONZ A COLOGNE

Lonza Biosciences also offers a comprehensive portfolio of high-quality human and animal primary cells and cell culture media for a variety of research applications throughout the drug discovery value chain. By providing primary cells and media that are pre-qualified, we help customers to reduce the time and money spent on evaluating primary cells for specific laboratory experiments.

Increase efficiency in your QC microbiology lab Lonza’s wide range of pyrogen and endotoxin testing solutions helps customers efficiently meet regulatory requirements for the safety of all injectable drugs and implantable medical devices. In 2023, Lonza expanded its QC instrumentation portfolio with the Nebula ® Absorbance Reader and Nebula ® Multimode Reader. Powered by a new version of WinKQCL® Software, these readers, as well as our PyroTec ® PRO Automated Robotic System, meet data integrity requirements and help to streamline QC laboratory workflows. Lonza also offers a range of endotoxin tests that deliver premium testing performance, from our absorbance-based endotoxin assays – the ­PYROGENT®-5000 Kinetic-Turbidimetric LAL Assay and the Kinetic-QCL® Kinetic-Chromogenic LAL Assay – to our sustainable recombinant PyroGene® rFC Assay for fluorescence-based endotoxin detection. The recent launch of the PeliKine human IL-6 Rapid ELISA Kit enhanced the classic PyroCell® Monocyte Activation Test (MAT) System and the new PyroCell® MAT Human Serum System, offering customers an improved testing protocol that increases the speed, simplicity, and efficiency of rabbit-free endotoxin and non-endotoxin pyrogen testing.

25 RD GUIDE TO GERMAN BIOTECH COMPANIES 2024 102

| 103


Name › metabion international AG / metabion GmbH Address/P.O. Box › Semmelweisstr. 3 Postal Code/City › 82152 Planegg State › Bavaria Contact Person › Diana Yulafci Telephone › +49-89-899-363-0 Email › info@metabion.com Website › www.metabion.com Social Media › I Number of Employees › 70 Founded (year) › 1997

metabion is a leading global manufacturer of custom nucleic acids. Since 1998, metabion has been providing academic research, pharma & biotech development, and genetic/diagnostics testing with a wide range of synthetic DNA/RNA-based compounds, consistently delivering high-quality products and related services. Synthetic nucleic acids and derivatives are key components of genetic R&D activities, as well as general and personalised medicine approaches acting as highly specific diagnostic agents or as active pharmaceutical ingredients. Successful translation of highest quality standards into daily practice is metabion’s business philosophy.

Areas of Activity › Small-, mid- and large-scale oligonucleotide components for in vitro diagnostics (ASRs) as well as ss and ds DNA/RNA Nucleic Acids and derivatives thereof for R&D and therapeutic applications (GMP grade)

metabion’s highly professional team is dedicated to understanding, anticipating, meeting, and ideally exceeding market requirements and quality standards by diligently listening to customers’ needs. Applied and certified quality standards are ISO 9001:2015, ISO 13485:2016 and EXCiPACT® GMP/GDP:2021.

Custom Third Party and OEM Services: Contract Manufacturing & Kitting in the Diagnostics and RUO space

metabion operates two state-of-the-art manufacturing sites in greater Munich: › Headquarter in Planegg – dedicated to small scale R&D oligos and ds gene fragments (m-blocks) 1.300m². › Newly built facilities in Kirchheim b. München - dedi­ cated to small scale diagnostic to mid/large scale R&D/IVD/therapeutic oligos. 1,800 m². Dedicated to enhance scientific progress and support diagnostic and therapeutic solutions, metabion has been continuously expanding its portfolio of tailor-made products and services.

Scale and Scope of metabion’s Diagnostic Oligonucleotide Manufacturing › Small- mid, and large scale IVD ISO 13485 compliant production of primers & probe (dlps and dqps) or differently labelled probes. › Supporting a vast range of modifications including a fully-fledged portfolio of reporters and quenchers as well as Tm increasing moieties including but not limited to LNA, MGB, and ZNA modifications.


METABION

› Best suited to provide CMO services to Biotech and Pharma clients from assay development to commercialisation.

Therapeutic Oligonucleotide Manufacturing › GMP manufacturing of oligonucleotide-based (pharmaceutical) additives and APIs – small, mid- & largescale including Design of Experiment (DOE) and process characterisation & process validation. › Manufacturing capacities ranging from mg to several hundreds of grams including scale-up & process transfer. › Best suited to provide CMO services to Biotech and Pharma clients from lead discovery & optimisation to pre-clinical development into clinical phase I and II. › Supporting manufacturing requirements of most of the prevalent types of therapeutic oligonucleotides like · CpG oligonucleotides – excipients/adjuvants · Antisense oligonucleotides (ASOs) · siNAs · miRNAs · sgRNA · Aptamers · Oligonucleotide-peptide/lipid/sugarconjugates

R&D Oligonucleotide and Gene Fragment Manufacturing › “Oligonucleotide boutique” with most complete standard portfolio (ss and ds DNA/RNA, single tube/ plates, low/medium/high throughput, modifications). › “Very special” oligo manufacturing capabilities upon inquiry. › ds gene fragments (m-blocks) up to 3kb upon inquiry.

Custom Third Party and OEM Services/Contract Manufacturing and Kitting › custom synthesis of DNA/RNA oligonucleotides. › custom formulations and aliquotations/replications in tube or plate formats. › custom filling of diagnostic assay components › custom labelling of kit components and complete kit assembly. › custom logistics including drop-shipping to your customers including application programming interface for integration with your customers’ ordering and billing systems. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 104

| 105


Name › Mettler-Toledo GmbH Address/P.O. Box › Ockerweg 3 Postal Code/City › 35396 Gießen State › Hesse Contact Person › Carmen Wiederuh Telephone › +49-641-507401 Email Address › Carmen.Wiederuh@mt.com Internet Websites › www.mt.com www.mt.com/global/en/home.html Social Media › F I  Number of Employees › ~18.000 (2022) 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


MET TLER 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 PipetteX 4.0 asset management software covers the customer along almost the entire workflow – 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 pipette’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.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 106

| 107


Name › Microcoat Biotechnologie GmbH Address/P.O. Box › Am Neuland 3 Postal Code/City › 82347 Bernried State › Bavaria Contact Person › Dr Ingrid Wanninger (Business Development) Telephone › +49-8158-9981-0 Fax › +49-8158-9981-10 Email › info@microcoat.de Website › www.microcoat.de Social Media › I Number of Employees › > 200 Founded (year) › 1992 Type of Laboratory › 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 GMP release testing as well as 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 compliant 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. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 108

| 109


Name › Microsynth Seqlab GmbH Part of Microsynth AG Address/P.O. Box › Maschmühlenweg 36 Postal Code/City › 37081 Göttingen State › Lower Saxony Contact Person › Dr Aaron M. Nuss Telephone › +49-551-370-00-10 Fax › +49-551-370-00-12 Email › info@microsynth.seqlab.de Website › www.microsynth.com Founded (year) › 1989 Type of Laboratory › S1/S2, GMP/GLP Areas of Activity › | Oligonucleotide synthesis | Sanger sequencing | Next generation sequencing | DNA/RNA isolation, qPCR, digital PCR, fragment length analysis, genotyping | Contract research/outsourcing Contract Research › Assay Development | Assay development for companion animal diagnostics, IVD, GMO, mRNA vaccines, etc. | Validaton according to ICH guidelines | Cross-validation against a reference method | Biologics Testing | Contamination and impurity testing | Lot and drug product release testing (e.g. mRNA vaccines via GMP Sanger sequencing) | Cell line characterisation | Viral clearance studies Gene Editing / Gene Therapy | CRISPR editing analysis | rAAV characterisation | Off-target analysis

The Company Microsynth is a leading European company in the field of nucleic acid synthesis and analysis. Its main activities involve oligonucleotide synthesis, DNA/RNA analysis and sequencing, as well as contract research. For over three decades, the company’s goal has been to serve its customers by delivering products and services of the highest quality, on time, while offering outstanding service – and all this at competitive prices. Microsynth has subsidiaries in Germany (Microsynth Seqlab GmbH), France (Microsynth France SAS), Austria (Microsynth Austria GmbH), and Switzerland (Ecogenics GmbH). In total, Microsynth employs a staff of more than 130 people.

Oligonucleotide Synthesis Microsynth is a premier expert in oligonucleotide manufacturing, providing solutions for diverse applications. From research primers to molecular diagnostics and therapeutic oligos (ASOs, siRNAs) for drug discovery and preclinical testing, we meet your needs. Choose from various backbones (DNA, RNA, 2’-MOE, 2’-OMe, LNA, PTO), >250 modifications (MGB, GalNac), and purification options. Backed by decades of expertise, we drive innovation through technology and protocols. High-throughput platforms and rigorous processes ensure quality, while skilled chemists optimise strategies. Whether it’s a specific project or complex demands, trust Microsynth for tailored oligonucleotide solutions.

DNA/RNA Analysis With over 30 years of experience, Microsynth is a leading provider of DNA Sanger sequencing services in Europe. Our strategically located Sanger sequencing laboratories in Switzerland, Germany, France and Austria enable efficient and environmentally friendly sample collection. Our commitment to innovation is exemplified by Ecoli Nightseq®, a groundbreaking service offering faster and more cost-effective E. coli plasmid sequencing. Microsynth’s expertise extends beyond Sanger sequencing. We embrace next-generation sequencing technologies and offer comprehensive support for Illumina and ONT platforms. Our services cover a wide range of applications, from DNA and RNA sequencing


MICROSYNTH SEQL AB

for various organisms to plasmids and cosmids. We accommodate projects of all sizes, from single loci to complex metagenomic studies. Our commitment to excellence doesn’t end with data generation; our customised bioinformatics pipelines and comprehensive support ensure accurate and user-friendly results. In addition to sequencing, we excel in nucleic acid isolation, PCR (from classic to digital), fragment length analysis, and genotyping by sequencing.

Contract Research Over the past decade, Microsynth has evolved into a globally renowned contract research organisation, offering cGMP services in assay development, qualification, validation, and sample testing. Our team has extensive knowledge and experience working with scientists, QA/QC professionals, and project managers from top notch pharma and biotech companies to achieve critical milestones cost-effectively and on time. Particularly, in the burgeoning domain of advanced therapy medicinal products, including gene, cell, and RNA therapies, we have carved a distinctive niche. Here, we have excelled in the development and application of nucleic acid-based analytical methods, establishing a noteworthy reputation.

Quality Management System Microsynth prioritises continuous production process enhancement with a focus on regulatory compliance. We have ISO 9001:2015 certification across all branches. Moreover, our NGS, Sanger, and fragment length analysis (FLA) departments at Balgach and Vienna (Sanger and FLA) are ISO/IEC 17025:2017 accredited (STS 0429), showcasing our commitment to precision. All our genetic analyses platforms are certified by Swissmedic as GMP-compliant for quality control (chemical, physical, biochemical and biological) of medicinal products as contract laboratory. The scope includes transplant products (TpP), gene therapy drugs (GT), as well as medicinal products involving genetically modified organisms (GMOs) or containing GMOs, all of them with intended use in humans. Lastly, we maintain ISO 13485:2016 certification for production and distribution of nucleic acids and components for medical use and provision of associated activities. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 110

| 111


Name › MLM Medical Labs Address/P.O. Box › Dohrweg 63 Postal Code/City › 41066 Mönchengladbach State › North Rhine-Westphalia Contact Person › Isabel Struik Telephone › +49-2161-4642-108 Fax › +49-2161-4642-190 Email › istruik@mlm-labs.com Website › www.mlm-labs.com Social Media › F I  Number of Employees › 120 Founded (year) › 1993 Type of Laboratory › Central laboratory for clinical trials Areas of Activity › Global central lab services for clinical trials

MLM Medical Labs is an industry-leading specialty and central laboratory utilised by biotechnology, pharmaceutical and other life-science companies globally to provide clinical testing for novel therapeutics. MLM currently operates one laboratory in Germany and two in the U.S. The team of 200 highly skilled and experienced personnel supports 300+ Phase I through Phase IV clinical trials as well as preclinical and translational research projects 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. MLM labs are operational 365 days a year to ensure valid results with industry-leading turnaround times. Upon expansion to the U.S. in 2020, MLM has become a perfect partner for fully harmonised central lab services across continents – supporting clinical sites in over 70 countries worldwide. Further external collaborations include strategic partnerships in China, Australia and Japan to significantly expand MLM’s global reach. 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 billion of equity capital currently under the management of 30 professionals, investing in the US, Canada, and Western Europe. MLM Medical Labs supports 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 BIOTECH

YOUR CENTRAL AND SPECIALTY LAB PARTNER FOR OVER 30 YEARS

Our services › Preclinical Services › Assay Development and Validation › Comprehensive Histology Lab Services › Routine and Biomarker Analysis › MLM Kit Building® › Biostorage › Advanced Sample Logistics

Analytical capabilities › Immunoassays › Enzymatic Assays › Coagulation Testing › Multiplex Analysis › Cell-Based Assays (incl. PBMC) › Flow Cytometry › Platelet Function Assays › RT-PCR › HPLC › Immunohistochemistry (IHC) › Immunofluorescence › Whole Slide Imaging › In-Situ Hybridisation › Cell Culture Modelling › In-Vivo Disease Modelling

Quality standards › ISO 15189 accredited › CAP accredited › CLIA accredited › GLP certified › AAALAC accredited › BVMA certified › NGSP certified

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 112

| 113


Name › Molzym GmbH & Co. KG Address/P.O. Box › Mary-Astell-Straße 10 Postal Code/City › 28359 Bremen State › Bremen Contact Person › Marina Linow Telephone › +49-421-69-61-62-0 Fax › +49-421-69-61-62-11 Email › info@molzym.com Website › www.molzym.com Social Media › I Number of Employees › 42 Founded (year) › 2003 Areas of Activity › Manufacturer and supplier of products: | CE IVD kits for infection diagnosis | Microbial DNA isolation (manual and automated solutions) | DNA-free PCR reagents, assays, and polymerases | Customised master mixes | OEM Request for › Molzym is interested in the following further collaborations partnerships or collaborations: | Development and production of individualised, pre-analytical, and analytical solutions, including automation | Service providers and companies in the field of Next Generation Sequencing, e.g. to establish and improve NGS-based workflows for pathogen identification directly from clinical samples

Nucleic acid extraction is an important step in molecular microbiological processes, as it significantly influences the entire downstream workflow. Molzym focuses on the culture-free detection of infectious agents that can cause severe diseases and has developed the most refined technology for the targeted enrichment and extraction of microbial DNA from clinical samples. Since 2003, Molzym’s sole aim has been to avoid the GIGO effect and to provide laboratories with solutions for highly sensitive, broad, and consistent detection and identification of pathogens. Molzym relies on 2 processes that ensure the most efficient extraction: the depletion of human DNA and the production of ultra-pure reagents. Incorporating these special characteristics, we provide various high-quality products for molecular microbial analysis by PCR- and NGS-based methods in over 30 countries worldwide.

Expertise Molzym manufactures ultra-clean and highly active amplification reagents and kits for microbial DNA extraction from a variety of 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 contamination by 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 the sensitivity of PCR, NGS, and microbiome analysis, especially at low microbial loads.


MOLZYM

Products & Automation MolYsis™ is Molzym’s proprietary technology of host DNA depletion, allowing targeted isolation of microbial DNA from a great variety of samples. Ultra-pure, DNAfree PCR reagents and master mixes enable the precise detection of microbes in humans and in 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. 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 employs the latest technical advances to fulfil the demand for contaminationfree 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. The Molzym team appreciates your interest and is at your disposal for further information about our products and developmental projects. Please contact us at: +49-421- 69-61-62-0 or send your enquiries to info@molzym.com.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 114

| 115


Name › MorphoSys Address/P.O. Box › Semmelweisstraße 7 Postal Code/City › 82152 Planegg State › Bavaria Telephone › +49-89-89927-0 Email › info@morphosys.com Website › www.morphosys.com Social Media › I Number of Employees › 550 Founded (year) › 1992 Areas of Activity › Development and commercialisation of innovative cancer medicines Request for › Incyte, Pfizer, Novartis, Roche, Further Collaborations Janssen, GSK, I-Mab Biopharma, HI-Bio, among others

Our story At MorphoSys, we bring together ambitious, collaborative and courageous people who are committed to finding ways to treat cancer differently. We began as a research and development technology provider 30 years ago, which positioned us as a valuable partner to pharmaceutical manufacturers worldwide and empowered our evolution into a fully integrated, commercial-stage biopharmaceutical company. Our growth can be attributed to the passionate people driving our mission: More life for people with cancer.

Our values Our work is driven by our commitment to one another and to society, and by the values that underscore our collective responsibility to operate with the highest level of integrity, respect and quality. › Innovation: We challenge ourselves to deliver everything we do in new and better ways. › Collaboration: We work together as one MorphoSys team, along with all stakeholders, to achieve our ambitious goals. › Courage: We pursue the unknown and strive to discover the undiscovered. › Urgency: We act with speed, never compromising quality or patient safety.

Our pipeline MorphoSys has a broad mid- to late-stage oncology pipeline. By 2025, we expect to have two novel medicines available to patients across multiple indications where there are dire needs for more effective treatment options.


MORPHOSYS

Our pipeline includes: Pelabresib*: An investigational, late-stage BET inhibitor, being explored in the Phase 3 MANIFEST-2 study in combination with ruxolitinib as a first-line treatment for patients with myelofibrosis. The latest Phase 2 data suggest pelabresib has the potential to enhance the standard of care for this debilitating disease. We are also exploring the potential to expand pelabresib’s use in other myeloid diseases. Tafasitamab: A humanised Fc-modified CD19 targeting immunotherapy. In the U.S., Monjuvi® (tafasitamab-cxix) is approved by the U.S. FDA in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In Europe, Minjuvi® (tafasitamab) received conditional marketing authorisation in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. Beyond the approved indication, we are exploring tafasitamab as a treatment for patients with newly diagnosed DLBCL and indolent lymphomas. Tulmimetostat*: Abnormal EZH2 function is implicated in several ways in cancer and may make tumours more resistant to anti-cancer treatment. Tulmimetostat is an oral, investigational next-generation selective dual inhibitor of EZH2 and EZH1 designed to improve on first generation EZH2 inhibitors via increased potency, longer residence time on target and a longer half-life. Tulmimetostat is currently being assessed in a basket trial for several solid tumours and lymphoma. *Pelabresib and tulmimetostat are being investigated as treatments for various cancers and have not yet been evaluated or approved by any regulatory authorities. Monjuvi® and Minjuvi® are registered trademarks of MorphoSys AG 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 116

| 117


Name › Navigo Proteins GmbH

Affinity ligands for protein purification and targeted therapeutic applications

Address/P.O. Box › Heinrich-Damerow-Straße 1 Postal Code/City › 06120 Halle/Saale State › Saxony-Anhalt Contact Persons › Priyanka Sahasrabudhe (Sr. Business Development Manager Precision Targeting) Florian Settele (Head of Business Unit, Precision Capturing) Telephone › +49-345-27996330 Email › info@navigo-proteins.com Website › www.navigo-proteins.com Social Media › I Number of Employees › 74 Founded (year) › 2017 Type of Laboratory › S1/S2

Navigo Proteins is a premier protein engineering company, specialized in creating novel affinity ligands for custom affinity purification of complex biologics (BU: PRECISION CAPTURING®) and as target binders for developing targeted therapies in precision oncology (BU: PRECISION TARGETING). The technology platforms are based on proprietary scaffold proteins which are small, stable, and highly engineerable to achieve different binding characteristics and combinations with a variety of effector modalities to develop a broad range of therapeutic and diagnostic applications.

Areas of Activity › | Custom affinity resin development | Affilin®-based Precision Medicine Biological patent › extensive patent portfolio around proprietary affinity ligand technology External › Repligen, eleva, Novavax, Mannin, ITM, collaborations Nostrum Biodiscovery Request for › Licensing, Partnerships, Further Collaborations Research Collaborations

Affinity chromatography for GMP-compliant protein purification Scientists continuously face pressure to purify biologics with maximum yield while minimizing costs and developing processes as quickly as possible. Downstream processing (DSP) often accounts for more than half the cost of goods overall and significantly impacts manufacturing timelines. Affinity Chromatography manages to achieve high purity and yield and allows a simpler process architecture. Precision Capturing ®, extends the benefits of Protein A chromatography beyond just antibody purification. It covers both recombinant protein and monoclonal antibody (mAb) purification under the platform names Precision X and Precision A, respectively. Over the years, Protein A has continued to evolve to keep up with increased performance pressure and Precision A contributed a major step to this evolution of next-generation antibody purification by the launch of the first two products: NGL Impact ® A, the leading product for emerging antibody developments, and NGL Impact® A HipH, an industry-first ligand enabling mild elution conditions.


NAVIGO PROTEINS

The Precision X platform brings the advantages of Protein A to non-mAb protein purification. Precision X based affinity resins are used for large-scale manufacturing with FDA and EMA approval. The ligands bind to non-antibody proteins making affinity chromatography a game changer in protein DSP development. Custom resins are generated in 4 months and manufacturing partners scale-up production in 5 additional months.

Targeted therapeutics based on Affilin® target binding proteins Precision Medicine relies on the precise targeting of molecular structures like Tumour Associated Antigens (TAAs) and checkpoint signalling pathways. Under its Precision Targeting Business Unit, Navigo brings together its expertise in protein engineering and drug design, with an unwavering commitment to developing innovative targeted therapeutics. With a clear focus on oncology, Precision Targeting is developing next-generation targeted therapies, based on the unique, proprietary Affilin® platform. Affilins® are a novel class of target binding proteins, that effectively mimic the target binding function of antibodies but bring to the table several additional advantages. Affilins ® can be easily customized as mono, bi-/ or multi-specific ligands and can be seamlessly coupled to functional moieties like cytotoxic payloads and radioactive isotopes to orchestrate highly targeted and potent anti-cancer therapeutics against Tumour Associated Antigens (TAAs) as well as immuno-oncology (I/O) targets. The growing portfolio of Affilin® assets with their unique pre-clinical data address some of the key challenges in targeted therapeutics, like fine tuning of biodistribution as well as targeting low or medium expressing tumours with exceptionally high and sustained tumour-specific accumulation, out-performing current benchmarks. With a drive to bring best-in-class therapies to patients and address the unmet medical need, Precision Targeting leverages the unique features of Affilins® to advance targeted therapeutics towards clinical development. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 118

| 119


Name › Neovii Biotech GmbH Address/P.O. Box › Am Haag 6+7 Postal Code/City › 82166 Gräfelfing State › Bavaria Contact Person › Sebastian Hofmann Telephone › +49-89-898888-0 Telephone › +49-89-898888-16 Email › info.germany@neovii.com Website › www.neovii.com Number of Employees › Approx. 110 Founded (year) › 2003 Type of Laboratory › BioStoffV S3** cGMP certified production facilities, EU (Annex 1 EU-MP guideline) up to grade A respectively ISO5 (according to EN-ISO 14644-1) Areas of Activity › | Transplantation Medicine | Haematological Oncology External › Academic research institutions and Collaborations other companies

The company The company Neovii Biotech GmbH – as part of the Neovii Group – is dedicated to delivering targeted bio­ pharmaceutical 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. All the manu­facturing activities are located in Gräfelfing/ Germany. Neovii has a presence in more than 40 countries worldwide. For further details please visit: www.neovii.com

Research and Development Neovii supports research and development activities in the fields of solid organ transplantation, stem cell transplantation, and immune and haemato-oncological disorders. Neovii actively seeks in-licensing and acquisitions opportunities. We are looking to expand our portfolio of products with novel life-transforming therapies that address severe unmet medical needs, in particular in the areas of transplantation, haemato-oncology, and immune disorders.

Areas of interest Since its inauguration Neovii Biotech has been manufacturing and commercialising 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.


NEOVII

The main fields of our operations are: › Stem Cell Transplantation › Solid Organ Transplantation › Aplastic Anaemia › Autoimmune Diseases

©Eva Orthuber

Transplantation: ATLGs (Anti-human T-lymphocyte immunoglobulins) – polyclonal antibodies ATLGs are antibody-based medicines for the targeted suppression of immune responses (immunosuppressants). They suppress immune responses by multiple mechanisms, such as immune cell depletion, inhibition of T-cell function, and induction of regulatory immune cells. Their immunosuppressive properties are used mainly in solid organ transplantation and stem cell transplantation. In stem cell transplantation (SCT) polyclonal antibodies are indicated for the prevention of graft-versus-hostdisease (GVHD). GVHD is recognised as a severe complication following SCT that negatively impacts on the 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, ATLGs significantly lower the incidence of GVHD. In solid organ transplantation (SOT), polyclonal antibodies are 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, ATLGs limit organ damage and prevent graft loss.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 120

| 121


be INSPIRED

drive DISCOVERY

stay GENUINE

Name › New England Biolabs GmbH Address/P.O. Box › Brüningstr. 50 – Geb. B852 Postal Code/City › 65926 Frankfurt am Main State › Hesse Contact Person › Dr Carsten Lanwert Telephone › +49-69-305-23140 Fax › +49-69-305-23149 Email › info.de@neb.com Website › www.neb-online.de Social Media › F I  I Founded (year) › 1981

New England Biolabs – be Inspired | drive Discovery | stay Genuine 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 has been shaping the landscape of bioscience research by discovering, developing, and supporting superior research reagents. Our passion is our promise. A supplier-ofchoice 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, value and unsurpassed technical support. In addition to NEB’s commitment to scientific innovation and customer satisfaction, NEB notably ensures the environmental sustainability of the company’s business practices.

Basic and applied science NEB’s scientists are engaged in basic 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 1,400 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 projects. With this dual focus on both basic and applied research, NEB’s culture is collaborative and academic.


NEW ENGL AND BIOL ABS

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 CRISPR/Cas9 based genome editing makes us a firstchoice supplier for today’s molecular biologists.

Quality, customer service, and the environment

New lyophilization capabilities at NEB

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/GMP – Grade & Lyophilization NEB’s OEM business unit has been delivering tailor-made enzyme formulations and packaging solutions to biotech, pharma and diagnostic customers for over 25 years. Building on this extensive experience, we have recently expanded our GMP-grade manufacturing capabilities to offer a range of customised products at scale, enabling commercial customers and partners to use NEB’s worldclass products in their specific applications and to support them in their efforts to access regulated markets. Recently, we established our new subsidiary NEB Lyophilization Sciences – experts in the design, development and manufacture of innovative solutions for ambient store products.

New England Biolabs GmbH

OEM GMP-grade www.neb-online.de

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. For up-to-date information please visit our web site at www.neb-online.de. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 122

| 123


Name › Nordmark Pharma GmbH Address/P.O. Box › Pinnauallee 4 Postal Code/City › 25436 Uetersen State › Schleswig-Holstein Contact Person › Dr Jan Heyland Telephone › +49-4122-712-907 Fax › +49-4122-712-545 Email › projects@nordmark-biotech.de Website › www.nordmark-biotech.de Number of Employees › ~ 700 Founded (year) › 1927 Areas of Activity › l Process development l Microbial fermentation l Mammalian cell culture Annual Turnover › ~ €120m

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 700 employees and generates revenues of around EUR 120 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 – 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.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 124

| 125


Name › Nova Biomedical GmbH Address/P.O. Box › Hessenring 13A, Geb. G Postal Code/City › 64546 Mörfelden-Walldorf State › Hesse Contact Person › Silke Hohmeier, Managing Director, Albina Abdrakhmanova, Account Manager Biotechnology Telephone › +49-6105-4505-0 Email › de-info@novabio.com Website › novabiomedical.com Social Media › F I Q  I Number of Employees › 1,450 Founded (year) › 1976 Areas of Activity › Cell culture analysis, autosampler, upstreaming, automation, cell counter, glucose reference analyzer US-FDA ­ in-vitro diagnostics, point-of-care testing, blood gas analysis, critical care, diabetology, emergency medicine Request for › Kidney disease screening & monitoring Further Collaborations partners

Innovation empowering the life sciences Nova Biomedical develops, manufactures, and commercialises analytical systems for cell culture and whole blood testing. The company is headquartered in Waltham, MA, USA. Worldwide more than 1,450 people are employed by Nova, which operates in 10 subsidiaries and in more than 110 countries through factory-trained distributors. In Germany, Nova Biomedical has a full commercial team, including a warehouse and distribution centre committed to customer excellence. Our commitment to scientific innovation and product quality has made Nova Biomedical a world leader in the development of whole blood analyzers for clinical applications and cell culture/fermentation analyzers for biopharma for more than 40 years.

Cell Culture Analysis GMP-compliant cell culture analysis made easy Nova offers the latest in maintenance-free cell culture analyzer technology: BioProfile® FLEX2. FLEX2 provides fully automated analysis of key chemistries and gases, cell density, cell viability, and osmolality with one sample and a single data output stream in under 4.5 minutes. The full test menu of 16 cell cultures includes: Gluc, Lac, Gln, Glu, NH4+, Na+, K+, Ca++, pH, PCO2, pO2, total cell density, viable cell density, viability, cell diameter, and osmolality. The system can be flexibly configured to meet diverse and changing needs with the optional and field upgradeable pH/gas, CDV, and osmolality modules. Automated sampling from 96-well plates, syringes, or a 24-position external “load-and-go” sample tray provides maximum workflow flexibility and efficiency for cell culture monitoring.


NOVA BIOMEDICAL

FLEX2 is the only cell culture analyzer designed for online sampling from 500mL vessels through commercial manufacturing-scale culture systems, as well as integration with the ambr ® 15 and 250 cell culture systems. An optional Sample Retain Collection system automatically collects cell culture samples from the On-Line Auto­ sampler and stores them in a refrigerated environment to enable further offline testing. IQOQ support can be offered by the local Nova representative. New FAST CDV analyzer Nova has just announced the launch of the BioProfile FAST CDV, a high-throughput, fully automated viable cell density and viability analyzer capable of running over 45 samples per hour with just 100µL of sample volume. In addition, it performs all sample dilutions internally, en­a bling cell culture samples up to 140e 6 c/mL to be analysed without any external sample dilution. Cell culture samples can be analysed via the external 32-position load-and-go tray or via an innovative 96-well plate option.

Basic cell culture chemistry For cell culture analysis of non-complex media formulations, the StatProfile Prime series offers solutions that analyse pH, gas, electrolytes, glucose, and lactate in systems that are optimised for workflow simplification.

Glucose Reference Analyzer New Nova Primary A new edition to the Nova product range is the Nova Primary whole blood glucose reference analyzer. Nova Primary fills the need for a replacement for the discontinued YSI STAT PLUS 2300 Glucose and L-Lactate analyzer. Nova Primary uses a single, reusable glucose electrochemical sensor based on glucose oxidase and has a measurement range of 20-900 mg/dL. It uses a small, 25 µL whole blood or plasma sample and provides results in under 2 minutes.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 126

| 127


Name › Pantherna Therapeutics GmbH Address/P.O. Box › Neuendorfstrasse 20b Postal Code/City › 16761 Hennigsdorf State › Brandenburg Contact Person › Dr Gerrit Maaß Telephone › +49-3302-202-240-0 Email › contact@pantherna-therapeutics.com Website › www.pantherna-therapeutics.com Social Media › I Number of Employees › 11 Founded (year) › 2017 Type of Laboratory › S1 Areas of Activity › > mRNA therapeutics utilising lipid nanoparticles (LNP) for functional nucleic acids delivery

External › Astellas Pharma, Evaxion Biotech, Collaborations Provirex GmbH Academic collaborations with Helmholtz, Charité Universitätsmedizin, Amsterdam University Medical Center, Universitätsmedizin Rostock and others

Request for › Co-development of mRNA Further Collaborations therapeutics; interest in research collaborations to explore new therapeutic modalities in various indications; strategic partnerships for developing and evaluating new LNPdelivery technologies

Our Company: Pantherna Therapeutics GmbH is a privately-held biotechnology company, developing first-in-class therapeutics based on its proprietary PTXmRNA-LNP technologies. Pantherna is based in Hennigsdorf (Brandenburg) with research laboratories at Bayer Campus, Berlin.

Our Mission: mRNA therapies are becoming potent pharmaceutical modalities – even beyond vaccination – to close the gap between existing medical approaches such as biologics and viral vectors. Delivering therapeutic mRNA to the desired cell type is a prerequisite for an effective and safe therapy. Pantherna uses and develops advanced lipid nanoparticle PTX∆LNPs® – carriers for novel mRNA therapeutic applications. Our primary goal is to treat diseases with dysfunctional vasculature, to restore endothelial function in the acute setting of lung injury. Other interests include medical conditions from rare diseases. New approaches are being designed to develop mRNA therapies for local administrations, such as intramuscularly.

Our Technology Platforms: PTXmRNA® – distinct mRNA expression modules: › Combination of potent, short untranslated sequen­ces (PTX_UTRs) that flank the coding region of the desired therapeutic protein for enhanced expression › Superior protein expression over standard mRNA constructs PTX∆LNPs® – Lipid nanoparticle carriers designed for selective organ targeting › various LNP-formulations based on different physico-chemical properties › LNPs with cationic, neutral or anionic surface charge › next-generation formulation candidates for tissuespecific delivery of mRNA › employing both ionizable & permanently charged lipids › covering formulations for local and systemic mRNA administration


PANTHERNA THERAPEUTICS

› optimized process development to obtain monodisperse particles

Our Pipeline: Pantherna’s first clinical development candidate: PAN004: A systemically administered, first-in-class locally acting mRNA-LNP as therapeutic Tie2-agonist for the prevention and treatment of pulmonary oedema in Acute Respiratory Distress Syndrome (ARDS): › mRNA delivery to capillary endothelium of the lung › activates Tie2-signalling pathway in a highly spatial manner in the pulmonary endothelium › designed to prevent ARDS progression at an early stage › in vivo Proof-of-Mechanism and Proof-of-Concept established › CMC and IND-enabling studies in preparation Pantherna is currently pursueing the characterization of additional drug candidates derived from the PTX∆LNP platform on the pre-clinical level for other medical conditions besides ARDS to strengthen its pipeline.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 128

| 129


Name › PHARMAPLAN GmbH Address/P.O. Box › Siemensstraße 21 Postal Code/City › 61352 Bad Homburg State › Hesse Contact Person › Anna Fey, Head of Business Development Telephone › +49-6172-8502-100 Fax › +49-6172-8502-501 Email › germany@pharmaplan.com Website › https://www.pharmaplan.com Social Media › I I Number of Employees › 230 (PHARMAPLAN D), 1,100 (TTP Group) Founded (year) › 1974 Areas of Activity › | Project Management | GMP & Quality Consulting | Process Engineering | Manufacturing IT & Automation | Laboratories | Facility-Building & Infrastructure | Facility-Technical Services Project Phases › | Feasibility Study | Conceptual Design | Basic Design | Detail Design | EPCM(V) | Procurement Support l Construction Management / Supervision | Installation and Commissioning Support | Qualification

PASSION FOR PHARMA ENGINEERING: This is what PHARMAPLAN stands for. As one of the leading pharmaceutical consulting and engineering companies in Europe, we are specialized in the integrated and holistic planning and realization of pharmaceutical and biotech production buildings and facilities as well as laboratories and thus shape the future of our industry. With our highly qualified employees working in areas such as project management, process engineering, GMP, laboratory planning, architecture, building services, and digital factory, we set the course for the global supply of medicines of tomorrow. Operating under the umbrella of TTP Group with around 1,100 employees at 29 international locations, we support the pharmaceutical and biotechnology industry with flexible, GMP-compliant, and future-proof solutions. From initiation to construction to handover, we handle projects of all sizes on behalf of our clients. All major global pharmaceutical manufacturers and several small-sized pharmaceutical companies have been counting on our expertise, our latest know-how, technology, and trends for years.

OUR SERVICES PHARMAPLAN is a consulting and planning company that – preferably as a General Design Contractor – provides integrated services in the disciplines GMP, PROCESS, LABORATORY, AUTOMATION, BUILDING & INFRASTRUCTURE, TECHNICAL SERVICES and PROJECT MANAGEMENT tailored to the needs of the pharmaceutical industry from a single source and close to the customer. PHARMAPLAN is divided into three business units: Consulting & Front End Projects Execution of capability reviews, site master planning, feasibility studies and conceptual design studies, analyses, and consulting concerning product portfolio, production capacity, and regulatory compliance. The objective is to develop standard facility and equipment designs, modular concepts, and optimal project execution strategies on a global level and then translate them into the site and project-specific concepts and requirements.


PHARMAPL AN

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 Design Contractor and construction manager (EPCMV-partner) and has a huge in-house pool of seasoned project managers and engineers, who are also experienced in the fast-track execution of large projects. 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 changeover, capacity optimization, and 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 structure reflect typical work packages of our projects: › Project Management (Project Management, Engineering Management, BIM Management, Project Controlling, Document Management, Project ­P rocurement, HSE Management & Sustainability Construction Management) › GMP & Quality Consulting › Process Engineering (Biotech, Bio & Chemical API, Fill & Finish, OSD, Packaging & Logistics, Process & Clean Utility, BIM & CAE Process) › Manufacturing IT & Automation › Laboratories (Laboratories General, Laboratories Biotech) › Facility-Building & Infrastructure (Design & Process Architecture, Construction Architecture & Civil Engineering, BIM-Building & Infrastructure) › Facility-Technical Services (HVAC & Utility, Electrical, Building Automation Systems, BIM-Technical Services) TTP GROUP is a group of companies specializing in engineering services for the process industry. The management company TTP GmbH has united the TRIPLAN and PHARMAPLAN companies under one roof since 2019. This has created one of the leading engineering companies for the process industry in Europe. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 130

| 131


Name › Phyton Biotech GmbH Address/P.O. Box › Alter Postweg 1 Postal Code/City › 22926 Ahrensburg State › Schleswig-Holstein Contact Person › Kai Schütte Telephone › +49-4102-4906-64 Fax › +49-4102-4906-69 Email Address › kai.schuette@phytonbiotech.com Internet Website › www.phytonbiotech.com Number of Employees › 75 Founded (year) › 1993 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 1993, Phyton Biotech offers comprehensive process development and commercial manufacturing services for fermentation-based products at its GMP facility near Hamburg with more than 200.000 liters of installed bioreactor capacity. 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 services 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 sustain­ ability, 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®.


PHY TON BIOTECH

Specialty fermentation solutions Phyton Biotech’s commercial-scale fermentation facilities can produce large volumes of high-quality fermentation-derived products (max. bioreactor size is 75,000L; more than 200,000L of installed capacity). We offer flexible production schedules and a range of fermentation vessel sizes to meet the needs of our clients. Our facilities are designed to meet the highest quality and regulatory standards, ensuring our clients receive the best quality products possible. Coupled with 30 years of experience in development and production this enables us to carry out other Specialty Fermentation projects 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 services for a wide range of high-value fermentation-based compounds.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 132

| 133


Name › PlasmidFactory GmbH Address/P.O. Box › Meisenstr. 96 Postal Code/City › 33607 Bielefeld State › North Rhine-Westphalia Contact Persons › Dr Martin Schleef/Dr Marco Schmeer Telephone › +49-521-2997-350 Fax › +49-521-2997-355 Email › info@plasmidfactory.com Website › www.plasmidfactory.com Social Media › I  Number of Employees › 44 Founded (year) › 2000 Areas of Activity › | Contract Manufacturing of plasmid and minicircle DNA in different quality grades for research up to clinical applications | High Quality Grade plasmid and minicircle DNA as starting material for GMP productions, e.g. of mRNA or viral vectors, also in gram scales | In Stock Service for AAV Helper & Packaging Plasmids (pDG/pDP) and for further plasmids and minicircles (e.g. reporter genes) | Analysis of plasmid topology Biological Patents › PlasmidFactory owns any relevant know-how, patents, and licences for plasmid and minicircle manufacturing External › Fruitful long-term cooperations with Collaborations renowned academic and industrial ­institutions in the fields of gene and cell therapy and vaccination Request for › PlasmidFactory is always interested in Further Collaborations working in long-term and strategic collaborations with pharmaceutical and biotech companies that require plasmid or minicircle DNA for (pre-) clinical applications.

The better way to DNA! PlasmidFactory is the 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 its 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, nanobiotechnology, gene therapy, cell or tumour therapy, and RNA or 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. Full GMP will be available from 2024.

In Stock Services Our “In Stock” products are deliverable immediately “off-the-shelf” – e.g. reporter genes (gfp, lacZ, luc), AAV Helper & Packaging plasmids (2-Plasmid-System, pDG/ pDP family, several serotypes) or pEPI / pEpito plasmids (containing S/MAR elements).

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, e.g. during storage.


PL ASMIDFACTORY

Minicircle – a safe vector system

The better way to DNA!

High Quality Grade Plasmid & Minicircle DNA Customized plasmid & minicircle production  Extensive expertise in manufacturing of minicircles e.g. for CAR-T cell production High Quality Grade DNA for GMP production of viral vectors & RNA QC including CGE service pDG/pDP plasmids for AAV production 2 plasmid system: AAV packaging and AdV helper genes in a single construct Various serotypes including AAV8 and AAV9 GFP transfer plasmids for ss- and sc-AAV Dedicated QC for ITR sequence integrity – ITRRESCUE® In Stock service

ask for

stock.adobe.com

GMP

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 any 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 clients’ requirements. As a special type of linear protected DNA vector PlasmidFactory established the production of MIDGE ® DNA.

Starting material for mRNA vaccines in large quantities In particular, the High Quality Grade production of plasmid DNA as a starting material for the production of RNA vaccines has gained in importance, especially in the context of the COVID-19 pandemic, as RNA is a promising vaccine candidate for the prevention of certain virus infections, with the additional advantage of not integrating into the genome of the cell and thus remaining as a potentially effective molecule in a ­patient’s body in the long term. PlasmidFactory has developed and established the process for the production of the corresponding ­plasmid DNA.

PlasmidFactory.com 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 134

| 135


Name › ProBioGen AG Address/P.O. Box › Herbert-Bayer-Str. 8 Postal Code/City › 13086 Berlin State › Berlin Contact Person › Dr Lutz Hilbrich (CEO) Telephone › +49-30-322-935-100 Fax › +49-30-322-935-400 Emails › info@probiogen.de cdmo@probiogen.de Website › www.probiogen.de Social Media › I Q Number of Employees › 320 Founded (year) › 1994 Type of Laboratory › S1, S2 Areas of Activity › l Biopharmaceutical development and GMP production facility l Proprietary technologies for improving product characteristics and process efficiency l Designer cell lines l Vector platforms 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. Boehringer Ingelheim, Bayer, CRISPR, Novartis, etc. Request for › ProBioGen works with biotech and Further Collaborations pharma companies that develop (complex) therapeutic proteins and antibodies or viral vaccines and viral vectors.

Intelligent biopharmaceutical solutions ProBioGen is a Berlin based CDMO, specializing in the development and manufacturing of biopharmaceutical active ingredients, viral vectors and vaccines through proprietary technologies to improve product quality and features. Combining state-of-the-art development services and intelligent product-specific technologies results in biologics with optimized properties. Rapid and integrated cell line and process development, comprehensive analytical development and GMP-compliant manufacturing is performed by a highly skilled and experienced team.

Unique services Cell line & process development for therapeutic proteins › CHO.RiGHT® expression system › DirectedLuck® transposase for efficient gene delivery & high titers › Proprietary chemically defined (CD) media platform/ multiple suppliers › Robust and economic platform processes › Classic and intensified processes › Reports to support investigational new drug (IND) filing › Modular services and open source concept

(GMP) Manufacturing for therapeutic proteins › Cell banking (MCB/WCB) › Up to 1000 L Tox manufacturing › Up to 1000 L GMP manufacturing › Disposable, stirred tank bioreactors

Development services for various viral vectors › Tailor-made solutions for the production of e.g. lentiviral and adenoviral vectors, AAV and MVA › Suitable cell substrates for the propagation of various viral vectors in suspension processes using CD medium › Robust upstream and downstream processing supported by comprehensive analytical tools › Cost-effective non-cGMP production for preclinical development phase

(GMP) Manufacturing for various viral vectors › Cell Banking (MCB, WCB) and Virus Banking (MSV/WSV) › Up to 200L Tox manufacturing


PROBIOGEN

› Up to 200L GMP manufacturing (up to biosafety level 2) › Aseptic filling of drug product and diluent under GMP conditions

Analytics, bioassays & quality management

Your Biologics. ® Elevated.

› Integrated analytical development › Validation according to bioanalytical guidelines (EMA/FDA) › Stability studies in accordance with ICH Q1 › Wide range of cell based and binding activity assays › Various cell based and instrumental analyses for content and identity testing of viral vectors and vaccines

Innovative technologies GlymaxX® ADCC enhancement & glyco-engineering › Prevents antibody fucosylation › Boosts ADCC cell-killing activity against tumors and infected cells › Applicable to both novel and existing producer cell lines › Allows adjustment of fucose, galactose, and sialic acid levels in glycoproteins

DirectedLuck® – Transposase system › Proprietary transposase for efficient gene delivery › Generates high-titer clones (up to 8 g/L) › Superior heterodimer rates for bi-specific mAbs

Lenti.RiGHT® packaging and producer cell line › GMP qualified starter cell bank based on HEK 293 › Efficient LV production in CD medium (107-108 TU/ml) › No requirement of GMP-grade plasmid DNA or transfection reagent › Straightforward purification of lentiviral particles for e.g. CAR-T therapies

AGE1.CR® Designer cell line & MVA viral vaccine manufacturing platform › Avian suspension cell line permissive for numerous human and veterinary viral vaccine strains › GMP-compliant chemically defined media and scalable suspension processes › Proprietary MVA strain, transgene expression design, and technology for rapid generation of recombinants

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 136

| 137


Name › Process Sensing Technologies PST GmbH Address/P.O. Box › Einsteinstrasse 17-23 Postal Code/City › 76275 Ettlingen State › Baden-Wuerttemberg Contact Person › Roland Scheurich, Managing Director Christoph Arnswald, Key Account Manager Telephone › +49-7243-383-250 Email › info@rotronic.de Website › www.processsensing.com Social Media › I Founded (year) › 1965 Areas of Activity › Measurement Instruments and Environmental Monitoring Solutions FDA 21 CFR Part 11/EU Annex 11 compliant GxP services including qualifications (thermal mappings), ISO17025 calibrations and validations.

Process Sensing Technology (PST) brings together well-established brands, each of which are trusted for the precision and reliability of their products, strong innovation and focus on customer service. Rotronic was founded in Switzerland in 1965 and is part of PST since 2017. Within the Group, Rotronic is positioned as the competence centre for humidity & temperature measurement and environmental monitoring systems. This enables PST to offer its customers a uniquely broad range of measurement technology products that perfectly meet the requirements of biotechnology. Biotechnology companies are subject to strict regulatory requirements and guidelines to ensure the safety and quality of their products. Environmental monitoring helps comply with regulations by tracking and documenting environmental conditions that could impact product quality and safety. Accurate and comprehensive environmental monitoring data is essential for maintaining data integrity and traceability. Environmental monitoring of a laboratory and laboratory equipment is an integral part of the quality management system. It helps promote the quality and validity of data generated during the testing process and prevents fraudulent practices. Trust in PST’s real-time monitoring experience and our wealth of knowledge of all critical environmental parameters to comply with the GLP/GSP/GMP/GDP regulations and ICH/FDA guidelines.

Applications › Fridges › Freezers › Incubators › Autoclave › Cryogenic storage › Laboratories & Cleanrooms › Rooms in general › Storage & Transport


PROCESS SENSING TECHNOLOGIES

Measurement types › Temperature range: -200...850 °C › Relative humidity › Carbon dioxide CO2 › Oxygen O2 › Differential pressure › Particle counting › Light (lumens, PAR, lux, etc.) › Door monitoring (open/closed) › Webcams (pictures)

Additional services › Calibration We offer a range of ISO-17025 and traceable calibration services, both within our facilities and onsite. › Qualification PST offers qualification services for rooms and equipment to help ensure the perfect environment throughout all facilities. The qualification will ensure the placement of the sensors within the various environments to ensure the highest quality of measurement data. › Validation Validation includes the provision of documented evidence that a system was planned/produced according to quality guidelines, is tested against specifications and has been operated in a qualified manner since it was introduced. The PST real-time monitoring solutions are validateable and PST offers complete documentation, including IQ/OQ and PQ, to fully validate the systems. › Consulting PST offers a range of consulting services from the start of a project, including the URS, through the complete validation master plan, including developing SOP’s and risk analysis. Maintenance and support ensure the long-term stability and accuracy of your system.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 138

| 139


Name › PROGEN Address/P.O. Box › Maassstrasse 30 Postal Code/City › 69123 Heidelberg State › Baden-Wuerttemberg Contact Person › Caroline Odenwald Telephone › +49-6221-8278-0 Fax › +49-6221-8278-24 Email › info@progen.com Website › www.progen.com/ Social Media › I Number of Employees › 39 Founded (year) › 1983 Type of Laboratory › S1, S2, L2 class laboratories, DIN ISO 13485 certification for the production of in vitro diagnostic kits and research reagents.

Immunochemicals that advance gene therapy and life sciences PROGEN helps life scientists worldwide to make new discoveries and to conduct breakthrough research. We also support the gene therapy community in developing safe and reliable treatments. Our mission is to advance research processes and new therapies by providing high quality analytical tools – quickly and affordably. As a manufacturer and provider of Adeno-AssociatedVirus (AAV) analytical tools, research antibodies, density gradient media and phage display technologies, we strive to understand what scientists need in research and gene therapy development. It is our goal that our products offer solutions for the manifold challenges in academia, biotech, and pharma along the complete value chain – from basic research to manufacturing and quality control, thereby enabling progress.

Areas of Activity › AAV gene therapy analytical tools and antibodies, antibodies and reagents for biomedical research, in vitro diagnostics, ELISA, antibody phage display technology, density gradient media Annual Turnover › €14.5m 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.

High quality tools for AAV gene therapy Labs attempting to find treatments for genetic disorders worldwide face obstacles such as a limited availability of accurate & reliable techniques for the characterization of AAV vectors. PROGEN is a leading manufacturer and exclusive provider of AAV antibodies and analytical tools for AAV titer determination, which facilitate the development of safe and efficient gene therapies. The density gradient media provided by us ensure a high yield purification of viral particles during production, while our AAV antibodies enable multi-step monitoring in vector manufacturing resulting in superior vector preparations. Exclusive AAV ELISA kits and controls ­allow an accurate capsid titer quantification that is critical for dose assessment. The pre-screening of patient sera for AAV-neutralizing antibodies using our AAV particle antibodies improves clinical safety and efficacy.


Making life sciences better. Together.

PROGEN

Serving the urgent need for premium research antibodies

AAV

High-quality antibodies which allow the generation of reliable and reproducible data are indispensable tools for the life science community. The four PROGEN founders came together in 1983 to fulfil exactly that requirement – high-quality antibodies for biomedical research, which can generate reproducible data time and time again. Initially a spin-off from the German ­Cancer Research Center and the University of Heidelberg, PROGEN has expanded to become a DIN ISO 13485 certified company, which to date continues to serve the life sciences community with over 600 high-quality antibodies worldwide.

Reliable partner for life sciences

Antibodies

Starting as a pioneer antibody manufacturer, PROGEN has now become a globally operating biotech company and a reliable partner for academia, biotech and pharma. What still drives us after all these years is the continuous dialogue with researchers so that we can offer advanced products that truly make life science better. PROGEN is 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 our product & service portfolio, which has been established for the last 38 years. CEOs Katja Betts & Maik Lander continue to expand their broad network and join forces with academia and industry to develop new solutions that add value.

Density Gradient Media

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 140

| 141


Name › ProJect Pharmaceutics GmbH Address/P.O. Box › Fraunhoferstrasse 22 Postal Code/City › 82152 Martinsried State › Bavaria Telephone › +49-89-45-22-89-700 Fax › +49-89-45-22-89-717 Email › info@project-pharmaceutics.com Website › www.project-pharmaceutics.com Social Media › I Founded (year) › 2010 Type of Laboratory › 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 › | Network for seamless development Collaborations from pre-clinic to fill/finish and market. | 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 › | Small biotechnology/mid-size pharma Further Collaborations companies, large top players in pharma/biotechnology. | From DSP development to early and late drug product phases up to life cycle management. | Customised solutions for challenges in formulation, analysis or process and tailored solutions for unmet needs not yet supported by the industry.

ProJect Pharmaceutics is one of the leading independent European CRO service providers specialised in formulation and manufacturing process development for parenteral drug products including biologics (rec. proteins, antibodies, fusion proteins), peptides, 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. 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.

Drug formulation › Accelerated development – faster to clinic and market › Pre-formulation, early state, and late phase formulation › Liquid and lyophilised formulation (DoE-based)

High concentration protein formulation › Low viscosity formulation for s.c. application › UF/DF process development › Particle size distribution and aggregate analysis › Analysis of subvisible particulate matter › Viscosity determination & s­ yringeability testing in prefilled syringe or cartridge

Process and manufacturing › Container closure system compatibility testing › Thermal characterisation › Forced stress studies › Real-time, accelerated, and in-use stability studies › Detergent and excipient quantification › Fill&finish process mock-up › Manufacturability assessment › Aseptic pre-clinical batch manufacturing

Downstream process › Smart optimisation of UF/DF & purification steps › Stabilisation concepts (e.g. higher yield, decreased loss) › Testing for a common BDS and DP formulation


PROJECT PHARMACEUTICS

Proprietary liposome technology › High encapsulation efficiency › Hydrophilic and lipophilic APIs › Cost-efficient aseptic manufacturing conditions

Freeze drying › Rational cycle development (robust, collapse-safe, cost and time efficient) › Bulk lyophilisation (solid or powder) › Freeze drying out of organic solvents › Annealing and controlled nucleation › Easy lyophilisate reconstitution › Aseptic freeze drying › 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) › Time lapse video and IR thermal camera monitoring

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.

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.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 142

| 143


Name › ProtaGene GmbH Address/P.O. Box › Inselwiesenstr. 10 Postal Code/City › 74076 Heilbronn State › Baden-Wuerttemberg Site USA: 4 Burlington Woods Drive Burlington, MA 01803 United States Contact Person › Raymond Kaiser Telephone › +49-7131-74504-0 Fax › +49-7131-74504-299 Email › contact@ProtaGene.com Website › www.ProtaGene.com Social Media › IQ Number of Employees › 220 Founded (year) › 1997 Type of Laboratory › GMP, GCLP, GLP & GCP compliant Areas of Activity › Biologic Drug Analytics: Antibodies, Antibody Drug Conjugates (ADCs), Bispecific Antibodies, Biosimilars, FAB Fragment, Fusion Proteins, Vaccines, New Biological Entities (NBEs) Cell and Gene Therapy Analytics: Integration Site Analysis, Vector Characterization, Bioinformatics, Sequencing Data Analytics, On-/OffTarget Analysis, Immune Repertoire Analysis, Gene Expressions Analysis, Biodistribution, Transgene Expression, Vector Shedding | Developability | Process Development | Protein Characterisation | Formulation Support | Comparability Demonstration | HCP Analytics | Method Validation and Verification | Forced Degradation Studies | Stability Testing | Release Testing

ProtaGene is synonymous with Analytical Excellence. We are a world-leading CRO partner for the biopharmaceutical and cell and gene therapy sectors, operating four sites in Europe and North America. From research to product commercialization, we provide the most advanced, integrated, and complete protein and gene analytic solutions for biologic therapeutics as well as cell and gene therapies. We take ownership of programs providing confidence in the integrity of our analytical data, our ability to support regulatory filings and manage project timelines and budgets.

ProtaGene stats › Global sites in Europe & North America › More than 200 employees worldwide › Supported development of over 400 biologics › Participated in >50 gene and immune gene therapy clinical trials › Supported AAV Integration Profile for approval of the 1st gene therapy (Glybera) in the Western World

Quality management systems › GMP, GCLP, GLP & GCP compliant › Data integrity & traceability › Equipment qualification & computerized systems based on Good Automated Manufacturing Practice (GAMP)

Solutions for biologics development Expertise in advanced method development and analytical package execution for all phases of development, including: › Phase-appropriate product characterization Pre-IND through BLA › Manufacturing & process analytic testing › ICH/GMP QC lot release & stability › Biosimilar program support-clone selection to commercial release › Clinical In Vivo sample analytics for quantitation & attribute monitoring


PROTAGENE

Biologic therapeutics platform expertise › Recombinant proteins—Including complex, highly glycosylated proteins › Multi-subunit complexes—protein, nucleotide, ligand › mAbs › ADCs & protein conjugates › PEGylated proteins › Bispecifics/multispecifics › Fusion proteins › Enzyme replacement therapies › mRNA › Oligonucleotides › Formulation development

Solutions for cell & gene therapy development We are at the forefront of developing DNA/RNA and protein vector analytics to advance gene therapy safety.

CMC & product development › Process development solutions › Complex vector characterization, CQAs & correlations › Custom process residuals & impurity methods › Genome & gene editing analysis › Gene expression quantitation

Capsid-based vectors › AAVs › Novel Systems › Adenovirus

Non-viral vectors › Polynucleotide (DNA/RNA) Formulations › Lipid Nanoparticles › Transposons › Plasmids

Bioanalysis support › Safety assessments by Integration Site Analysis › Biodistribution › Transgene expression › Vector shedding

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 144

| 145


Name › Rentschler Biopharma SE Address/P.O. Box › Erwin-Rentschler-Str. 21 Postal Code/City › 88471 Laupheim State › Baden-Wuerttemberg Contact Person › Dr Latika Bhonsle-Deeng (Senior Director Corporate Communication) Telephone › +49-7392-701-0 Fax › +49-7392-701-300 Email › communications@ rentschler-biopharma.com Website › www.rentschler-biopharma.com Social Media › F I Q I Number of Employees › 1,200 Founded (year) › 1872 Type of Laboratory › S1 Areas of Activity › Contract development and manufacturing organization (CDMO) for biopharmaceuticals, including complex therapeutic proteins, mRNA and viral vectors External › Strategic alliance with Leukocare 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 contract development and manufacturing organization (CDMO) focused exclusively on client projects. Rentschler Biopharma’s high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. Rentschler Biopharma is a family-owned company with about 1,200 employees, headquartered in Laupheim, Germany, with a second site in Milford, MA, USA. A third site in Stevenage, UK, is dedicated to cell and gene therapies.

Your trusted partner from concept to market The company offers process development and manufacturing of biopharmaceuticals, including adeno-associated virus (AAV) gene therapies, as well as related consulting activities, 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 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.

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 We look forward to partnering with clients that have late stage, commercial projects with our expertise and capacity at our Rentschler Biopharma Manufacturing Center in Milford, USA. Thanks to a 22,000 square feet of manufacturing cleanroom space and four 2,000 L single-use bioreactors, we meet our clients’ changing needs by building design to accommodate future adaptions for scale and capacity. 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.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 146

| 147


Name › Richter-Helm BioLogics GmbH & Co. KG Address/P.O. Box › Suhrenkamp 59 Postal Code/City › 22335 Hamburg State › Hamburg Contact Person › Dr Thilo Kamphausen Telephone › +49-40-55290-801 Fax › +49-40-55290-888 Email › BusinessDevelopment@richter-helmbiologics.eu Social Media › I Number of Employees › < 320 Founded (year) › 1987 Areas of Activity › Contract development and manufacturing of biopharmaceuticals derived from microbial systems Biological Patents › Several patents on manufacture of recombinant proteins and pDNA 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 to the next level. Please contact our experts for more detailed information.

High class GMP-compliant microbial production of biopharmaceuticals – Plasmid DNA and Proteins Richter-Helm is a leading and expanding Germanybased contract development and manufacturing organisation (CDMO) specialised in a broad range of products derived from bacteria and yeasts. With a 35-year long track record in GMP manufacturing, Richter-Helm provides its clients with a unique knowledge base in process and analytical validation, process performance qualification (PPQ) procedures, commercial production of therapeutic proteins and peptides, antibody-like scaffolds (e.g., VHH/ Nanobodies, Fab-fragments), bacterial vaccines, and plasmid DNA (pDNA) products. Our seasoned, highly educated, and motivated teams support the global pharmaceutical and biotechnological industries with one-stop-shop services from process development to analytical development, manufacturing, QC testing and filling of finished product. We operate two GMP-compliant production sites with bioreactor capacities of up to 1,500L. Two additional bioreactors with capacities of 300L and 1,500L for ­m icrobial production are installed to further provide manufacturing solutions for large and commercial scales. Richter-Helm consistently works to the highest standards of pharmaceutical quality as verified by major regulatory bodies including EMA, FDA, PMDA, ANVISA, MFDS, and more, 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.


RICHTER-HELM BIOLOGICS

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 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) › In-house QC testing and release › Stability studies according to ICH guidelines › Strain and process development › RHB-pART – pDNA for different purposes at scales needed › GMP manufacturing for clinical phases I to III › Commercial GMP manufacturing › Process validation and PPQ procedures 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.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 148

| 149


Name › RNATICS GmbH Address/P.O. Box › Am Klopferspitz 19a Postal Code/City › 82152 Martinsried State › Bavaria Contact Person › Dr Johannes Schmidt Telephone › +49-89-200006040 Email › info@rnatics.com Website › https://rnatics.com/ Social Media › I Number of Employees › 6 Founded (year) › 2021 Areas of Activity › RNA therapeutics, drug development, Inflammatory lung diseases

RNATICS develops first-in-class nucleic acid therapies targeting disease-causing RNAs in tissue resident macrophages via inhalation. This novel mode of targeted delivery enables access to immune cells previously not accessible to nucleic acid therapies, thus offering tremendous therapeutic opportunities. The discovery of small non-coding RNAs has dramatically expanded our understanding of gene expression control. They are involved in virtually all human phases of life and offer unforeseen potential for the therapy of diseases via modulating oligonucleotides (e.g. antimiRs), allowing highly specific and selective control of RNAs. The major hurdle for these therapies to date is the delivery to the target cells. “Naked” oligonucleotides are inefficiently absorbed and not tissue-selective, which poses a considerable risk of side effects.

The unmet clinical need There is a high unmet clinical need for the treatment of inflammatory lung diseases with fibrotic lesions. Acute viral infections, such as Influenza or SARS-CoV-2, often result in fibrotic lung damage due to hyperinflammation, severely compromising the lung’s function and structural integrity with patients needing mechanical ventilation. To date, there is no targeted treatment for these hyperinflammatory lung diseases and only symptomatic treatment with immunosuppressants are available with significant side effects.

The technology Our proprietary technology delivers nucleic acid drugs specifically and efficiently to lung macrophages. The therapeutically active oligonucleotide is coupled to a carbohydrate-based ligand enabling uptake by macrophages through cell-specific receptors. The oligonucleotide then selectively regulates the respective RNA’s function. The therapy is administered via inhalation. This novel approach allows for a more precise and targeted treatment, enabling higher local doses to achieve the therapeutic effect with fewer side effects.


RNATICS

Current Status Our most advanced drug candidate, RCS-21, an antisense oligonucleotide against miR-21 coupled to the macrophage-targeting moiety, is in development for the treatment of inflammatory lung disease after viral infection. It is designed to prevent scarring of lung tissue and selectively targets the hyperinflammation triggered by virus-mediated cell death. The therapeutic effect of the drug is independent of virus types. The therapeutic efficacy of RCS-21 was tested in a preclinical model for acute lung damage. A single inhaled dose resulted in significant improvement of pulmonary dysfunction, reduction of lung damage, and a partial normalisation of the accumulation of lung macrophages. Based on these promising results, already considered by the BfArM to be sufficient to start clinical trials, we are currently completing IND-enabling work and aim to start first-in-human clinical trials within the next 12 months.

The bigger picture There are additional lung diseases, acute and chronic, in which pulmonary hyperinflammation mediated by macrophages plays a crucial role. We’re actively developing treatments based on our technology for these clinical needs. Furthermore, because macrophages, the immune cells targeted by our technology, can be found in virtually all organs of the human body, there are ample opportunities to develop novel RNA therapies for other macrophagedriven diseases.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 150

| 151


Name › Roche Diagnostics GmbH Address/P.O. Box › Nonnenwald 2 Postal Code/City › 82377 Penzberg State › Bavaria Contact Person › Dr Johannes Ritter Telephone › +49-8856-60-2600 Fax › +49-8856-60-3417 Email › deutschland.kommunkation@roche.com Website › www.roche.de/ueber-roche/standorte/ penzberg Number of Employees › 7,500 Founded (year) › 1896 (Group) Type of Laboratory › S1–3 Areas of Activity › Biotechnology based research, development, production of diagnostics and raw materials (including Custom Biotechs), active pharmaceutical ingredients Annual Turnover › CHF 63.3 bn (Group) Relevant R&D Budget › CHF 14.1 bn (Group) Request for › www.roche.com/innovation/ Further Collaborations partnering/

Company profile Penzberg is the Bavarian location of Roche Diagnostics GmbH. Situated south of Munich on 590,000 m2, and with a workforce of more than 7,500 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 50 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 a total of €1,1bn 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 crossnetworking 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 Diagnostics 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, women’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 1.000 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 Roche’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. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 152

| 153


Name › Sanofi-Aventis Deutschland GmbH Address/P.O. Box › Industriepark Höchst, Gebäude K703 Postal Code/City › 65926 Frankfurt am Main State › Hesse Contact Person › Roger Jung Telephone › +49-69-305-84280 Email › Roger.Jung@sanofi.com Website › www.sanofi.de Number of Employees › 7,700 Founded (year) › 2004 Type of Laboratory › Pharma Biotechnology, S1 and S2 GMP facilities for clinical and commercial manufacturing of APIs, DPs, and devices Areas of Activity › Focus on improving human health R&D as well as process development and production of biopharmaceuticals incl. commercial activities, medical devices

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 90 countries with 59 manufacturing and 20 R&D sites, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. Sanofi is increasingly focusing on biotechnology. Our R&D pipeline includes 78 clinical-stage projects, 23 of which are in phase 3 or have been submitted to regulatory authorities for approval and a large proportion of which are biologics.

Pharmaceutical value creation in Frankfurt The BioCampus Frankfurt is the largest integrated production and manufacturing site within Sanofi and an important part of the European research network. Here, around 6,000 of the 7,700 employees in Germany research the origins of diseases and look for targets for medicinal treatment or prevention, and are dedicated to drug development, active ingredient production and drug manufacturing, medical device development up to distribution in around 80 countries. These include insulins, monoclonal antibodies and drugs for medical treatment in oncology. An important research area in Frankfurt is immunology and inflammatory diseases. In addition to a long history in diabetes research, research expertise focussed on rare diseases, oncology and neuroscience.

Technology platforms With the BioCampus and its state-of-the-art technologies, the site combines numerous research activities and expertise in various fields: Technology platforms for peptides, antibody and Nanobody ® -molecules; integrated development center for the development and production of biologics such as antibodies, ­S ynthorinTM- or Nanobody ® -molecules - from early research to production for clinical trials.


SANOFI

Biotech manufacturing Sanofi has a global network of biotech manufacturing sites for APIs from mammalian cell cultures as well as for microbial fermentation, sterile drugs and medical devices. The Frankfurt BioCampus specialises in the production and manufacturing of biotechnological drug substances and sterile drug products and devices. The manufacturing activities also covers the insulin portfolio.

Partnerships Through partnership and collaboration that focuses on transformative science, we strive to ensure the successful development and commercialisation of medicines and vaccines for patients everywhere. The German research site itself has almost 50 collaborations in ­Germany and abroad.

At a glance - selection of our competencies › Multidisciplinary teams › Several large-scale biotechnological production ­facilities (bacterial/mammalian) › Lab to industrial scale technologies in up- and downstream processes for microbial fermentation and mammalian cell-culture. › Licensed GMP facilities for APIs › Full value chain from API production, DP aseptic filling and Device technology › State of the art bio analytical capabilities › High quality standards and inspection records › Integrated drug discovery › Pre-clinical safety (In-silico, Artificial Intelligence, Genotoxicity) › Large Molecules Research & Development e.g., antibody, Nanobody®- and SynthorinTM -Molecules › Tissue imaging › Modelling and simulation › Multispecifics and high-throughput discovery

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 154

| 155


Name › Sartorius CellGenix GmbH

High-quality GMP reagents for cell and gene therapy manufacturing

Address/P.O. Box › Am Flughafen 16 Postal Code/City › 79108 Freiburg State › Baden-Wuerttemberg Contact Person › Prof. Dr Felicia Rosenthal Telephone › +49-761-888-89-0 Fax › +49-761-888-89-800 Email Address › info@cellgenix.com Internet Website › cellgenix.com Social Media › I Q Number of Employees › >80 Founded (year) › 1994

Sartorius CellGenix is a leading global supplier of highquality raw materials for the expanding market of cell and gene therapy as well as regenerative medicine. We develop, manufacture, and market human cytokines, growth factors 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 a former 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.

Type of Laboratory › GMP Clean Room facilities A/B/C/D S1/S2 Areas of Activity › Ex vivo raw materials for Cell & Gene Therapy Regenerative Medicine Request for › l T cells Further Collaborations l MSCs l iPSCs, ESCs l NK cells

Sartorius CellGenix is headquartered in Freiburg, Germany. In Juli 2021 the life science group Sartorius acquired a majority stake in CellGenix.

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 Sartorius CellGenix has more than two decades of in-house expertise in GMP manufacturing and the ­development of products (DC, HSC, cord blood cells, and chondrocytes) in the field of cell and gene therapy


SARTORIUS CELLGENIX

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. Sartorius 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). With many years of experience in the field of cell and gene therapy, Sartorius 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 more than 20 years ago and co-authored chapter <92> with the USP in 2010.

Regulatory excellence Sartorius CellGenix GMP products are based on three major quality standards: › Safety Safe and qualified raw materials in compliance with our ADCF 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 20399. GMP cytokines are tested and released according to USP Chapter <92> as applicable.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 156

| 157


Name › ScheBo®• Biotech AG (Head office) ScheBo®• Biotech UK Ltd. ScheBo®• Biotech USA Inc. Address/P.O. Box › Netanyastrasse 3 Postal Code/City › 35394 Giessen State › Hesse Contact Persons › René M. Kröger, PhD Sonja Scheefers Jeffrey Scheefers Telephone › +49-641-4996-0 Fax › +49-641-4996-77 Email › schebo@schebo.com Website › www.schebo.com Number of Employees › 48 The academic staff has many years of experience in the research and development of diagnostics Founded (year) › 1989

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 › is completely privately funded and independent, › operates internationally, › develops innovative diagnostics.

Areas of Activity › Development, production and marketing of diagnostics Biological Patents › 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. essian Innovation Award of Awards › 1993 – H the MBG and Certificates 1998 – Hessian Innovation Award of the MBG 2002 – “Hidden Champion 2002” 2002 – “ Innovationspreis der deutschen Wirtschaft“ (4 certificates) 2004 – A mong the finalists for the “Innovationspreis der deutschen Wirtschaft”

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) › S cheBo ® • 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. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 158

| 159


Name › SciRhom GmbH Address/P.O. Box › Am Klopferspitz 19 (IZB) Postal Code/City › 82152 Martinsried State › Bavaria Contact Person › Dr Jan Poth Telephone › +49-89-614241230 Email › info@scirhom.com Website › www.scirhom.com Social Media › I Number of Employees › 9 Founded (year) › 2016 Areas of Activity › Preclinical and early clinical development of therapeutics with novel mode of action, treatment of autoimmune and inflammatory diseases, key inflammation pathways, iRhom2/TACE signal transduction biology Biological patent › Comprehensive international patent portfolio External › Hospital for Special Surgery, New York, collaborations expert academic collaborators, highly reputable Contract Research Organisations

SciRhom and its Vision SciRhom is a pioneering biotech enterprise with the vision to translate advanced scientific findings into game-changing therapies for the treatment of autoimmune and inflammatory diseases. Based on a decade of ground-breaking research by Prof. Carl Blobel, M.D., Ph.D., co-founder of SciRhom and Director of the Arthritis and Tissue Degeneration Program at Hospital for Special Surgery, New York, SciRhom is developing first-in-class antibodies against the cellular target protein iRhom2 for the selective inhibition of the inflammatory master switch TACE.

SciRhom’s Approach TACE (TNFα converting enzyme or ADAM17) controls several major signalling pathways in health and disease, including TNFα, IL-6R, and EGFR signalling, and has therefore been considered a highly attractive target to block pro-inflammatory pathways. However, direct inhibition of TACE causes severe side effects, such as skin and intestinal lesions, since it leads to the blockade also of physiologically important and protective pathways. Very recently, iRhom2 (inactive Rhomboid 2, RHBDF2) was discovered as the exclusive key regulator of TACE for the disease-associated release of TNFα, IL-6R, and HB-EGF from immune cells. In contrast, the activation of TGFα as a crucial mediator of skin and intestinal barrier function is supported by both iRhom2 and its closely related family member iRhom1. SciRhom’s highly specific antibodies against only iRhom2 open the exciting opportunity to selectively and simultaneously target the iRhom2-mediated pro-inflammatory activities of TACE, while preserving its iRhom1-supported protective functions important for normal physiology. This new mode of action allows for a highly efficacious but safe treatment of various disorders, including major debilitating autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease, and lupus glomerulonephritis.


SCIRHOM

SciRhom’s Asset

The Innovation & Gründerzentrum Biotechnologie (IZB) in Martinsried near Munich, home of a number of biotech companies (© IZB)

SciRhom’s key asset is a series of first-in-class humanised monoclonal antibodies (mAbs) against iRhom2 with excellent physicochemical, pharmacokinetic, and pharmacological properties. Reflecting the simultaneous blockade of several disease-driving pathways and the restoration of immune-balancing mechanisms, our antibodies have proven superior efficacy over the current standard of care single pathway inhibitors Humira, Remicade, RoActemra, and Skyrizi in various disease mouse models. Further to the unique mode of action, our anti-iRhom2 antibodies promise a better tolerability and a real disease-modifying effect. The CMC development of the clinical candidate and its toxicological assessment required for regulatory approval of a first clinical study were successfully completed with the goal to start the first-in-human trial in early 2024. SciRhom’s antibodies are protected by four strong patent families that cover the antibodies themselves, their iRhom2 target epitopes, as well as their therapeutic use until 2039.

SciRhom’s Management Illustration of iRhom1/TACE and iRhom2/TACE complexes and their role in driving inflammatory processes (iRhom2/TACE) as well as protecting the skin & intestinal barrier (iRhom1/TACE and iRhom2/TACE)

Our management team unites several decades of biotech and big pharma experience in advancing therapeutics into early clinical development and beyond, and consists of › Jan Poth, Ph.D., Managing Director & CEO › Jens Ruhe, Ph.D., Co-Founder, Managing Director & COO › Matthias Schneider, Ph.D., Co-Founder & CSO › Jürgen Reeß, M.D., Ph.D., CMO

Inhibiting iRhom2/TACE complexes by binding our antibody to iRhom2 simultaneously blocks a number of pathways driving inflammation, while the physiological effects, such as skin & intestinal barrier protection, are preserved through the activity of unaffected iRhom1/TACE complexes

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 160

| 161


Name › Secarna Pharmaceuticals GmbH & Co. KG Address/P.O. Box › Am Klopferspitz 19 Postal Code/City › 82152 Planegg/Martinsried State › Bavaria Contact Person › Alexander Gebauer, MD, PhD, CEO & Managing Director Konstantin Petropoulos, PhD, MBA, CBO & Managing Director Telephone › +49-89-215-46-375 Fax › +49-6421-98300599 Email › info@secarna.com Website › Secarna.com Social Media › I Number of Employees › 17 Founded (year) › 2015 Areas of Activity › Discovery and development of highly specific, safe, and efficacious 3rd generation ASOs to address areas of high unmet medical need in immunooncology and fibrotic/ inflammatory diseases External › Denali Therapeutics, Inc. collaborations Engelhard Arzneimittel Evotec SE Firebrand Therapeutics, Inc. First Affiliated Hospital at Guangzhou Sun Yat-sen University (SYSU) Lipigon Pharmaceuticals AB SciNeuro Pharmaceuticals Request for › Secarna strives to become the global Further Collaborations partner of choice for all ASO drug discovery and development programs and is open to new partnerships

Secarna Pharmaceuticals is a next generation antisense oligonucleotide (ASO) company that addresses high unmet medical needs. Although Secarna has active partnerships across multiple therapeutic areas, the focus of its proprietary pipeline is in the areas of immuno-oncology and fibrotic/inflammatory diseases. The Company’s mission is to leverage its proprietary next generation ASO platform, LNAplus, to bring, highly specific, safe, and efficacious ASO therapies to patients. Founded in 2015, Secarna is proud to have established its discovery and development unit with more than 2,000 square feet of lab and office space at the IZB Martinsried – one of Europe’s most vibrant biotechnology clusters. Antisense oligonucleotides offer new avenues for ­addressing a variety of targets deemed undruggable by current therapies. Excitingly, the RNA pipeline has grown at a faster rate than gene therapies in recent times, suggesting that it is finally taking its well-deserved share of the spotlight. Secarna offers a compelling approach to antisense drug discovery and development with the only independent next-generation ASO platform, making it the leading European player.

LNAplus – Streamlined, high-efficiency candidate generation LNAplus is a 3rd generation ASO platform that encompasses all aspects of drug discovery and ­pre-clinical development. The platform includes the powerful proprietary Oligofyer™ bioinformatics and LNA Vit(r) ox™ screening system, best-in-class high throughput screening, and target-specific functional assays. A key advantage of the LNAplus platform is the rapid generation of high-quality clinical development candidates, typically within 6 - 12 months after project initiation.


SECARNA

The technology’s (pre-)clinical validation Secarna’s ASOs have been validated by in-house projects and in several successful pharma-partnered programmes, including a large programm with Lipigon, who has advanced the first ASO derived from the LNAplus platform into the clinic. Secarna maintains a diversified in-house pipeline of 11 encouraging ASO programmes, with advanced pre-clinical programmes in the immunoncology and fibrotic/inflammatory disease spaces. This offers promising projects for in-house development and shareholder value creation as well as attractive licensing opportunities for regional or global pharma partners. In-house Discovery & Development Pipeline: High value programmes progress through early-stage clinical studies, followed by the potential out-licensing of these candidates. Discovery & Research Alliances: Platform deals for broader discovery and development collaborations leveraging Secarna’s entire toolbox to generate partnered and co-owned ASO pipelines Secarna seeks to establish ASO therapeutics as the third pillar in drug development, next to small molecules and antibodies, thereby expanding the universe of druggable targets. Therefore, the Company strives to become the partner-of-choice for ASO drug discovery and development programmes and to form strategic partnerships fully leveraging its collaborators’ as well as the Company’s own strengths. To learn more about the competitive edge of the LNAplus platform, visit www. secarna.com or get in touch: partnering@secarna.com.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 162

| 163


Name › SERVA Electrophoresis GmbH Address/P.O. Box › Carl-Benz-Straße 7 Postal Code/City › 69115 Heidelberg State › Baden-Wuerttemberg Contact Person › Dr Barbara Müller Telephone › +49-6221-13840-0 Fax › +49-6221-13840-10 Email › info@serva.de Website › www.serva.de Number of Employees › 45 Founded (year) › 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 (pro­ teomics, 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 “PRiME TM” (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

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).

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 ope­r ation quality assurance to process quality assurance within the framework of maintenance contracts, adapted to your needs at the silver, gold, or platinum level.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 164

| 165


Name › SGS Analytics Germany GmbH Address/P.O. Box › Bayerstr. 53 Postal Code/City › 80335 Munich State › Bavaria Contact Person › Jennifer de la Peña Telephone › +49-175-1637081 Email › de.hn.muc.proposals@sgs.com Website › http://www.sgs-institut-fresenius.de/ www.sgs-institut-fresenius.de Social Media › I Number of Employees › 35 Founded (year) › 1994 Areas of Activity › Central Lab Services

SGS Health Science enables the medical and health innovators of the world to deliver life-changing solutions in the quickest, safest, and most efficient way, helping improve the lives of many. We provide the highest quality services, reliable ­e xper tise, and guidance through our network of ­laboratories c ­ onveniently located around the globe to ­deliver harmonised quality and scientific solutions to our ­biotechnology and pharmaceutical partners. Take advantage of our longstanding exper tise, ­commitment, and broad portfolio!

Our portfolio includes: Central lab services Services incl. customised visit kits and instructions for the clinical study sites. Our solution-minded project management teams oversee materials expiry and global sample logistics at ambient, cooled, or frozen temperatures. Our comprehensive testing portfolio ranges from standard safety analysis to biomarkers and bioanalysis (small and large molecules, PK, ADA, NAb) to complex personalised testing solutions, as well as PBMC/BMMC isolation services, all according to the highest quality standards. Highly customised lab reports and data transfers result in further advantages, as easy automated uploads to eCRFs. Study Services › Customised, visit-specific kit building › Supply of kits and ancillary material to sites, including expiry tracking › Worldwide samples logistics at ambient, cooled, and frozen temperatures › Extended sample storage at ambient temperature, 2-8°C, -20°C, -80°C, or liquid N2 › Global study data base, identical lab reports worldwide › Customised lab reports and data transfers › Committed and experienced project and data mana­g ement, providing local support and global oversight › Secure online access › Services also available as stand-alone services


SGS ANALY TICS

Customised Lab Services › Assay development › Method validation according to EMA/FDA guidelines › PBMC/BMMC cell isolation › Biomarker screening and development Analytical Services › 24/7 lab service for early phase trials › Safety analysis (hematology, biochemistry, serology, and much more) › Advanced analytical spectrum (advanced coagulation panel, large allergy panel, immunological analysis, PK, PD, immunogenicity, biomarkers) › Genetics incl. NGS › Histopathology and cytology › Experience with various matrices (e.g. serum, plasma, CSF, ascites, bone marrow) Quality Assurance › GCP, GCLP compliant › Independent QA department › Periodic audits from customers as well as inspections by the relevant agencies incl. FDA › 21 CRF Part 11 compliant study database › Quality Agreements in place with other SGS labs

CRO Services Specializing in clinical trials in the field of respiratory/ infection diseases (our own phase 1 unit with capabilities to perform human challenge studies) and dermatology/ ophthalmology, we offer sponsors around the world customised and innovative solutions, dedicated study units, and a growing network of qualified external sites.

Production control services (GMP) The previous services are rounded off by our contract laboratory services to support our clients during the ­development and production of the IMP/ authorised drug. The services include CDMO quality control, stability ­studies, and characterisation as well as impurity analysis, ­nitrosamines, and Leachable and Extractables (L&Es).

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 166

| 167


Name › Sino Biological Europe GmbH Address/P.O. Box › Düsseldorfer Str. 40 Postal Code/City › 65760 Eschborn State › North Rhine-Westphalia Contact Person › Bin Hu, Ph.D. Telephone › +49-6196-96786-56 Fax › +49-6196-96786-57 Email › order_eu@sinobiologicaleu.com Website › www.sinobiological.com Social Media › F I  Number of Employees › 960+ Areas of Activity › An internationally recognized reagent supplier and contract research organisation, specialising in recombinant protein production and antibody development.

About Sino Biological Sino Biological is a global leading provider of biological research reagents and related contract research services. The company is headquartered in Beijing, China, and has established subsidiaries in the US, Germany, and Japan. Sino Biological became a public company in August 2021, when it successfully completed an IPO on the stock exchange ChiNext, a subsidiary of the Shenzhen Stock Exchange (Sino Biological, 301047). The company offers a vast portfolio of about 6,500 recombinant proteins, 14,000 antibodies, 47,000 genes, and multiple serum-free mammalian cell culture media products. These reagents are used by over 7,000 customers from pharmaceutical and biotechnology companies to research institutions in over 90 countries and regions worldwide. Sino Biological’s proprietary technology platforms also enable customized end-toend solutions for customers with complex protein and antibody needs.

Strengths of Sino Biological Led by a group of experienced scientists, the company is constantly striving for growth, quality, and innovation. Sino Biological’s team is continuously growing and currently has over 960 members, among whom a third have masters or doctoral-level degrees. In recent years, the company has expanded to over 346,000 square feet, including 268,000 square feet of R&D and production facilities and over 78,000 square feet of GMP-level manufacturing workshops and laboratories, where over 2,000 new protein and antibody products are developed every year. Many of these new products are best-in-class on the market, including GMP-grade cytokines, enzymes and kinases, and full-length multi-transmembrane proteins. The Company has also achieved ISO9001, ISO13485, and CNAS quality system certifications.


SINO BIOLOGICAL EUROPE

Comprehensive Solutions for Life Sciences Covering Cell Therapy, Antibody Drug Development, Vaccine Development, and More

GMP-grade Cytokines for Cell Therapy Research Extensive Range of GMP-grade Cytokines with High-purity and High-bioactivity

Sino Biological has long been recognized for its contribution to the field of infectious disease research. The Company’s ProVir™ reagent collection is the world’s leading viral antigen bank, featuring thousands of antigens and antibodies covering a wide range viral types including influenza, RSV, HIV, Ebola, coronavirus strains, and more. Many of these reagents have been used to manufacture rapid antigen and antibody diagnostic tests around the globe. In addition, the company has received CiteAb’s “Supplier Succeeding in SARS-CoV-2 Research” and “Protein Supplier to Watch” awards for two consecutive years. Sino Biological aims to advance life science and improve human health through the provision of superior quality research reagents and CRO services. The Company will continue to develop new products to address the unmet needs and demands from today’s biomedical research community.

Sino Biological’s location

High-quality Reagents for Hot Therapeutic Targets

Sino Biological Europe is located in Frankfurt, Germany, providing the close-to-customer local services. If you have any questions, please feel free to contact our ­local team in Germany (order_eu@sinobiologicaleu.com).

• Premium Recombinant Proteins and Antibodies • Multiple Citations in Top-tier Journals

ProVir®: World's Largest Viral Antigen Bank • Covering SARS-CoV-2, Influenza Virus, RSV, HIV, HPV, Ebola, Zika, and More • 1,100 Antigens from 380 Strains

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 168

| 169


Name › Sirius Fine Chemicals SiChem GmbH Address/P.O. Box › Fahrenheitstr.1 Postal Code/City › 28359 Bremen State › Bremen Contact Person › Dr Miriam Rittner Telephone › +49-421-2208-228 Fax › +49-421-2208-226 Email Address › mrittner@sichem.de Internet Website › www.sichem.de Number of Employees › 17 Founded (year) › 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 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. purification of APIs and intermediates, pesticides, natural produts / isolation of API impurities and metabolites › 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 complemented by innovative tools for click chemistry (Si-Click®): › clickable unnatural amino acids › clickable dyes › bi- and trifunctional clickable lipids › clickable (PEGylated) tools

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 170

| 171


Name › T-CURX GmbH Innovations- und Gründerzentrum Würzburg Address/P.O. Box › Friedrich-Bergius-Ring 15 Postal Code/City › 97076 Würzburg State › Bavaria Contact Person › Dr Ulf Grawunder Telephone › +49-931-250-99-712 Email › info@t-curx.com Website › www.t-curx.com Social Media › I Number of Employees › 15 Founded (year) › 2017 Areas of Activity › Cancer, Oncology, CAR-T therapies, virus-free, scalable, autologous CAR-T manufacturing

T-CURX GmbH is a private biopharmaceutical company, spun out from the University of Würzburg and located in Würzburg and Munich, Germany. T-CURX focuses on identifying, developing and commercializing nextgeneration autologous CAR-T cell therapies in cancer indications of high medical need. The company´s proprietary CAR-T technologies were developed in the laboratories of co-founder Prof. Michael Hudecek at Universitätsklinikum Würzburg and are centered around a novel, proprietary virus-free, Sleeping Beauty (SB) Transposon-based gene transfer technology, which is exclusively licensed to T-CURX. The company is both a technology/platform company, as well as a company developing a pipeline of clinical CAR-T programs against novel targets with first- and best-in-class potential. The first product is in clinical development (Ph I), the 2nd CAR-T program (in AML) is currently prepared for clinical trial application.

Innovative technologies T-CURX‘ technologies address major limitations of the current CAR-T cell therapy market – the high costs and the low scalability. The company’s virus-free gene transfer, based on the Sleeping Beauty Transposon technology, is highly scalable, as it only requires manufacturing of DNA and mRNA vector components, as opposed to complex virus-based vectors. Therefore T-CURX’, manufacturing process is less complex than standard technologies leading to lower COGS and better suitability for decentralized manufacturing. Additional proprietary technologies that will leverage T-CURX’ CAR-T cell product pipeline include the proprietary Matchmaker technology for optimized potency and efficacy of CAR-T cell products, which is a key requirement for addressing solid tumour targets. In addition, T-CURX has developed a proprietary safety-switch allowing the control of CAR-T cell function after infusion into patients for improved safety. T-CURX’ technology platform is protected by a strong IP portfolio consisting of 8 patent families covering our 3 CAR-T technologies and 5 CAR-T pipeline programs.


T-CURX

Team T-CURX is led by the company´s co-founder and CEO Ulf Grawunder, PhD, a serial entrepreneur with a proven track record in company building and deal making (founder and ex-CEO of NBE Therapeutics AG sold to Boehringer-Ingelheim for $1,4 billion). His expertise is matched by a management team and Board of Directors with complementary skills and established networks, both in Europe and the US. T-CURX is also supported by its Scientific Advisory Board, a highly regarded network of leading experts in immune- and cell therapies that serve as external advisors. CEO Ulf Grawunder highlights “With T-CURX, being the third company I am building from ground up, I am excited to see our technology develop into innovative novel therapies as well as new gold-standard manufacturing technologies to make CAR-T therapies available to many more patients at need.”

Our vision T-CURX’ transposont echnology is a potential gamechanger by enabling scalable and affordable CAR-T cell therapies. T-CURX aims to establish its manufacturing technology as the future gold-standard in CAR-T manufacturing. The application of Transposon and Matchmaker technologies will overcome limitations of current CAR-T cell therapies by lowering complexities, COGS, and enabling highly scalable manufacturing. We aim to become a leading European CAR-T cell company focused on democratizing CAR-T cell therapies for many more cancer patients.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 172

| 173


Name › Tentamus Pharma & Med Deutschland GmbH, site Bad Kissingen Address/P.O. Box › Columbiastraße 14 Postal Code/City › 97688 Bad Kissingen State › Bavaria Telephone › +49-971-785-580 Fax › +49-971-785-58-25 Name › Tentamus Pharma & Med Deutschland GmbH, site Karlsruhe Address/P.O. Box › Am Hubengut 3 Postal Code/City › 76149 Karlsruhe State › Baden-Wuerttemberg Telephone › +49-721-957-919-500 Fax › +49-721-957-919-900 Name › Tentamus Pharma & Med Deutschland GmbH, site Oldenburg Address/P.O. Box › Würzburger Straße 3 Postal Code/City › 26121 Oldenburg State › Lower Saxony Telephone › +49-441- 3613-265-440 Fax › +49-441-3613-265-441 Contact Persons › Dr Sven Asche Email › info-tpmd@tentamus.com Website › Tentamus-pharma.de Social Media › I I Number of Employees › 100 Founded (year) › 2021 Type of Laboratory › Contract Laboratory for Pharmaceutical and Medical Device Analytics Areas of Activity › Pharmaceuticals, Medical Devices, Bioanalytics, In vitro Analytics, Instrumental Analytics (ASS, ASA, AES, ICP-MS, GC, LC, IC, IR, TOC, TLC), Celland Immune Analytics, Micro- & Molecularbiology, GMP Laboratory

Tentamus Pharma & Med Deutschland GmbH is your Contract Laboratory for Pharmaceutical and Medical Device Analytics Together with our clients, we tailor the chosen testing methods precisely and efficiently to the relevant requirements and regulations and document the analyses reliably and in compliance with regulatory rules. If required, we also develop and validate individual testing methods.


TENTAMUS

Our laboratories are › GMP-certified › Registered with the FDA › Accredited in accordance with ISO 17025 › Our microbiological laboratory is authorised to handle biosafety level 2 microorganisms (human and animal pathogens as defined by the German Infection Protection Act (Infektionschutzgesetz) and the German Animal Health Act (Tiergesundheitsgesetz) and biosafety level 2 GMOs. › We have a licence from the Federal Opium Agency of the German Federal Institute for Drugs and Medical Devices (BfArM) to handle various narcotic drugs. › We offer batch certification and EU retests performed by qualified personnel. › We hold a manufacturing licence in accordance with Section 13 of the German Drugs Act (AMG), which enables our qualified personnel to monitor pharmaceuticals testing and release products. › We have a specially equipped cytostatic area in which we can safely process and analyse cytotoxic raw materials and pharmaceuticals.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 174

| 175


Name › TheryCell GmbH Address/P.O. Box › Schlossstrasse 110 Postal Code/City › 12163 Berlin State › Berlin Contact Person › Dr Steffen Hennig Telephone › +49-30-548298-90 Fax › +49-30-546116-98 Email › hennig@therycell.de Website › www.therycell.com Number of Employees › 5 Founded (year) › 2017 Type of Laboratory › Molecular Biology Lab Areas of Activity › | Cancer immunotherapy | T cell profiling | Immune system | Tumour-reactive T cells | Immuno-Oncology | Adoptive Cell Therapy Biological Patents › EP2746405 ‘Methods and primer sets for high throughput PCR sequencing’ EP3180433 ‘Method for providing tumour-specific T cells’ External › | Vivantes Clinics, Berlin Collaborations | Charité, Berlin | Fraunhofer Institute for Cell Therapy and Immunology, Leipzig | Max Delbrück Center, Berlin Request for › Pharma companies with R&D in Further Collaborations immunotherapies

Background Cancer immunotherapy has transformed the therapeutic management of difficult to treat cancers. Immune checkpoint inhibition and adoptive cell therapy with immune receptor-engineered (CAR-, TCR-) T cells have demonstrated the power of T cells to control cancer. However, most patients either do not benefit from treatment or are not eligible for available therapy options. This situation is particularly dire for patients with advanced solid cancers, i.e., carcinomas, which account for more than 85% of cancer-related deaths. In fact, almost all solid cancers are infiltrated by T cells with at least some showing signs of suppressed tumour reactivity. TheryCell applies a proprietary technology to identify these tumour-specific T cells, decipher the coding sequences of their TCRs, synthesize the TCRs and make them available for the genetic engineering of fresh T cells of each individual patient for adoptive cell therapy.

TheryCell was founded in 2017 by a multidisciplinary team with expertise in immuno-oncology, molecular biology, and bioinformatics as well as management experience in start-up companies and pharma industry. At TheryCell, we are committed to the development of a unique personalized TCR-T cell therapy against solid cancers. Based on comparative deep sequencing of the TCR repertoires of tumours and adjacent normal tissues, we identify for each patient an individual set of tumour-specific TCRs and use them for genetic engineering of fresh autologous TCR-T cells. Our method is the only antigen-agnostic approach to the detection of tumour-specific TCRs on the market and can be applied to any patient with available tumour material. To manufacture tumour-specific TCR-T cells, we work together with leading institutions in the fields of nonviral genetic engineering of cells and manufacturing of cellular therapeutics.


THERYCELL

DNA Sequencing is our key to identify the tumor-reactive T-cells

What makes us different? Following tissue preparation, cell sorting and immune sequencing, our patented technology identifies tumour-reactive T-cells by comparative sequencing of TCR repertoires of tumour and adjacent normal tissue. Cutting-edge single-cell sequencing unravels any detail of tumour-specific TCRs, enabling us to produce the receptors for the genetic engineering of bonafide tumourreactive TCR-T cell therapeutics. We employ a non-viral approach for the manufacturing of the tumour-specific TCR-T cells which is as efficient as state-of-the-art viral methods but has a superior safety profile. The lower complexity of the process and smaller scale required for the manufacturing of individual charges of therapeutic cells is expected to reduce the costs of adoptive cell therapies significantly.

Our mission

T-cells attacking and killing a cancer cell.

The development of a personalized cellular therapy employing each patient’s tumour-specific TCRs for the manufacturing of therapeutic TCR-T cells is a significant extension to the existing arsenal of advanced medicinal therapeutic products (ATMPs), i.e., CAR-T and TCR-T cells. Whether a patient with advanced disease is eligible for therapy does not depend on specific target antigens or the HLA type of the patient but solely on the availability of tumour material suitable for analysis. The application of non-viral technologies to the manufacturing of the TCR-T cells is an effective, safe, and cost-effective alternative to state-of-the-art viral methods. This will be an enabling factor for the personalization of adoptive cell therapies for patients with advanced solid cancers.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 176

| 177


Name › Tosoh Bioscience GmbH Address/P.O. Box › Im Leuschnerpark 4 Postal Code/City › 64347 Griesheim State › Hesse Contact Person › Regina Roemling Telephone › +49-6155-7043700 Fax › +49-6155-8357900 Email › Info.tbg@tosoh.com Website › www.tosohbioscience.de Number of Employees › >20 Founded (year) › 1989 Areas of Activity › 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 SkillPak columns pre-packed with best-in-class TOYOPEARL resins for quick and reproducible development and scale-up of purification methods and a holistic multicolumn chromato­graphy solution for DSP intensification, the Octave BIO instrument and dedicated SkillPak BIO columns. 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 12,000 people. Our brands TOYOPEARL® and TSKgel® 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.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 178

| 179


Name › Valicare GmbH

Valicare – ONE-STOP SHOP for Quality and GMP Services

Address/P.O. Box › Eschborner Landstrasse 130-132 Postal Code/City › 60489 Frankfurt on the Main State › Hesse Contact Person › Dr E. Sons-Brinkmann Telephone › +49-69-153-293-700/709 Email › info@valicare.com Website › www.valicare.com Social Media › I Number of Employees › > 100 Founded (year) › 2002

Valicare GmbH is a GMP service supplier headquartered in Frankfurt/Main since 2002 and a subsidiary of Syntegon Technology GmbH, a leading supplier of process and primary packaging technology for the pharma and food industry. Valicare is ISO 9001:2015 certified and has a subsidiary (joint venture) in Turna/ Slovakia. Multidisciplinary teams of engineers, scientists, pharmacists, experienced project managers and senior GMP consultants support customers in the pharma, biotech, and medical device industry and specially manufacturer of Advanced Therapy Medicinal Products (ATMPs). More than 5.000 GMP projects have been successfully completed worldwide so far ranging from ISO and GMP compliance consulting to hands-on qualification and validation support.

Areas of activity › GMP compliance services for Pharma, Biotech, ATMP & Medical Device manufacturer

Our approaches are always risk-based, efficient but also pragmatic-according to the motto: as little as possible but as much as necessary. Together with the qualification, validation, and documentation services, we offer high-level GMP (and GxP) consulting support: › GMP and ISO compliance consulting based on your demands › Structuring and moderation of workshops (e.g., risk analysis, risk assessment) › Design and planning of GMP-compliant project workflows › Definition of high-level process or project specifications (URS) for GMP new and rebuild projects › Establishment, adaptation, or optimisation of comprehensive GMP quality assurance systems › Individual concepts for topics like risk, change or deviation management or validation strategies › GMP, gap and target-performance analyses for every topic in the GxP-regulated environment and for quality systems according to DIN EN ISO 9001 and DIN EN ISO 13485 › Supplier audits of contract laboratories and external manufacturers (on your request, we organise and take over the complete qualification of your suppliers)


VALICARE

› Broad spectrum of GMP trainings (for beginners & advanced) and preparation of any kind of GMP documentation › Pilot plant planning (conceptual and basic design) and construction support for GMP cleanrooms in cooperation with Syntegon We offer risk-based, integrated qualification and validation support in compliance to GMP guidelines, especially Annex 15 of EU GMP guideline independent of the manufacturer. Our service includes, but is not limited to: › Design review, plant-specific technical and process risk analyses, qualification of equipment from laboratory to large machines and (clean-) rooms, FAT, SAT, preparation of qualification documentation and definition of test conditions, calibration and requalification after modernisation, HMI upgrades or format change › Qualification and validation of decontamination processes in isolators as well as of systems for optical inspection control (one of our special competences) › Validation of manufacturing processes, cleaning processes, analytical methods, and computer systems › SMEPAC (Standardised Measurement of Equipment Particulate Airborne Concentration) planning & execution

Our passion: GMP for Advanced Therapy Medicinal Products (ATMPs) – support throughout the whole life cycle Our service packages offer expert advice on the development, transfer, and implementation of straight and GMP-compliant ATMP manufacturing processes. Our concept for turnkey manufacturing solutions (cult.tainer), fully equipped GMP-compliant cleanroom modules, enable process development and manufacturing of ATMPs on-site, accompanied and supported in all GMP issues by our experts. Due to the large number of successfully implemented projects in very different GMP subject areas, we know efficient and pragmatic solution approaches. Benefit from our expertise!

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 180

| 181


Name › Vetter Pharma International GmbH Address/P.O. Box › Eywiesenstrasse 5 Postal Code/City › 88212 Ravensburg State › Baden-Wuerttemberg Contact Person › Andrea Wesp Telephone › +49-751-3700-0 Email › EU and other international inquiries: info@vetter-pharma.com US inquiries: infoUS@vetter-pharma.com Asia Pacific inquiries: info@vetter-pharma.com Website › www.vetter-pharma.com Number of Employees › 6,000 Founded (year) › 1950 Areas of Activity › Drug Product Development, Aseptic clinical and commercial fill and finish, Device Assembly and Packaging, Analytical Services, Regulatory Support, Logistic services External › Strategic collaboration with Rentschler Collaborations Biopharma SE, headquartered in Laupheim, Germany, for bioprocess development and API production (since July 2020)

We place heightened focus on your success as your strategic partner We produce aseptically prefilled syringes, cartridges, vials and dual-chamber systems as a globally operating CDMO partner. We are a family-owned, independent company rooted in 70+ years of history. We do not manufacture our own drugs – we focus on providing highly skilled support and state-of-the-art manufacturing resources. We support our customers from the initial phases of clinical drug product development and filling to commercial manufacturing, device assembly and packaging, and lifecycle management. Over 80% of our active projects are biologics.

We are a reliable, responsive, and progressive partner Our portfolio of services includes dedicated resources for clinical development and commercial manufacturing as well as assembly and packaging, and more. We provide tailored solutions to meet your product’s specific market needs.

Services › Drug Product Development Support in navigating key early decisions in your product’s evolution with scalability, quality and efficiency in mind. › Aseptic Filling & Visual Inspection Comprehensive expertise in manufacturing injectable drug products and related visual inspection systems. › Device Assembly & Packaging Strategic, technical and packaging support for patient-friendly combination products. › Analytical Services Robust, customizable testing methods for drug products including evaluation and quality verification. › Regulatory Support Support to achieve milestones related to compliance during clinical development, market authorization and beyond. › Logistic Services Cutting-edge solutions that maximize efficiency, transparency and precision of a vital supply chain.


VETTER PHARMA INTERNATIONAL

Fast facts: Vetter-at-a-glance › Headquartered in Ravensburg, Germany › Commercial production sites in Ravensburg and Langenargen, Germany › Dedicated clinical production facilities in Rankweil, Austria, and Chicago, USA › Branch offices for Asia Pacific in Singapore, Japan, South Korea, and China › More than 6,000 employees worldwide › Global specialist in the aseptic production of prefilled drug delivery systems › International expertise with regulatory authorities including FDA, EMA, PMDA (Japan), and RP (Germany) › Service offerings for pharma and biotech firms of all sizes and locations › Numerous patents including technologies for protection against tampering and counterfeiting › Lyophilization (freeze-drying) and siliconization specialist › CO2 neutral at all corporate sites since 2021

For more information, please scan the QR code.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 182

| 183


Name › Viscofan BioEngineering, a business unit of Viscofan DE GmbH Address/P.O. Box › Badeniastraße 13 Postal Code/City › 69469 Weinheim State › Baden-Wuerttemberg Contact Person › Dr Lluís Quintana Telephone › +49-6201-86-358 Fax › +49-6201-86-226 Email › contact@bio.viscofan.com Website › www.viscofan-bioengineering.com Social Media › I Number of Employees › 14 Founded (year) › 2008 Areas of Activity › Development and manufacturing of collagen products for | regenerative medicine | biomedical R&D External › | University of Tübingen (Germany) Collaborations

| University of Navarra (Spain) | Fraunhofer Institut IGB (Stuttgart, Germany) | Hospital Gregorio Marañón (Madrid, Spain) | FC Barcelona (Spain) | CELLINK (Sweden) | FILK Institute (Freiberg, Germany) | TriAnkle EU Project (Horizon 2020, Project Coordinator) | ARDAT Project (Innovative Medicines Initiative IMI-2) | VASCage GmbH (Austria)

Your partner for collagen in regenerative medicine Viscofan BioEngineering is a business unit of V ­ iscofan DE GmbH – the centre of excellence for collagen within the Viscofan group, a global leader in collagen production. Building on over 90 years of experience in industrialscale bovine collagen production for the food market, we use this extensive know-how to develop advanced solutions for the biomedical sector. With the goal of facilitating cell biology research and ultimately enabling the development of novel therapies in regenerative medicine, we have established a unique portfolio of collagen products.

Collagen scaffolds for a wide range of applications As an essential structural component of the extracellular matrix, collagen type I provides a scaffold that supports cell attachment and function as well as organ integrity. Due to these cell- and tissue-promoting properties and the flexibility of use in different formats, collagen matrices are established biomaterials in research and development. Applications range from vessel coatings and inserts for 2D- and 3D-cultures to implantable membranes for regenerative surgery, medical device coatings, or bioinks for tissue engineering. What sets our collagen matrices apart is firstly the intense yet gentle purification of insoluble collagen type I fibres, which preserves their native and complex structure, resulting in high biocompatibility and mechanical strength. Secondly, we shape the collagen fibre suspension into customisable scaffolds with unique properties that enable novel applications and therapeutic solutions.


VISCOFAN BIOENGINEERING

Our portfolio at a glance: › Collagen Cell Carrier ® › Collagen Membranes › Collagen BioTubes › Bovine Soluble Collagen › Fibercoll-Flex® Bioinks › Viscolma® Collagen Suspension › Collagen Gel™ › Collagen Sponges

Certified manufacturing for safe products Viscofan BioEngineering stands for biocompatible, safe, and reliable collagen products. Our quality management ensures optimal purity, structure, and biological safety from batch to batch. The in-house manufacturing starts with traceable bovine raw material with negligible BSErisk and covers the entire workflow from processing of the skin splits to the ready-to-use collagen product. The industrial production process together with a thorough quality control management system according to DIN ISO 9001 or DIN ISO 13485 for medical grade Viscolma® collagen suspension ensures the consistent high quality of all our collagen-based biomaterials.

Enabling global breakthroughs in regenerative medicine Our collagen products permit easy and cost-efficient bench-to-bedside transfer and are sold worldwide. In addition, Viscofan BioEngineering is also developing its own pipeline of products in regenerative medicine in collaboration with renowned partners and consortia. With the combination of premium products, our all-round know-how in collagen manufacturing, as well as expert customer support, Viscofan BioEngineering promotes new break-throughs in medical development and is open to collaborations.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 184

| 185


Name › Vivoryon Therapeutics N.V. 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 › Anne Döring, CFA Telephone › +49-345-555-99-00 Email › info@vivoryon.com Website › www.vivoryon.com Social Media › I Number of Employees › 18 Founded (year) › 1997 Areas of activity › Alzheimer´s, Clinical Trial Ph 2

Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY) is a clinical-stage company focused on the discovery and development of small molecule medicines. Driven by passion for ground-breaking science and innovation, the company strives to change the lives of patients in need suffering from severe diseases. Vivoryon leverages its in-depth expertise in understanding post-translational modifications to develop medicines that modulate the activity and stability of proteins which are altered in disease settings. Vivoryon’s lead program varoglutamstat is in Phase 2 clinical development for the treatment of Alzheimer’s disease (AD). The anti-N3pE antibody PBD-C06, currently in pre-clinical development, complements the company’s differentiated strategy to counter AD. Furthermore, Vivoryon has established a solid pipeline of orally available small molecule inhibitors for various indications.

Tackling AD at the roots: early intervention to address multiple hallmarks of AD The Challenge AD drug development is marked by a low success rate and a long development phase. This delays new treatments and discourages investments. Studies of drug development programs for various diseases have identified important strategies to reduce the risk and increase the likelihood of success of drug development programs. These experiences guide Vivoryon’s approach to AD drug development.


VIVORYON

Targeting QPCT/L in AD Vivoryon strives to overcome the challenges in AD drug development by pursuing an entirely new mechanism of action. N3pE amyloid is a particularly neurotoxic variant of abeta peptides, which is only found in AD patients and not present in the brains of healthy individuals. N3pE amyloid in the brain acts as a seeding element for abeta aggregation, thus providing a starting point for plaque formation. It has been described to correlate with the cognitive ability of AD patients. N3pE amyloid is formed by the enzyme glutaminyl cyclase (QPCT). Vivoryon’s lead candidate in clinical development, varoglutamstat (PQ912), blocks QPCT thereby addressing amyloid-related pathology as well as other downstream pathologies, such as tau pathology and synaptic impairment. Through a second mode of action, the inhibition of full CCL2 maturation via QPCT’s isoenzyme QPCTL, varoglutamstat also modulates pro-inflammatory signaling and tau pathology, thereby simultaneously addressing multiple hallmarks of AD. Data from a completed Phase 2a study of varoglutamstat provided important safety information and also showed first evidence of the disease-modifying capabilities of varoglutamstat, most importantly with statistically significant changes from baseline in working memory as an important cognitive ability after only 12 weeks of treatment. Vivoryon has received Fast Track designation for ­varoglutamstat in early AD by the U.S. Food and Drug Administration (FDA) and is currently in clinical Phase 2 development with studies ongoing in Europe and the United States.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 186

| 187


Name › WuXi Biologics Germany GmbH Address/P.O. Box › Chempark Leverkusen, Building C152, Tor 15 Postal Code/City › 51368 Leverkusen State › North Rhine-Westphalia Contact Person › Martin Wans Telephone › +49-214-357-62001 Email › Info.germany@wuxibiologics.com Website › Locations & Facilities (wuxibiologics.com) Social Media › I Number of Employees › 400+ Founded (year) › 2020

WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development, and Manufacturing Organisation (CRDMO) offering end-to-end solutions that enable partners to discover, develop, and manufacture biologics – from concept to commercialisation – for the benefit of patients worldwide. The company’s history and achievements demonstrate its commitment to providing a truly one-stop service offering and strong value proposition for its global clients. With total estimated capacity for biopharmaceutical production planned in the US, China, Ireland, Germany, and Singapore exceeding 580,000 litres after 2026, WuXi Biologics will provide its biomanufacturing partners with a robust and premier-quality global supply chain network.

State of the art – Drug Product & Drug Substance facilities in Germany Since 2020, WuXi Bio has significantly invested in the purchase and retrofitting of two state-of-the-art manufacturing facilities in Germany, enabling the company to offer end-to-end services spanning the entire biologics manufacturing process.

Leverkusen – Drug Product Fill Facility Acquired in 2020 from Bayer, the WuXi Biologics Leverkusen facility is a fill and finish drug product manufacturing plant that offers over 13,000 sq. m. of commercial-scale drug product fill capabilities. The site achieved its GMP approval for Drug Product manufacturing in June 2020. Located in the heart of the CHEM­ PARK Leverkusen, the center of Europe’s chemical market between the highly attractive cities of Cologne and Dusseldorf, the sterile filling and freeze-drying plant provides an annual capacity of approximately ten million doses and is being expanded to include a second variable filling line. Together with our drug substance facility in nearby Wuppertal we support the entirety of the biologics manufacturing process.


WUXI BIOLOGICS

Wuppertal – Biologics Manufacturing Facility The WuXi Biologics Wuppertal site is a state-of-theart Drug Substance (DS) facility with flexible and open spaces for future expansion. Ideally located in Wuppertal, an important focal point of Germany’s Pharma industry, the facility offers more than 30,000 sq. m. of operating space, including two cell culture suites with multiple 2000L bioreactor capacity, as well as multiple upstream and downstream suites, integrated laboratory space, and a warehouse within the building. The drug substance facility is expected to double its total capacity from 12,000L to 24,000L by 2025. Its close proximity to our Leverkusen fill and finish facility enables WuXi Biologics Germany to offer integrated drug substance and drug product services. The Wuppertal facility expects its GMP approval in 2023 to support WuXi Biologics’ Global Dual Source supply chain network strategy, which ensures that materials can be sourced and products can be manufactured at multiple facilities.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 188

| 189


Name › X-act Cologne Clinical Research GmbH Address/P.O. Box › Rudi-Conin-Strasse 4 Postal Code/City › 50829 Cologne State › North-Rhine Westphalia Contact Person › Olivia F. Hoffmann, Sales & Marketing Manager Jasmin Atarodi, Managing Director Ilka Strehlau, Head of Clinical Data Management Telephone › +49-221-337716-0 Fax › +49-221-337716-33 Email › business@x-act-cologne.com Website › https://x-act-cologne.com Social Media › I Q Number of Employees › 35+ Founded (year) › 1994 Areas of Activity › | Specialised service provider | Clinical data management | Biostatistical services

Passion for evidence since 1994! We are an experienced partner to the life science industry, obtaining reliable study results for the development of safe and innovative therapies. › Owner-managed CRO. › Established 1994 and located in Cologne, Germany. › Successful conduct of more than 450 interventional (Phase I to IV), non-interventional and medical device studies. › 35 + seasoned and technophile team members ­contribute to the success of your project.

Biostatistical Services › Statistical consulting, assuring that your scientific questions are answered. › Delivering sample size determinations and statistical input to your study protocols. › Development of a randomisation plan. Performing randomisation according to your study requirements. › Developing Statistical Analysis Plans with a clear focus on the statistical programming of key results and analyses. › SDTM and ADaM Mapping supporting the submisson of your study results. › Biostatistical reporting as part of your clinical study / investigational report, publication or dossier.


X-ACT COLOGNE

Clinical Data Management › Strategic consulting to find the best eClinical solution for your project. › eCRF implementation according to CDSIC | CDASH supporting submission. › Development of all essential DM documents for your successful project conduct. › Implementing Good Clinical Data Management Practices throughout your project. › The conduct of all DM activities is supported by the excellent procedures of our SOPs. › Targeted data review and data cleaning in close collaboration with your CRA team. › Benefit from expressive status reports providing transparency and overview to the study team. Curious about our special services? Please contact: business@x-act-cologne.com

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 190

| 191


Name › XL-protein GmbH Address/P.O. Box › Lise-Meitner-Str. 30 Postal Code/City › 85354 Freising State › Bavaria Contact Person › M. Gebauer, U. Binder Telephone › +49-8161-5373090 Fax › +49-8161-5373099 Email › info@xl-protein.com Website › www.xl-protein.com Social Media › I Number of Employees › 8 Founded (year) › 2009 Areas of Activity › | PASylation® technology | Biologics with extended half-life: proteins, enzymes, antibody fragments, cytokines, peptides, nanoparticles | Innovative Biopharmaceuticals Patents › Global IP portfolio, covering both the technology platform and emerging drug candidates

XL-protein is a privately owned biotech company commercializing its clinical-stage PASylation® technology, which enables the design of biopharmaceuticals with enhanced action and extended half-life upon systemic application or in the eye. XL-protein’s mission is the preclinical as well as clinical development of innovative biologics with superior performance by applying its proprietary and versatile PASylation® platform while offering licensing and technology partnerships to support pharmaceutical and biotech companies with their own drug development programs.

PASylation® technology PASylation ® involves the genetic fusion or chemical conjugation of a therapeutic protein or pharmaceutically active compound with a conformationally disordered polypeptide of defined length and sequence comprising the small natural amino acids Pro, Ala, and/or Ser. Due to the biophysical size effect, the typically rapid clearance of the original drug, mainly driven by renal filtration, can be retarded by a factor of 10-100, depending on the length of the PAS chain. PAS biopolymers offer a range of benefits: › high solubility in aqueous buffers as well as in polar aprotic organic solvents › totally uncharged biopolymer, no influence on the isoelectric point of the pharmacologically active component › stable in blood plasma, ocular vitreous as well as other body fluids, but traceless proteolytic degradation after intracellular uptake › biochemically inert, non-toxic and non-immunogenic › compatible with recombinant protein production in a variety of established biotechnological host organisms › available as monodisperse polymer substances with tailored lengths and linker groups on demand › genetically encodable as part of a recombinant fusion protein.


XL-PROTEIN

XL-protein’s PASylation® technology has been validated by multiple commercial and academic collaboration partners and successfully applied to a wide range of pharmacologically active proteins and peptides, including hormones, cytokines, antibody fragments, enzymes as well as nanocarriers, both for therapeutic use and in vivo diagnostics. Beyond in vivo stabilisation and half-life extension, PAS biopolymers offer exciting opportunities for the delivery of nucleic acids, as vaccines or as therapeutic entities, either by direct chemical conjugation or by way of lipid nanoparticle (LNP) formulation, while avoiding undesirable immune reactions as they have been reported for the non-biodegradable poly-ethylene glycol (PEG).

Partnerships & networks XL-protein is engaged in a growing network of partnerships at different levels with international pharmaceutical and biotech companies that are driving the development of first-in-class therapies, including several PASylated products in ophthalmology (e.g. Akari Therapeutics), cardiovascular disease (e.g. Antlia Bioscience) or oncology (e.g. Jazz Pharmaceuticals). Our team of expert protein engineers is committed to supporting our partners during the drug discovery and development process, thus facilitating the transformation from preclinical to the clinical stage while offering technology transfer to the extent needed. Furthermore, XL-protein has established non-exclusive partnerships with a series of C(D)MOs and demonstrated bioprocess development and manufacturing of PAS fusion proteins or PAS biopolymers in multiple expression systems including mammalian cells (Rentschler Biopharma), E. coli (Wacker Chemie), C. glutamicum (Ajinomoto BioPharma), yeast as well as other production organisms.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 192

| 193


Name › YMC Europe GmbH Address/P.O. Box › Schöttmannshof 19 Postal Code/City › 46539 Dinslaken State › North Rhine-Westphalia Contact Person › Dr Friederike Becker Telephone › +49-2064-427-0 Fax › +49-2064-427-222 Email › info@ymc.eu Website › www.ymc.eu Social Media › I Q Number of Employees › 50 (Europe) 485 (worldwide) Founded (year) › 1993 Areas of Activity › | Glass Columns for Lab and Pilot Scale | Prepacked Glass Columns | Laboratory Services | Preparative Liquid Chromatography | Analytical Liquid Chromatography

Your resource for chromatography As a research-driven chromatography specialist, YMC provides chromatographic solutions for compounds such as peptides and proteins, mAbs, and ADCs, as well as oligonucleotides from R&D scale through scale-up to production and final quality control in your lab. We supply innovative bio-chromatography resins and columns for preparative processes, as well as highly reproducible BioLC-(U)HPLC-columns for SEC, IEX, RP, & HIC. Furthermore, YMC glass columns in laboratory as well as pilot scale are designed to meet bio-chromatographers’ demands. You can choose them empty as well as prepacked according to your requirements by YMC’s inhouse packing service. In addition, you can make use of on-demand services for application support, screening, analytical, or preparative method development. Trainings on different chromatographic topics complement the products and services.

Innovations The most recent and interesting developments include: › The new standard for columns for bio purification suitable for self-packing: YMC PilotPLUS › Next generation RP phase for peptide purification: YMC-Triart Prep Bio200 C8 › Innovative solutions for BioLC: YMC-Triart Bio (U)HPLC columns, also available in bioinert hardware The broad and continuously growing portfolio of stationary phases especially designed for the separation of biomolecules provides high flexibility for the chromatographer and ensures successful lab results, day after day. Additionally, the availability of particle sizes from analytical to preparative scale guarantees smooth and easy scale-up processes.


YMC EUROPE

Worldwide availability and support guaranteed YMC products are available worldwide through a dedicated support network that guarantees qualified and meaningful practical assistance with regard to method development, method transfer, method validation, purification services, and custom column packing – ­locally, personally, and efficiently. It is not only product specifications that represent YMC quality, also but the positive energy and dynamics of our employees, who provide competent and consistent performance together with pronounced reliability even for the most difficult and demanding separations. The YMC network consists of highly focused product specialist teams to provide active support for chromatographers.

Regulatory Support Since all YMC processes and working procedures are thoroughly monitored and documented, YMC resins and glass columns are fully compliant with requirements. Full technical documentation is available to show compliance with all applicable regulations.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 194

| 195


Name › YUMAB GmbH Science Campus Braunschweig-Süd Address/P.O. Box › Inhoffenstr. 7 Postal Code/City › 38124 Braunschweig State › Lower Saxony Contact Person › Alexander Ehm Telephone › +49-531-481170-0 Email › info@yumab.com Website › www.yumab.com Social Media › I Number of Employees › 30 Founded (year) › 2012 Type of Laboratory › S1, S2 Areas of Activity › | Fully human antibody discovery & lead development | Antibody Libraries | Engineering & Humanisation | R&D services (CRO) | Partnered innovation Request for › YUMAB seeks clients & partners for Further Collaborations human antibody development in the biopharma, biotech, & diagnostic industries.

Bridging the gap from target to lead 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 since become a global player that advances medicine by accelerating the development of next-generation biotherapeutics. Our advanced discovery platform provides access to challenging targets, enables new formats, and accelerates the development of human antibodies at a high success rate. From target discovery to fully characterised lead – our experienced team leads biotech and pharma teams worldwide through the development process as your trusted, de-risking partner.

Jump start for translation The YUMAB® R&D platform delivers fully human anti­ bodies, the closest to natural germline among those on the market, using fast and reliable in vitro discovery technologies. The company’s highly diverse, human anti­ body libraries contain 1011 natural antibody sequences and specificities to all types of antigens. Unlike animalderived, 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. 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.

Proven success Our contract research and partnered development has been proven successful by more than 200 projects over the past decade with over 120 clients and partners worldwide.


YUMAB

1

When the Corona pandemic hit in 2020, YUMAB collaborated with the University Braunschweig and other partners to develop antibodies against SARS-CoV-2, generating leads in only four months. The awarded fast track collaboration led in 2020 to the spin-out of ­CORAT Therapeutics GmbH, which is pursuing the clinical testing of the antibody drug candidate COR-101 (phase Ib/II) in hospitalised patients with moderate to severe COVID-19. COR-101 is designed not to induce elevated immune responses that contribute to lung damage, which enables treatment of patients with high viral loads.

E A R

S

ANNIVERSAR 2012 - 2022

BRIDGING THE GAP FROM TARGET TO LEAD

Trusted partner 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. Our expert team values close communication with customers and partners, whom we consult and guide through the entire process of antibody development – from target to lead.

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 formats, all disease areas › Robust process, high success rates 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 › CRO: fee-for-service & flexible licensing options › No technology access fees › Collaborative development

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 196

| 197


Name › Zedira GmbH

Business Unit: Drug Discovery Design of small molecule transglutaminase inhibitors

Address/P.O. Box › Roesslerstrasse 83 Postal Code/City › 64293 Darmstadt State › Hesse Contact Person › Dr Ralf Pasternack Dr Martin Hils (Managing partners) Telephone › +49-6151-66628-0 Fax › +49-6151-66628-19 Email › contact@zedira.com Website › www.zedira.com Social Media › I Number of Employees › 16 Founded (year) › 2007 Areas of Activity › Drug Discovery: Transglutaminase inhibitors | Celiac disease | Fibrotic disorders | Anticoagulation Specialty Reagents: | Pharma | Diagnostics | R+D Patents › Portfolio covering different classes of small molecule transglutaminase inhibitors External › Licensees: Takeda, Dr. Falk Pharma Collaborations Request for › Zedira offers co-development Further Collaborations opportunities in the fields of fibrosis and anticoagulation

TG2 blocker for Celiac Disease: ZED1227 › First transglutaminase blocker in clinics › Proof-of-concept in Celiac Disease (CD) › Currently P2b in CD and P2a in NASH/NAFLD › Licensed to Takeda and Dr. Falk Pharma

TG2 blocker for fibrotic disorders: ZED3269 › Oral, systemic availability › Unique, reversible mode-of-inhibition

FXIIIa blocker for anticoagulation: ZED3197 › Novel, untapped target › Anticoagulation without increased bleeding ­tendency


ZEDIRA

Business Unit: Specialty Reagents Transglutaminase specialty reagents

Microbial Transglutaminase (AndraconTM) › Antibody drug conjugate (ADC) generation › Tissue scaffold formation

Diagnostic antigens and enzymes › TG2, TG3 TG6 › DGPx1 › FXIIIa › Plasmin › …

Transglutaminase R&D › 250 unique products › Transglutaminases › Assays and substrates › Antibodies › Inhibitors › …

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 198

| 199


Engage with customers all over Europe. Europe is a common research area and, for the industry, it represents a huge unified market with more than 500 million potential customers. The magazine European Biotechnology has been both monitoring and shaping this economic area for 22 years now. Together, we can keep improving. Join us!

Annual subscription €80 Please order online: european-biotechnology.com

european-biotechnology.com BIOCOM Interrelations GmbH I Jacobsenweg 61 I 13509 Berlin I Germany Tel. +49 (0)30 264921-54 | info@biocom.de I www.biocom.de


Profiles of Service Providers

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 200

| 201


Name › BIO.NRW The Home of Biotech Address/P.O. Box › Merowingerplatz 1 Postal Code/City › 40225 Dusseldorf State › North Rhine-Westphalia Contact Person › Dr Nils Schrader Telephone › +49-211-385-469-9200 Fax › +49-211-385-469-9220 Email › bio.nrw@bio.nrw.de Website › www.bio.nrw.de Social Media › I  Number of Employees › 9 Founded (year) › 2008

BIO.NRW – Business for biotech Since 2008, BIO.NRW is the official biotechnology network of the German 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 science technologies, which are key to answering the most challenging tasks of our society.

Our services include: Central Platform for Life Science Topics

Areas of Activity › | Technology transfer | Effective Network for Scientists, Founders and Entrepreneurs | Assisting Start-Ups and SMEs in Terms of Financing and Internationalisation | National and international fairs, exhibitions and conferences | Analysis of biotechnology in North Rhine-Westphalia for location data | Central Platform for Life Science Topics | Supporting Students and Young Talents | Online jobfair External › | Local to international companies, research institutions, financiers, and Collaborations further biotech stakeholders

We organise events, congresses, workshops, expert panels and roundtable discussions to promote the dialogue between business, research, investors and policymakers to activate cooperation.

Effective Network for Scientists, Founders and Entrepreneurs 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

Assisting Start-Ups and SMEs in Terms of Financing and Internationalisation 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.

Supporting Students and Young Talents Tech transfer support is a key contribution from BIO.NRW. The network takes special interest in assisting young professionals in biotechnology. We offer a range of ­a ctivities and events with different topics that are of ­specific interest for founders and start-ups. The BIO.NRW Business Angel Network for example helps financing and funding biotec start-ups.


BIO.NRW

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 5.0% of the European GDP (EU-27). If classified as an independent nation, NRW would rank 20th 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. NRW offers the most extensive network of academic institutions in Germany. Five of the ten largest universities (by number of students) in Germany are located in NRW. More than 20 Max Planck Institutes, Fraunhofer Institutes, Leibnitz Association facilities and Helmholtz research centers complement the academic research in the field of life sciences in NRW. This variety of academic institutions is a good basis for an agile start-up scene. Young, innovative companies such as Detechgene, Serengene and PROSION, together with international global players such as Bayer, Qiagen, Miltenyi and a strong network of SMEs form the economic backbone of NRW. Most of the NRW biotech companies are traditionally active in the pharmaceutical sector. For this reason, the thematic focus BIO.NRW.red was launched in 2010. It bundles the diverse competencies of academic institutions, companies, clinics, biomedical and technology centers in the field of red biotechnology. The interactive network addresses the most important topics in medicine, health, and the pharmaceutical industry in NRW. Another strength of NRW’s biotech industry is industrial (‘white’) biotechnology, which benefits from the states strong chemical industry, e.g. Evonik, Henkel, Covestro, Lanxess. The sector is connected by the bioeconomy and circular-economy activities of BIO.NRW. Since 2021 these forward-looking activities are bundled in the thematic focus BIO.NRW.eco.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 202

| 203


Name › BIOCOM Interrelations GmbH – a BIOCOM AG company Address/P.O. Box › Jacobsenweg 61 Postal Code/City › 13509 Berlin State › Berlin Contact Person › Andreas Mietzsch Telephone › +49-30-264921-0 Fax › +49-30-264921-11 Email › service@biocom.de Website › www.biocom.de Number of Employees › 34 Founded (year) › 1986 Areas of Activity › | Consulting | Publishing | Events | Video production

Our mission Information and communication for the biotechnology, content-driven and results-oriented - that has been BIOCOM’s self-formulated mission statement since it was founded 38 years ago. A lot has developed scientifically and technically in these four decades, but the core task is more topical than ever. In times of looming climate catastrophe and a rapidly ageing population in many countries, biotechnological solutions are the means of choice. Yet reliably informing all actors in the economic, political and social arena about this is a greater task than ever. At BIOCOM today, a dedicated team of young as well as more experienced staff is ready to take on this information task via many different channels.

Publishing With our journals |transkript (German) and European Biotechnology Magazine (English), which are published both in print and online, we have the two leading B2B publications in Europe in our programme. Plus various books, such as this Guide to German Biotech Companies. BIOCOM’s media are useful for the reader and attractive for the companies. From advertisements to advertorials and online campaigns to corporate publishing, many things are possible.

Information platforms Comprehensive information platforms on behalf of the public sector are a very successful business area for BIOCOM. An excellent example is biooekonomie.de: This is the information portal on the bioeconomy in Germany and worldwide. Here everyone can find news, portraits, interviews and reports, videos and podcasts, innovative multimedia stories as well as databases on funding programmes, researchers and research institutions. In addition, exhibitions, information stands and on-site events help to communicate the bioeconomy to a broad target group.

Events BIOCOM organises large and small events, such as the INDUSTRIA BIOTEC. At this conference, industrial biotechnology solutions are discussed and presented to a wider public.


BIOCOM

Consulting and studies BIOCOM prepares market, financial and technologyspecific studies with the highest user value for its clients. It conducts qualitative and quantitative analyses, developed closely with customers and delivering focused, accurate data. The result is clear, informative dossiers with highest quality information to effectively support professionals in industry and politics.

Industry surveys Consistent and internationally comparable statistics are a valuable tool for political decision makers. BIOCOM has long-standing experience in sector-specific surveys of both industry and academia. Based on global definitions such as the OECD’s biotechnology statistics framework, we have so far performed surveys in several European countries. Survey results are kept in proprietary databases of the European life science sector and are aggregated and processed for publication.

Horizon Europe and beyond BIOCOM compiles targeted communication for projects such as the EU Framework Programme for Research and Innovation (e.g. Transition2bio, COMBINE, BE-Rural). Our communication expertise ranges from strategy development, digital and print communication, public relations, website development, film and animation, and social media. Besides network management and secretariat organisation (e.g. for the International Advisory Council on Global Bioeconomy), we create memorable experiences in the form of inspiring conferences, exhibitions, innovative workshops and dialogue formats. Beyond this, we draw on years of experience in policy analysis and evidence-based policy advice and capacity building.

Video production BIOCOM offers the full range of services for the creation of audiovisual content: from consulting and conception, filming and post-production to strategies for the distribution in social media. The portfolio includes image and corporate films, recruiting videos, product and explainer videos, documentaries and portraits as well as animations in 2D and 3D. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 204

| 205


Name › BioM Biotech Cluster Development GmbH Address/P.O. Box › Am Klopferspitz 19a Postal Code/City › 82152 Martinsried, Munich State › Bavaria Contact Person › Prof. Dr Ralf Huss Telephone › +49-89-899679-0 Fax › +49-89-899679-79 Email › info@bio-m.org Website › www.bio-m.org Social Media › I Number of Employees › 21 Founded (year) › 1997 Areas of Activity › | Supporting start-ups regarding foundation and financing with specialised coaching, training, and mentoring programmes | Start-up Incubator MAxL (Munich Accelerator Life Sciences & Medicine) | Supporting biotech and pharmaceutical companies with an extensive network | Connecting Bavarian life sciences companies with national and international companies, investors, and relevant stakeholders | National and international conferences, exhibitions, and fairs | Seminars and workshops | Company database | Online job market | News, press releases, report „Biotech in Bavaria“

BioM – Biotechnology Cluster Management for Munich and Bavaria Since 1997, BioM has been 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.


BIO M BIOTECH CLUSTER DEVELOPMENT

BioM for founders

BioM - Biotechnology Cluster Management Gateway to the Bavarian Biotech Community

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. In total, BioM has supported more than 250 startup companies in over 25 years. From idea to success: › Startup Coaching – get hands-on support › Mentor Circle – inspired by experience › Pitch Doctor – how to convince investors › BioTech Boot Camp – validate your business idea › BioEntrepreneur Lounge – join the community › BioAngels – find the right investor › m4 Award – create the future of medicine

BIOTECH IN BAVARIA TOWARDS NEW HORIZONS

REPORT 2022 | 23

MAxL - Munich Accelerator Life Sciences & Medicine

managed by

BIOTECH IN BAVARIA

MAxL is BioM’s unique start-up incubator and supports selected Bavarian pre-seed and early-stage start-up teams from the life sciences and healthtech sectors with well-targeted funding. On 900m2 MAxL offers exclusive high-end infrastructure and access to a vibrant start-up community and BioM’s extensive network. 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 Bio M publishes the report “Biotech in Bavaria”, a compilation of current business figures and success stories of the Bavarian biotechnology and pharma­ceutical industry with a comprehensive company list and detailed company profiles.

TOWARDS NEW HORIZONS

managed by

REPORT 2022| 23 including more than 300 company profiles

www.bio-m.org 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 206

| 207


Name › biomindz Standortentwicklungsgesellschaft Mainz mbH Address/P.O. Box › Schillerplatz 18 Postal Code/City › 55116 Mainz State › Rhineland-Palatinate Contact Person › Felix Wälder Telephone › + 49-6131-126280 Email › info@biomindz.com Website › https://www.biomindz.com Social Media › I Number of Employees › 4 Founded (year) › 2023 Areas of Activity › Campus Development: | support for life sciences and biotechnology companies interested in setting up or growing at the Life Science Campus Mainz Network Management: | enabling access to the biotechecosystem in Mainz | connecting start-ups and companies with inter:national companies and startups, investors and other relevant stakeholders | Organisation of regular networking events International marketing: | advertising and communication activities | presence at national and international fairs, exhibitions and conferences

The Life Science Hub Mainz – For People’s Benefit Thanks to the success of BioNTech in particular, the science and biotechnology location of Mainz has moved into the worldwide focus of attention. The city of Mainz is making targeted use of this momentum and is to become an internationally visible and successful biotechnology location. The goal is based on a socially relevant core: life sciences and biotechnology from Mainz improve the quality of life of people – everywhere.

biomindz - to support the biotech industry in Mainz To enable startups and companies to successfully establish and grow in Mainz, the biomindz Standortentwicklungsgesellschaft Mainz mbH (biomindz) was founded as a municipally owned company. The organisation’s primary task is to support the ongoing development and promotion of the life sciences and biotechnology sector in Mainz. In doing so, biomindz will be closely coordinating its activities with departments within the city responsible for urban planning and development as well as sustainable mobility.


BIOMINDZ

Our Services The company’s activities are divided into four key areas: › Development of the Life Science Campus close to the University, the University Medical Center and the University of Applied Sciences Campuses. › Sustainability management to ensure sustainable and, as far as possible, net zero carbon development from the outset that is intended to serve as a showcase for subsequent projects. › Networking management to connect various local partners and to support the creation of structures for a supra-regional and neutral cluster organisation in Rhineland-Palatinate. › Public relations and marketing activities to raise the international profile of and market the location as well as to provide regular updates to the public.

Our promise In Mainz, you can successfully research, found and grow sustainably – for people’s benefit!

More Information On our website (www.biomindz.com), you will find information on the prospects, strengths, and potential for life sciences and biotechnology in Mainz. In addition, the website provides an overview of all life sciences and biotechnology companies as well as R&D organisations and science institutions. It offers direct contact to various persons who may help you if you have any interest in the Life Science Hub Mainz.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 208

| 209


Name › BIOPRO Baden-Württemberg GmbH Address/P.O. Box › Alexanderstraße 5 Postal Code/City › 70184 Stuttgart State › Baden-Wuerttemberg Contact Person › Dr Barbara Jonischkeit Telephone › +49-711-218185-00 Fax › +49-711-218185-02 Email Address › jonischkeit@bio-pro.de Internet Website › www.bio-pro.de Social Media › I Number of Employees › 25 Founded (year) › 2003 Areas of Activity › Bioeconomy, Healthcare Industry

Our mission: pooling competencies – pushing innovations BIOPRO Baden-Wuerttemberg comes under the auspices of the Baden-Wuerttemberg government and is specifically focused on the following areas: biotechnology, pharmaceutical industry, and medical technology (healthcare industry). › We work in partnerships 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-Wuerttemberg. One of our major objectives is to push innovations in the healthcare industry and help with the translation of inventions into the broader market for the benefit of society as a whole. As a central point of contact for issues relating to the healthcare industry, we represent Baden-Wuerttemberg 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. For example, we work as a networking partner and provide an information database in the field of regulations for medical and pharmaceutical products. Furthermore, we offer a whole platform of information about regulatory affairs and help the industry to keep track of recent regulations, European and national. Our vast experience as a coordinator allows us to help firms, stakeholders, 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 BadenWuerttemberg, from research and development to production and sales. Baden-Wuerttemberg 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 cooperation with the well-positioned healthcare industry. We are working with stakeholders from industry, politics and universities to push our healthcare sector to be more sustainable and therefore more resilient in the future. This starts with minimizing waste by making products reusable and leads to the transformation of the whole branch, which includes customers as well as producers. BIOPRO is the central partner for companies and scientific institutions in the fields 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 constantly growing network.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 210

| 211


Name › btS – Life Sciences Studierendeninitiative e.V. btS e.V. Address/P.O. Box › Jacobsenweg 61 Postal Code/City › 13509 Berlin State › Berlin Email › kooperationen@bts-ev.de Website › https://bts-ev.de/ https://bts-sciecon.de/ Social Media › F I I Number of Employees › More than 1,300 members Founded (year) › 1996 Areas of Activity › On a nationwide level, we organise biannual career fairs, the “ScieCons”, and we are running an online tool called “ScieMatch” to match talents with companies based on the cultural fit. At the local level, we organise excursions, company presentations, workshops, and various other events. External › The success of our commitment to life Collaborations science students is enabled by the support of our various partners, such as Thermo Fisher Scientific Inc., jobvector GmbH, Sartorius AG, Vetter Pharma-Fertigung GmbH & Co. KG, HOX Life Science GmbH, HORBACH Wirtschaftsberatung GmbH, A.S.I. Wirtschaftsberatung AG, BIOCOM AG, BIO Deutschland e.V., DECHEMA e.V., Gesellschaft für Virologie e.V., VBIO e.V. and Verband deutscher Studierendeninitiativen e.V. Request for › The btS is always interested in new 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.

Further Collaborations

The btS – Life Sciences Studierendenintiative e.V. is a Germany-based student initiative that is active in 23 cities all over Germany. The btS creates an interface between students, universities, research institutes and companies. For this purpose, we organise career fairs, excursions, networking events, lectures, workshops and scientific symposia. With more than 1300 members, the btS is the largest student initiative in the life science sector. In addition to the large network of students, we are supported by alumni and associate members from both university and industry backgrounds. We offer students the chance to realise their creative ideas and gain valuable experience for their personal development. In addition to the acquisition of key competences in ­areas such as project management, communication, time management, leadership and teamwork, our members get insights into various fields of work early on during their studies since we work together with many different partners from academia and industry.

Opportunities for partnering up with btS Would you like to get in touch with highly skilled life science students? In this case, the btS is the perfect partner for you! We offer a wide range of events, ­c ontributions to our career blog and newsletters as well as other cooperation opportunities. In addition to bringing you to the university, we are also interested in organising an excursion to your company. Those local events offer unprecedented insights for us as well as external students.


BTS

Another great chance to meet many life science students face-to-face is our career fair, the ScieCon. The fair is specifically targeted to students, graduates and doctoral candidates in the field of life sciences and offers a perfect link between industry and academic education. The ScieCon attracts students from local universities and from all over Germany. It offers companies a platform for self-presentation and the recruiting of new employees. Our newest achievement targets the need of companies to find graduates that share their company values and philosophy. Therefore, we have launched ScieMatch, a digital career matching platform that was awarded the Stifterverband’s Hochschulperle of the year 2021. Through our unique matching algorithm, we can bring talents to your attention that match with your company based on a high cultural fit. Do you want to ensure the long-term success of your life science 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!

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 212

| 213


Name › Carl Roth GmbH + Co. KG Address/P.O. Box › Schoemperlenstrasse 3-5 Postal Code/City › 76185 Karlsruhe State › Baden-Wuerttemberg Contact Person › Andre Houdelet (CEO) Oliver Lautenschläger (Head of Chemical Department) Telephone › +49-721-5606-0 Fax › +49-721-5606-149 Email › a.houdelet@carlroth.de o.lautenschlaeger@carlroth.de Website › www.carlroth.com Social Media › F I I Number of Employees › 300 Founded (year) › 1879 Areas of Activity › | Lab supplier (labware, life science, chemicals) | Own brands | Industrial applications | Customer tailored solutions | Various e-procurement interfaces

Strong roots for sustainable growth Since it was founded in 1879, Carl Roth GmbH + Co. KG has become a renowned expert in the fields of laboratory supplies, life science and chemicals. With over 140 years of tradition and experience, the company is one of the leading wholesalers in Europe and supplies customers in over 100 countries worldwide. Carl ROTH has its headquarters in Karlsruhe, from where it supplies its five European subsidiaries. The family business stands for continuity and the highest quality in supplying laboratories, scientific institutions and manufacturing companies.

Variety, availability, reliability Carl ROTH supplies its customers with high-quality products from an extensive range that currently numbers over 36,000 items. From laboratory chemicals to state-of-the-art laboratory equipment, the company offers a wide range of products that is regularly expanded and optimised for new applications. The product range is characterised by both high quality and fair prices, and current offers are quickly and flexibly adapted to urgent customer requirements. Carl ROTH’s own products form an important part of the product range. These are the result of continuous, close and trusting cooperation with research projects as well as with specialised manufacturers worldwide. This innovative mix makes Carl ROTH a reliable partner for laboratories, scientific institutions and manufacturing companies in research, analytics and industry.


CARL ROTH

Long-term partnerships built on day-to-day quality At Carl ROTH, we cultivate open and appreciative cooperation and a high standard of quality. Scientific product experts and a competent sales team support customers with sound knowledge and many years of experience in order to find customised solutions for their specific questions, requirements and needs. This is complemented by a broad product selection based on many years of market and industry knowledge, professional advice, fast delivery, comprehensive service and Carl ROTH’s clear commitment to sustainability.

ROTH for future In a social context, every company is asked to work towards a better future through sustainable solutions. Carl ROTH has accepted this challenge and, as a result, has firmly anchored sustainable thinking and action in its corporate philosophy. Examples of this can be found throughout the company, from production to the vehicle fleet, to the building stock and product range. For example, in our range of chemicals, ‘green solvents’ are increasingly complementing traditional, non-sustainable solvents and thus helping to minimise risk in customers’ laboratories. Carl ROTH relies on renewable raw materials and environmentally friendly manufacturing processes, labelling corresponding products with the ‘ROTH for Future’ seal. As we like to say at Carl ROTH: We apply 140 years of experience to shape the future for the benefit of all.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 214

| 215


Name › HealthCapital – Cluster Healthcare Industries Berlin-Brandenburg Address/P.O. Box › Fasanenstr. 85 Postal Code/City › 10623 Berlin State › Berlin Contact Person › Dr Kai Bindseil, Clustermanager HealthCapital Berlin-Brandenburg Telephone › +49-30-46302-463 Email › info@healthcapital.de Website › www.healthcapital.de Social Media › I #HealthCapitalBB Areas of Activity › 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 (CEBR) l Member and contact point in Berlin for Enterprise Europe Network (EEN) l Collaborations with European Life Science clusters and SMEs in several European projects and other activities l Bio Deutschland l Global Health Hub

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. Around 280 biotechnology and more than 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 140 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).

… 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 2024 at › BIO Europe Spring | March 18-20, Barcelona, Spain › Deutsche Biotechnologietage | April 16-19, Berlin, Germany › BIO International Convention | June 3-6, San Diego, CA, USA › BIO Europe | November 4-6, Stockholm, Sweden

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 216

| 217


Name › HOX Life Science GmbH Address/P.O. Box › Gutleutstraße 169-171 Postal Code/City › 60327 Frankfurt State › Hesse Contact Person › Dr Marta Lee Telephone › +49-698-700-664-21 Email › marta.lee@hox.de Website › www.hox.de Social Media › I I Number of Employees › 60+ Founded (year) › 2019 Areas of Activity › Human Relations & Business Consulting; Life-Science Career Companions & Academy External › | btS - Life Sciences Collaborations Studierendeninitiative e.V. | DKFZ Heidelberg

Just as HOX Genes play a crucial role in embryonic development, at HOX Life Science we would like to make a vital contribution to the life science community. Since we ourselves are scientists with “first-hand ­experience” in the life sciences industry, we understand the language, needs, and requirements of our business partners and clients. Our motto is: “Scientists supporting Scientists”.

HOX for Companies Staffing, Recruiting & Employer Branding Our holistic Human Relation Services Program is tailo­ r­ed to the life science industry. To support and lighten the workload on internal HR, recruitment and staffing can be outsourced in full or in part, depending on actual needs. We will support you with customized solutions so that you can concentrate on your day-to-day operations even during peak times or staff shortages and still get in contact with many highly educated and experienced life-science-experts and -specialists. Candidates go through multiple steps in the candidate journey before they decide to apply to your company. We support you to improve the candidate experience along all touchpoints with your company as one part of our individually tailored employer branding strategy to position your company as an outstanding employer. With customized job ads and recruiting videos for social media and your webpage we attract and retain suitable new employees for the long term. Support in Marketing and Sales We at HOX Life Science firmly believe that companies in the life science industry in particular need contentdriven marketing concepts. This means that even when implementing the marketing mix, the focus should always be on the scientific content. Because after all, these are products that require a high level of explanation. And, very often, special compliance rules also need to be observed when advertising and selling life science products and pharmaceuticals.


HOX

According to our motto “Scientists supporting Scientists”, we offer marketing concepts tailored to the life ­science industry along with the corresponding operational tools and measures. In joint sessions, together we will develop the marketing strategy that meets the technical and scientific specifics of your product and develop from these the target-oriented marketing measures. We use intelligence to attract clients, not showmanship.

HOX for Experts Job offers At HOX, you may be certain that your CV will be understood and that you will be treated as an individual. Since we are scientists ourselves, we discuss your expertise at a professional level. We understand your goals and wishes, but also your “where it hurts”. By combining our own professional experience in the life science sector with comprehensive HR know-how, we can be a competent and, above all, honest partner in helping you achieve your professional goals. Due to our life ­science background, we have a large network of business partners ranging from: › Pharma to Biotech › Food to Chemistry › Laboratory Equipment to Research Products › Diagnostics to Medical Technology.

HOX Academy Join our Online Courses and be ready for the life ­science industry. › Business Administration Learn more about the value chain of drug development, the importance of marketing and sales, and all the possible positions for Scientists in the Pharma and Biotech sector. › Project Management Master the tools of project management, get acquainted with Microsoft Project and become skilled at planning and managing projects with real life examples from the Pharma and Biotech industry. 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 218

| 219


Name › Fördergesellschaft IZB – Innovations- und Gründerzentrum Biotechnologie mbH Address/P.O. Box › Am Klopferspitz 19 Postal Code/City › 82152 Planegg/Martinsried State › Bavaria Contact Persons › Dr Peter Hanns Zobel Telephone › +49-89-5527948-0 Fax › +49-89-5527948-29 Email › info@izb-online.de Website › www.izb-online.de Number of Employees › 36 Founded (year) › 1995 Type of Labaratory › S2 labs Areas of Activity › l Biotechnology l Life Sciences Number of Firmes › over 50 start-ups External › l Collaborations with the scientific Collaborations faculties on the Campus Martinsried l Munich Life Science Pitch Day with the High-Tech Gründerfonds Management GmbH l IZBrunch - Science meets Sciencs l Law Lab - law for biotech businesses l Biotech Press Lounge

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, nearly 40 start-ups biotech companies with over 700 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 Biological Intelligence.

Magnet for biotech start-ups Since 1995, the Planegg-Martinsried location, now covering 23,000 m 2, 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 Max Planck-Institutes for Biochemistry and Biological Intelligence, 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


IZB

Prion Research (ZNP), the Gene Center and Institute for Biochemistry, the Biomedical Center, the BioSysM Bavarian Research Network for Molecular Biosystems, the I­nstitut of Chemical Epigenetics, Research Center ICON for Diseases of the Cardiovascular System of the LMU and the LMU Hospital 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 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 › 26,000 m2 laboratory and office space for start-ups and growing companies › Home for nearly 40 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 THE BOWL Food Lounge, Café The Bowl › 2 day care centres (Bio Kids & Bio Kids2) 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 220

| 221


Name › Life Science Nord Management GmbH Address/P.O. Box › Falkenried 88 Postal Code/City › 20251 Hamburg State › Hamburg Contact Person › Jan Phillip Denkers (PR & Communications Manager) Telephone › +49-40-593-62-61-23 Email › denkers@lifesciencenord.de Website › www.lifesciencenord.de Social Media › I Number of Employees › 18 Founded (year) › 2004 Areas of Activity › Cluster Management External › | BIO Deutschland e. V. Collaborations | Council of BioRegions in Germany (AK-BioRegio) | Council of European Bioregions (CEBR) | Programm “go-cluster” | TransferAllianz e.V. | Nordic Mentor Network for Entrepreneurship (NOME)

Together for Innovative Medicine The Life Science Nord cluster in the federal states of Hamburg and Schleswig-Holstein embraces over 600 biotechnology, pharmaceutical, and medical techno­ logy companies, clinics, and research institutes. More than 55,000 employees work in the industrial health economy. Particular features of the cluster are the broad business base and the complete value chains from basic and ­a pplied research to clinical studies and the marketable end product. The outstanding, close cooperation ­between researchers, clinicians, and industrial partners in many fields is reflected in innovative products, projects, and technologies.

More than 280 Members, One Common Goal The cluster management organisation Life Science Nord was set up by the Northern German federal states of Schleswig-Holstein and Hamburg to develop the cluster into a leading international life science network. The cluster agency Life Science Nord Management GmbH and the association Life Science Nord e.V. work as one together to achieve that goal. More than 280 regional companies and institutions from the healthcare sector are active members of Life Science Nord. All members benefit from numerous competitive services and activities to promote regional networking, exchange experience and know-how, and jointly represent the life science sector of the two northernmost German federal states on a national and international level. 2021 Life Science Nord was awarded the GOLD label “Excel in Cluster Excellence” by the European Secretariat for Cluster Analysis (ESCA) for the third time in a row.


LIFE SCIENCE NORD

What Life Science Nord Offers › 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 › Organizing and hosting working groups, collaborative events, and networking activities › Access to platforms on which the cluster players can exchange information and which support the dissemination of new developments in the cluster. This includes the online newsletter and the Life ­Science and online magazine, which can be read completely free of charge via the LSN website, as well as promoting cluster related news via social media.

BIOTECHNOLOGY

PHARMA

MEDICAL TECHNOLOGY 25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 222

| 223


Name › Lumis Life Science Consulting GmbH Address/P.O. Box › Giesebrechtstrasse 15 Postal Code/City › 10629 Berlin State › Berlin Contact Person › Heike Schön Telephone › +49-30-235911-599 Email › info@lumisconsult.com Website › www.lumisconsult.com Social Media › I Number of Employees › 10 Founded (year) › 2020 Areas of Activity › | Regulatory Consulting and Services Quality Management as a Service | Vendor Selection and Vendor Management | Clinical Oversight Management

Lumis Life Science Consulting GmbH provides ­consulting services to small and mid-sized medical device and biopharmaceutical companies that outsource their clinical activities.

Services Our services cover the following areas: › Regulatory Consulting and Services: preparing, organising, and follow-up of scientific advice meetings with national authorities and European Medicines Agency (EMA). Applying for orphan drug designation with the EMA and supporting the application as Small Medium Enterprise (SME) › Outsourcing and oversight of clinical trials: vendor selection and management, clinical trial project management and inhouse training, sponsor-vendor conflict resolution › Quality management as service: analysis and estab­ish­ ment of complete quality management systems to ­enhance our client inspection readiness We develop tailored solutions jointly with our customers to optimise their clinical product development programme. We work with experienced subject matter experts, ­c ooperation partners, and consultants to guarantee high quality in each service area.

From our 20 years+ of experience Small to midsize pharmaceutical or medical device companies often face the challenges of limited human resources. Therefore, outsourcing of clinical trials is a common way to proceed with clinical development. The survival of such companies may depend on successful, timely completion of one or two key clinical trials on a limited budget. Thus, high efficiency in managing clin­ ical vendors is crucial, while the safety of patients and the quality of clinical data must not be compromised.


LUMIS LIFE SCIENCE CONSULTING

Especially during initial clinical investigations, it is not easy for companies to decide on which activities to outsource and which to perform in-house. Consequently, each activity should be evaluated in advance: › For its strategic importance › For the main reasons to outsource, e.g. cost savings, access to clinical and/or regulatory experience › For related risks and benefits, e.g. increased complexity of project and oversight management, access to opinion leaders

Our Expertise Lumis’s experts support the development and implementation of effective risk-based management systems for sponsors, to ensure efficient and active monitoring and evaluation of vendor performance. We apply Key Performance Indicators to oversee the progress of clinical investigations. Lumis facilitates the integration of a shared governance model, which is vital for ­s uccess, to guarantee that the sponsor and vendor share one vision and have common goals. We optimise the interaction between sponsor, CROs, and vendors by mastering different corporate cultures and expectations, so that your company will smoothly advance your drug development. Our experts have been creating successful partnerships between sponsors and CROs/ vendors for over 20 years.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 224

| 225


Name › Meissner Bolte Patentanwälte Rechtsanwälte Partnerschaft mbB Address/P.O. Box › Widenmayerstr. 47 Postal Code/City › 80538 Munich P.O. Box 860624, 81633 Munich State › Bavaria Contact Persons › Dr Lukas Bischoff, Dr Felix Letzelter Telephone › +49-89-2121860 Fax › +49-89-21218670 Email › mail@mb.de Website › www.meissnerbolte.com Social Media › I Q I Number of Employees › 350 Founded (year) › 1908 Areas of Activity › Fields: | Organic and Inorganic Chemistry | Polymers | Pharma | Biotech | Food and Agriculture | Plant varieties | Bioinformatics | Artificial Intelligence | Computer Implemented Inventions | Medical technology Legal Areas: | IP Prosecution | IP Litigation | Patents | Utility Models | Supplementary Protection Certificates | Plan Variety Protection | Trademarks | Designs | Employee Invention Law | Inspection Proceedings | UPC Services: | IP Portfolio Management | IP Search | Freedom to Operate analyses

Developing new chemical products and medications is often a lengthy process involving very high costs. In order to ensure that the high investments ultimately pay off, most chemical and pharmaceutical companies rely on the monopoly granted by patents on end products.

Main areas of practice Our qualified team of Patent Attorneys, specialised in chemistry and pharmaceuticals, routinely support multinational and medium-sized companies, start-ups, and scientific institutions in protecting the results of their research and development. We are ready and able to advise on obtaining, enforcing, and defending protective rights in the chemical and pharmaceutical field. Areas in which we have proven expertise include the fields of: detergents, cosmetics, food and dietary supplements, textiles, tyres, alternative fuels, paints and coatings, adhesives, nanotechnology, polymers, construction chemicals, paper, packaging, classical active pharmaceutical ingredients, as well as pharmaceutical formulations and antibody drugs. As the modern field of life sciences merges increasingly with the field of computer science to provide bioinformatics tools or artificial intelligences for solving biological problems, we offer an interdisciplinary team of computer- and life-scientists in order to best advise in this rapidly developing field of technology. We are here to assist you in the preparation of patent applications and support and accompany you on the road to a patent grant and to further represent and support you in opposition, nullity, and infringement proceedings. Expert opinions, FTO analyses, and due diligence examinations in the chemical and pharmaceutical sector are also part of our daily business. In the pharmaceutical sector, we also handle applications for supplementary protection certificates (SPC). Our Patent Attorneys specialising in chemical, in biotech and pharmaceutical patents look forward to your contact at any time!


MEISSNER BOLTE

Meissner Bolte Meissner Bolte is a fully integrated IP law firm providing legal services in all areas of intellectual property. Filing more than 2,000 patent applications per year, Meissner Bolte is one of the largest specialised IP boutique firms in Germany. Boasting eleven offices throughout Germany and one office in the UK, our professionals combine close contact to clients with short lead times. With more than 60 patent attorneys and a total of 350 employees, Meissner Bolte handles patent portfolios of all sizes. Our strong team of attorneys at law works in close cooperation with our patent attorneys to resolve all IP disputes, making use of the full know-how and technical expertise available. Our attorneys are currently handling over 50 cases before all major patent courts, with our clients benefitting from detailed knowledge of both the proceedings and judges at these courts. All patent attorneys are qualified to represent clients before the novel Unified Patent court. We further have an in-depth knowledge of German inspection proceedings, having successfully concluded dozens of cases to date. Well-known “Of Counsel” support at Meissner Bolte: › Rainer Engels, presiding judge BPatG, retired › Dr Hans-Peter Felgenhauer, Member of the Board of Appeal, EPO, retired Native speaking experts, including of English and Japanese, provide valuable support to many of our international clients. Industrial strengths: › Specialist Chemistry/Pharmaceutical/Biotech ­Department › Special department for handling computerimplemented inventions

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 226

| 227


Name › restracon GmbH & Co. KG Address/P.O. Box › Schroefelhofstrasse 66 Postal Code/City › 81375 Munich State › Bavaria Contact Person › Dr Claudia Reusch Telephone › +49-89-78576867 Email › info@restracon.com Website › www.restracon.com Social Media › F I Q Number of Employees › 6 Founded (year) › 2005 Areas of Activity › Professional recruitment and talent acquisition through systematic research and direct approach of highly qualified candidates for the life sciences industry in the areas of: | Medical technology | Laboratory diagnostics | Biotechnology | Pharma | Industrial technology | Medical services providers and payors

Competence and continuity restracon is a highly specialized owner-managed recruitment agency dedicated to the life sciences industry. Since 2005 restracon systematically investigates target companies, identifies and directly approaches the most suitable candidates for the specific staffing needs of its customers nationwide. restracon‘s expertise covers the whole range of the life sciences from the core sectors biotechnology, medical devices, laboratory diagnostics, pharmaceuticals, clinical research, chemicals and also extends into the fields of the neighbouring disciplines, e.g. environmental sciences and medicine. Within the healthcare industry, restracon has a strong focus on expert positions in research and development, clinical and regulatory affairs, quality and risk management, biostatistics and data management as well as administrative and medical leadership positions for medical services providers and payors.

The smart way to find the best candidates The restracon team has profound market and technology knowledge, proprietary research tools and an extensive international network in science and industry which enable us to provide excellent advice and service to our customers. Our approach to each search assignment is finding the ideal candidate for the specific position. We are passionate about offering a smart, customised, lean and transparent recruitment process by combining technology-driven strategies with face-to-face interactions and establishing long-term relationships with our customers and candidates based on mutual trust. Weekly updates will keep you in the loop of the recruitment efforts delivered by restracon. Our way of billing does not link the fee to the annual salary of the position to be filled. Therefore you can be sure that we are definitely looking for the best candidate and not the most expensive one.


RESTRACON

Your reliable partner in talent acquisition Benefit from our vast industry expertise and market insights to gain the talent you need! You can rely on us that we will fulfil your expectations: We are happy to go the extra mile and find the needle in the haystack for you. It is our firm belief that close personal interactions create strong relationships which are one of our biggest assets. The restracon team members are known for their discreet, honest and reliable manner and high service orientation. Please contact us directly via phone­ (+49 89 78576867) or e-mail (info@restracon.com) for finding out more about our tailor-made solutions and follow us on LinkedIn, Xing and Facebook.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 228

| 229


Name › Technologiepark Heidelberg GmbH Address/P.O. Box › Im Neuenheimer Feld 582 Postal Code/City › 69120 Heidelberg State › Baden-Wuerttemberg Contact Person › Dr André H.R. Domin Telephone › +49-6221-50257-00 Fax › +49-6221-50257-11 Email › technologiepark@heidelberg.de Website › www.technologiepark-heidelberg.de Social Media › I Number of Employees › 15 Founded (year) › 1984 Type of Laboratory › S2 standard, GLP, and GMP labs Areas of Activity › | Biotechnology | Pharmaceuticals | Digital health | Medical technology | Bioinformatics | Organic electronics | Environmental technologies | IT / Artificial Intelligence / VR External › | Association of University Research Collaborations Parks (AURP) | BIO Deutschland e.V. | Biotechnology Innovation Organisation (BIO) | BioRN Network e.V. | Bundesverband Deutscher Innovations-, Technologie- und Gründerzentren e.V. (BVIZ) | Heidelberg Startup Partners e.V. | International Association of Science Parks and Areas of Innovation (IASP) | K I Bundesverband Request for › | Biotechnology Further Collaborations | Pharmaceuticals | Digital health | Medical technology | Bioinformatics | Organic electronics | Environmental technologies | IT

World-renowned life science site 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.

Strong partners at your side Since 1984, Heidelberg Technology Park has been ­offering lab space, clean rooms, and offices to ­science and technology-driven companies. Today, more than 100 companies and about 3,000 employees share approx. 100,000 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.

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 programs Four Accelerator Programs at Heidelberg Technology Park offer a fast lane for Life Science, IT and AI startups. The Life Science Accelerator Baden-Württemberg includes seminars, workshops and mentoring by seasoned entrepreneurs and market experts. The Up2B Accelerator for IT startups with a B2B focus includes programs for business modelling, product development and funding. The AI-Garage and the AI Lab are helping to turn AI research results into products and services via startups and tech transfer in SME.


TECHNOLOGIEPARK HEIDELBERG

AI LAB Heidelberg Heidelberg Technology Park with its regional AI Lab “KI LAB Heidelberg” is funded by the Ministry of Economics, Labor and Tourism Baden-Wuerttemberg. AI LAB Heidelbergs’ aim is to give small and medium-sized enterprises access to the future technology AI.

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), KI Bundesverband, 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 We continue to expand in the area of the Heidelberg Innovation Park (hip). Beside our first construction stage of the Business Development Center (BDC), which opened its doors for startups in the life science sector in 2019 and offers 7,000 sqm of wet lab, cleanroom, and office space, we now have a new building in our portfolio: the LAB22. One half of LAB22 is already leased and used as a WetLab CoWorking Space by BioLabs Heidelberg, the other half with lab and office spaces for SMEs with 4,000 sqm, will be rented out by the beginning of 2024.

Park – in brief › Approx. 100,000 sqm wet lab, cleanroom, and office space for startups and growing companies › Startup support office and Heidelberg Startup Partners network › Accelerator Programs for life science, IT and AI startups › Access to a large network of investors › Business development support › Entrée to an international network › Central location

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 230

| 231


Name › Wuesthoff & Wuesthoff Patentanwälte PartG mbB Address/P.O. Box › Schweigerstrasse 2 Postal Code/City › 81541 Munich State › Bavaria Contact Person › Dr Hendrik Wichmann Telephone › +49-89-621-800-0 Email › wichmann@wuesthoff.de Website › www.wuesthoff.de Social Media › I Number of Employees › 120 Founded (year) › 1927 Areas of Activity › | Drafting IP rights | IP prosecution | Challenging IP rights | Defending IP rights | Litigation | IP strategy | Portfolio Management | 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 non-binding initial consultation with one of our experts.

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 232

| 233


German Biotech Companies 2cureX GmbH, Hamburg

AmplexDiagnostics GmbH, Gars Bahnhof

2na fish, Garching

AmpliVak Immunotherapy GmbH, Berlin

3a-diagnostics GmbH, Frickenhausen

Amptec GmbH, Hamburg

3B Pharmaceuticals GmbH, Berlin

AMSilk GmbH, Planegg

4 Animals AlsterScience GmbH, Hamburg

AnalytiCon Discovery GmbH, Potsdam

4base lab AG, Reutlingen

Anavo Therapeutics, Heidelberg

4Gene GmbH, Freising

Anchor Diagnostics GmbH, Hamburg

4HF Biotec GmbH, Freiburg

AngioBiomed GmbH, Hennigsdorf

4SC AG, Martinsried

ANiMOX GmbH, Berlin

4TEEN4 Pharmaceuticals GmbH, Hennigsdorf

Aokin AG, Berlin Apogenix GmbH, Heidelberg

A

Aptamimetics GmbH, Stegen

Aachen Proteineers GmbH, Baesweiler

Aptarion biotech AG, Berlin

Aamuthera Biotech GmbH, Würzburg

Aquarray GmbH, Eggenstein-Leopoldshafen

AATec Medical GmbH, Hohenbrunn

Arcensus GmbH, Rostock

AaviGen GmbH, Heidelberg

Ariceum Therapeutics GmbH, Berlin

AB Diagnostic Systems GmbH, Berlin

arrows biomedical Deutschland GmbH, Münster

AB Enzymes GmbH, Darmstadt

ARTCLINE GmbH, Rostock

Abalos Therapeutics GmbH, Düsseldorf

Artemiflow GmbH, Potsdam

Abcalis GmbH, Braunschweig

ARTES Biotechnology GmbH, Langenfeld

ABiTEP GmbH, Berlin

ASA Spezialenzyme GmbH, Wolfenbüttel

ACA CELL BIOTECH GmbH, Heidelberg

ASC Oncology GmbH, Berllin

Acaryon GmbH, Berlin

Ascendis Pharma GmbH, Heidelberg

Accelero ® Bioanalytics GmbH, Berlin

Assay.Works GmbH, Regensburg

acCELLerate GmbH, Hamburg

Astaxa GmbH, Ritschenhausen

Acousia Therapeutics GmbH, Tübingen

Astra Biotech GmbH, Berlin

acphis GmbH & Co. KG, Halstenbek

ATG:biosynthetics GmbH, Merzhausen

Across Barriers GmbH, Saarbrücken

Athenata GmbH, Wuppertal

ActiTrexx GmbH, Mainz

ATLAS Biolabs GmbH, Berlin

Actome GmbH, Freiburg

Atriva Therapeutics GmbH, Tübingen

Acus Laboratories GmbH, Düren

ATTO-LAB GmbH, Lübeck

adivo GmbH, Martinsried

Attomol GmbH, Bronkow, OT Lipten

AdrenoMed AG, Hennigsdorf

attyloid GmbH, Düsseldorf

advanceCOR GmbH, Martinsried

Aucteq Biosystems GmbH, Mannheim

AdVita Lifescience GmbH, Gundelfingen

Auto Tissue Berlin GmbH, Berlin

AESKU.DIAGNOSTICS, Wendelsheim

Ava Lifescience GmbH, Denzlingen

Aeterna Zentaris GmbH, Frankfurt a. Main

AvenCell Europe GmbH, Dresden

Affimed GmbH, Mannheim

AVENTRA Gesellschaft für biologische Diagnostik mbH, Osnabrück

AGC Biologics GmbH, Heidelberg

Axolabs GmbH, Kulmbach

Agrobiogen GmbH, Hilgertshausen-Tandern

Axxam GmbH, Konstanz

AgroProtect GmbH, Geilenkirchen

axxelera UG, Karlsruhe

AiCuris Anti-infective Cures AG, Wuppertal aidCURE AG, Frankfurt

B

Aignostics GmbH, Berlin

b.fab GmbH, Köln

aimed analytics, Bonn

Badische Peptide & Proteine GmbH, Mannheim

Alacris Theranostics GmbH, Berlin

baseclick GmbH, Neuried

Albutec GmbH, Rostock

BASF Metabolome Solutions GmbH, Berlin

Algenium GmbH, Bielefeld

BAST GmbH, Heidelberg

Algiax Pharmaceuticals GmbH, Erkrath

Bavarian Nordic GmbH, Martinsried

Alife Foods GmbH, Leipzig

BBT Biotech GmbH, Baesweiler

Allecra Therapeutics GmbH, Freiburg

BELANO medical AG, Hennigsdorf

Alpspitz Bioscience GmbH, Gattendorf

Belyntic GmbH, Berlin

altona Diagnostics GmbH, Hamburg

beniag GmbH, Jülich

Alvotech Germany GmbH, Jülich

Berlin Cures GmbH, Berlin

Alvotech Hannover GmbH, Hannover

betaSENSE GmbH, Münster

alytas therapeutics GmbH, Jena

beworm GbR, Garching

amcure GmbH, Eggenstein-Leopoldshafen

Bex-Biotech GmbH & Ko.KG, Bönen

Amgen Research (Munich) GmbH, München

Biaffin GmbH & Co KG, Kassel

AMODIA Bioservice GmbH, Braunschweig

BianoScience GmbH, Zwickau


BIBITEC GmbH & Co. KG, Bielefeld

BRAIN Biotech AG, Zwingenberg

Bicoll GmbH, Planegg/Martinsried

BrainRepair UG, Bochum

bicomer.de, Bielefeld

Brandenburg Antiinfektiva GmbH, Borstel

Bind-X GmbH, Martinsried

Breakpoint Therapeutics GmbH, Hamburg

BINOMED GmbH, Ulm

BromMarin GmbH, Freiberg

Bio-Protect GmbH, Konstanz

BSL BIOSERVICE Scientific Laboratories Munich GmbH, Planegg

bio.logis digital health GmbH, Frankfurt

BSV Bioscience GmbH, Baesweiler

BioAgilytix Europe GmbH, Hamburg

Byonoy GmbH, Hamburg

Bioanalytics Gatersleben UG, Gatersleben BioCheck GmbH, Münster

C

BioControl Jena GmbH, Jena

c-LEcta GmbH, Leipzig

BioCopy GmbH, Emmendingen

cAHRmeleon Bioscience GmbH, Heidelberg

BIOCYC, Potsdam-Golm

CalTIC GmbH, Dortmund

BioDataAnalysis GmbH, München

Cambrex IEP GmbH, Wiesbaden

BioEcho Life Sciences GmbH, Köln

Cambrium GmbH, Berlin

Biofidus AG, Bielefeld

candidum GmbH, Stuttgart

Biofrontera AG, Leverkusen

CarboCode Germany GmbH, Konstanz

BioGenes GmbH, Berlin

Cardior Pharmaceuticals GmbH, Hannover

BioKryo GmbH, Saarbrücken

Carpegen GmbH, Münster

Biolog Life Science Institute GmbH & Co. KG, Bremen

CASCAT GmbH, Straubing

BioMed X GmbH, Heidelberg

Catalent Düsseldorf GmbH, Langenfeld

Biomedro – Biomedizinische Forschung &

CatalYm GmbH, Martinsried

Entwicklung Rostock GmbH, Bad Doberan

CCRP Therapeutics GmbH, Berlin

Biomes NGS GmbH, Wildau

CeCaVa GmbH, Tübingen

BioNTech Cell & Gene Therapies GmbH, Mainz

CeGaT GmbH, Tübingen

BioNTech Delivery Technologies GmbH, Halle

Celares GmbH, Berlin

BioNTech Diagnostics GmbH, Mainz

Cell.Copedia GmbH, Leipzig

BioNTech GmbH, Martinsried

cellasys GmbH, Kronburg

BioNTech Innovative Manufacturing Services GmbH, Idar-Oberstein

Cellbricks GmbH, Berlin

BioNTech Manufacturing GmbH, Mainz

CellDEG GmbH, Berlin

BioNTech Manufacturing Marburg GmbH, Marburg

Cellendes GmbH, Reutlingen

Biontex Laboratories GmbH, München

Cellerna Bioscience GmbH, Baesweiler

BioNukleo GmbH, Berlin

CELLphenomics GmbH, Berlin

BIOPHARM GmbH, Eppelheim

CellServe GmbH, Berlin

Biophotonics Diagnostics GmbH, Jena

Cellsystems GmbH, Troisdorf

BioPlanta GmbH, Grimma

Celltec Systems GmbH, Lübeck

BIOPRACT GmbH, Berlin

CellTrend GmbH, Luckenwalde

Bioresources Technology & Engineering GmbH, Gießen

Cellzome GmbH, Heidelberg

BIOSERV Diagnostics GmbH, Rostock

Celonic Deutschland GmbH & Co. KG, Heidelberg

BioSolveIT GmbH, Sankt Augustin

Cenata GmbH, Tübingen

BioSpring – Gesellschaft für Biotechnologie mbH, Frankfurt a. Main

Centogene AG, Rostock

biotechrabbit GmbH, Berlin

Cevec Pharmaceuticals GmbH, Köln

BioTeSys GmbH, Esslingen

Charles River Laboratories Germany GmbH, Erkrath

BioTeZ Berlin-Buch GmbH, Berlin

Chembiotech - DNA Technologies, Materials and Reagents, Münster

BioThrust GmbH, Aachen

Cherry Biolabs GmbH, Winterhausen

biotx.ai GmbH, Potsdam

Chimera Biotec GmbH, Dortmund

Biotype GmbH, Dresden

Chr. Hansen HMO GmbH, Rheinbreitbach

BioVariance GmbH, Waldsassen

Chromatec GmbH, Greifswald

BIOVOX, Darmstadt

ChromoTek GmbH, Martinsried

Bioweg UG, Quakenbrück

Cilian AG, Münster

Bioworx, Berlin

Cinference, Berlin

bitop AG, Dortmund

CLS Cell Lines Service GmbH, Eppelheim

bj-diagnostik GmbH, Göttingen

CMR CureDiab Metabolic Research GmbH, Düsseldorf

Black Drop Biodrucker GmbH, Aachen

CO.DON GmbH, Leipzig

BluCon Biotech GmbH, Köln

CO2BioClean GmbH, Kronberg

Blue Biolabs GmbH, Berlin

Colipi Biotech, Hamburg

BlueBioTech GmbH, Büsum

Computomics GmbH, Tübingen

BlueLab Wasseranalysesysteme GmbH, Tübingen

Conaris Research Institute AG, Kiel

Bluu Seafood GmbH, Berlin

CONGEN Biotechnologie GmbH, Berlin

Boehringer lngelheim Therapeutics GmbH, Ochsenhausen

CORAT Therapeutics GmbH, Braunschweig

Bosque Foods GmbH, Berlin

corlife oHG, Hannover

botiss biomaterials GmbH, Zossen

Creative Therapeutics GmbH, Wuppertal

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 234

| 235


Crelux GmbH, Martinsried

Esencia Foods UG, Berlin

CrystalsFirst GmbH, Marburg

Eternygen GmbH, Berlin

Cube Biotech GmbH, Monheim

ethris GmbH, Planegg

Cultimate Foods UG, Berlin

Eupheria Biotech GmbH, Dresden

Curetis GmbH, Holzgerlingen

Eurofins BioPharma Product Testing Munich GmbH, Planegg

CureVac AG, Tübingen

Eurofins GeneScan GmbH, Freiburg

Curexsys GmbH, Göttingen

Eurofins Genomics Europe Sequencing GmbH, Konstanz

Cygenia GmbH, Aachen

Eurofins Genomics Germany GmbH, Ebersberg

Cysal GmbH, Münster

Eurofins LifeCodexx GmbH, Planegg

Cytecs GmbH, Münster

EVANIUM Healthcare GmbH, Regensburg

cytena GmbH, Freiburg

eversyn, Magdeburg

Cytolytics GbR, Tübingen

Evotec SE, Hamburg

CytoPharma GmbH, Darmstadt

evoxx technologies GmbH, Monheim am Rhein

Cytophorics GbR, München

EW Biotech GmbH, Leuna Exciva GmbH, Heidelberg

D

Eximmium Biotechnologies GmbH, München

Davids Biotechnologie GmbH, Regensburg

Experimentelle Pharmakologie & Onkologie Berlin-Buch GmbH, Berlin

Deep LS GmbH, Limburg denovoMATRIX GmbH, Dresden

F

Deoxy GmbH, München

Feral GmbH, Berlin

Dermagnostix GmbH, Freiburg

Formo Bio GmbH, Berlin

DermaTools Biotech GmbH, Darmstadt

Formycon AG, Martinsried

Detechgene GmbH, Köln

Freeline Therapeutics GmbH, Planegg-Martinsried

Dewpoint Therapeutics GmbH, Dresden

FRIZ Biochem GmbH, Neuried

Diarect GmbH, Freiburg

FundaMental Pharma GmbH, Heidelberg

Digital Diagnostics AG, Mainz

Fusix Biotech GmbH, München

DiosCURE Therapeutics SE, Bonn

FyoniBio GmbH, Berlin

DISCO Pharmaceuticals GmbH, Köln

GA Generic Assays GmbH, Dahlewitz

Discovery Life Sciences Biomarker GmbH, Kassel Dispendix GmbH, Stuttgart

G

DMG Deutsche Malaria GmbH, Hamburg

GALAB Technologies GmbH, Hamburg

Doderm GmbH, Koblenz

Gen-H Genetic Engineering Heidelberg GmbH, Heidelberg

Dr. Rölleke – Labor für Genetische Analytik GmbH, Potsdam

GEN-IAL GmbH, Troisdorf

DyNAbind GmbH, Dresden

GenArc (Genome Architecture) GmbH, Dresden

Dynamic Biosensors GmbH, Martinsried

Genaxxon bioscience GmbH, Ulm

Dynamic42 GmbH, Jena

Genedata Bioinformatik GmbH, München

Dynavax GmbH, Düsseldorf

Generatio GmbH - Center for Animal Genetics, Tübingen GeneSurge GmbH, München

E

Genetek Biopharma GmbH, Berlin

e~nema GmbH, Schwentinental

Genevention GmbH, Göttingen

EastCyte Biosciences GmbH, Halle

GENEWIZ Germany GmbH, Leipzig

ecolocked GmbH, Berlin

geneXplain GmbH, Wolfenbüttel

ecSeq Bioinformatics GmbH, Leipzig

Genome Biologics, Frankfurt

Eisbach Bio GmbH, Martinsried

Genovac GmbH, Freiburg

Electrochaea GmbH, Planegg

GenXPro GmbH, Frankfurt am2016 Main

eleva GmbH, Freiburg

GFE Blut mbH, Frankfurt a. Main

Ella Biotech – Gesellschaft für angewandte Biotechnologie mbH,

Global Bioenergies GmbH, Leuna

Fürstenfeldbruck

Glycotope GmbH, Berlin

EMC microcollections GmbH, Tübingen

GlycoUniverse GmbH & Co.KGaA, Potsdam

Emergence Therapeutics AG, Duisburg

glyXera GmbH, Magdeburg

EMP Genetech, Ingolstadt

GNA Biosolutions GmbH, Martinsried

EnFin GmbH, Heidelberg

GOENOMICS GmbH, Göttingen

Enzymaster Deutschland GmbH, Düsseldorf

Gold Standard Diagnostics Kassel GmbH, Kassel

Enzymicals AG, Greifswald

GQ Bio Therapeutics GmbH, Hamburg

Epiblok Therapeutics GmbH, Berlin

Green Elephant Biotech GmbH, Gießen

Epigenomics AG, Berlin

GVG Diagnostics GmbH, Leipzig

EpiLogic GmbH, Agrarbiologische Forschung und Beratung, Freising

H

Epimune GmbH, Berlin

Hain Lifescience GmbH, Nehren

epinamics GmbH, Berlin

HD Therapeutics GmbH, Ketsch

EpiQMAx GmbH, Martinsried

Heidelberg Biolabs GmbH, Heidelberg

EPITOPIC GmbH, Leipzig

Heidelberg Delivery Technologies GmbH, Heidelberg


Heidelberg ImmunoTherapeutics GmbH, Heidelberg

ISAR Bioscience GmbH, Planegg

Heidelberg Pharma AG, Ladenburg

Isarna Therapeutics GmbH, München

HepaRegeniX GmbH, Tübingen

Isoloid GmbH, Düsseldorf

Heppe Medical Chitosan GmbH, Halle

IVD – Gesellschaft für Innovative Veterinärdiagnostik mbH,

highQu GmbH, Kraichtal

Seelze-Letter

HMNC Brain Health, München

Ix Therapeutics GmbH, Hamburg

HS Diagnomics GmbH, Berlin Human Gesellschaft für Biochemica und Diagnostica mbH, Wiesbaden

J

Human Tissue and Cell Research-Services (HTCR) GmbH,

Jena Bioscience GmbH, Jena

Planegg/Martinsried

JeNaCell - An Evonik company, Jena

humatrix AG, Pfungstadt

JPT Peptide Technologies GmbH, Berlin

Hummingbird Diagnostics GmbH, Heidelberg

JunctuCell Biomed Manufacturing GmbH, Hohenbrunn

Hygenia Diagnostics GmbH, Potsdam HYpharm GmbH, Bernried

K Katairo GmbH, Kusterdingen

I

Keen 4 Greens GmbH, Jelmstorf

IBA Lifesciences GmbH, Göttingen

KHR Biotech GmbH, Mainz

ibidi GmbH, Gräfelfing

Koralo GmbH, Baldham

IBT GmbH, Ertingen

Kosmas Therapeutics GmbH, Nürnberg

IcanoMAB GmbH, Polling

KreLo GmbH, Ulm

Icon Genetics GmbH, Halle

Kupando GmbH, Schönefeld

IdentXX GmbH, Stuttgart

Kyoobe Tech GmbH, Leinfelden-Echterdingen

Idorsia (Berlin) Pharmaceuticals GmbH, Berlin IFB Halle GmbH, Halle

L

IFM Therapeutics GmbH, Bonn

LABOR FÜR DNA-ANALYTIK, Freiburg

IIT - Institut für Innovationstransfer, Bielefeld

Labvantage - Biomax GmbH, Martinsried

IMD Natural Solutions GmbH, Dortmund

Lallemand Biologicals GmbH, Wismar

IMGM Laboratories GmbH, Martinsried

LAMPseq Diagnostics GmbH, Bonn

immatics NV, Tübingen

Larova GmbH, Jena

Immundiagnostik AG, Bensheim

Lead Discovery Center GmbH, Dortmund

Immungenetics AG, Hamburg

LenioBio GmbH, Düsseldorf

Immunic AG, Gräfelfing

LEUKOCARE AG, Martinsried

immunoGlobe Antikörpertechnik GmbH, Himmelstadt

LGC Genomics GmbH, Berlin

Immunologik GmbH, Berlin

Life & Brain GmbH, Bonn

ImmunoQure AG, Düsseldorf

LifeGlimmer GmbH, Berlin

Immunservice GmbH, Hamburg

lifespin GmbH, Regensburg

Immutep GmbH, Leipzig

Ligandis UG, Gülzow-Prüzen

imusyn GmbH & Co. KG, Hannover

Lignilabs GmbH, Wiesbaden

in.vent DIAGNOSTICA GmbH, Hennigsdorf

LIMAA Technologies GmbH, Berlin

Independent Data Lab UG, München

LINDIS Biotech GmbH, Martinsried

Indical Bioscience GmbH, Leipzig

Lindis Bloodcare GmbH, Hennigsdorf

INDIVUMED GmbH, Hamburg

Lionex GmbH, Braunschweig

InfanDx AG, Köln

Lipotype GmbH, Dresden

inflamed pharma GmbH, Jena

Lipozyt Marker GmbH, Bremen

InflaRx N.V., Jena

Lonza Cologne GmbH, Köln

Innocent Meat GmbH, Papendorf

Lovely Day Foods GmbH, Berlin

Innovative Molecules GmbH, München

Lumatix Biotech GmbH, Garching

innoVitro GmbH, Jülich

Lumobiotics GmbH, Karlsruhe

InSCREENeX GmbH, Braunschweig

Lysando Innovations Lab GmbH, Regensburg

Insempra GmbH, Martinsried

Lysatpharma GmbH, Jena

Institut Virion\Serion GmbH, Würzburg Intana Bioscience GmbH, Martinsried

M

Intavis Peptide Services GmbH, Tübingen

Magna Diagnostics GmbH, Leipzig

INVICOL GmbH, Berlin

Mainz Biomed NV, Mainz

INVIGATE GmbH, Jena

MalVa GmbH, Heidelberg

Invitek Molecular GmbH, Berlin

Matricel GmbH, Herzogenrath

Invitris GmbH, Garching

MBBL Dr. Bartling GmbH, Bielefeld

InVivo BioTech Services GmbH, Hennigsdorf

mbiomics GmbH, München

iOmx Therapeutics AG, Martinsried

Mediagnost GmbH, Reutlingen

Ionera Technologies GmbH, Freiburg

Medical Biomaterial GmbH, Neustadt-Glewe

Iris Biotech GmbH, Marktredwitz

Medigene AG, Planegg/Martinsried

IRUBIS GmbH, München

MEDIPAN GMBH, Dahlewitz

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 236

| 237


Meidrix Biomedicals GmbH, Esslingen

Neracare GmbH, Frankfurt

MELEMA Pharma GmbH, Hamburg

Neurevo GmbH, München

Merlion Pharmaceuticals GmbH, Berlin

Neuron-D GmbH, Dresden

Mermaid Bio GmbH, München

NeuroProfile GmbH, Regensburg

metabion GmbH, Planegg

NEUWAY Pharma GmbH, Bonn

Metabolon GmbH, Hallbergmoos

new/era/mabs GmbH, Potsdam

Metaron Diagnostics GmbH i.G., Oberschleißheim

nextplant UG, Berlin

MetaSysX GmbH, Potsdam

NExtTec GmbH, Hilgertshausen

Micro Pro GmbH, Magdeburg

NH DyeAGNOSTICS GmbH, Halle

Microbify GmbH, Straubing

Ningaloo Biosystems GmbH, Köln

Microcoat Biotechnologie GmbH, Bernried

Nomad Bioscience GmbH, Halle

MicroDiscovery GmbH, Berlin

Norbitec GmbH, Uetersen

MicroHarvest GmbH, Hamburg

Norden Vaccines GmbH, Braunschweig

Micromun, Greifswald

Noscendo GmbH, Duisburg

Microsynth Seqlab GmbH, Göttingen

Nostos Genomics GmbH, Berlin

MiGenTra GmbH, Berlin

NOVA green GmbH, Vechta-Langförden

Mikrogen GmbH, Neuried

Novaliq GmbH, Heidelberg

Milenia Biotec GmbH, Gießen

NovaTec Immundiagnostica GmbH, Dietzenbach

Miltenyi Biomedicine GmbH, Bergisch Gladbach

Novis GmbH, Tübingen

MILTENYI GmbH, Bergisch Gladbach

Novozymes Berlin GmbH, Berlin

Minaris Regenerative Medicine GmbH, Ottobrunn

NUMAFERM GmbH, Düsseldorf

Minerva Analytix GmbH, Rangsdorf

numares AG, Regensburg

Minerva Biolabs GmbH, Berlin

NxFoods, Plamegg

mir|detect GmbH, Bremerhaven Mireca Medicines GmbH, Tübingen

O

mk2 Biotechnologies GmbH, Planegg

Ocean Pharma GmbH, Reinbek

MLM Medical Labs GmbH, Mönchengladbach

oceanBASIS GmbH, Kiel

MoBiTec GmbH, Göttingen

Octapharma Biopharmaceuticals GmbH, Heidelberg

MODAG GmbH, Wendelsheim

Okmed Biotech GmbH, Halle

Moderna Germany GmbH, München

OligoScience Biotechnology GmbH, Bönen

Molecular Health GmbH, Heidelberg

OMEICOS Therapeutics GmbH, Berlin

moloX GmbH, Berlin

OmicEra Diagnostics GmbH, Planegg

Molzym GmbH & Co.KG, Bremen

OmicScouts GmbH, Freising

MorphoSys AG, Planegg

oncgnostics GmbH, Jena

Mosaiques Diagnostics and Therapeutics AG, Hannover

Oncimmune Germany GmbH, Dortmund

MSAID GmbH, Garching

OncoLead GmbH & Co. KG, Karlsfeld

Mukocell GmbH, Dortmund

Oncoscience GmbH, Schenefeld

multiBIND biotec GmbH, Köln

one.five GmbH, Hamburg

multimmune GmbH, München

OneWorld Diagnostics GmbH, Düsseldorf

Multiplexion GmbH, Friedrichshafen

OntoChem GmbH, Halle

Mushlabs GmbH, Hamburg

OPSYON Therapeutics GmbH, München

MyBiotech GmbH, Überherrn

ORGENTEC Diagnostika GmbH, Mainz

Myelo Therapeutics GmbH, Berlin

origenis GmbH, Martinsried

MyoPax GmbH, Berlin

ORYX GmbH & Co. KG, Baldham

myPOLS Biotec GmbH, Konstanz

Oxacell AG, Potsdam

Myriad GmbH, München

OxProtect GmbH, Münster

Myriad International GmbH, Köln myriamed GmbH, Göttingen

P PAIA Biotech GmbH, Köln

N

PAION AG, Aachen

nadicom Gesellschaft für angewandte Mikrobiologie mbH, Uhingen

PAM Theragnostics GmbH, Hennigsdorf

nandatec GmbH, Lübeck

PAN-Biotech GmbH, Aidenbach

Nanion Technologies GmbH, München

PAN-Seratech GmbH, Aidenbach

Nanogami GmbH, Leipzig

Panosome GmbH, Heidelberg

NanotecMARIN GmbH, Ingelheim am Rhein

Pantherna Therapeutics GmbH, Hennigsdorf

NanoTemper Technologies GmbH, München

PELOBIOTECH GmbH, Martinsried

nanoTOOLS Antikörpertechnik GmbH & Co. KG, Teningen

PEPperPRINT GmbH, Heidelberg

nanozoo GmbH, Jena

Peptide Specialty Laboratories GmbH, Heidelberg

Navigo Proteins GmbH, Halle

peptides&elephants GmbH, Hennigsdorf

NEOsphere Biotechnologies GmbH, Martinsried

PerioTrap Pharmaceuticals GmbH, Halle

Neovii Biotech GmbH, Gräfelfing

perora GmbH, Heidelberg

Nephrolyx GmbH, Berlin

PharmaInformatic, Emden


Pharmbiotec GmbH, Schiffweiler

Roche mtm laboratories AG, Mannheim

Phenex Pharmaceuticals AG, Heidelberg

ROSCUE Therapeutics GmbH, Wolfratshausen

Phenos GmbH, Hannover Phialogics GmbH, Frankfurt am Main

S

Phyton Biotech GmbH, Ahrensburg

Saaten-Union BIOTEC GmbH, Leopoldshöhe

Phytowelt GreenTechnologies GmbH, Nettetal

SanoLiBio GmbH, München

Pieris Pharmaceuticals GmbH, Hallbergmoos

Sartorius CellGenix GmbH, Freiburg

Pixelbiotech GmbH, Schriesheim

Sartorius Stedim Cellca GmbH, Ulm

PL BioScience GmbH, Aachen

Sartorius Xell GmbH, Schloß Holte-Stukenbrock

PLANTegg GmbH, Kiel

SCG Cell Therapy GmbH, Martinsried

Planton GmbH, Kiel

ScheBo ® Biotech AG, Gießen

PlasmidFactory GmbH, Bielefeld

Scienion GmbH, Berlin

Plectonic Biotech GmbH, Garching

Scientific Research and Development GmbH, Oberursel

PLS-Design GmbH, Hamburg

Sciomics GmbH, Neckargemünd

pluriSelect Life Science UG, Leipzig

SciRhom GmbH, Martinsried

PolyQuant GmbH, Bad Abbach

ScobyTec GmbH, Halle

PortaCellTec biosciences GmbH, Göttingen

ScreenFect GmbH, Eggenstein-Leopoldshafen

PRAMOMOLECULAR GmbH, Berlin

ScreenSYS GmbH, Freburg

Precision for Medicine GmbH, Berlin

Seamless Therapeutics GmbH, Dresden

PreOmics GmbH, Martinsried

Secarna Pharmaceuticals GmbH & Co. KG, Martinsried

Priavoid GmbH, Düsseldorf

seedalive GmbH, Osnabrück

PRIMACYT Cell Culture Technology GmbH, Schwerin

selectION Therapeutics GmbH, Martinsried

Prime Vector Technologies GmbH, Tübingen

Senova Gesellschaft für Biowissenschaft und Technik mbH, Weimar

ProBioGen AG, Berlin

SenseUp GmbH, Jülich

PROGEN Biotechnik GmbH, Heidelberg

SensID GmbH, Rostock

ProJect Pharmaceutics GmbH, Martinsried

Senzyme GmbH, Troisdorf

Prolytic GmbH, Frankfurt am Main

SEQ-IT GmbH & Co. KG, Kaiserslautern

PromoCell GmbH, Heidelberg

SequentiX - Digital DNA Processing, Klein Raden

PROSION GmbH, Köln

sequiserve GmbH, Vaterstetten

ProtaGene CGT GmbH, Heidelberg

Seracell Pharma GmbH, Rostock

ProtaGene GmbH, Heilbronn

Seratec Gesellschaft für Biotechnologie mbH, Göttingen

ProteinDistillery GmbH, Ostfildern

Serengen GmbH, Dortmund

Proteome Factory AG, Berlin

serYmun Yeast GmbH, Bernburg/Saale

Proteome Sciences R&D GmbH & Co. KG, Frankfurt a. Main

SeSaM-Biotech GmbH, Aachen

Proteros Biostructures GmbH, Martinsried

Sidanis Pharma GmbH, Hamburg

PROVIREX Genome Editing Therapies GmbH, Hamburg

sifin diagnostics gmbh, Berlin

provitro AG, Berlin

Sigma-Aldrich Biochemie GmbH, Hamburg

PXBioVisioN GmbH, Hannover

Signatope GmbH, Reutlingen Signature Diagnostics GmbH, Potsdam

Q

SILANTES GmbH, München

Q-bios GmbH, Edingen-Neckarhausen

Silence Therapeutics GmbH, Berlin

QIAGEN, Hilden

Simris Biologics GmbH, Berlin

QITHERA GmbH, Heinsberg

Singleron BioTechnologies GmbH, Köln

QLi5 Therapeutics GmbH, Dortmund

Sirana Pharma GmbH, Plannegg-Martinsried

qubeto GmbH, Münster

SIRION Biotech GmbH, Grafelfing

Quidel Germany GmbH, Kornwestheim

Sirius Fine Chemicals SiChem GmbH, Bremen siTOOLs Biotech GmbH, Martinsried

R

Smartbax GmbH, München

R-Biopharm AG, Darmstadt

Soluventis GmbH, Bochum

ravo Diagnostika GmbH, Freiburg

SP Sourcon Padena GmbH, Tübingen

Reaction Biology Europe GmbH, Freiburg

Spexis Germany GmbH, Leipzig

ReliaTech GmbH, Wolfenbüttel

Sphingotec GmbH, Hennigsdorf

Rentschler Biopharma SE, Laupheim

Spindiag GmbH, Freiburg

Repairon GmbH, Göttingen

SpinPlant GmbH, Schollene

Resolve BioSciences GmbH, Monheim

Squarix GmbH, Marl

RHEACELL GmbH, Heidelberg

SRTD biotech GmbH, Jülich

Ribocon GmbH, Bremen

Stabizym GmbH, Roßdorf

Richter-Helm BioLogics GmbH & Co. KG, Hamburg

StarSEQ GmbH, Mainz

Ridom GmbH, Münster

Steffens Biotechnische Analysen GmbH, Ebringen

RLP AgroScience GmbH, Neustadt

StemVAC GmbH, Bernried

rnatics GmbH, Martinsried

sterna biologicals GmbH & Co. KG, Marburg

Roboscreen GmbH, Leipzig

SternEnzym GmbH & Co. KG, Ahrensburg

25 TH GUIDE TO GERMAN BIOTECH COMPANIES 2024 238

| 239


Subitec GmbH, Stuttgart

Vibalogics GmbH, Cuxhaven

Sumaya Biotech GmbH & Co. KG, Heidelberg

ViGeneron GmbH, Martinsried

Surflay Nanotec GmbH, Berlin

Vincerx Pharma GmbH, Monheim

SymBiosis GmbH, Eppelheim

Viramed Biotech AG, Planegg

Synaptic Systems, Göttingen

VIROTECH Diagnostics GmbH, Dietzenbach

Synimmune GmbH, Tübingen

Vita 34 AG, Leipzig

Syntab Therapeutics GmbH, Würselen

VivaCell Biotechnology GmbH, Denzlingen

Sysmex Inostics GmbH, Hamburg

vivo Science GmbH, Gronau

Sysmex Partec GmbH, Görlitz

Vivoryon Therapeutics NV, Halle

Systasy Bioscience GmbH, München

Volition Germany GmbH, Gräfelfing

T

W

T-CURX GmbH, Würzburg

Wacker Biotech GmbH, Jena

T-knife GmbH, Berlin

WeissBioTech GmbH, Ascheberg

Tacalyx GmbH, Berlin

WMT AG, Heidelberg

Taconic Biosciences GmbH, Leverkusen targenomix GmbH, Potsdam

X

Telexos GmbH, Weiden

X-Zell Biotech GmbH, Lennestadt

Tentamus Pharma & Med Deutschland GmbH, Karlsruhe

XanTec bioanalytics GmbH, Düsseldorf

TETEC – Tissue Engineering Technologies AG, Reutlingen

XL-protein GmbH, Freising

tgcBIOMICS GmbH, Bingen

Xvir Therapeutics GmbH, München

TherapySelect Dr. Frank Kischkel, Heidelberg Therawis Diagnostics GmbH, München

Y

Therawis Pharma GmbH, München

Yokogawa Insilico Biotechnology GmbH, Stuttgart

Thermo Fisher Scientific – B.R.A.H.M.S GmbH, Hennigsdorf

YUMAB GmbH, Braunschweig

Thermo Fisher Scientific GENEART GmbH, Regensburg Thermosome GmbH, Martinsried

Z

Therycell GmbH, Berlin

Zedira GmbH, Darmstadt

tiakis Biotech AG, Kiel

zell-kontakt GmbH, Nörten-Hardenberg

Tib Molbiol Syntheselabor GmbH, Berlin

Zellkraftwerk GmbH, Leipzig

TICEBA GmbH, Heidelberg

Zellwerk GmbH, Oberkrämer OT Eichstädt

tilibit nanosystems GmbH, München

Zimmer BioTech GmbH, Neu-Ulm

TissUse GmbH, Berlin

ZytoVision GmbH, Bremerhaven

TME Pharma NV, Berlin TolerogenixX GmbH, Heidelberg Topas Therapeutics GmbH, Hamburg TOPLAB Gesellschaft für angewandte Biotechnologie mbH, Martinsried traceless materials GmbH, Hamburg

Abbreviations: EBN: European Biotechnology Network (All data is povided without guarantee.)

Tranquil Immune GmbH, Bonn Transimmune AG, Düsseldorf TransTissue Technologies GmbH, Berlin trenzyme GmbH, Konstanz TRION Research GmbH, Martinsried Tubulis GmbH, Martinsried TunaTech GmbH, Düsseldorf

U Ucaneo Biotech GmbH, Berlin

Become partner of the next guide edition! Contact:

UGA Biopharma GmbH, Hennigsdorf UGiSense AG, Dortmund upcyte technologies GmbH, Hamburg

V Varicula Biotec GmbH, Wismar Vaximm GmbH, Mannheim Vaxxinova Autogenous Vaccines GmbH, Cuxhaven Vaxxinova Diagnostics GmbH, Leipzig Velvio GmbH, Regensburg Veraxa Biotech GmbH, Heidelberg veriNOS pharmaceuticals GmbH, Würzburg vermicon AG, Hallbergmoos VEROVACCiNES GmbH, Halle

Wolfgang Gutowski Sales & Marketing Tel. +49-30-264921-35 w.gutowski@biocom.de



25th Guide to German Biotech Companies 2024

ISBN 978-3-928383-89-9

2024 Jubilee Edition


Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.