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19th Guide to German Biotech Companies 2018

19 Guide to German Biotech Companies th


In cooperation with: BIO Deutschland – German Biotech Industry Organisation European Biotechnology Network ISBN 978-3-928383-64-6

VBU Association of German Biotechnology Companies

19 th Guide to German Biotech Companies 2018 In cooperation with: BIO Deutschland – German Biotech Industry Organisation European Biotechnology Network VBU Association of German Biotechnology Companies

© BIOCOM AG, Berlin 2017 19th Guide to German Biotech Companies Published by:

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Executive Producer: Andreas Macht Production Editor: Benjamin Röbig Graphic Design: Oliver-Sven Reblin

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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: 978-3-928383-64-6


A steady upward movement The latest OECD figures show that the biotechnology sector in Germany is growing steadily. Not disruptive, but constant (see p. 7). At the same time, there is also a lively M&A activity: large companies swallow up small ones, German companies buy foreign, foreign enterprises buy German ones. So far, so normal. As a world-open economy, Germany is relaxed about this coming and going. Especially since the abolition of interest rates by Mr. Draghi and the associated flood of capital looking for investments, company acquisitions seem more attractive than they would have been in earlier times. However, some people still see a fly in the ointment: the biotech sector consists to a large extent of small and medium-sized companies, whose research and development was largely financed by the state or better yet by the taxpayers. If such a company is sold to another part of the world, the intellectual property for the national economy is, of course, lost. “So what?” many people say, it’s also the other way around. True, but it tends to be aggressively growing economies that benefit most from this giving and taking. Many people are worried that entrepreneurial ambition – i. e. the desire to run a company on a long-term and independent basis – is not the best thing in Germany. On the other hand, research and development in Germany is so high class that the upswing in the biotech industry will continue.

Andreas Mietzsch Publisher

There are many hidden champions in Germany’s medium-sized businesses who are doing well on the world market. This book offers a wonderful cross-section of the living, growing biotechnology industry in Germany in its 19th year of publication. The Guide once again presents a premium width perspective of German biotechnology companies involved in research and development. Both within the country and abroad, the book has become something of an international business card for the country’s biotech industry. We hope you’ll take the time to leaf through it and learn more about the very diverse activities, concepts and products, visions and business models that distinguish this vibrant business location at the heart of Europe. Dear reader, once again BIOCOM invites you to browse through the pages of Germany’s vibrant life sciences sector. I wish you an enjoyable and informative read.

19 th Guide to german biotech companies 2018



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


The German Biotech Sector 2017 . .


Prefaces of Biotech Associations . . Dr Peter Heinrich, BIO Deutschland – German Biotech Industry Organisation. . . . . . . . Magnus von Cramm, European Biotechnology Network. . . . . . . . . . . . Dr Kathrin Rübberdt, Dr Sebastian Hiessl, DECHEMA e.V. and VBU Association of German Biotechnology Companies. . . . . . . . . . . . . . . . . .


Profiles of German Biotech Companies. . . . . . . . acCELLerate GmbH . . . . . . . . . . . . . . . . . . . . . . . advanceCOR GmbH. . . . . . . . . . . . . . . . . . . . . . . Affimed GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . AiCuris Anti-infective Cures GmbH. . . . . . . . . . . . AnalytiCon Discovery GmbH. . . . . . . . . . . . . . . . . apceth Biopharma GmbH. . . . . . . . . . . . . . . . . . . Apogenix GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . ARTES Biotechnology GmbH. . . . . . . . . . . . . . . . Axolabs GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . . Berlin Cures GmbH. . . . . . . . . . . . . . . . . . . . . . . . Biaffin GmbH & Co KG . . . . . . . . . . . . . . . . . . . . . Bioassay GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . Bioengineering AG. . . . . . . . . . . . . . . . . . . . . . . . . BIOMEVA GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . BioNTech AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . biosyn Arzneimittel GmbH. . . . . . . . . . . . . . . . . . . BIOTECON Diagnostics GmbH. . . . . . . . . . . . . . . Boehringer Ingelheim . . . . . . . . . . . . . . . . . . . . . . BRAIN AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cardior Pharmaceuticals GmbH. . . . . . . . . . . . . . Carpegen GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . CellGenix GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . CEVEC Pharmaceuticals GmbH. . . . . . . . . . . . . . co.don AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Coriolis Pharma Research GmbH. . . . . . . . . . . . . CRS Clinical Research Services Andernach GmbH

14 16


21 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

CureVac AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74 Eurofins BioPharma Product Testing Munich GmbH. 76 Evotec AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 FGK Clinical Research GmbH. . . . . . . . . . . . . . . . 80 FILTROX AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Fraunhofer ITEM. . . . . . . . . . . . . . . . . . . . . . . . . . 84 glyXera GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . 86 Greenovation Biotech GmbH . . . . . . . . . . . . . . . . 88 Heidelberg Pharma Research GmbH . . . . . . . . . . 90 Hyglos GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92 IBA GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 in.vent Diagnostica GmbH. . . . . . . . . . . . . . . . . . . 96 Indivumed GmbH . . . . . . . . . . . . . . . . . . . . . . . . . 98 ITM Isotopen Technologien München AG. . . . . . . 100 Janssen-Cilag GmbH . . . . . . . . . . . . . . . . . . . . . . 102 JenLab GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Jennewein Biotechnologie GmbH. . . . . . . . . . . . . 106 JPT Peptide Technologies GmbH. . . . . . . . . . . . . 108 LIFE & BRAIN GmbH. . . . . . . . . . . . . . . . . . . . . . . 110 Lipotype GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . 112 Lonza Cologne GmbH. . . . . . . . . . . . . . . . . . . . . . 114 M+W Central Europe GmbH. . . . . . . . . . . . . . . . . 116 Microcoat Biotechnologie GmbH . . . . . . . . . . . . . 118 Microsynth AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . 120 Miltenyi Biotec GmbH. . . . . . . . . . . . . . . . . . . . . . 122 Minerva Biolabs GmbH. . . . . . . . . . . . . . . . . . . . . 124 MLM Medical Labs GmbH. . . . . . . . . . . . . . . . . . . 126 MOLOGEN AG . . . . . . . . . . . . . . . . . . . . . . . . . . . 128 MorphoSys AG . . . . . . . . . . . . . . . . . . . . . . . . . . . 130 Neovii Biotech GmbH. . . . . . . . . . . . . . . . . . . . . . 132 New England Biolabs GmbH. . . . . . . . . . . . . . . . . 134 Nordmark Arzneimittel GmbH & Co. KG. . . . . . . . 136 Novaliq GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . 138 NUMAFERM GmbH. . . . . . . . . . . . . . . . . . . . . . . . 140 ORGANOBALANCE GmbH. . . . . . . . . . . . . . . . . . 142 PeproTech GmbH . . . . . . . . . . . . . . . . . . . . . . . . . 144 Peptide Specialty Laboratories PSL GmbH . . . . . 146 PlasmidFactory GmbH & Co.KG. . . . . . . . . . . . . . 148 Probiodrug AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . 150 ProBioGen AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . 152 PROGEN Biotechnik GmbH . . . . . . . . . . . . . . . . . 154 ProJect Pharmaceutics GmbH. . . . . . . . . . . . . . . 156 ProQinase GmbH . . . . . . . . . . . . . . . . . . . . . . . . . 158 Protagen Protein Services GmbH. . . . . . . . . . . . . 160

Rentschler Biotechnologie GmbH. . . . . . . . . . . . . 162 Richter-Helm BioLogics GmbH & Co. KG. . . . . . . 164 Roche Diagnostics Deutschland GmbH. . . . . . . . 166 Sartorius Stedim Biotech GmbH. . . . . . . . . . . . . . 168 Sartorius Stedim Cellca GmbH. . . . . . . . . . . . . . . 170 SYNIMMUNE GmbH. . . . . . . . . . . . . . . . . . . . . . . 172 Synovo GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . 174 Taconic Biosciences GmbH . . . . . . . . . . . . . . . . . 176 TIB MOLBIOL Syntheselabor GmbH. . . . . . . . . . . 178 Tosoh Bioscience GmbH. . . . . . . . . . . . . . . . . . . . 180 Vetter Pharma International GmbH. . . . . . . . . . . . 182 Vibalogics GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . 184 Vita 34 AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186 X-act Cologne Clinical Research GmbH. . . . . . . . 188 Xell AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190 YUMAB GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . . 192

Profiles of Service Providers . . . . . . . 195 BIO.NRW. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196 Brainloop AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198 CW-Research & Management GmbH . . . . . . . . . 200 Dentons Europe LLP. . . . . . . . . . . . . . . . . . . . . . . 202 Evosciences Leasing GmbH. . . . . . . . . . . . . . . . . 204 HealthCapital Berlin-Brandenburg . . . . . . . . . . . 206 IZB mbH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208 Life Science Nord Management GmbH. . . . . . . . 210 Technologiepark Weinberg Campus . . . . . . . . . . 212 Trockle Unternehmensberatung. . . . . . . . . . . . . . 214 TVM Capital Life Science. . . . . . . . . . . . . . . . . . . 216

German Biotech Companies . . . . . . . . . 218

19 th Guide to german biotech companies 2018


The German Biotechnology Sector 2017

In terms of key economic factors, 2016 was the best year for the German biotech sector ever. According to the company survey, which BIOCOM AG conducts annually via the information platform for more than ten years, the generated turnover of the German biotech sector for the third year exceeded €3bn. In 2016, total figures increased by 8% to €3.54bn compared to the year before.

Key figures with all-time high Further upswing has been observed regarding spending on research and development (R&D). For the second time since 2010, the innovation budget cracked the one billion euro mark (+6.3%) and now stands at €1.1bn (2015: €1.04m). With a total of 20,280 (2015: 19,010), there were more employees than ever before working in biotech companies that are occupied wholly or predominantly with modern biotechnological methods. The total number of these companies rose to 615 (2015: 593). Thereby, the following figures and conclusions relate only to the ‘dedicated’ biotechnology companies, as defined by the OECD.

Stable financing situation The financial investments showed stable conditions, but have not reached the record numbers of 2015. In 2016,

around €505m were invested in German biotech companies. Compared to €550m in the year before, this is a decrease of 8.2%. A large proportion of the money (€216m) went into the private biotech sector, but the majority of the money (€258m) was invested into already listed public companies (+5%). In 2016, one German biotech IPO (€31.5m) took place.

Record employee numbers There is sustained interest in biotechnological processes and services from big business. This is confirmed by a consistently high number of companies in which biotechnology represents only one aspect of business. In 2016, the category of ‘other biotechnology-active companies’ comprised a total of 137 companies (2015: 133). These included both pharmaceutical and chemical companies focused on innovative biotechnological processes as well as companies from the areas of environment, waste management, energy and agriculture. In 2016, a total of 22,000 people were employed in the biotechnology-oriented areas of such companies. Compared to the previous year (2015: 20,250), this represents a growth of 8.6%. For the first time, total headcount in commercial biotechnology increased above the 40,000 mark to 42,280 (2015: 39,260) (+7,7%).

Key figures of the biotech sector in Germany 2010







Number of dedicated biotechnology companies








Number of other biotechnology-active companies








Number of employees in dedicated companies








Number of employees in the other biotechnology-active companies








Turnover of dedicated biotechnology companies








R&D expenditures of dedicated biotechnology companies








19 th Guide to german Biotech Companies 2018


Strength in medical biotech Observers of the German biotech sector will have noted a pretty unchanged picture of the sector when it comes to focal areas: the key task of most biotech companies is developing drugs or new diagnostic methods. 306 companies (49.8 %) belong to the field of ‘red’ biotechnology – a proportion that has remained steady for many years, but which showed an increase in turnover of 8.1% (€2.5bn), and an augmentation in R&D expenditure of 6.6% (€911m) in 2016 (see below).

High interest in immunotherapy A large majority of the companies (158) are either in the preclinical stage of therapeutic research or developing technology platforms. Here, 2016 demonstrated that German know-how is in greater demand than ever before. As it was already last year, in 2016 again German biotech companies hit the headlines with large investments involving foreign investors. This was true for the startup iOmx Therapeutics AG, based in Martinsried near Munich. The company is developing cancer thera-

peutics by targeting novel immune checkpoints. With its €40m Series A financing, co-led by US-based investor MPM Capital and French Sofinnova Partners, it was the largest German biotech VC round in 2016. A strong tie to chinese research groups helped Jenabased Inflarx GmbH to close a €31m Series C financing in 2016, Staidson Hongkong Investment Company ltd. (STS) participated as new investor, further support came from bm-t Beteiligungsmanagement Thüringen GmbH, KfW group and several other industrial and private investors.

Double-digit VC financings In 2016, Tübingen-based CureVac AG (see p. 74) succeeded to add further €26m to its record €100m financing round from 2015. The fresh cash came from the new investors Baden-Württembergische Versorgungsanstalt für Ärzte, Zahnärzte und Tierärzte (via the LBBW Asset Management Investmentgesellschaft mbH, Stuttgart), and the Landeskreditbank Baden-Württemberg. Cure-

Fig. 1: Turnover and R&D expenditure of dedicated biotech companies



R&D Expenditure

3,000 2,191


2,011 +14%

2,000 1,500













1,000 +1.1%




500 0 2006





Vac plans to utilise these funds to advance the development of its messenger RNA product portfolio. Another double-digit VC round was completed by German-French company Allecra Therapeutics SAS. The antibiotics specialist raised €22m in a Series B financing led by Forbion Capital partners and Sofinnova to further develop its novel treatments to combat multi drug-resistant Gram-negative bacterial infections. Some movements also took place in the preclinical area. Among others, the autoimmune specialists from Berlin Cures GmbH (see p. 40) entered the group of drug developers with the start of a phase I clinical trial to treat heart insufficiency.

Fig. 2: Drug candidates of dedicated biotechs

Phase I

34 34


42 43

48+1* 48 49 48 49

Phase II

10 9 9 9 10

Phase III

Growing relevance of diagnostics

2016 2015 2014 2013

A growing part of the biotech sector (91 firms) is dedicated to the development of diagnostics, which reflects the increasing demand for early disease detection, e.g. in the field of infectious diseases, and the relevance of accompanying diagnostics for therapeutic treatments,

12 12 10 10 9



2012 * Pivotal study of 4SC AG included






3,545 3,284 2,903 2,619


























19 th Guide to german Biotech Companies 2018


Drug developers with full pipeline

Top 3 financing rounds of private companies in 2016 Capital raised iOmx Therapeutics AG


InflaRx GmbH


CureVac AG


e.g. for a personalised medicine in the field of cancerous diseases. This growth is underlined by a large increase of turnover (€1.79bn, +9,3%) and R&D expenditure (€280m, +15,9%), showing the importance of these companies for the German biotech sector. Some financings such as the €4.25m secured by Regensburg-based Lophius Biosciences GmbH or the €25m debt financing by listed Curetis N.V. are reflecting this positive trend.

A total of 57 German biotech companies are fully dedicated to drugs and have one or more candidates in clinical development. Last year, a total of 101 biologically active compounds were in one of the three phases (see fig. 2). The establishment of a robust clinical pipeline is partly due to the high overall interest in immuno-oncology and cell therapies. In addition, many German companies succeeded in developing their technology platforms to advanced stages which are now resulting in clinical projects. In 2016, a total of 42 active substances were recorded in phase I (2015: 43). The majority of clinical candidates of German companies were in phase II in 2016, amounting to a total of 49 active substances (2015: 48). Here, there was little change in the number of trials, however some movement took place. Among others, listed company Pieris, which is advancing novel biotherapeutics through its proprietary Anticalin technology platform, completed a new phase II trial with its anemia drug candidate PRS080. Another new Phase II trial was started by Munich-based Multimmune GmbH that fo-

Fig. 3: Sources of financing for dedicated biotech companies €m

Venture capital  


Investments in public equity


656 335

600 500

485 126





+15% 258




400 300

448 −26% 296

24 297

−100% −32%



264 122




−20% 142

100 0 2006






cuses on new cancer therapeutics. 4SC AG started a pivotal clinical trial to evaluate the epigenetic cancer drug resminostat for maintenance treatment of patients suffering from advanced-stage cutaneous T-cell lymphoma (CTCL). Total numbers of phase III candidates raised to 10 this year. Most of the trials are still ongoing ones from last year. Only Vasopharm GmbH from Würzburg started a new phase III trial with its VAS203 drug candidate to treat acute brain injury. To conduct this trial the company secured a €20m financing co-led by existing investors Entrepreneurs Fund, Heidelberg Capital Private Equity and new investor, UK based Fort Rock Capital.

Services as a solid business model Apart from the health sector, the second largest pillar of the German biotech scene is comprised of companies (186) that are not active in a specific field. This includes all companies providing services exclusively or primarily for other biotech firms, or which function as suppliers. In 2016, all these companies together had a turnover of €740.8m (+7.4%) and an R&D budget of €113.5m

Top 3 financing rounds of listed companies in 2016 Capital raised Morphosys AG


Probiodrug AG


Pieris AG & Biofrontera AG


(+4.6%), demonstrating that the service business model has proven to be a guarantee for continuous growth within the German biotech sector since 2011 when turnover was €556m.

More turnover in bioeconomy There are 63 companies developing industrial applications in various other sectors, which highlights the

550 +61%



505 258

401 355 300 +26% 142 70






95 205

−33% 137











32 216

72 2011






19 th Guide to german Biotech Companies 2018

10 | 11

Fig. 4: Number of annual new biotech start-ups over the time As reported in Q1 of the following year Current state as of Q1/17



Positive financial environment

32 30




17 13


14 10


0 2012



Dynamic employment market In terms of jobs, the German biotech sector is a dynamic employment market. In 2016, the 615 dedicated companies reported a total increase of more than 1,270 employees. As already observed in 2015, most of the increase this year was generated by middle-sized companies.



relevance of biotech processes throughout the industry as a whole. This is also reflected by a rise of 9.5% in industrial biotechnology turnover. The takeover of Berlin-Based Organobalance GmbH (see p. 142) by Danish Novozymes also demonstrates the dynamic in this field. The application of biotechnology in the plant breeding and agricultural sector has decreased over the years, but since 2015 the situation is slightly improving. In 2016, the 19 companies generated a plus of 2.8% in turnover (€33.2m).

New start-up peak With a total of 20 start-ups already known today the founding dynamics in 2016 doubled compared to 2015, now reaching levels last seen in 2012. As shown in figure 4 above, there is an increase of total start-up numbers during the course of the year and, from experience, a further plus can be expected for 2016. Most of the newcomers known today are active in the health biotech area (14), four in the non-specific services field and two in bioinformatics. Four insolvencies and six liquidations were reported in 2016.

The financial situation also mirrors a sustainable positive trend over the last years: in 2016, around €505m was invested in German biotech companies (see fig. 3), which did not reach the record levels of 2015 (€550m), but still is a high amount of money compared to previous years. The majority of the money was spent in public companies (€258m, +5%, among others in MorphoSys AG (see p. 130) and Probiodrug AG (see p. 150). With bioeconomy pioneer BRAIN AG (see p. 58), the first biotech IPO since 2007 took place at the German stock exchange in Frankfurt. Total numbers of listed German biotech companies increased to 21. Among them are five firms that are listed on a foreign stock exchange. In 2016, Berlinbased Noxxon Pharma choose that way, too, and went public on Euronext in Paris.

Interest of pharma and crowd A closer look into the financings of the private firms, which secured a total of €216m in 2016, reveals that despite overall lower levels (-17%) than in 2015, a lot of double-digit rounds were raised. Foreign investors participated in eight of the 21 private financing rounds, demonstrating that German companies are able to attract high levels of interest. In addition, two crowdfunding campaigns for biotech companies took place in 2016. Some major multimillion euros licensing deals, such as BioNTech (see p. 50) with Genentech (€278m), or Medigene with Bluebird Bio (€917m), or Proteros with MSD (€157m), further support the theory that German firms are quite attractive from an international point of view. The growing attractiveness of German technology platforms was also highlighted by several mergers and acquisitions. Nine out of 15 buyers came from abroad, the others were takeovers by German companies or German-German consolidation activities.

Prefaces of Biotech Associations

19 th Guide to german Biotech Companies 2018

12 | 13


Germany: innovation in the land of inventors Germany just went through a federal election, and German voters have handed Chancellor Angela Merkel a fourth term. Most likely, Merkel will have to start talks with the Free Democrats (FDP) and the Green Party to form a so-called “Jamaica coalition,” after the Social Democrats (SPD) ruled out entering a new grand coalition. Thus, who will govern the country for the next four years is not yet clear as of the writing of this foreword. Because of the limited possible options, coalition talks will become very difficult and could last anywhere from weeks to months. In preparation for this federal election BIO Deutschland formulated a set of position papers in which the association asks legislators for changes in regulation and frame conditions that will help to boost the key field of biotechnology and allow small and medium-sized biotech companies to grow and thrive. Dr Peter Heinrich Chairman of the Board of the biotechnology sector association BIO Deutschland

The German biotech sector Why are these changes necessary? BIO Deutschland’s annual assessment of key performance indicators of the sector showed that Germany’s biotech sector continues to grow. Significant increases have been seen in revenue as well as in the number of companies and employees. The number of people employed in the sector rose by 17 percent to nearly 25,000 over the past year and the number of biotech companies climbed by 5 percent to 623 in the same period. Revenue generated in 2016 was up 7 percent at €3.6 billion. Publicly traded companies invested heavily in research and development, although R&D investment by private companies stagnated, dropping 2 percent to €667 million. German Biotech companies raised about €505 million in capital in 2016. The amount was distributed relatively evenly across companies, unlike in 2015 where the total sum raised was higher (€550 million), but one company received two thirds of the capital. VC numbers in 2017 so far are lagging behind those of 2016. The industry has also recently seen some impressive trade sales. Oncology specialist Ganymed (2016) and immune oncology player Rigontec (2017) were both acquired by pharmaceutical corporations for several €100 million each. While the key indicators for German biotech in general look promising, stagnation in venture capital and the decrease in R&D investment in private companies are a concern. The previous government made some necessary changes to create incentives for investors to put their money into high-tech companies. But BIO Deutschland’s assessment is that these changes have not been far-reaching enough to raise sufficient money for capital-intensive innovations such as generated by biotech. There is a large amount of private capital in Germany which could be mobilised with tax incen-

tives for a citizens’ innovation fund similar to the “fonds commun de placement dans l’innovation” (FCPI) in France. Also, Germany is one of the very few European countries that does not use tax credits to promote R&D activities and to strengthen innovation potential. While project funding is an indispensable pillar for the biotech sector, examples from other countries such as Austria show that tax credits can boost innovation. Therefore BIO Deutschland strongly suggests the introduction of tax credits with a special consideration for small and medium-sized enterprises (SME) in Germany. The innovation intensity, which describes the relation of innovation expenses to total revenue, has been steadily declining in German SME, unlike in large corporations. This is why we need to put a particular focus on these smaller companies to reach a turnaround in innovation intensity in this segment. Most political parties have incorporated the introduction of tax credits in their programmes, albeit to a varying extent. We can only hope that whichever government coalition Germany will have for the next four years will finally stick to the plan to introduce these tax credits.

BIO Deutschland Geschäftsstelle Am Weidendamm 1a 10117 Berlin Germany

Biotechnology agenda Even before the parties had started their official election campaigns, the head of the chancellery Peter Altmaier explained at a national research summit that he thinks a biotechnology agenda for Germany may be needed. This plan was also included in the election programme of his party, the Christian Democrats. A biotechnology agenda would greatly contribute to promoting the key field of biotechnology and highlight the potential and key role of biotechnology not only for medical treatment but also in the transformation from a petrol-based into a bio-based economy, a bioeconomy. Because we consider the implementation of a biotechnology agenda of outmost importance for Germany, BIO Deutschland has drafted recommendations to the future government. The association suggests a set of five action points, each with more detailed measures that should be taken. These action points include agenda setting, education and qualification, frame conditions, trans-national and cross-sectoral value chains, as well as entrepreneurship and start-up culture. Many measures compiled by BIO Deutschland for a biotech agenda are supported by studies and recommendations of other expert committees, such as the bioeconomy Council and the Commission of Experts for Research and Innovation (EFI). We think that a biotech agenda together with a new bioeconomy strategy would give Germany the necessary impetus to promote innovation and lead the country into a carbon-neutral, healthy, and sustainable future. In the global innovation index report 2017 Germany ranks number nine. Since Germany is highly dependent on an efficient innovation system to guarantee a growing economy, action should be taken to foster, secure, and expand the potential we have in this country. The life science industry, with its important biotech sector, is highly innovative and is the key to a sustainable economy and future in Germany. 19 th Guide to german Biotech Companies 2018

14 | 15


Europe’s challenges

All in all, we can’t complain. The biotech industry in Europe is doing quite well, although the past year certainly can’t compete with the astounding IPO-driven years of 2014/15. Nevertheless, 226 existing listed biotech companies in Europe with 16 newly listed companies this year is a very good sign. But we can’t ignore the turmoil, which still has a hold on Europe. With the UK leaving the union and Catalonia dreaming of independence, the EU faces many challenges that can and will have impacts on the biotech industry in Europe and its member states.

Magnus von Cramm Communication Manager European Biotechnology Network

Now, more than ever, it’s crucial to stand and work together. The same goes for the biotech industry in Europe. The EU unitary patent will be a milestone for biotech companies all over Europe to operate more freely and efficiently across borders, as soon as it is ratified. It is important for Europe’s future to pool our knowledge and resources to defend our position as one of the world’s leading biotech research locations. With several thousand members across all European countries, the European Biotechnology Network is just such a place to connect and benefit. Our vision is a more connected and interlinked Europe, which empowers, accelerates, and increases the use of advances in science and research as they make the transition from the lab to general use. Our members share our goal to encourage European cooperation in the fields of biotechnology and life sciences. It has been almost 10 years since the European Biotechnology Network was founded. Much has happened in that time, but Europe has still much untapped potential concerning knowledge exchange and connectivity. An opportunity we should not miss.

Consistent growth Germany on its own has had quite a positive and stabilizing development in 2016. There was growth in the privately held as well as the listed biotech sector. More than 22 new companies and almost 1,350 new jobs (+6.7%) are a satisfying result. Germany confirms once more that it belongs to the biotechnological core countries within Europe and continues to strengthen its position.

Onwards together While it still remains uncertain which path the USA under President Trump will take concerning the bioeconomy and biopolitics, the most recent elections in France,

the Netherlands, and Germany have shown that Europe rejects backwards thinking and clinging to outdated resources and industry. Europe can set an example as an open society, which stands as a bastion against rising nationalism, populism, and dreams of returning to times, thankfully, long past. Besides, we must not forget what enormous advantages open boarders and shared know-how facilitate. Our gaze is forward, towards biotechnology and the future. With these pompous words I’ll leave you to enjoy the 19th Guide to German Biotech Companies 2018 and wish you all the best in your research and business.

European Biotechnology NET WORK

European Biotechnology Network AISBL Rue de la Science 14b 1040 Brussels, Belgium

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Exploitation of potential

The Biotech industry in Germany never has been in such a good shape. According to the report “The German Biotechnology Sector Facts & Figures, 2017” the turnover of the dedicated biotechnology companies has steadily increased over the past years to a volume of more than € 3.5 bn in 2016. Furthermore, the number of employees within the sector has reached a new all-time high. According to the latest surveys, the optimism of the German Biotech industry remains unbounded. In addition, the statements and election programmes of the parties recently elected to the Bundestag suggest that efforts to strengthen the biotechnology sector in Germany will continue and the expenditure on research and development will further be increased. Dr Kathrin Rübberdt, Head of Biotechnology, DECHEMA e.V.

Dr Sebastian Hiessl, VBU Vereinigung Deutscher Biotechnologie-Unternehmen

However, as the 5th Innovation Dialogue of the 18th Legislature Period already identified at the end of 2016, existing potentials and resources are still not being fully exploited. Although biotechnology research in Germany is excellent, and with more than 600 Biotech companies, Germany is in the top section in Europe, the technology transfer is not yet optimal. Furthermore, Germany’s biotechnology companies often still lag behind those of the USA, e.g. regarding turnover and market capitalisation. At this stage the Association of German Biotechnology Companies (VBU) supports its member companies as it creates prerequisites for a more efficient technology transfer and for the establishment of the companies’ innovations on the market. As an integral part of DECHEMA (Society for Chemical Engineering and Biotechnology) the VBU offers its 200 member companies an interdisciplinary network with nearly 6000 experts from industry and academia, and creates an environment where knowledge can easily be exchanged and new ideas can jointly be developed. We organise professional conferences, expert workshops, and webinars specifically tailored to the needs of our members and support them in the targeted search for suitable cooperation partners. Together with DECHEMA, the VBU also directly supports the implementation of research results into technical applications within the framework of projects. One of the most important reasons for inefficient technology transfer is a lack of capital. Here again, VBU supports its member companies by e.g. connecting financing partners and companies, presenting funding options for R&D&I projects, and supporting the companies in project applications . The VBU also offers its member

companies – especially start-ups and smaller companies – the opportunity to present themselves in webinars, on events, and in websites or newsletters to a broader audience and thus significantly increase their visibility and that of their products. With a background of more than 20 years of activity, the VBU will continue to support German biotechnology companies by pointing out existing opportunities, providing input, enabling cooperation and exchange, and actively supporting technology transfer – and thereby contributing to the success of the bio-economy in Germany. Your personal contact: VBU – Association of German Biotechnology Companies in DECHEMA e. V.

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

Find more about VBU and DECHEMA

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Profiles of German Biotech Companies

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

· · · · · · · · · · · · ·

Osterfeldstraße 12–14 22529 Hamburg Hamburg Dr Oliver Wehmeier +49-637-303-00 +49-637-303-09

LI 10 2014 Biolab BSL2 l Drug Discovery l Toxicology l Drug Development l Quality Control

External · l upcyte technologies Collaborations l CLS Cell Lines Service l ChromoTek l B’SYS l Evercyte l BIOjump

Over the course of the last 10 years the use of assay ready cells has become well established in drug discovery, safety assessment, and the quality control of biologics. Assay ready cells can be used in bioassays instantly after resuscitation from a frozen stock without prior cultivation, passaging, or even cell counting, basically like any other assay reagent. This relatively new approach not only releases the operator from maintaining a continuously passaged cell culture but also increases the reliability, reproducibility, and flexibility of any cell-based assay. Assay ready cells are prepared in large homogenous and prequalified batches and can be stored like this for more than a year. So they are always available at exactly the time, quantity, and quality as needed. acCELLerate develops bioassay kits based on assay ready cells and provides custom production of assay ready cells for small molecule drug discovery and quality control of biologics in clinical development and manufacturing. Assay ready cells can be prepared basically from any provided cell line, e.g. recombinant cells expressing a target receptor, reporter cell lines, or non-engineered human cell lines or primary cells. acCELLerate has experience with a broad range of cell lines as well as primary and immortalised cells from various tissues, including classical host cell lines (e.g. CHO, HEK, U-2 OS), epithelial cell lines (e.g. Caco-2, Calu-3, MDCK, HaCaT keratinocytes), endothelial cells (e.g. HUVEC, LSEC), lymphocyte cell lines (e.g. Jurkat, THP-1, MOLT-4, TF-1, U937), and many more. Assay ready cells are prepared in homogeneous batches of tens of billions of cells, which are automatically dispensed in up to 1,000 vials of custom aliquot size (1 to 100 million cells per vial). The cells become functionally cryopreserved in a controlled rate freezer applying optimised and cell-type specific conditions and freezing media. To comply with GMP standards of bioassays in clinical development and quality control, assay ready cells are provided with comprehensive documentation of the production process and the quality control including not only sterility, viability, and batch homogeneity but also proliferative capacity and functional performance.


acCELLerate has a production facility of about 700 m2 which is located in Hamburg and operates an additional cell storage and distribution centre based in Hillsborough, NJ for the local support of US clients. acCELLerate’s processes are certified according to ISO 9001:2008. A recertification according to the revised 9001:2015 standard is in preparation.

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

· · · · · · · · · · · ·

Fraunhoferstraße 9a 82152 Martinsried Bavaria Prof. Dr Götz Münch +49-89-2000-204-10 +49-89-2000-204-20 25 2012 S2, GMP/GLP l Personalized medicine in inflammation l Cardiovascular diseases

advanceCOR is a drug-developing biotech company which focuses on personalised medicine in cardiovascular diseases. We concentrate on innovative biological drugs in indications with unmet medical needs. The overall aim is to develop highly specific drugs with broad therapeutic windows and very limited side effects. Our most advanced innovative drug, Revacept is currently in phase II clinical development for the treatment of stroke and acute coronary and cerebral vascular syndromes. Revacept is a lesion-specific inhibitor of atherothrombosis without further impairment of platelets and haemostasis. As a consequence, Revacept shows highly specific inhibition of the pathological, plaque-mediated thrombosis (as in myocardial infarction and stroke) without bleeding complications. This has been shown in different animal models of disease such as plaque-rupture, myocardial infarction, transient middle cerebral artery ischemia, and stroke. In phase I studies in human volunteers Revacept showed reliable ex vivo inhibition on platelet aggregation without any prolongation of bleeding. Currently, Revacept is in Phase II studies in patients with stroke due to symptomatic carotid artery stenosis and in patients with coronary artery disease undergoing stent implantation. The patient studies are double-blind placebo-controlled studies. Therefore only safety data are currently available, showing no increase in bleeding complications compared to standard treatment. The efficacy data will be available at the end of the study, due mid-2018. Along with Revacept we have developed a companion diagnostic detecting early platelet activation with a simplified blood biomarker assay. With this assay patients at high risk of future ischemic events, who will benefit most from intensified anti-platelet therapy, can be identified. The assay detects the same platelet activation pathway (glycoprotein GPVI) which is inhibited by Revacept. Thus Revacept is the ideal, companion drug for treatment of these high-risk patients who will benefit most from treatment.


A second-line candidate of Revacept is GP VI-CD39, a therapeutic protein combining the effects of Revacept with further lesion-specific inhibition of ADP-mediated thrombus formation. ADP is the most abundant platelet agonist currently treated with various ADP receptor blockers such as Clopidogrel. However, GPVI-CD39 modulates increased ADP production at the hot-spot of plaque rupture and leaves the overall platelets unaffected. In animal models an increased efficacy over Revacept in inhibiting plaque-mediated thrombosis without increase in bleeding is supporting the hypothesis of the mode of action.

AdvanceCOR: Pipeline Summary

COR-4 is a peptide to inhibit autoimmune-mediated thyroid inflammation in Grave´s disease (M. Basedow). COR-4 selectively modulates anti-TSH receptor autoimmunity without general suppression of the immune system. In an animal model of Grave´s disease COR-4 normalised hyperthyroid metaboslim, reversing cardiac abnormalities (atrial fibrillation) and eye symptoms (retro-orbital fibrosis), all cornerstones of the human disease. Cor-5 is a anti-GP VI antibody for the treatment of plaque-mediated thrombosis in acute CAD and is currently in preclinical development.

AdvanceCOR: Team

advanceCOR has the permission and quality level for good laboratory practice (GLP) assays and good manufacturing practice (GMP) to support the clinical studies with high-class assays, as well as for final drug release of study drugs (“Medikamenten-Herstellung”). advanceCOR is financed by the MIG AG, KfW Bank, Bayernkapital, HTGF, First Capital Partner, and BioM AG. The founders and management of advanceCOR bring together knowledge and reputation in research and clinical medicine together with biotech entrepreneurship including successful exits (Corimmun to Johnson & Johnson in 2012).

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

· · · · · · · · · · · ·

Im Neuenheimer Feld 582 68120 Heidelberg Baden-Wuerttemberg Anca Alexandru +49-6221-64793341 +49-6221-6530749 74 2000 Immuno-Oncology Tetravalent Bispecific and Trispecific Antibodies

External · l Leukemia and Lymphoma Society Collaborations l MSD (Merck & Co.) l MD Anderson Cancer Center

Affimed – Engaging immune cells to fight cancer Affimed (Nasdaq: AFMD) engineers targeted immunotherapies, seeking to cure patients by harnessing the power of innate and adaptive immunity (NK and T cells). We are developing single and combination therapies to treat cancers and other life-threatening diseases.

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 (a part of the innate immune system, the first line of defense) and T cells (a part of the adaptive immune system, the second-stage defense system) cannot recognise tumour cells as foreign or aberrant and therefore cannot fight them. To overcome these limitations, we have developed a technology that disables the tumours’ evasion mechanisms and activates immune cells. Leveraging our proprietary, next-generation tetravalent antibody platform, we have developed a pipeline of promising clinical and preclinical bi- and trispecific antibody product candidates for which we retain global commercial rights.

Our technology and platforms Our antibodies are immune cell engagers with a tetravalent architecture characterised by four binding domains. We have developed products from three platforms: ·· Bispecific antibodies engaging NK cells (via CD16A) ·· Bispecific antibodies engaging T cells (via CD3) ·· Trispecific antibodies engaging either NK or T cells Our tetravalent antibodies are developed to substantially increase the efficacy and specificity and/or to extend the therapeutic window of current therapeutics. Binding to targets on both the immune and the tumour cell, they redirect immune cells and establish a bridge between either NK cells or T cells and cancer cells,


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


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


Engager Therapy

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


triggering a signal cascade that leads to the destruction of cancer cells. In clinical studies, our products have already demonstrated promising signs of therapeutic activity in patients.

Our products AFM13 (bispecific NK cell engager) NK cell target: CD16A | Tumour target: CD30

Immunological Synapse

AFM13 engages NK cells and is designed to treat CD30positive malignancies including Hodgkin lymphoma (HL) and cutaneous T cell lymphoma (CTCL) and is currently being investigated in HL as a monotherapy (Phase 2a) and in combination with Merck’s checkpoint inhibitor KEYTRUDAŽ (Phase 1b), as well as in cutaneous T cell lymphoma (CTCL, Phase 1b/2a). AFM11 (bispecific T cell engager) T cell target: CD3 | Tumour target: CD19 AFM11 is specifically designed to treat B cell malignancies including non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL), in which CD19 is expressed at abnormally high levels. AFM11 is currently in Phase 1 clinical development for NHL and ALL.

Release of Perforins and Granzymes

AFM24 (bispecific NK cell engager) NK cell target: CD16A | Tumour target: EGFRwt AFM24 binds to the EGFR wild-type, which is constitutively active in some solid tumours. AFM24 has demonstrated the killing of tumour cells independent of their mutational status (e.g. Ras) and is currently in preclinical development. AFM26 (bispecific NK cell engager) NK cell target: CD16A | Tumour target: BCMA

Tumour Cell Lysis

AFM26 binds to B cell maturation antigen (BCMA), a particularly attractive target due to its limited expression on healthy tissues and almost universal expression on multiple myeloma cells in the majority of patients. AFM26 is currently in preclinical development. 19 th Guide to german biotech companies 2018

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Name · AiCuris Anti-infective Cures GmbH Address/P.O. Box · Friedrich-Ebert-Str. 475 Building 302 Postal Code/City · 42117 Wuppertal State · North Rhine-Westphalia Contact Person · Katja Woestenhemke Telephone · +49-202-317-63-0 Fax · +49-202-317-63-11 77 Email · Website · Social Media · L I Number of Employees · 55 Founded (year) · 2006 Type of Laboratory · S2, S3 for Anti-Infective Research and Pharmacokinetic Investigations Areas of Activity · Anti-Infectives 1. Antivirals against: Human Cytomegalovirus (HCMV), Herpes Simplex Virus (HSV), Hepatitis B Virus (HBV), Adenovirus 2. Antibacterials against: Gram negative and Gram positive multiresistant hospital infections 3. Immune modulators External · Merck & Co. (MSD): Licensee of Collaborations AiCuris’ HCMV drug Letermovir Request for · AiCuris is interested in collaborations Further Collaborations with academic and industrial partners and pursues an active in- and outlicensing strategy

Company overview AiCuris is a pharmaceutical company focused on discovery, research and clinical development of novel, resistance-breaking antiviral and antibacterial agents for the treatment of severe and potentially life-threatening infectious diseases. AiCuris was formed in March 2006 as a spin-out of the anti-infectives unit of Bayer HealthCare, and established itself as a “powerhouse for anti-infectives”. Majority investors in AiCuris are Drs. Strüngmann, the founders and previous owners of Hexal. The head office and laboratories of AiCuris are located at the Life Science Park in Wuppertal, Germany, where the Company occupies 3,000 square meters. Biology laboratories (S2 and S3) as well pharmacokinetic laboratories are available for the discovery and the support of the development of novel anti-infective agents. Founding CEO of AiCuris was Prof. Dr. Helga RübsamenSchaeff. In 2015, Dr. Holger Zimmermann, former CSO, took over CEO responsibilities. AiCuris’ management team combines international drug development experience from both small and large pharma companies as well as scientific expertise in anti-infectives enabling it to not just discover novel therapies but also move these drugs through clinical development. In 2012, AiCuris licenced its HCMV portfolio to Merck & Co., USA (MSD) and granted MSD worldwide rights to develop and commercialise it. With €110 million upfront and milestone payments of up to €332.5 million as well as royalty payments this was one of the largest agreements of this kind in the European biotech industry.

Corporate strategy AiCuris is dedicated to develop innovative drugs in the field of anti-infectives targeting severe and potentially life-threatening infectious diseases with high medical needs. The compounds represent novel chemical classes and/or act via new modes of action and are directed against new targets. Based on that AiCuris


therapeutics are resistance-breaking by design. AiCuris follows a proof-of-concept strategy before out-licensing its development projects.

AiCuris CEO – Dr Holger Zimmermann

AiCuris R&D Pipeline

Currently, the company has seven clinical development programs. The most advanced is Letermovir, a first in class molecule derived from a novel chemical class and designed to inhibit the HCMV viral terminase in immunosuppressive patients. This compound, licensed to MSD, has successfully completed a pivotal phase 3 trial and met the primary endpoint as an investigational prophylactic therapy against HCMV in bone marrow transplant patients. Letermovir has been assigned priority review status by the FDA with a PDUFA date in November 2017. AIC649 is a novel biological immune modulator that aims to provide patients with a curative treatment for hepatitis B virus (HBV). Pritelivir, a helicase-primase inhibitor, being developed to treat herpes simplex virus Type 1 (HSV-1) and Type 2 (HSV-2) infections has successfully completed a Phase II clinical trial as an oral formulation against genital herpes whereas a topical form, targeted against labial herpes, is currently in an ongoing Phase II trial. Other preclinical and clinical programs include small molecules against HCMV, HBV, Adenovirus, and resistance breaking hospital antibiotics. The anti-infectives market targeted by AiCuris is composed of the antiviral (>24 bn USD) and the antibacterial field (approx. 45 bn USD). In these AiCuris addresses high growth areas like antiviral drugs and hospital antibiotics. One key growth driver is the growing resistance of pathogens to existing antiviral and antibacterial drugs, causing serious concerns to healthcare providers and regulatory authorities worldwide. In addition, these markets show significant growth in emerging countries. AiCuris is actively in-licensing preclinical projects that help making a real difference in the anti-infectives field. AiCuris’ key areas of interest are viral indications, in particular HBV, adenovirus, influenza virus, norovirus, and life-threatening nosocomial bacterial infections especially caused by Gram-negative pathogens.

AiCuris Building – laboratory and office space

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

· · · · · · · · · · ·

Hermannswerder Haus 17 14473 Potsdam Brandenburg Dr Lars Haustedt +49-331-2300-300 +49-331-2300-333 67 2000 Chemical, Microbiological (L2, S1) Areas of Activity · | Pharma | Cosmetic | Food External · | Astellas, Japan Collaborations | DSM, Switzerland | Johnson & Johnson, Belgium | Memorial Sloan-Kettering Cancer Center, USA | Merck, Germany | Novartis, Switzerland | Philip Morris International, Switzerland | Roche, Switzerland | Symrise, Germany | UCB, UK | several others non-disclosed

Our company Our focus is on natural products – that is what AnalytiCon Discovery is all about. In the course of evolution, natural products have been optimised in various ways and for a wide range of biological effects. Hence, AnalytiCon is taking advantage of an opportunity that is already inherent in these small molecule compounds. The company is the globally preferred partner to companies in pharmaceutical, cosmetic, food, and agriculture sectors. As a research and development company, we cover the entire spectrum from establishing substance libraries, identifying active ingredients, and synthetically optimising them to production on a commercial scale.

Excelling in natural product research – everything under one roof Natural product chemistry is a focusing of modern drug research on the biosynthetic products of plants and microorganisms. Abundant resources of nature – molecules designed and produced in living cells – are exploited to find starting points for the development of innovative products. The combination of microbiology, natural product isolation, analytics, and structure elucidation, as well as natural product synthesis and biological profiling, makes AnalytiCon unique.

Vast and continuously growing strain collection Its current in-house strain collection of 25,000 highly diverse microorganisms enables AnalytiCon to isolate an unrivalled diversity of microbial substances with potentially interesting biological activity. Prokaryotic and microbial kingdoms allow AnalytiCon to provide a fascinating diversity of taxonomic and ecological groups, including, inter alia, actinomycetes, myxobacteria, and endophytic fungi.

Analyticon Discovery

State-of-the-art fermentation Current fermentation technologies extend far beyond liquid fermentation. AnalytiCon profiles its strains with regard to their biosynthetic potential for secondary metabolites by means of complementary fermentation systems. In addition to liquid fermentation, solid fermentation and membrane (biofilm) fermentation are also used. For the scale-up, after successfully optimised 10 L fermentation, AnalytiCon has established a collaborative network of partners in the 200–1,000 L scale.

AnalytiCon’s high throughput isolation platform A unique technology platform allows AnalytiCon to isolate pure natural products in high throughput fashion. Beginning with the extraction of the material, followed by the use of individually optimi,ed column chromatography and concluding with HPLC-MS and NMR analytics, AnalytiCon can purify thousands of molecules every year and determine their chemical structure. Every stage of the process is accompanied by a proprietary data management system – the guarantee of a subsequent, successful follow-up of the initial steps of drug development.

Achieving synthetic optimisation of natural products Medicinal chemistry starting from natural products has long been considered time-consuming and tedious. AnalytiCon has many years of experience in the field of medicinal chemical optimisation of natural product hits or drug candidates. This also includes the total synthesis of complex natural products and the isolation of similar compounds from fermentations or plant extracts. Our objective here is to establish initial structure activity relationships swiftly. Toxicity studies, stability tests, and first efficacy studies can be conducted in tandem with the development of a scale-up process of the target substance.

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

· · · · · · · · · · ·

Haidgraben 5 85521 Ottobrunn (near Munich) Bavaria Dr Christine Guenther, CEO +49-89-700-9608-0 +49-89-700-9608-130 80 2007 Certified Cleanrooms ISO5, ISO7, ISO8, GMP, BSL2 Areas of Activity · l Advanced Therapy Medicinal Products (ATMPs) l Cell and gene therapeutics l Proprietary drug candidates in inflammation, autoimmunity, and oncology l Contract Development and Manufacturing (CDMO)

Biological Patents · IP portfolio in the field of non-hematopoietic stem cells and their genetic modification External · l European and American large and Collaborations mid-size pharma l Academic partners Request for · Partnership with companies focused Further Collaborations on clinical development and commercialisation of ATMPs

Company profile apceth Biopharma is a leading company in cell-based gene therapeutics with an innovative portfolio of drug candidates for the treatment of chronic inflammation, autoimmunity (immunomodulation), and solid cancer (immuno-oncology). apceth Biopharma is also an experienced and certified Contract Development & Manufacturing Organisation (CDMO) for complex cell and gene therapy products (Advanced Therapy Medicinal Products, ATMPs) with a high international reputation for quality and reliability.

Technology apceth’s proprietary cutting-edge technology is based on the clinically validated genetic engineering of allogenic Mesenchymal Stem Cells (MSCs) obtained from healthy individuals, which allows the company to guarantee consistent product quality while reducing manufacturing time and costs. Through the introduction of different therapeutic transgenes into MSCs, apceth is developing two potent nextgeneration cell-based gene therapies with an ability to either suppress and control the overshooting immune system during inflammation, or boost the suppressed immune system to fight cancer. In both cases, the modeof-action is based on synergy between the therapeutic effects of the transgene (gene therapy) with the natural properties of MSCs (cell therapy).

Proprietary pipeline apceth-201 are MSCs expressing the immunomodulatory protein Alpha-1 Antitrypsin and target diseases with pathology based on chronic inflammation and/or autoimmune processes, such as inflammatory bowel disease, diabetes type I, vasculitis, or chronic lung disease. apceth-201 will soon enter clinical development for Graft-vs-Host-Disease (GvHD), a frequent, severe, and very often fatal complication of allogeneic Hematopoietic Stem Cell (HSC) transplantation.


apceth-301 expresses a potent immunostimulatory “cocktail” of cytokines which locally activates the patient’s immune system to eradicate cancer. apceth-301 is currently being developed for glioblastoma, an extremely aggressive and deadly form of brain cancer.

Contract development & GMP manufacturing apceth offers its comprehensive expertise and capabilities in the field of cell-based and gene therapy products for contract development and manufacturing of ATMPs to a growing number of large pharma and biotech clients. The company has state-of-the-art manufacturing facilities (cleanrooms ISO5, ISO7, ISO8, BSL2), is certified for GMP production, and has an extensive quality management system, allowing apceth to ensure full regulatory compliance as well as the highest GMP and quality standards according to EC regulations on ATMPs. apceth has successfully obtained several manufacturing licenses for different types of native and genetically engineered cells and cell-based products, and was the first company worldwide to obtain approval for the clinical testing of genetically engineered MSCs in patients. Irrespective of the type of cells and cell products (HSC, MSC, various types of immune cells; native or genetically engineered), or the cell source, apceth provides fully customised solutions in development and production of every customer product and process. Located centrally in the heart of Europe, apceth can provide an efficient and rapid supply of the client’s IMPs across the continent.

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

· · · · · · · · · · · ·

Im Neuenheimer Feld 584 69120 Heidelberg Baden-Wuerttemberg Juergen Gamer, Ph.D. +49-6221-58608-0 +49-6221-58608-10 45 2005 S1 Drug development

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

Company overview Apogenix develops innovative immuno-oncology therapeutics for the treatment of cancer and other malignant diseases. The company has built a promising pipeline of drug candidates that target different tumour necrosis factor superfamily (TNFSF)-dependent signaling pathways, thereby restoring the anti-tumour immune response. The company’s lead immuno-oncology candidate asunercept (APG101) is in clinical development for the treatment of a variety of solid tumours and malignant hematological diseases. It has demonstrated statistically significant efficacy in a controlled phase II proof-of-concept trial in recurrent glioblastoma – the most frequent and aggressive brain tumour – and was also evaluated in a phase I trial for the treatment of myelodysplastic syndromes (MDS) – a stem cell disorder that can lead to severe anemia.

Lead immuno-oncology candidate Asunercept Apogenix’s lead drug candidate asunercept is a fully human fusion protein that consists of the extracellular domain of the CD95 receptor and the Fc domain of an IgG antibody. Asunercept inhibits CD95 ligandmediated signaling, which plays an important role in the progression of solid tumors. In a randomised, controlled phase II efficacy trial in recurrent glioblastoma, treatment with asunercept in combination with radiotherapy has shown clinical superiority in all study endpoints compared to treatment with radiotherapy alone. Glioblastoma patients expressing a certain biomarker associated with the CD95 ligand experienced the greatest benefit from treatment with asunercept. The median overall survival rate in biomarker-positive patients treated with asunercept more than doubled to 16 months compared to patients treated with radiotherapy alone. Apogenix is developing a companion diagnostic test based on this biomarker, so asunercept can be used as a personalised therapy. Recently, Apogenix was granted PRIME designation by European Medicines Agency for asunercept to treat glioblastoma. This will greatly facilitate the clinical development towards approval in the EU.


In MDS, the CD95 ligand inhibits the differentiation and development of red blood cells. Asunercept blocks the CD95 ligand, thereby enabling the maturation of erythrocyte precursor cells to functional erythrocytes. Final results of a phase I trial with asunercept in low and intermediate-I-risk MDS patients reveal an increase in erythrocyte precursor cells and a strong trend toward reduction in transfusion frequency after treatment with asunercept. The substance was well tolerated. In addition, investigation of parameters involved in erythropoiesis delineated how asunercept stimulates the production of red blood cells in these patients. The CD95 system, which is inhibited by asunercept, plays an important role in the progression of other solid tumors and hematological diseases, underlining the tremendous potential of this compound for the treatment of malignant diseases beyond glioblastoma and MDS

Technology platform Apogenix’s highly qualified scientific team has developed a proprietary technology platform for the construction of novel fusion proteins that target different TNFSF-dependent signaling pathways. The TNFSF comprises more than a dozen proteins that have a crucial role in the regulation of the immune response, making them attractive immunooncology targets. Apogenix’s fusion proteins offer clear advantages over other biologics such as antibodies and have the potential for broad application in oncology. Apogenix has successfully out-licensed its first program based on this technology platform – HERA-TRAIL receptor agonist APG880 and derivatives – to AbbVie. AbbVie initiated clinical trials with HERA-TRAIL (ABBV-621) in March 2017. New projects to engineer novel CD40, CD27, OX40, HVEM, GITR, and 4-1BB agonists for cancer immunotherapy have been initiated. The molecules combine very good efficacy with an excellent tolerability

Management Thomas Hoeger, PhD (CEO) Harald Fricke, MD (CMO) Peter Willinger (CFO)

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Name · ARTES Biotechnology GmbH Address/P.O. Box Postal Code/City State Contact Person

· · · ·

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

· · · · · · · ·

Elisabeth-Selbert-Straße 9 40764 Langenfeld North Rhine-Westphalia Dr Melanie Piontek (Business Development Director) +49-2173-27587-12 +49-2173-27587-77 24 2002 S1 Development and technology transfer of biopharmaceutical production processes

Biological Patents · Patents and exclusive Licenses on: | Hansenula yeast expression platform | VLP based vaccine technology (METAVAX®) | Enhanced secretion via Chaperones | Fermentation processes | Protein isolation External · Co-developments: amatsiQBiologicals, Collaborations instrAction GmbH, PAC, (Peschek Analytic Consulting), Burnet Institute, PATH Request for · Customer excerpt: Johnson&Johnson, Further Collaborations PT Bio Farma, Boehringer Ingelheim Vetmedica GmbH, DuPont, Minapharm Biogenetics, Cadila Pharmaceuticals, Sun Pharmaceutical R&D collaboration and strategic partnerships with biopharmaceutical companies.

ARTES Biotechnology ARTES Biotechnology is a globally active R&D company, specialised in developing biopharmaceutical production processes. Since 2002, ARTES has positioned itself as a valued partner for the pharmaceutical industry with several technology transfers successfully implemented worldwide at our partners’ sites. Today, ARTES is a strong, well-established partner for the development of customer driven projects up to supply of pre-clinical material. In addition, we are developing own VLP based vaccine candidates up to proof-ofconcept in animals. ARTES is actively looking for partnerships to identify and to create new opportunities, especially in vaccine research as well as for out-licensing its own developments.

Process development and technology transfer Biopharmaceutical process development at ARTES typically starts with the generation of high yield production cell lines based on our proprietary microbial expression platforms Hansenula polymorpha and E. coli. Up- and downstream process development is performed at lab and pilot scale. Fermentation processes are designed to ensure low-cost manufacturing with optimal productivity from fully synthetic media, avoiding expensive additives and extended fermentation times. The purification process of the product aims at high titers of purified Active Pharmaceutical Ingredient (API). Gram amounts of highly purified API for pre-clinical testing can be delivered from ARTES’ pilot plant. By providing the full set of the documentation of biopharmaceutical process development and of the manufacturing of the pre-clinical material, ARTES ensures the smooth and direct transfer into large scale cGMP manufacturing. Arms-length assistance is available for the transfer of the process to the CMO or client´s plant. ARTES has developed biopharmaceutical processes available for out-licensing, including bio-similar therapeutics such as interferon-alpha and hirudin, as well as vaccines such as HepB, and continues to expand this portfolio.


Vaccine development platform (METAVAX® Technology) New vaccine candidates are developed based on our chimeric duckHepB virus like par ticle plat form METAVAX®. This technology platform is best suited for the development of highly immunogenic vaccines in human and animal health. Vaccines build on our METAVA X ® Technology and manufactured in the WHO recommended, stable yeast platform Hansenula polymorpha build an economical approach to low-cost mass production of safe, effective and self-adjuvanting vaccines. We obtain chimeric VLPs using stable co-expression of multiple different genes in one and the same production cell line. Currently, our METAVAX® Technology is applied in several client projects and in own developments of adjuvant-free vaccines. Internal R&D at ARTES focuses at present on veterinary (Classical Swine Fever, Bovine Viral Diarrhoe, West Nile Virus, Feline Leukemia Virus) and human vaccines (Malaria, Hepatitis C, Flu).

Partnerships and networking ARTES builds alliances with well renowned academic institutes and pharmaceutical companies around the world. We are involved in funded R&D projects (EuroTransBio, PATH Malaria Vaccine Initiative), collaborative research and in contract R&D projects. Our key expertise is on development candidates and production processes based on yeast for recombinant sub-unit vaccines presented as highly immunogenic virus-like-particles. The METAVAX® Technology is a highly competitive platform for the development of vaccines for both human and veterinary applications. Together with a network of collaboration partners (e.g. the Australian Burnet Institute, amatsiQBiologicals) ARTES offers the full range of competencies from cell line and process development, manufacturing and testing of preclinical samples and up-scaling/cGMP manufacturing. ARTES is open to discuss individual business models, including fee-for-service contract R&D, milestone based collaboration (shared risk/shared benefit) and co-development. 19 th Guide to german biotech companies 2018

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

· · · · · · · · · ·

Fritz-Hornschuch-Str. 9 95326 Kulmbach Bavaria Dr Roland Kreutzer +49-9221-82762-0 +49-9221-82762-99 65 2000 (under the name of Ribopharma; acquired by LGC in March 2017) Type of Laboratory · S1, S2 Areas of Activity · Preclinical research solutions with focus on oligonucleotide therapeutics and other nucleic acid medicines, including high-quality oligonucleotide manufacturing, analytics, bioanalytics, lead molecule identification, in vitro and in vivo pharmacology Biological Patents · Proprietary bioanalytics assay for the detection and quantification of oligonucleotides in blood and tissue; proprietary lipid platform for the cellular delivery of nucleic acids External · Axolabs collaborates with the majority Collaborations of research groups in the field of oligonucleotide therapeutics worldwide, including > 10 Big Pharma enterprises, > 100 Biotech companies and > 30 academic research institutes

Request for · Axolabs is looking for partners to Further Collaborations combine our expertise in preclinical development of oligonucleotide therapeutics with promising therapeutic approaches

Expertise and scientific excellence Axolabs is the leading CRO focused on the discovery and preclinical drug development of oligonucleotide therapeutics and other nucleic acid medicines. Based on our world-leading know-how and 16+ years of experience, we provide high-end preclinical solutions tailored to our clients’ specific needs. As Axolabs is part of the LGC group, our customers benefit from additional resources and expertise right across LGC, including a wide range of analytical services, leading capabilities in CMC, GMP, and research-grade oligonucleotide manufacturing, as well as custom synthesis of specialty phosphoramidites and solid supports.

Services and products Manufacturing ·· High-quality oligonucleotide synthesis – from discovery to pre-clinical and GMP (at LGC Biosearch) ·· Custom-tailored process optimisation ·· Long RNA/DNA, e.g. for CRISPR/Cas applications ·· Chemically modified oligonucleotides and conjugates ·· Custom amidites and solid supports (at LGC) ·· Potency and stability improvement ·· Regulatory documentation ·· Impurity markers and reference standards ·· Lipid synthesis Oligonucleotide and nucleic acid analytics ·· Physicochemical and thermodynamic characterisation ·· Stability determination in biological matrices ·· Identification of metabolites by LC/MS ·· mRNA identity ·· Characterisation of nucleosides and nucleotides ·· Analysis of nucleic acid-protein interactions


Bioanalytical services ·· Detection of oligonucleotides from biological matrices ·· Quantitative detection of mRNA therapeutics from biological matrices ·· GLP-certified test site (also qualified for GCP) ·· Small and large molecules (at LGC) ·· Biomarkers (at LGC) Oligonucleotide lead identification ·· Bioinformatics assessment for sequence pre-selection ·· Drug design and synthesis ·· High-throughput in vitro screening ·· Lead characterisation and optimisation ·· In vivo efficacy and early safety assessment Biological and pharmacological tests and analyses ·· Safety analyses ·· Cell-based assays for cell function, proliferation and toxicity ·· Ligand-receptor interaction and uptake studies/histology ·· Flow cytometry ·· Protein analysis (at LGC) ·· Analysis of mRNA up- and downregulation Platform for functional cell type-specific delivery of oligonucleotides and mRNAs ·· In vitro functional analysis and in vivo models ·· Rational design tailored for specific delivery systems ·· Proprietary lipid nanoparticle formulations CMC analytical services (at LGC) ·· GMP compliant (FDA inspected) ·· Broad analytical capabilities ·· Materials science

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Name · Berlin Cures Address/P.O. Box Postal Code/City State Contact Person Telephone Email Website Number of Employees Founded (year) Areas of Activity

· · · · · · · · · ·

Knesebeckstr. 59–61 10719 Berlin Berlin Dr Peter Göttel +49-30- 8891364050 10 2014 Oligonucleotide therapeutics

Berlin Cures – Aptamers against autoimmune disease Berlin Cures GmbH is a spin-off company from Charité Berlin and Max Delbrück Center Berlin, founded in September 2014 in order to bring a successful research project to the market. A group of scientists from the Max Delbrück Center (MDC), the Charité Berlin, and the German Heart Institute Berlin has been studying the significance of autoantibodies in heart disease and other autoimmune diseases for over 10 years. Gerd Wallukat from the MDC discovered these functional autoantibodies and described them for the first time in 1987. They have the special characteristic of stimulating cells via a highly specific signal pathway (so-called G-proteincoupled receptors), thereby sending pathological information and activating the cells in such a way that leads to long-term organ damage. The term we use for the resulting disease is functional autoantibody disease. The positive effect of autoantibody elimination has been clinically demonstrated by the use of immunoadsorption in patients with chronic congestive heart failure. Autoantibody removal in those patients led to a highly significant improvement in left ventricular function as well as in survival. The researchers have identified a drug (an aptamer) that can neutralise these autoantibodies in the patient’s blood after a single intravenous administration. The scientists will continue their work at Berlin Cures, using their expertise to support the drug approval process and to identify further diseases that are induced or maintained by autoantibodies. The idea of binding autoantibodies with a highly specific aptamer is protected by two patents exclusively licensed to Berlin Cures for commercial exploitation.

berlin cures

Berlin Cures’ lead drug candidate BC007 is a 15-mer DNA-aptamer, that binds to and neutralises functional autoantibodies directed against the beta1-(GPCR)adrenoceptor. Pre-clinical studies of BC007 to support the application for the Phase 1 clinical study showed that BC007 was well tolerated with no adverse dose identified. The drug is currently in a Phase 1b clinical study to evaluate its potency to neutralise GPCR-autoantibodies in healthy subjects who test positive for autoantibodies.

Mode of Action of BC007. Autoantibodies (purple) bind to GPCR-Receptors (blue) and exert agonistic effects. Dimerisation of GPCRs prevents desensitisation and internalisation. BC007 molecules bind to the autoantibody and neutralise them

The first indication being pursued by Berlin Cures is chronic congestive heart failure in patients who test positive for GPCR autoantibodies. Autoantibodies against GPCR-receptors are not only associated with chronic congestive heart failure but also who a number of other autoimmune diseases. Berlin Cures will expand the field of indications in the near future.

Ball-and-Stick-Structure of BC007 Proof of concept of autoantibody removal. Long-term benefit of autoantibody-removal by immunoadsorption. Removal of autoantibodies leads to highly significant improvement of survival in patients with chronic congestive heart failure.

Reference: Dandel, M, Wallukat, G, Englert, A, Lehmkuhl, HB, Knosalla, C and Hetzer, R (2012): Long-term benefits of immunoadsorption in beta(1)adrenoceptor autoantibody-positive transplant candidates with dilated cardiomyopathy. Eur J Heart Fail 14 (12): 1374-88

Both patients groups were tested positive for autoantibodies, but only one patient group (grey line) was immunoadsorbed. All patients on the waiting list for heart transplantation.

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Name · Biaffin GmbH & Co KG Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Websites

· · · · · · · ·

AVZ 2, Heinrich-Plett-Str. 40 34132 Kassel Hesse Dr Bastian Zimmermann +49-561-8044668 +49 561-8044665

Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · ·

FIQ 8 2001 Analytical, ISO 9001:2015 certified Service provider for biomolecular interaction analysis and enzymatic assays, 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 generally interested in Further Collaborations joining publicly funded research projects and serves as a supplier for contract research for scientific institutions and industrial partners

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 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 as a competent partner the drug development programs of pharma, biotech and generic drug companies, as well as scientific institutions worldwide. The service is performed by a highly specialised team (PhD level scientists) in a laboratory well equipped with several state-of-theart SPR instruments (Biacore). The company’s expertise is documented by a number of peer-reviewed publications in renowned scientific journals. Sufficient capacities in SPR instruments enable Biaffin to start interaction studies at short notice, to rapidly perform a number of projects in parallel and to obtain results on time.

Analytical services Biaffin’s SPR services in pre-clinical drug development comprise customised assay development, hit validation, secondary screening, kinetic profiling and lead optimisation of small-molecule drugs. Early ADME studies (serum protein binding) and detailed studies on the mode of action, including thermodynamic binding analysis, further support the drug development process. In the field of therapeutic antibody and biosimilar development, Biaffin offers SPR services for qualitative kinetic ranking, comprehensive kinetic characterisation, determination of active concentrations based on binding activity (using calibration curves or calibration-free methods), batch to batch comparison, assay qualification/validation and stability analyses for diagnostic and therapeutic purposes. Pair-wise epitope mapping, tests for specificity, cross-reactivity, immune-reactivity, variances in binding kinetics based on species differences and interaction analysis with Fc gamma receptors (CD16, CD32, CD64) and neonatal Fc receptor (FcRn) complement Biaffin’s antibody services.


In addition, Biaffin offers customised SPR assay development and contract research elucidating specificity, selectivity, cofactor requirements, mechanism of action and thermodynamics of given interactions of proteins, peptides, nucleic acids, small molecules, carbohydrates and membranes. Biochemical and enzymatic assays based on microfluidic mobility shift technology (MMSA) and bioluminescence broaden the range of services to meet the complex issues of clients regarding inhibitor recognition by target enzyme, effects of small-molecule inhibitors on enzyme activity, substrate specificity and mode of action.

Catalogue products Apart from analytical services, Biaffin offers a broad range of products serving customers’ needs in kinase research and exploring cellular signal transduction pathways. Biaffin’s high-quality product portfolio, available from the online shop, comprise recombinant proteins (kinases, phosphatases, cytokines, receptors, CD antigens), peptide substrates, specific inhibitors and antibodies, as well as biochemical assays (ATP determination kit) for customers’ inhouse research.

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

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

· · · · · · · · · · ·

Im Neuenheimer Feld 515 69120 Heidelberg Baden-Wuerttemberg Dr Sven-Michael Cords +49-6221-433 88-911 25 2002 Bioanalytical contract laboratory l GMP-potency assays l BioPharma efficacy l Biopharma safety

Bioassay – bioanalytical contract laboratory Bioassay GmbH is an independent bioanaly tical contract laboratory, specialising in the development, validation, and routine performance of bioanalytical assays in the area of Pharmacology and Toxicology. We carry out qualified analytical services on the sound basis of our GMP & GLP certification, which provides an excellent framework for successful projects and routine bioanalysis. Key global players as well as startup companies in the pharmaceutical and chemical industries trust in the experience and dedication of our bioanalytical experts.

Bioassay – portfolio Bioassay GmbH is specialised in the development, validation, and execution of biological assays within the framework of Development & Quality Control of pharmaceutical and chemical products. Our portfolio contains 4 focus areas: BioPharma Potency, BioPharma Efficacy, BioPharma Safety, & Chemicals/Cosmetics Safety. In our in-vivo and in-vitro facilities we are running state-of-the-art-equipment and our analytical experts will welcome you to visit us in our laboratories located directly in the Heidelberg Technology Park (Germany). Potency assays Bioassay GmbH offers the execution and assessment of potency assays within quality control of active pharmaceutical ingredients and drug products. Furthermore we have extended experience in the development and validation of new assays accordingly to ICH-Guidelines, as well as in optimisation of existing assay formats and transference into routine applications. Established potency assays of therapeutic antibodies are run under GMP at Bioassay GmbH. Further, the development of assays regarding antibody dependent cell mediated cytotoxicity (ADCC), attributed to the mode of action of several therapeutic antibodies, in particular tumour cell targeting, is one our focus areas. Bioassay GmbH offers ADCC assays for development and quality control for the biopharmaceutical industry.


Hormones and growth factors are widely used within the biopharmaceutical industry. Our portfolio includes most of them and potency assays based on monographs of EP and USP are run under GMP in a daily quality control routine for stability testing and batch release of active pharmaceutical ingredients and drug products. BioPharma efficacy Bioassay GmbH has established efficacy models to address the demand for the characterisation of new drugs, especially in the field of biopharmaceuticals like monoclonal antibodies, hormones or cytokines, including FACS-based receptor binding assays, specific cell line development, or neutralising antibody assays. Bioassay GmbH has extended experience in the field of characterisation of biosimilars or modified biologics (e.g. pegylated products). Bioassay – your bioanalytical contract laboratory Located in Heidelberg (Germany) Bioassay GmbH has specialised since 2002 in biological assays within the framework of the development & quality control of pharmaceutical and chemical products. We combine standardised processes with flexible organisation to fulfill the demands of our customers. Experienced project managers will work with you from the beginning until the end of your project. Please test us!

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

· · · · · · · · · ·

Sagenrainstrasse 7 8636 Wald Switzerland Stefan Lugert +41-55-256-81-11 +41-55-256-82-56 140 1972

Areas of Activity · l Engineering & design l Service l Plants l Bioprocess control l Lab & pilot l Components

Company profile The visionary idea to provide the biotechnological industry and research community with equipment for excellence led to the foundation of Bioengineering in 1972. This idea has been put into practice by designing and constructing fermentation systems, including all components for large and small scales. By expansion of our product portfolio, based on the latest advancements in biotechnology, we are carrying this founding concepts into the 21st century. Our company has been independent and autonomous since it was established. This approach has little in common with current corporate mind sets and the vast array of management models, which allegedly have answers for everything. It gives us the liberty for result-orientated commitment to the process specifications. Our research and design teams know how to set customers’ ideas on the road to implementation and turn them into practical reality, based on optimised organisational structures and – not least – sound financial planning.

Product portfolio Engineering & Design We build plants for our customers that meet their specific requirements. We do this at Bioengineering by having a team of dedicated engineers and designers working on every stage of a project. From the idea to the finished plant, there is a strong culture of innovation. Our many years of experience in project management enable us to implement fast-track projects efficiently. Service The support we offer goes beyond the planning, construction, and commissioning of plants. We provide expert knowledge, servicing, inspection, and documentation to assist with the operation of your plants. We perform two roles in one: that of an expert and a reliable partner. Plants We design and build complete bioreactor and fermenter systems for well-known pharmaceutical and food companies. These systems are used in laboratories


and production facilities to manufacture vaccines, biosimilars, starter cultures, and other products. It is no accident that our plants serve as a reference for an entire industry. With more than 45 years of experience in building plants, we have the experience, the knowledge, and the innovative capacity to realise even the most complex of plants. Bioprocess Control We develop complex automation solutions with software and hardware for the plants and are thus in a position to offer a wide range of architectures and designs. This helps our customers to manage and monitor their plants perfectly and reliably. Lab & Pilot We develop and build fermenters and bioreactors for laboratories and production facilities across the world. These range from small expandable modular bench-top devices for research and development departments to scalable big plants for the manufacturing industry. Components We develop and build components for our customers’ plants which perform very specific tasks depending on the application and the requirements. For example, components which ensure that cleaning is carried out in compliance with strict hygiene regulations and which have been reliably carried out in our plants for many years. Every customer enjoys the advantages of our modular design approach: cost-effective transport, rapid installation, and streamlined testing and quality control. Our quality-assurance manual is the control system that ensures unified monitoring and documentation of the entire production sequence, with precise specifications, instructions, and prescribed procedures. But the commitment to our customer does not end, once the system is installed and qualified. For us quality assurance also means providing our customers with aftersales services and replacement parts for many years to come. We have honoured that commitment for every facility built by Bioengineering since 1972. 19 th Guide to german biotech companies 2018

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

· · · · · · · · · · · ·

Czernyring 22 69115 Heidelberg Baden-Wuerttemberg Dr Thomas Pultar (CEO) +49-6221-90260 +49-6221-902690 70 1983 S1, GMP Contract manufacturing of: | Biopharmaceuticals | Process development | Microbial fermentation | Microbial cell banking | Bioanalytical services

External · | AGC (Tokyo) Collaborations | CMC Biologics (Copenhagen/Seattle)

Company profile BIOMEVA GmbH, a reliable and experienced contract manufacturing organisation (CMO) in the biopharmaceutical industry, is dedicated to meeting the manufacturing needs for the production of microbially expressed protein products. Since 1993, BIOMEVA has produced more than 450 batches of CGMP compliant material for pharmaceutical and biotech companies at a 150 L and 1,500 L scale. BIOMEVA has served more than 40 customers worldwide. Partners benefit from BIOMEVA’s trackproven operational expertise in the transfer, development, scale-up and validation of cGMP processes. Since September 2016, Biomeva is part of the AGC group, the world-leading manufacturer of glass, chemicals and high-tech materials, with headquarters in Tokyo, Japan.

Large-scale production of API Our facility specialises in the manufacture of active pharmaceutical ingredients expressed in microbial systems. Recombinant material on a clinical and commercial scale can be produced in two independent GMP manufacturing units with 100 L resp. 1,000 L working volume. This facility houses classified laboratories for microbial cell bank production and storage and state-of-the-art production facilities (Class A, B, C, D) for fermentation, chromatography, bulk filling and QC laboratories. Chromatography purification steps can be performed at ambient or cold rooms (2–8°C) temperatures. A class A/B filling suite is maintained for bulk drug substance filling. Production and purification systems include: ·· Fermenters with working volumes of 10 L, 100 L and 1,000 L ·· Continuous centrifugation ·· High-pressure homogenisation ·· Protein micro-filtration and ultra-filtration ·· Sterile filtration ·· Column chromatography ·· Bulk drug substance filling


Microbial cell banking Master and Working Cell Banks are manufactured, characterised, tested and stored according to FDA and ICH requirements.

Process development Fermentation and purification processes are developed as reproducible, robust and scalable processes with focus on product quality and cGMP compliance. Process development includes: ·· Best clone screening ·· Media optimisation ·· Productivity optimisation: Establishing of high cell density cultivation strategies for either inclusion body or soluble production in cytoplasm or periplasm ·· Identification and optimisation of suitable cell lysis methods ·· Screening for precipitation and solubilisation based separation methods ·· Identification of optimal refolding process ·· Screening for best purification strategy/Membrane filtration methods for ultra-, dia- and sterile filtration ·· Laboratory scale fermentation at 5 or 10 L scale

Quality control To support cGMP production activities, BIOMEVA’s quality control (QC) group ensures that all facilities, equipment and critical materials are under control and cGMP-compliant. The QC group is responsible for supporting manufacturing in the following activities: ·· Testing and release of raw materials to the manufacturing group ·· Sample testing during the manufacturing process ·· Environmental monitoring of the production suites during and between manufacturing campaigns ·· Release testing of the active pharmaceutical ingredient

Quality assurance BIOMEVA’s quality assurance (QA) group ensures that all manufacturing fulfills cGMP requirements and meets client’s quality expectations. 19 th Guide to german biotech companies 2018

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

· · · · · · · · · · · ·

An der Goldgrube 12 55131 Mainz Rhineland-Palatinate Sean Marett (COO) +49-6131-9084-0 +49-6131-9084-390 700+ 2008 BSL 2 and S 2 Cancer Immunotherapies Infectious Diseases Immunotherapies Rare Diseases

Biological Patents · More than 100 patent families comprised of >700 patent applications covering core technologies, key product candidates, and ancillary inventions. External · l Genentech Collaborations l Sanofi l Eli Lilly and Company l Genmab l Bayer Animal Health Request for · We are looking for additional partners Further Collaborations to co-develop and co-commercialise our cutting-edge treatments. Management · l Prof. Dr Ugur Sahin (Co-founder & CEO) l Sean Marett (COO) l Dr Sierk Poetting (CFO) This international and highly experienced management team has backgrounds spanning academia, Big Pharma, entrepreneurial, and innovative emerging biopharma from across multiple geographies, including the US, UK, and continental Europe.

Individualised medicine BioNTech, Europe’s largest privately held biopharmaceutical company, is pioneering the development of individualised therapies for the treatment of cancer and other diseases. The company combines all elements of individualised immunotherapy under one roof – from diagnostics and drug development, to manufacturing. Its cutting-edge therapeutic programmes include individualised mRNA-based medicines, chimeric antigen receptor-based and T-cell receptor-based products, novel bispecific antibody-based immunomodulators, and small molecule immunomodulator programmes. Founded in 2008, BioNTech has grown rapidly to more than 700 employees. Its financial shareholders include the MIG Fonds, Salvia, and the Strüngmann Family Office, with the latter as the majority shareholder.

Partnerships and network BioNTech is actively engaged in various collaborations, partnerships, and licensing deals that support the development of its first-in-class therapies. The company also maintains a global network of academic and clinical thought leaders who provide pivotal insights and expertise that inform all aspects of early- and latestage research and development. BioNTech’s technology platforms are validated by five top-tier corporate partnerships: ·· Eli Lilly and Company – Novel tumour targets and corresponding T-cell receptors ·· Sanofi – mRNA-based cancer immunotherapies ·· Genentech – mRNA-based, individualised cancer vaccines ·· Genmab – Bispecific antibodies ·· Bayer Animal Health – mRNA vaccines for animal health applications These co-development, co-commercialisation, and licensing agreements enable BioNTech to take a strategic and comprehensive approach to bringing novel therapies to market.


Clinical pipeline Based on its unique technology platforms, BioNTech is developing and commercialising a broad product pipeline through a variety of cutting-edge scientific approaches. The company’s clinical pipeline represents a number of industry firsts, notably ·· implementing a medical genomics-driven design and GMP-approved manufacturing process for individual patient-specific therapies ·· advancing into the clinic an mRNA-based individualised cancer vaccine targeting neoantigens ·· testing an intravenous formulation of an mRNA vaccine

Individualised therapies against cancer The company’s main focus is the development and commercialisation of tailor-made and individualized cancer immunotherapies, recognising that each patient’s tumour is different. The promising pre-clinical and clinical results have been acknowledged in three consecutive Nature publications, the latest of which was published in July 2017.

Everything under one roof The BioNTech Group covers everything from diagnostics to manufacturing and consists of: ·· BNT RNA Pharmaceuticals ·· BNT Cell & Gene Therapies ·· BNT Protein Therapeutics ·· BNT Diagnostics ·· BNT Small Molecules ·· BNT Innovative Manufacturing Services (former EUFETS GmbH) ·· JPT Peptide Technologies For more information about services provided to third parties, please visit the following websites: BNT Innovative Manufacturing Services (, JPT (, and BNT Small Molecules (www.

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Name · biosyn Arzneimittel GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Websites

· · · · · · · ·

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

biosyn Arzneimittel GmbH is a pharmaceutical and Biotech company with headquarters in Fellbach, Germany, in the state of Baden-Wuerttemberg. The firm specialises in trace elements, is a global market leader for high-dose selenium injections, and is the developer and operator of the only two GMP active-ingredient manufacturing sites of Sodiumselenite-Pentahydrate and Keyhole Limpet Hemocyanin (KLH) in the world. Moreover, in the Biotech sector the company actively promotes a glycoprotein isolated from the Megathura crenulata, a sea snail native to the Californian coast. The glycoprotein KLH is extracted from the hemolymphs of the sea snail by means of a non-lethal puncture carried out at the American subsidiary in California. After a precleaning procedure the substance is subsequently highly purified by biosyn Arzneimittel GmbH in Fellbach. The immunocyanin obtained from one sea snail is sufficient to treat a patient with urinary bladder carcinoma for a year. This active ingredient has a tremendous therapeutic potential. Marketed as IMMUCOTHEL®, KLH has been approved for recurrence prevention of superficial urinary bladder carcinoma in a number of different countries, including Austria, the Netherlands, Korea, and Argentina. The gene sequence of the protein has been determined and a patent registered. Therefore manufacture of the genetically-engineered recombinant protein is imaginable in the future. This high-molecular glycoprotein also acts as a carrier molecule for diverse antigens in new generations of vaccines, and is used for this purpose by international vaccine manufacturers under the trade name VACMUN®.


The first success of such a vaccine was demonstrated in a phase III study of Biovest International Company (Worcester, MA, a subsidiary company of Accentia Biopharmaceuticals, Inc., on patients with non-Hodgkin lymphoma; the group of participants treated with vaccine containing KLH survived significantly longer than untreated participants. The company has invested over two decades of research and development as well as millions of euros in the transatlantic project and in productive exploitation of the snail. Seventy percent of sales of biosyn Arzneimittel GmbH are currently achieved outside of Germany – in 26 countries worldwide. Active in the areas of intensive care, oncology, and endocrinology, biosyn is an esteemed partner of hospitals and office-based physicians, as well as naturopathic physicians and natural health practitioners. The employees at biosyn are dedicated to research and development, and are also responsible for maintaining a solid knowledge base concerning current medicalscientific publications and modern online marketing. The medium-sized family enterprise, founded in 1984, maintains an open, engaged, and customer-oriented corporate culture.

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Name · BIOTECON Diagnostics GmbH Address/P.O. Box Postal Code/City State Contact Persons

· · · ·

Telephone Fax Email Website Social Media

· · · · ·

Hermannswerder 17 14473 Potsdam Brandenburg Dr Kornelia Berghof-Jäger (CEO) Alois Schneiderbauer (CBO) +49-331-2300-200 +49-331-2300-299

F I Q

Company profile BIOTECON Diagnostics, located in Potsdam, Germany, is one of the world’s leading companies for rapid microbiological testing methods for the food, feed, beverage and pharmaceutical industries, as well as for other, related industries. Founded in 1998, the internationally operating biotechnology company develops, manufactures, and markets its foodproof ® and microproof ® product lines. The high-quality products offer innovative rapid solutions for DNA/RNA extraction and detection of a wide range of test parameters based on real-time PCR.

foodproof ® products BIOTECON Diagnostics’ foodproof® product line ensures fast and accurate detection of pathogens, viruses, spoilage organisms such as beer spoilers or Alicyclobacillus, GMOs and allergens, as well as animal species testing from all kinds of food, feed and beverage matrices. The kits are used by producers of food and beverages, including some of the biggest food companies in the world, as well as by government laboratories, research facilities and private custom service laboratories. Many foodproof® kits for the detection of pathogens are validated and approved by independent institutions such as AOAC , NordVal and MicroVal. These include the kits for Salmonella, Listeria monocytogenes, Cronobacter spp., E. coli O157, Enterobacteriaceae and others.

foodproof ® automation solutions for the food industry The foodproof® RoboPrep+ Series including the unique new RoboPrep Fusion system, represents a set of commercially available, fully automated DNA-extraction and PCR setup systems validated and certified for the food and beverage industry. The RoboPrep+ Series provides fully automated solutions for DNA extraction and PCR setup for all food testing applications and throughput demands, effectively reducing hands-on time and error sources, while significantly increasing laboratory efficiency. The systems have been optimized especially for the food industry and are applicable for the detection of all food-related organisms in various food matrices and environmental samples. Several foodproof ® Magnetic Preparation Kits enable the automated extraction


of DNA from food and feed samples for the detection of pathogens, GMOs, animal species and allergens. The foodproof® RoboPrep+ Series comprises different types of robots suitable for food testing applications. E.g. the KingFisher® Flex instrument isolates DNA from bacteria, GMO or allergens within 45 minutes for up to 96 samples.

microproof ® products The microproof ® product line offers highly specific and fast solutions for the pharmaceutical and cosmetic industries. For example, Staphylococcus, Micrococcus, and Corynebacterium are easily and simultaneously detected and identified in environmental monitoring samples with the microproof ® Hygiene Screening System.

Certified quality BIOTECON Diagnostics is dedicated to providing the highest quality products and services. The company markets its products directly as well as through a continually growing network of local distributors and worldwide sales channel partners. Through certification and accreditation, the company builds trust and demonstrates transparency to customers. BIOTECON Diagnostics has been DIN EN ISO 9001 certified since 2003 and has maintained DIN EN ISO 17025 accreditation in the service sector since 2005.

Service testing & development The company’s ISO 17025 accredited custom service laboratory provides superior experience in microbiological and molecular biological service testing of food and beverages, water and disinfectants, as well as pharmaceutical and cosmetics products. BIOTECON Diagnostics offers a customized contract development. Due to close contacts with many different industries, the company is well aware of customers’ current and future challenges in the fields of real-time PCR, MALDI-TOF MS solutions including customized MALDI Biotyper reference libraries (e.g. D-MASS) for fast microorganism identification, microarrays, and sequencing. BIOTECON Diagnostics is thus able to provide flexible solutions to production and processing companies through new, tailored, and economical approaches. 19 th Guide to german biotech companies 2018

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

· · · · · · · · · · · ·

Binger Strasse 173 55216 Ingelheim Rhineland-Palatinate Dr Julia Knebel +49-6132-77-0 +49-6132-72-0 >45,600 in 2016 1885 in Ingelheim, Germany S1 Focus on human pharmaceutical and animal health business

Net Sales · €15,850 million in 2016 Relevant R&D Budget · €3,112 million in 2016 Request for · Boehringer Ingelheim BioXcellence™ Further Collaborations seeks companies in need of biopharma development and GMP manufacturing services and helps customers to get their products to market on time.

Company profile The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 143 affiliates and more than 45,600 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing, and marketing novel medications of high therapeutic value for human and veterinary medicine. In 2016, Boehringer Ingelheim achieved net sales of about 15.8 billion euros. Boehringer Ingelheim Contract Manufacturing is represented by its brand Boehringer Ingelheim BioXcellenceTM, your dedicated biopharma contract manufacturer. As a leading biopharmaceutical contract manufacturer with more than 35 years of experience it has brought more than 25 biopharma products to market. Boehringer Ingelheim BioXcellenceTM offers tailor-made contract development and manufacturing services to the biopharmaceutical industry, providing the entire production technology chain from DNA to fill and finish under one roof at its facilities in Biberach (Germany), Vienna (Austria), Fremont (USA), and Shanghai (China). Boehringer Ingelheim BioXcellenceTM can secure product supply throughout the entire product lifecycle, transferring customer projects at any stage, delivering to almost any scale. Boehringer Ingelheim BioXcellenceTM makes outsourcing easy.

Boehringer Ingelheim’s BioXcellence™ services At our cell culture sites in Biberach (Germany), Fremont (USA), and Shanghai (China) we have a total capacity of more than 270,000 L with flexible scales for clinical and commercial supply of between 100 L and 15,000 L. At our microbial site in Vienna (Austria) we have around 12,000 L with flexible scales for clinical and commercial supply from 300 L to 6,000 L. We offer the following: ·· Genetic engineering ·· Cell line and strain development ·· Up- and downstream processing ·· Fast and tailored project transfers

Boehringer Ingelheim

·· L  arge-scale GMP facilities licensed by the EMA, the FDA and the MHLW ·· Formulation and pharmaceutical process development ·· Fill and finish (including innovative application devices) ·· Quality control and assurance

Boehringer Ingelheim’s BioXcellence™ experience Boehringer Ingelheim BioXcellenceTM offers reliable world-class biopharmaceuticals contract manufacturing to the pharmaceutical and biotechnology industry. We offer a complete range of services, from cell line and strain development through process development and large-scale manufacturing to fill and finish. Our extensive portfolio of capabilities and technologies includes the production of antibodies, recombinant proteins, nonantibody scaffolds, Fab fragments, as well as pDNA from both mammalian cell culture and microbial fermentation systems.

Opportunities for our partners ·· From DNA to drug product in one seamless, integrated process. ·· Small- as well as large-scale cGMP production in multi-product facilities that are approved by the major authorities. ·· The confidence that you are working with a contract manufacturer that has helped bring 27 biopharmaceuticals to the market and an outstanding track record of >200 projects successfully optimised and transferred. ·· Transparent processes and first-class project management allowing you to step in at any stage of development.

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Name · B·R·A·I·N Biotechnology Research And Information Network AG Address/P.O. Box · Darmstädter Str. 34–36 Postal Code/City · 64673 Zwingenberg State · Hesse Contact Person · Dr Martin Langer (EVP Business Development) Telephone · +49-6251-9331-0 Fax · +49-6251-9331-11 Email · Website · Social Media · L Number of Employees · 240 Founded (year) · 1993 Type of Laboratory · S1, S2, L1, L2 Areas of Activity · Discovery and development of novel enzymes, bioactive compounds, and performance microorganisms; strain development, synthetic biology, screening systems, process engineering – based on our unique BioArchive Biological Patents · IP in metagenome technologies, enzymes and enzyme-libraries, bioactives and technical proteins, microorganisms, processes External · BASF, Bayer, Evonik, Henkel, Nutrinova, Collaborations RWE, Sandoz, Schering, Südzucker, Symrise (D), CIBA (CH), Clariant (CH), Diana (F), DSM (NL), Roquette (F), Genencor (US), and others; global academic R&D network Request for · l development of industrial bulk & Further Collaborations specialty enzymes, biocatalysts, bioactive compounds for cosmeceuticals, nutraceuticals, pharmaceuticals l development of producer strains l marketing partnerships for cosmetics, food, feed, cosmetics, health, skin & wound care, biobased chemicals, waste management, metal extraction markets

BRAIN promotes innovation in the field of bioeconomy and pioneers sustainable industrial biotechnology. BRAIN stands for the biologisation of industries and products with the aim of preserving valuable resources, replacing unfavourable solutions, as well as providing new breakthrough approaches. Economic efficiency and quality improvement in various industry sectors are a hallmark of BRAIN. BRAIN’s key success factors are more than twenty years of experience in the arenas of sustainability and biodiversity and its exceptional innovation culture. BRAIN Group develops innovations based on highly modern discovery and screening platforms for the natural diversity of species and its proprietary BioArchive. This “toolbox of nature” includes some 53,000 highly diverse characterised microorganisms, more than 50,000 natural substances and highly diverse metagenome libraries, as well as a multitude of enzymes with specific properties. BRAIN owns a comprehensively protected high-tech portfolio and employs state-of-the-art technologies such as high-throughput sequencing, digital 3D-modelling and experiment simulation, as well as protein engineering and big data analysis. Key research and development activities include solutions for both the consumer goods industry and the chemical sector such as ·· bioactive compounds for foodstuffs and animal feed, as well as cosmetics, skin & wound care, and biobased chemical products; ·· enzymes and biocatalysts of natural sources which meet the specific process and application requirements called for by a multitude of product classes; ·· customised high-performance microorganisms which deliver functional biomass and sustainably enhance industrial production processes such as Urban Mining or Green Mining.


Engineering Biology BRAIN is a driver of bioeconomy and a hightech pioneer of sustainable industrial biotechnology.

BRAIN delivers fast and reliable results in customised R&D collaborations and exclusive strategic partnerships including licensing agreements. BRAIN can look back on more than 100 successfully concluded collaborative projects. In addition, internal research and development programmes are pursued e.g. in the NatLifE 2020 and the ZeroCarbFP innovation alliances, both set up by the German Federal Ministry of Education and Research and coordinated by BRAIN. BRAIN has developed a multitude of products and processes which were unavailable before, including ·· enzymes for the production of foodstuffs, detergents or wound care, as well as plastics and lubricants; ·· producer strains with optimised multi-step bioconversion routes for customised “designer bugs” based on synthetic biology approaches; ·· special screening systems based on human taste cells for sugar substitutes, sugar taste enhancers, and taste modulators – e.g. in our DOLCE programme (#DOLCEbiotech); ·· active ingredients for the cosmetics industry; ·· procedures that extract biomass or precious metals from waste streams or ore to establish modern circular economy systems – e.g. in our BioXtractor programme (#BioXtractor). R&D collaborations and partnerships with industries are organized in the BioScience segment. Additionally BRAIN is investing in its BioIndustrial segment for the development of own product candidates as well as their commercialisation through direct market access and license partnerships. BRAIN’s headquarter is located in Germany’s Rhine Main Neckar Metropolitan Region. Other companies complement the BRAIN Group, each of them acting as independent entities in the areas of R&D, process development, manufacturing, or as product vendors in specific markets. As part of a business and growth strategy, BRAIN is listed on the Prime Standard of the Frankfurt Stock Exchange.

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

· · · · · · · · · · · ·

Feodor-Lynen-Str. 15 30625 Hannover Lower Saxony Dr Claudia Ulbrich, CEO +49-511-338599-30 +49-511-338599-39 10 2016 S1 Research & Development of RNA-based diagnostics and therapeutics

External · l MHH Collaborations l IMTTS l Fraunhofer ITEM l CRC Request for · Cardior is looking for a partner to Further Collaborations develop their proprietary biomarker to a CDx.

Cardior is a privately held biopharmaceutical company founded in June 2016 by Prof. Thomas Thum out of the Institute of Molecular and Translational Therapeutic Strategies (IMTTS) of Hannover Medical School (MHH). A Series A Financing round of about 15m Euro was successfully closed in May 2017 with 5 international leading Venture Capital funds including Pharma (LSP, BioMedPartners Fund III, BIVC, Bristol-Meyers Squibb (BMS), HTGF).

Technology Cardior is developing a proprietary RNA technology to revolutionise heart failure treatment. The molecular target is a noncoding RNA, that simultaneously controls cardiac growth, autophagy, and calcium handling / contractility of cardiomyocytes and thus, through their inhibition, reverses maladaptive cardiac remodeling and restores normal cardiac function. Cardior has a proprietary technology platform and access to a large patent portfolio also consisting of several back-up candidates for heart failure therapy.

Unmet medical need New innovative treatment approaches to heart failure are scarce, even among those that are in early phases of development. With the revolutionary noncoding RNA inhibitory approach, our clear advantage is having a well-characterised innovative target and convincing preclinical efficacy data with low toxicity for heart failure indications. Indeed, and in contrast to the other therapeutics mentioned, which are mainly symptomatic or disease-halting, Cardior’s proprietary innovative strategy is designed as the first real curative approach for heart failure.


Development lead compound Cardior’s lead compound has shown preclincial proofof-concept and will be developed into FIM studies within the next 2 years. Cardior is embedded into a strong network of academic and industrial partners. This includes the Hannover Medical School (MHH), The Fraunhofer Institute ITEM, the Clinical Research Center (CRC) Hannover, and the Institute of Prof. Thum (Institute of Molecular and Translational Therapeutic Strategies - IMTTS). There is active cooperation with many academic partners from Europe. We work closely together with Axolabs, Kulmbach on drug detection and quantification.

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

· · · · · · · · · · · · ·

Mendelstr. 11 48149 Münster North Rhine-Westphalia Dr Antje Roetger +49-251-980-2320 +49-251-980-2321

FI 10 2001 molecular biology, ISO 9001 l molecular diagnostics l point-of-care diagnostics l qPCR assay development l nucleic acid isolation techniques l diagnostics of clinical, dental, F&B, and water pathogens

Biological Patents · back-license on several patent families covering POC platform technology Gyronimo®; nucleic acid isolation techniques External · intensive cooperation with industrial Collaborations and academic partners, research centres Request for · licensing and co-development Further Collaborations agreements concerning non-clinical applications of POC platform Gyronimo®, e.g. F&B, water analytics; contract development of qPCR assays, e.g. for clinical studies

Overview Carpegen is a provider and developer of high quality molecular diagnostics. Within the scope of collaborations, contract development, and research projects, the company focuses on developing and out-licensing quantitative PCR (qPCR) assays and point-of-care diagnostics/integrated systems, e.g. for the diagnosis of specific infections and the detection of genetic biomarkers. Carpegen’s expertise includes the development and validation of highly sensitive and specific qPCR assays, nucleic acid preparation from problematic samples (e.g. dental, food, environmental), and the adaptation of complex molecular analytic procedures to the requirements of cartridge-based sample-to-answer point-of-care systems. Carpegen applies very high-quality standards and strongly emphasises a sound scientific basis for its diagnostics, as well as accurate validation and standardisation. Carpegen’s diagnostic assays are well-known for delivering reliable and reproducible results. Thus, they are favoured in clinical studies and recommended by clinicians and opinion leaders.

Dental diagnostics As a quality market leader in dental diagnostics, Carpegen provides the diagnostic testing system Carpegen® Perio Diagnostics for the detection and quantification of periodontal pathogens in gingival samples. The microbiological results of Carpegen® Perio Diagnostics provide a reliable aid for decision-making in the treatment of patients with periodontitis and periimplantitis. Thus, this widely accepted high-quality qPCR testing system is broadly used by German, European, and international dentists for optimising periodontal therapy.


Point-of-care diagnostics In point-of-care diagnostics, Carpegen has developed the proprietary Gyronimo ® System, a benchmarking point-of-care platform technology which is based on qPCR and delivers rapid, easy-to-use, and highly specific and sensitive pathogen and genetic marker diagnostics. At the same time, Gyronimo® is highly cost- and personnel-efficient and can be applied in a broad range of clinical and industrial applications. At the end of 2016, the Gyronimo ® platform was purchased by Curetis GmbH, Holzgerlingen, for commercialising the clinical applications of the new technology. The worldwide rights for the non-clinical applications (environmental, water, and F&B safety testing) as well as dental diagnostics have been retained by Carpegen and are available for licensing and co-development projects.

Research & development Carpegen is currently participating in two joint research projects also relating to qPCR and point-of-care diagnostics: The PathoSept project (2016–2019) includes the development of a modular diagnostic system for clinically relevant pathogens and their antibiotic resistances. As the molecular diagnostics partner in this project, Carpegen develops highly sensitive qPCR assays for the specific molecular identification of the selected nosocomial pathogens. As a winning project of the Lead Market Competition Lifesciences.NRW, PathoSept is funded by the state of North-Rhine Westphalia. The AnDiPOC project (2016 –2019) focuses on the development of a portable module for decentralised molecular testing of water contaminants (e.g. Legionella spec.) in natural and industrial water samples. The joint project (2016–2019) is funded by the Federal Ministry for Economic Affairs and Energy (ZIM programme).

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

· · · · · · · · · · · ·

Am Flughafen 16 79108 Freiburg im Breisgau Baden-Wuerttemberg Prof. Dr med. Felicia Rosenthal +49-761-888-89-0 +49-761-888-89-800

I 60 1994 l S1/S2 l GMP l Clean room facilities A/B/C/D

Areas of Activity · l Ex vivo cell culture reagents and tools l Cell and gene therapy l Regenerative medicine External · Distribution in Europe of Saint Gobain Collaborations FEP cell culture and cryopreservation bags Request for · l T cells Further Collaborations l MSCs l PSCs, ESCs

High-quality GMP reagents for cell and gene therapy manufacturing CellGenix is an internationally leading supplier of high quality reagents and tools in the expanding market of cell and gene therapy, and regenerative medicine. The company was founded in 1994 and is located in Freiburg, Germany, where it operates a state-of-theart GMP manufacturing facility. As the first company to obtain a GMP manufacturing authorization for cell processing in Europe, CellGenix has more than 20 years of expertise in the development and GMP manufacturing of cell and gene therapy products. As a trusted supplier, CellGenix offers a comprehensive product portfolio to ensure a seamless transition from research to commercialisation. Included in our product portfolio are cytokines, serum-free media, and closed cell-culture systems. Our products combine a maximum of quality and safety with excellent performance due to state-of-the-art production, stringent in-house control, and comprehensive documentation. All these factors help to simplify qualification and validation for your market authorisation.


Regulatory excellence GMP


cytokines & media

cytokines & media

Research Preclinical

Clinical trials phase I / II / III

Manufacturing/ Commercialization

From Research to ATMP

Partner for Cell Therapy

CellGenix GMP products are based on three major quality standards: ·· Safety – Safe and qualified raw materials in compliance with our animal-derived component-free and serum-free policy. ·· GMP Compliance – Manufacturing and quality control following all applicable GMP guidelines to provide documented evidence of purity, potency, consistency and stability. ·· Qualified Products – GMP products are manufactured, tested, released and distributed under an ISO 9001:2008 certified Quality Management System and allow for safe use in accordance with USP Chapter <1043> and Ph.Eur. General Chapter 5.2.12. GMP cytokines are tested and released according to USP Chapter <92> as applicable. We offer expert regulatory and technical support as well as FDA Drug Master Files for most of our products. Customised solutions can be provided to meet special compliance needs. Safe | GMP Compliant | Reliable

Cytokines, serum-free media & more

Dendritic Cell

Hematopoietic Stem Cells

T Cells

NK Cells

Mesenchymal Stromal Cells


ESC and iPS Cells

CellGro® and CellGenix® are registered trademarks of CellGenix.

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Name · CEVEC Pharmaceuticals GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · · ·

Gottfried-Hagen-Straße 60-62 51105 Cologne North Rhine-Westphalia Dr Nico Scheer +49-221-46020800 +49-221-46020801

I 30 2003 Centre of expertise for the production of recombinant proteins previously out of reach (CAP-Go) and for scalable gene therapy vector production (CAP-GT) using a unique human cell production system.

CEVEC is a centre of expertise for the production of biopharmaceuticals using a unique human cell-based expression system.

CAP®Go Technology – Production of recombinant proteins previously out of reach CAP®Go addresses the increasing need in the pharmaceutical and biotechnology industries for the manufacture of difficult to express therapeutic glycoproteins. Using CAP®Go it is possible to produce glycoproteins with tailor-made or fully human glycosylation patterns for significantly improved physicochemical and pharmacological properties. Therapeutic proteins expressed on conventional mammalian expression platforms like CHO or HEK293 cells often do not match the glycosylation and pharmacokinetic profiles of the naturally occurring proteins. CAP®Go Technology provides an efficient way, with up to 10fold higher yields than conventional cell lines, to glyco-optimised proteins that previously have been out of reach to the life science industry. CAP®Go derived glyco-optimised proteins show authentic human posttranslational modifications. CEVEC’s regulatory endorsed CAP ® Go expression platform comprises a comprehensive portfolio of glycooptimised human suspension cell lines that have different glycosylation capabilities. CAP®Go allows for the optimisation of complexly glycosylated proteins such as plasma proteins, coagulation factors, cytokines and other high molecular mass multimeric proteins.

CEVEC Pharmaceuticals

CAP®GT Technology – Scalable gene therapy vector production The ability to produce viral vectors in a fully scalable industrial process is a main bottleneck for commercial gene therapy applications. So far, industrial scale vector production could not be efficiently addressed by conventional expression systems such as HEK293. CAP®GT is a novel, fully developed and regulatory endorsed expression platform for the scalable industrial production of viral vectors for gene therapy applications. CAP®GT cells propagate a broad spectrum of viral species supporting lentiviral (LV), adenoviral (AV) and adeno-associated viral (AA V) vectors. Growing in serumfree suspension culture, CAP ® GT grows to high cell densities, reduces production costs, and allows for safer and more efficient scale-up when compared to adherent cell culture systems. As demonstrated in adenoviral vector production runs, the CAP®GT platform offers the safe production of adenoviral vectors. Unlike HEK293 cells, no replication competent adenovirus (RCA) can be detected in the vector preparation. Independent study results show that CAP®GT derived lentiviral vector production delivers vector titers comparable to or even exceeding production with HEK293 cells.

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Name · CO.DON AG Address/P.O. Box · Warthestr. 21 (Headquarters) Postal Code/City · 14513 Teltow State · Brandenburg Ernst-Reuter-Platz 2 10587 Berlin Berlin Contact Person · Matthias Meißner, MA (Director Corporate Communications/ IR/PR) Telephone · +49-30-240352-330 Fax · +49-30-240352-309 Email · Website · Number of Employees · 90 (2017) Founded (year) · 1993 Type of Laboratory · GMP/Integrated Isolator Technology (IIT) Areas of Activity · Tissue Engineering Biological Patents · On cell-based human tissue engineering therapeutics External · Various ongoing projects with several Collaborations well-renowned hospitals, universities, and university hospitals in Germany and Europe in the field of product distribution (Germany), product development, clinical evaluation, and research Request for · CO.DON AG is seeking national and Further Collaborations international corporate partners who have substantial resources in the field of tissue engineering and regeneration for distribution and marketing of the company’s products (internationaly) as well as for the development of product lines.

The company CO.DON AG develops, produces, and markets autologous cell therapies for the minimally invasive repair of knee cartilage defects following trauma or degeneration. The medicinal product is a cell therapy product that uses only the patient’s own cartilage cells (“autologous chondrocytes”). The method has been used for more than 10 years in over 150 clinics to treat more than 11,000 patients. In Germany, the statutory health insurance companies have reimbursed the treatment of knee and hip joints since 2007. In July 2017 the company received EU marketing authorisation for its articular cartilage product, which is distributed under the name of Spherox. The shares in CO.DON AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227). Executive Board: Dirk Hessel (CEO), Ralf M. Jakobs (CFO). CO.DON AG manufactures cell-based tissue engineering therapeutics of the highest purity and to the highest quality standards. Its products represent a revolutionary process in the biological regenerative treatment of articular cartilage defects. The products are 100% autologous and free of additives, setting the stage for the highest level of personalised healing. Because no exogenous materials are used, the risks of rejection, inflammation, and infection are very low. Due to a minimally invasive or arthroscopic application of the product, surgery and rehabilitations times can be significantly reduced. Moreover, results of recent trials provide evidence for the effectiveness of the product. CO.DON AG has been certified in accordance with European Guidelines for Good Manufacturing Practice (EU-GMP) since 1997. In 1997 CO.DON AG was the first biopharmaceutical company in Europe to be granted a permit for the manufacture of autologous chondrocyte transplants under section 13 of the German Drugs Law (AMG). CO.DON has also developed a proprietary platform technology: The Integrated Isolator Technology (IIT).


Technology platform â&#x20AC;&#x201C; Integrated Isolator Technology (IIT) CO.DON has an established tissue engineering programme for the development, production, and distribution of biotechnological products for the treatment of articular cartilage defects. For the manufacturing process and quality control of autologous tissue engineering therapeutics, the company has developed its own clean room production plant with proprietary Integrated Isolator Technology (IIT) (a cleanroom in a cleanroom) and thus set a totally new standard for the manufacture of cell-based tissue engineering therapeutics in Germany and worldwide. CO.DONâ&#x20AC;&#x2122;s technological, production, and regulatory expertise makes the company a first mover in the market for biological cartilage replacement and a provider of highly effective, safe treatment options between pain therapy and endoprothetics, with the aim to become market leader in arthrosis prophylaxis. Moreover, the product is currently the only cell-based medicinal product for the regenerative treatment of knee cartilage defects that is available and authorised EU-wide, which is to say that there is currently no European competitor in the market segment. With that, CO.DON has the chance to open up a market that is worth millions and to raise its company value.

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Name · Coriolis Pharma Research GmbH Address/P.O. Box · Fraunhoferstr. 18 b Postal Code/City · 82152 Martinsried State · Bavaria Contact Person · Dr Jörg Müller Telephone · +49-89-41-77-60-111 Fax · +49-89-41-77-60-222 Email · Website · Social Media · I  Number of Employees · 80+ Founded (year) · 2008 Type of Laboratory · Contract research and development Areas of Activity · Formulation excellence for biopharmaceuticals l Liquid and lyophilised formulation development l Lyophilisation process development Leading analytical competence for biologics l Biophysical characterisation l Higher order structure (HOS) Level: R&D, GMP, S1 (BSL1), S2 (BSL2) External · Experience with 500+ different Collaborations molecules gained in 1000+ projects Request for · We successfully serve customers Further Collaborations worldwide in all stages of product development (from early R&D up to marketed products). Our customer range includes small virtual biotech firms, mid-size pharma-biotech up to TOP20 pharma-biotech companies. We’re eager to discuss formulation, stability, and analytical challenges you might face. We provide our customers with expert support on a high-quality scientific level, vast experience in the biopharmaceutical field, flexibility and responsiveness.

Coriolis is a world-leading independent contract research and development organisation specialised in biopharmaceutical formulation and drug product development, including, lyophilisation processes and analytical development for proteins, peptides, monoclonal antibodies, RNA/DNA, etc., as well as vaccines. This contains highly concentrated protein formulations or developments for subcutaneous administrations or other complex formulations. This is complemented by outstanding analytical capabilities and know-how in the fields of protein characterisation (e.g. higher order structure characterisation, aggregation, subvisible particles, surfactant characterisation, etc.). Coriolis is expert in highly specialised and innovative analytical technologies (e.g. analytical ultracentrifugation, Resonant Mass Measurement, quantitative Far- and Near-UV CD). Most recently we also offer polysorbate analytics such as quantification and characterisation of degradation products. In addition, we also offer as standalone services GMPcompliant analytics for subvisible particle analysis and aggregation characterisation (e.g. light obscuration (LO), flow imaging spectroscopy (MFI), asymmetrical flow field-flow fractionation (AF4)), and other innovative techniques. As of 2017 Coriolis has received the regulatory approval for the operation of a genetic engineering facility of safety level S2 (BSL2), allowing handling of S1 and S2 classified samples.

Coriolis is specialised in the provision of: ·· Formulation development services for liquid and lyophilised products ·  Pre-formulation and candidate selection ·  Early stage formulation development ·  Late phase formulation development ·  Lyophilization cycle optimisation ·  Scale-up and transfer studies ·· Support in container closure system selection ·· In-use stability studies

coriolis pharma research

·· Stability testing including forced degradation studies ·· R&D and GMP-compliant contract analytical services ·· Orthogonal analysis of sub-visible aggregates and particles ·· Testing of S1 and S2 GMO material ·· Outstanding scientific expertise Coriolis supports customers in R&D development projects, e.g. by developing the most robust formulation or lyophilisation process for a biopharmaceutical, identifying suitable stability-indicating analytical methods to monitor real-time and accelerated stability studies, or support in process trouble-shooting. Freeze-drying capabilities up to 6 sqm shelf area, featuring state-of-the-art process analytical tools, including controlled nucleation, ensure that we develop and optimise lyophilisation processes specifically for our customers’ needs that are ready to be up-scaled and transferred to commercial production units worldwide. With a strong expertise in aggregate and subvisible particle testing, Coriolis supports in method development and validation for low-volume applications (e.g. ophthalmic products) and/or high viscosity material in a GMP-compliant environment. Equipped with several AF4, HP-SEC, multiple AUC (including Optima AUC), and DLS systems, Coriolis can perform comprehensive studies on aggregation characteristics.

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

· · · ·

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

Lohmannstraße 2 56626 Andernach Rhineland-Palatinate l Kiel l Berlin l Wuppertal l Mönchengladbach l Mannheim Dr Volker Menschik SVP Business & Corporate Development +49-30-859-949-401 +49-151-526-416-33

· · · · · IQ · 275 · Merger 2006, Foundation of Legacy up to 1977 Type of Company · Full-Service CRO

Areas of Activity · l Consultancy l Project Management l Clinical Conduct l Quality Assurance l Clinical Trial Supply Management l Clinical Data Management l Statistics l Medical Writing l Laboratory/Bioanalytical Services provided by external partners In-house Capacity · 260 beds Request for · Our Business Development team is Further Collaborations happy to discuss your project and to propose tailor-made solutions for the clinical development of your product. Please do not hesitate to contact us: INFO@CRS-GROUP.DE

Top class in early phase CRS is one of the leading European full-service CROs in early clinical development and has 40 years of experience in the performance of clinical trials (Phase I–IIa). The excellent quality of CRS’s services is demonstrated by an outstanding track record of more than 2,000 successfully completed trials. Five Clinical Pharmacology Units (CPUs) of CRS are located in the most important German metropolitan regions, with a total of over 30 million inhabitants and thousands of resident physicians of all medical specialities. This ensure rapid recruitment and the availability of a large pool of volunteers (e.g. FIM) as well as reliable access to special populations as well as patients across numerous therapeutic indications. Especially for settings of patient trials or complex designs, CRS provides a specific supersite concept, i. e. five sites acting as one with centralised project management under a single contract, which creates maximum operational and financial synergies. Furthermore, the close connection to University Hospitals gains access to subjects affected by special indications, to additional hospital infrastructure, and also to opinion leaders in various therapeutic areas. The CPU Kiel is situated close to the University Hospital Schleswig-Holstein (UKSH); the one in Berlin is close to the famous Charité and the Federal Military Hospital. The CPU Mannheim is located in a region that is home to famous research institutes such as the German Cancer Research Centre (DKFZ) as well as the renowned University Hospital Heidelberg and University Medical Centre Mannheim (UMM). Through the strictly standardised Phase-I environment and the internal QA/QC procedures in the CPUs, CRS is able to handle multi-centre settings within its company. CRS is regularly audited by sponsors and inspected by the authorities (FDA, EMA, BfArM, AFSSAPS, ANVISA, etc).


Special fields of expertise



CRS has experience in all kinds of trial designs and indications, especially in: ·· Renal & hepatic impairment ·· Men’s & women’s health ·· Dermatology ·· Endocrinology ·· Medical devices ·· Respiratory/inhalative devices ·· High-precision QTc trials (updated ICH E14 Guideline) ·· Interaction trials (food, drug, & genotype) ·· Vaccines ·· CNS

Infrastructure – Locations – Expertise Andernach, headquarters of CRS, coordinates the activities and central services (listed under Areas of Activity). CPU Kiel (25 beds) is located in close proximity to the University Hospital Schleswig-Holstein (UKSH). Kiel has excellent experience in the conduct of patient trials in renal and hepatic impairment. CPU Berlin (35 beds) has outstanding expertise in clinical trials concerning women’s health, including gynaecological examinations on-site. CPU Wuppertal (45 beds) has a focus on metabolic & cardiovascular diseases and is experienced in complex ECG trial designs as well as FIM. CPU Mönchengladbach (55 beds) is specialised in trials regarding men’s health, skin safety, cardiovascular diseases, and nutritionals. CPU Mannheim (100 beds) provides special expertise in respiratory research and in challenging trial designs e.g. FIM & thorough QT. In addition to that each site provides strong project management. 19 th guide to german biotech companies 2018

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Name · CureVac AG Address/P.O. Box Postal Code/City State Contact Person

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Telephone Fax Email Website Number of Employees Founded (year) Areas of Activity

· · · · · · ·

Paul-Ehrlich-Str. 15 72076 Tübingen Baden-Wuerttemberg Verena Lauterbach (Senior Manager Communications) +49-7071-9883-1756 +49-7071-9883-1101 ~350 2000 Research, development, and manufacturing of therapeutics based on messenger RNA (mRNA) l Cancer therapeutics l Prophylactic vaccines l Molecular therapies

External · CureVac AG collaborates with Collaborations l Boehringer Ingelheim l Sanofi Pasteur l Bill & Melinda Gates Foundation l and others

CureVac – The RNA people ® CureVac is a clinical stage biopharmaceutical company, based in Tübingen. The company is pioneering the use of natural and chemically unmodified messenger RNA (mRNA) as a data carrier, to instruct the body to produce its own proteins capable of fighting a wide range of diseases. CureVac’s broadly protected mRNA platform allows for rapid, low-cost production of multiple drugs and vaccines.

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

mRNA cancer therapeutics CureVac’s mRNA-based cancer vaccines represent a potential novel approach in cancer treatment. For the first time mRNA could be optimised to mobilise the patient’s own immune system to fight the tumour with a specific immune response. CureVac also explores combination approaches with checkpoint inhibitors as well as innovative routes of administration to treat cancer with RNA. In the field of cancer, CureVac collaborates with Boehringer Ingelheim, who in-licensed the lung cancer immunotherapy CV9202 in September 2014. CureVac also partners with the Cancer Research Institute and Ludwig Cancer Research and others.


mRNA prophylactic vaccines mRNA-based prophylactic vaccines can be developed against almost any infectious disease and can be produced rapidly. In July 2017, CureVac published results of its phase I clinical trial with a prophylactic rabies vaccine. The study was the first worldwide in-human proof-of-concept clinical trial of a prophylactic mRNA-based vaccine. Data from the study indicate that the vaccine is generally safe with a reasonable tolerability profile and induces boostable functional antibodies against a viral antigen when administered using a needle-free jet injection device. CureVac is developing second generation prophylactic vaccines with an optimised formulation. In the field of prophylactic vaccines, CureVac collaborates with the Bill and Melinda Gates Foundation, which has also invested 46 Mio Euro in the company. Furthermore, IAVI and Sanofi Pasteur are partners of CureVac in developing mRNA-based vaccines.

mRNA-based molecular therapy CureVac’s technologies RNArt ® and RNAntibody ® are being developed as molecular therapy to trigger the body’s own production of therapeutic proteins including antibodies. Without stimulating the immune system, this therapy can, for example, be used for protein replacement or passive immunisation.

mRNA manufacturing Since 2006, CureVac has been operating the first GMPcompliant production plant worldwide, with two multiproduct suites. In 2017, the company completed the development of its third in-house suite which is capable to deliver for late stage clinical trial supply. In 2017, CureVac started the construction of a new building, which is designed for the development of a GMP production process on an industrial scale. The new facility, GMP IV, is expected to be fully commissioned in 2019. 19 th Guide to german biotech companies 2018

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

· · · · · · · · · · ·

Behringstraße 6–8 82152 Planegg near Munich Bavaria Dr Bettina Katterle +49-89-899-650-0 +49-89-899-650-11 1984 GMP/GLP Facilities Testing services for bio-/ pharmaceutical and medical device companies

External · BSL BIOSERVICE Collaborations Scientific Laboratories Munich GmbH

Eurofins BioPharma Product Testing Global BioPharma Product Testing within your Reach. Eurofins BioPharma Product Testing is the largest network of harmonised bio/pharmaceutical GMP product testing laboratories worldwide, providing comprehensive laboratory services for the world’s largest pharmaceutical, biopharmaceutical, and medical device companies. Our service offerings are fully comprehensive and include testing of drug substances, final products, intermediates, and starting materials for both small and large molecule drug products. With a global capacity of more than 92,000 square metres and facilities located in Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, India, Netherlands, New Zealand, Spain, Sweden, Switzerland, UK, and the US, our network of GMP laboratories operates under the same strict quality procedures, LIMS, and centralised billing system across 28 locations worldwide. We give our clients the flexibility to choose from three unique service models to meet specific project needs, including our Professional Scientific Services® (PSS), Full Time Equivalent (FTE), or traditional fee-for-service. Clients can choose the best, most cost-effective service solution to meet project goals.

Experience our Expertise at Eurofins Munich Our focus at Eurofins Munich, Germany lies on bioassays/Biacore, microbiology, in vitro toxicology, immuno- and bioanalytical studies. Additionally we work in close cooperation with our preferred partner BSL BIOSERVICE Munich, an international active contract research organization, to assess biological safety and activity of bio-/pharmaceuticals and medical devices.

Eurofins Biopharma Product testing

Eurofins BioPharma Product Testing acts as a onestop-shop, covering the whole range from standardised test designs to special requirements and tailor-made studies, with a focus on early development as well as release and stability testing strategies for small and large molecules. Our services for pharmaceuticals, biologics, and ATMPs include: ·· Toxicology/Pharmacology/Biocompatibility ·· Bioanalytics ·· Immunoanalytics ·· Bio-/Pharmaceutical Lot Release and Stability Testing ·· Microbiology ·· Bioassays/Biacore ·· Professional Scientific Services®

International presence means global regulatory compliance Operating under the same strict quality procedures, our worldwide laboratories offer a broad range of methodologies under GMP authorisation, ISO 17025 accreditation, and ISO 9000 certification, and all analyses are performed according to European and British Pharmacopoeia (EP), United States Pharmacopeia (USP), and Japanese Pharmacopeia (JP), as well as specific customer methods. The fundamental philosophy of Eurofins BioPharma Product Testing is to help clients efficiently allocate their research and manufacturing expenditures by strategically engaging them to meet their unique outsourcing needs.

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Name · Evotec AG Address/P.O. Box · Manfred Eigen Campus Essener Bogen 7 Postal Code/City · 22419 Hamburg State · Hamburg Contact Person · Gabriele Hansen, VP, Corporate Communications & Investor Relations Telephone · +49 -40-56081-255 Fax · +49-40-56081-222 Email · Website · Social Media · L I Number of Employees · > 2,000 Founded (year) · 1993 Type of Laboratory · Chemical, Biological, Cell culture S1, S2 Areas of Activity · Drug discovery and development alliances as well as proprietary research with focus on CNS/neurology, diabetes and complications of diabetes, pain and inflammation, oncology, and infectious diseases; iPSC Annual Turnover · € 164.5 million (2016) Relevant R&D Budget · € 18.1 million (2016) Biological Patents · A broad portfolio of patent families relating to compounds, targets, and assays. Evotec has nearly 65 patent families under its full control. External · The company is working with more than Collaborations 250 Pharma and biotech companies, not-for-profit organisations, academia, and foundations on a global basis. Request for · Our team of business development Further Collaborations managers would be happy to discuss our R&D solutions, in- and out-licensing opportunities and how we can assist you in meeting your needs in drug discovery and development. For more information, please contact us at

Company profile Evotec is a drug discovery partnership company providing drug discovery solutions. With a large pool of highly experienced scientists, state-of-the-art technology platforms, first-class scientific operations, and key therapeutic expertise in the areas of neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, and infectious diseases, Evotec aims to identify and develop best-in-class and first-inclass differentiated therapeutics for collaborators or for its own internal pipeline development. Today, Evotec drives research and development projects in numerous alliances and partnerships with Pharma and Biotech companies as well as academia. Its strategy follows a clear goal: achieving the leadership position in high-quality drug discovery solutions and building a partnered product pipeline based on the highest-quality drug discovery science and through innovative collaborations. Evotec is a publicly listed stock corporation operating under German law. The Company’s headquarters are located in Hamburg, Germany. Including the newly acquired Aptuit sites, additional major operating sites in the UK, Italy, Germany, the USA, and France handle Evotec’s international business development activities, which are closely integrated with the Group’s operations. Building on this expertise in the field of drug discovery services, the Company has evolved into a drug discovery engine in its own right with its two business segments EVT Execute and EVT Innovate.

EVT Execute – Speed, expertise, and new technologies Evotec’s core expertise in the life sciences market lies in early-stage drug discovery from target to new drug (“IND”) and high-end Chemistry, Manufacturing and Control (“CMC”). Evotec’s drug discovery platform and business deliver an industrialised, cutting-edge, comprehensive, and unbiased infrastructure to meet the industry’s need for innovation in drug discovery and to accelerate the population of its partners’ drug discovery portfolios.


The EVT Execute segment provides stand-alone or integrated drug discovery solutions for collaborators’ targets and programmes on a typical fee-for-service basis or through a variety of commercial structures including research fees, milestones, and/or royalties. Projects are selected to match Evotec’s expertise and technology. In these projects, EVT Execute contributes efficiency, project management, and speed in the drug discovery process. The Company is continuously upgrading its platforms with new licences (e.g. Trianni, CRISPR).

EVT Innovate – Source of new pipeline entries The EVT Innovate segment focuses on investing and developing its own internal assets including early-stage discovery programmes as well as more advanced drug candidates, which are subsequently positioned for partnering with Pharma companies. Evotec’s internal programmes focus on first-in-class and best-in-class projects based on innovative biology. These so-called Cure X or Target X initiatives are typically developed internally or through academic partners. Evotec is also an integral part of highly innovative academic BRIDGE partnerships, e.g. LAB282 and LAB150, which are focused on identifying and translating promising projects out of academia through access to Evotec’s industrialscale discovery platforms and expertise. Evotec has expanded its EVT Innovate segment through equity participation in selected companies.

Paradigm shift in drug discovery Over the last five years, Evotec has built an industrialised induced pluripotent stem cell (iPSC) infrastructure that represents one of the largest and most sophisticated iPSC platforms in the industry. Evotec’s iPSC platform has been developed with the goal to industrialise iPSCbased drug screening in terms of throughput, reproducibility, and robustness to reach the highest industrial standards.

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Name · FGK Clinical Research GmbH Address/P.O. Box Postal Code/City State Contact Persons Telephone Emails

· · · · · ·

Heimeranstr. 35 80339 Munich Bavaria Dr Edgar Fenzl, Martin Krauss +49(0)-89-893-119-0 Websites · Number of Employees · > 100 Founded (year) · 2002 Areas of Activity · Full service CRO (contract research organization) offering a complete range of clinical development and consulting services: l Regulatory Affairs l Project Management and Monitoring l Medical Safety/Pharmacovigilance l Data Management l Biostatistics and Programming l Quality Assurance With our daughter companies, FGK Pharmacovigilance and FGK Representative Service, we also offer pharmacovigilance services and legal representation.

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 more than 100 employees – all very experienced in their respective fields and trained according to the latest standards in clinical research. Covering all phases and areas of clinical development, we have a special focus on phase II and phase III trials. We have experience in all important medical indications, including in particular in oncology, cardiology, neurology, dermatology, and gastroenterology. 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. FGK’s headquarters are located in Munich. We directly supervise international projects and operate Europewide with staff located in our headquarters in Munich and in our subsidiaries in the Czech Republic, Hungary, Poland, and the UK. With regard to monitoring, we cover many countries with our own staff and have established long-term partners for some European countries and the US/Canada.

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. Next to that, FGK is a full-service CRO which 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 the majority of 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.

FGK Clinical Research

Timely approvals and efficient trouble-shooting are achieved by the combination of this centralized project management together with local monitoring as well as local expertise in regulatory submissions within the country of study conduct.

Services We design a project according to our clientsâ&#x20AC;&#x2122; needs and local practice, help identify potential investigators, take care of regulatory submissions and contract negotiation, and set up effective project management and monitoring of sites. We also perform data management including data collection, data validation, query management and overall biostatistical analysis by means of the latest technological tools. Through cooperation with an online solutions provider, we offer top-notch electronic management tools and eCRFs. We also cover medical writing and provide IT support. FGK operates according to a regularly reviewed and updated set of SOPs and its quality system is audited on a regular basis. Our Quality Assurance department regularly performs audits on behalf of sponsors and assists during inspections from regulatory bodies around Europe. We take pride in strictly adhering to GCP principles and keeping up with ever-changing national legislations and requirements. Since 2017, we have also been participating in an independent â&#x20AC;&#x153;GCP Qualification Programmeâ&#x20AC;?, offering our clients the possibility to obtain an all-encompassing audit report from a third party.

Special services FGK Clinical Research has two daughter companies: FGK Pharmacovigilance and FGK Representative Service. FGK Pharmacovigilance offers a broad range of pharmacovigilance services; FGK Representative Service offers legal representation for non-European customers.

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Name · FILTROX Group Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · ·

Moosmühlestr. 6 9000 St. Gallen Switzerland Ralph Daumke +41-71-272-9236 +41-71-272-9100 300 1938 l Microfiltration and treatment of high value liquids l Depth filtration l Single-use cell harvest l Activated carbon filter

External · l ZHAW Wädenswil, Switzerland Collaborations l FH Trier, Bioverfahrenstechnik Prof. Kampeis, Germany l HES-SO, Institut of Life Technologies, Switzerland Request for · Partners for business and product Further Collaborations development

Company profile As the global leader in depth filtration, the FILTROX Group offers complete solutions for filtration of valuable liquids using depth filter systems. We are experts in the development, manufacturing, production, and delivery of Swiss quality products for a wide range of applications in the pharmaceutical, biotechnology, chemicals, and cosmetics industries. Since 1938, filter media and filter systems have been developed and manufactured at our corporate headquarters in St. Gallen. Based on this experience, we offer a complete range of products and solutions. With the FILTROX Academy we also offer filtration trainings, seminars, audits, and customised trainings. It is our pleasure, to share our expertise in the area of application and filtration technology, to optimise your processes. The FILTROX Group has a worldwide distribution network, which provides comprehensive technical support and will help you in improving your filtration process. Our well trained sales teams provide you with on-site assistance and ensure a rapid product availability worldwide. For more information, please visit our website.

Products FILTRODISC™ BIO SD FILTRODISC™BIO SD is the first depth filter using the advantages of the well-established method of alluvial (cake or precoat) filtration technology in a disposable format. FILTRODISC™BIO SD is used e.g. for singleuse cell separation, as the system is fully scalable and disposable, fulfilling all validation requirements. Depth filter sheets and lenticular filter modules: PURAFIX® depth filter sheets have been specifically developed for use in critical applications in the pharmaceutical or biological industries. They are characterized by their extremely low levels of ions and pyrogens. SYNTHAFIX™ filter sheets, reinforced with HDPE fibres, are typically used when a very high wet strength or stability against cellulase enzymes is required. The new SYNTHFIX™ P media has been developed specifically


for the high requirements of the life sciences industry. With its very high stability, easy handling, and efficient filtration properties it is ideal for precoat or cake filtrations, e.g. in the plasma fractionation industry. CARBOFIL™ sheets allow the user to handle immobilised activated carbon in a much cleaner way than with loose carbon powders. It offers a lot of potential for API manufactures around the world to optimise their processes. Plate and frame filters and module housings: NOVOX® systems are high-precision stainless steel plate and frame filters for heavy duty use. The NOVOX® CP filter is designed and built for pharmaceutical and other critical applications. The plates are available in stainless steel, polypropylene or PVDF (other materials on request). The NOVOX® CP is an enclosed filtration system completely sealed for CIP without filter sheets. It eliminates any drip loss and prevents the liquid from having contact with the outside environment. DISCSTAR™ is a highly precise stainless steel filter housing for filter modules for everyday use. The enclosed system allows for depth filtration to be carried out without drip loss. The DISCSTAR™P, with its tri-clamp connections and pharma-approved valves and pressure gauges, is the ideal housing for highly sensitive applications in life science, pharmaceutical and biotech applications (biomass removal), APIs, and injectables.

Locations FILTROX AG Switzerland All depth filter sheets and modules for pharmaceutical applications manufactured here. FILTROX France s.a.r.l., Sales office FILTROX North America USA, Sales office FILTROX MICROFILTRACIONES, SA de CV Mexico, Sales office FILTROX (Shanghai) Filtration System Co., Ltd. China, Sales office FILTROX UK & Northern Europe UK, Sales office FILTROX Southern Europe Spain, Sales office FILTROX Asia-Pacific Pte Ltd. Singapore, Sales office 19 th Guide to german biotech companies 2018

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Name · Fraunhofer Institute for Toxicology and Experimental Medicine ITEM Address/P.O. Box Postal Code/City State Contact Person

· · · ·

Telephone · Fax · Email · Number of Employees · Founded (year) · Type of Laboratory · Areas of Activity ·

Inhoffenstr. 7 38124 Braunschweig Lower Saxony Dr Holger Ziehr (Division of Pharmaceutical Biotechnology) +49-531-6181-6000 +49-531-6181-6099 biopharmaceutical-services@item. 303 (Pharmaceutical Biotechnology: 45) 1981 S1, S2, clean rooms of grades D, C, and B Biopharmaceutical consultancy service, cell line development, contract manufacture of cell banks and investigational biopharmaceuticals, bioprocess development, analytical development and bioanalytical service, aseptic fill and finish of investigational medicinal products, preclinical drug research (GLP), clinical trials phases I-II (GCP), allergy research, toxicology testing, regulatory support, registration of chemicals, biocides and pesticides

Annual Turnover · €26.4 million (2016) Request for · Collaborations concerning GMP Further Collaborations manufacture for clinical trials phase III and analytical development

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 to comply with current Good Manufacturing Practice (GMP) requirements. For its pharmaceutical clients the division performs manufacture of APIs and investigational medicinal products (IMPs) for use in early-phase clinical trials. The division’s GMP facilities have been licensed since 1997. They are equipped with stirred-tank bioreactors of up to 400 litres volume, with technical-scale process chromatography systems and process filtration systems, enabling GMP-compliant manufacture of investigational biopharmaceutical APIs in 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. To complete the service portfolio, a clean-room unit for sterile manufacture of final dosage forms as IMPs has been GMP licensed by the regulatory authorities since 2012.

Fraunhofer ITEM

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

Services ·· D  evelopment of cell lines based on insect cells, mammalian cells (e.g. CHO), and microorganisms (e.g. E. coli) for manufacture of biopharmaceutical APIs ·· GMP manufacture (ICH Q5D) of master (MCBs) and working cell banks (WCBs) ·· GMP-compliant N2 gas-phase storage and shipment of cell banks ·· D evelopment of manufacturing processes for biopharmaceutical active ingredients based on proteins, glycoproteins/antibodies, nucleic acids/plasmids, virus-like particles, and bacteriophages ·· Validation of cultivation (USP) and purification (DSP) unit operations and processes ·· Development and validation (ICH Q2) of bioanalytical methods ·· ICH Q5C stability testing of intermediates, purified bulks, and finished IMPs ·· N on-GMP and GMP contract manufacture of biopharmaceutical active ingredients ·· Aseptic manufacture of final dosage forms as IMPs for clinical trials labelling and QP release of IMPs for clinical trials ·· GCP 

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Name · glyXera GmbH Address/P.O. Box · Leipziger Strasse 44 ZENIT Building 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 · Website · 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, specialized in high performance glycoanalysis. We are utilising separation and mass spectrometry based glycoanalytical tools and have substantial experience in providing glycoanalytical services tailored to the specific needs of our customers. Worldwide exclusively glyXera provides the highperformance 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, 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 as 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 and other body fluids) samples.

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


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: ·· Glycofingerprintinting: 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 ·· Glycofingerprintinting & 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 ·· N- & O-Glycoproteomics ·· General (Glyco)-Protein Characterisation by Protein Gel Electrophoresis Pattern Analysis

Our products ·· glyXboxCE: High performance glycoanalysis system based on xCGE-LIF (incl.: glyXtoolCE software) ·· glyXboxLC: Standard glycoanalysis system based on HILIC-FLR (incl. glyXtoolLC software) ·· Tailored reagents/kits for glycoanalysis 19 th Guide to german biotech companies 2018

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

· · · · · · · · · · · ·

Hans-Bunte-Str. 19 79108 Freiburg im Breisgau Baden-Wuerttemberg Manon Kirstein +49-761-470-99-0 +49-761-470-99-191

LI 22 1999 S1 and S2

Areas of Activity · l Biopharmaceutical production l Product development Request for · Biopharmaceutical development and Further Collaborations production from lab to large scale

Biopharmaceutical production Greenovation offers the full range of contract development and manufacturing from small-scale feasibility studies to validated clinical- and commercial-scale production processes. This enables our clients not only to test potential protein candidates quickly, but also to receive drug substances for clinical trials and the market.

BryoTechnology BryoTechnology offers a wide range of advantages for biopharmaceutical development and production processes. Our broad IP portfolio covers plant production processes, N-glycosylation techniques, proprietary drug candidates, and mechanisms-of-action. We offer contract manufacturing and licensing models.

Outstanding product quality Exploiting the unique advantages of the moss Physcomitrella patens, BryoTechnology is a production process based on single-use technology and a chemically-defined fermentation medium free of antibiotics and animal-derived components. The process is cGMPcompliant, highly scalable, and allows for straightforward tech transfer to any given manufacturing plant.

Your advantages ·· ·· ·· ·· ··

Glyco-designed products High levels of batch-to-batch homogeneity Customised production strains Free of animal components Antibiotic-free

Wide range of proteins expressed BryoMaster ® offers an improved solution, targeting complex, difficult-to-express, posttranslationally modified proteins.


Successfully produced (examples) ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ··

IgG IgG-toxin fusion monomeric IgA Glucocerebrosidase alpha-Galactosidase A acid alpha-Glucosidase Complement factor H C1i VEGF FGF7 (KGF) EGF

Pipeline Greenovation has established a pipeline of proprietary drug candidates for orphan diseases like Fabry disease, C3 glomerulopathy, and Pompe disease.

Clinical studies Greenovation completed its moss-aGal phase I clinical trial safety study in 2017 and plans to start the clinical phase II soon. Moss-aGal will be the first enzyme replacement treatment for Fabry disease based on moss that exhibits optimised N-glycosylation patterns of the protein alpha-galactosidase A. Studies in mice show that this translates into enhanced cellular uptake and favourable organ distribution.

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Name · Heidelberg Pharma AG Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · ·

Schriesheimer Strasse 101 68526 Ladenburg Baden-Wuerttemberg Professor Andreas Pahl +49-6203-1009-0 +49-6203-100 9-19 55 1997 (as WILEX) Chemistry l Molecular biology l Pharmacology l Bioanalytics

Annual Turnover · l ADC technology platform Relevant R&D Budget · l Drug research and development l Preclinical services provider External · l German Cancer Center (DKFZ) Collaborations l Heidelberg University l MD Anderson (Texas) l Indiana University’s Simon Cancer Center Request for · Antibodies against high tumour Further Collaborations specific antigens to conjugate with Amanitin, ADC collaborations

Heidelberg Pharma is a publicly listed, biopharmaceutical company focused on oncology. It is the first company developing the toxin Amanitin into cancer therapies, using its proprietary Antibody Targeted Amanitin Conjugates (ATAC) technology. Amanitin has a unique biological mode of action and has the potential to be used to develop highly effective, innovative drugs. Amanitin is a member of the amatoxin group of natural poisons, which occur in the death cap mushroom (Amanita phalloides). It works by selectively inhibiting RNA polymerase II, which results in apoptosis. Almost all chemotherapy drugs used to date, including payloads of other Antibody Drug Conjugates (ADC), either function as what are known as “spindle poisons” (tubulin inhibitors) or work by binding to DNA, which makes them dependent on cell division. RNA-Polymerase II inhibition is a novel principle in cancer therapy and differs from other chemotherapeutics in its ability to kill also non-dividing cells. Amantin as a payload of ADCs offers the possibility of breaking through drug resistance or destroying dormant tumour cells, which could provide major clinical advances.

ADC technology platform This proprietary technology platform is being applied to create a variety of ATAC candidates in collaboration with third parties, as well as to develop the company’s own therapeutic ATAC pipeline. Heidelberg Pharma grants licenses to its ATAC technology for application to antibodies provided by customers. Under these license agreements, toxin linker prototypes are made available, conjugated to the customer’s antibodies, and tested biologically. Heidelberg Pharma also 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.

ndd 10

Heidelberg pharma

In its product partnerships, Heidelberg Pharma provides the toxin linker technology, while its partner provides antibodies or innovative antibody formats. Together, Heidelberg Pharma and its partner will develop novel ATACs up to preclinical proof of concept. A decision will then be made with the partner to determine the best path for further development, be it joint clinical development, direct licensing by the partner, or sale of the product to another party. In addition to collaborating with partners, Heidelberg Pharma is increasingly focused on developing its own ATAC candidates. Its lead ATAC product candidate, HDP-101, is being developed for the treatment of multiple myeloma using a BCMA (B-cell maturation antigen) antibody. HDP-101 has demonstrated strong efficacy and good tolerability in several animal models. A Phase I/IIa clinical trial with HDP-101 is planned to start by the end of 2018.

Preclinical services business The company has the expertise and infrastructure for in vivo pharmacology and bioanalytics and offers preclinical research services in these fields for cancer, as well as inflammatory and autoimmune diseases. The companyâ&#x20AC;&#x2122;s services are focused on early-stage research (e.g. optimisation of lead structures) up to the profiling of preclinical candidates.

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Name · Hyglos GmbH – a bioMérieux company Address/P.O. Box Postal Code/City State Contact Persons Telephone Fax Email Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · · ·

Am Neuland 1/3 82347 Bernried am Starnberger See Bavaria Dr Wolfgang Mutter, General Manager +49-8158-90-600 +49-8158-90-60-210

FL I  20 at the Hyglos site in Bernried 2009 S1 and R2 Endotoxin Detection & Services Since 2016 we belong to the bioMérieux group – a world-leading in-vitro diagnostics company with a presence in more than 150 countries through 42 subsidiaries and a large network of distributors.

Biological Patents · Several patent families covering technology and applications. External · Hyglos collaborates with research Collaborations institutes, such as the Max von Pettenkofer-Institute, and private companies.

Driving innovation in endotoxin testing Hyglos GmbH – a bioMérieux company since June 2016 – is a biotech company located in Biotechnology Center Bernried in the Munich area of southern Germany. We have a strong focus on innovation in the field of Endotoxin Detection for pharmaceutical and medical device quality control and medical research, ensuring patient safety and scientific soundness completely without the use of endangered horseshoe crabs. Our sustainable endotoxin assays are based on Phage Recombinant Proteins and Recombinant Horseshoe Crab Factor C (rFC). Since 1 July 2016, our endotoxin test methods have been included in the European Pharmacopoeia as approved alternative methods. Our endotoxin assay ranges EndoLISA® and EndoZyme® bring important advantages to users in biopharmaceutical research and industry, overcoming the limitations of the LAL test (Limulus amebocyte lysate). With a thorough scientific approach, we at Hyglos also address pressing analytical issues, such as Low Endotoxin Recovery (LER). Our Endo-RS® Endotoxin Recovery Method is a world-first sample preparation method for full recovery of endotoxin in samples affected by LER. We offer comprehensive service for LER solutions, including hold-time studies according to regulatory requirements as well as full demasking protocol development. Endotoxin detection Endotoxins are the major cause of sepsis in humans. The testing of such contaminants from the processes involved in developing and producing biopharmaceutical drugs is therefore regulated by law. With EndoLISA®, Hyglos introduced a ground-breaking new method. Through specific built-in sample preparation, EndoLISA® revolutionises endotoxin quantification in complex pharmaceutical and biological products. The use of rFC ensures that the results of EndoLISA® match with those of the existing assay formats. The Hyglos assay overcomes the limitations of currently used methods, such as LAL. The advantages of EndoLISA® include the very broad measurement range and pH tolerance range as well as the exceptional tolerance regarding buffer components such as salts, organic solvents, detergents, and protease inhibitors.





In January 2013, Hyglos introduced EndoZyme ®, an enhanced homogeneous recombinant Factor C (rFC) endotoxin detection assay. This end-point fluorescence microplate assay is suitable for non-critical samples such as water and medical device testing, which requires a highly sensitive test. A further development of the EndoZyme® assay is being launched by HyglosbioMérieux in in 2018; the EndoZyme® II Go assay, uses the same reagents in a more efficient way to make the method easier, much faster to use and enable a significant reduction of human error. The key component of the new kit is the GoPlate™, a ready-to-use microplate incorporating Control Endotoxin Standard (CSE) concentrations for the standard curve as well as Positive Product Controls (PPCs). The GoPlate™ eliminates the risk to fail doing the standard curve preparation and saves a lot of valuable time for the routine testing lab. Low Endotoxin Recovery (LER) Hyglos has developed a world-first demasking method, Endo-RS®, which is a sample preparation method enabling full endotoxin recovery in biopharmaceutical drug formulations typically containing nonionic surfactants such as Polysorbate or Octylphenol ethoxylates. Non-ionic surfactants are well known to cause Low Endotoxin Recovery (LER). Intensive studies of the phenomenon have shown that the physicochemical properties of surfactants render endotoxin molecules inaccessible (masked) for detection in such samples. Applying the Endo-RS® endotoxin recovery method prior to endotoxin detection will ensure compliant and accurate results in spike validation studies and routine quality control testing. Endotoxin services We offer comprehensive Endotoxin Services using our expertise in enabling technologies, including: ·· Hold-time studies according to regulatory requirements ·· Root-cause analysis of Low Endotoxin Recovery (LER) ·· Demasking Protocol development ·· Method transfer, training, & support ·· BET validation and feasibility studies

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

· · · · · · · · · · · · ·

Rudolf-Wissell-Str. 28 37079 Göttingen Lower Saxony Dr Wolf Jockusch +49-551-50672-0 +49-551-50672-181

FL I  G >50 1990 S1 l Cell Selection & Expansion l Protein Production & Assays l Custom Oligos & Predefined DNA/RNA

Biological Patents · l Strep-Tactin®XT l Strep-Tactin® l Twin-Strep-tag® l Streptamer ® External · Numerous in- and out-licensing Collaborations contracts

IBA GmbH – Solutions for Life Sciences For more than two decades IBA Lifesciences develops and provides innovative solutions for your life science applications. Our portfolio includes tools for Cell Selection & Expansion, Protein Production & Assays as well as Custom Oligos & Predefined DNA/RNA.

Product portfolio Cell selection & expansion Fab-TACS technology ensures automated cell selection directly from whole blood employing IBA’s design awardwinning FABian® device. Customised protocols depending on the cell type, the sample volume, and the intended yield allow for convenient fully automatic cell isolation. Strep-tagged Fab fragments (Fab-Streps) reversibly capture and release the target cells during the selection process. This delivers label-free, nonactivated target cells in a standardized man­n er of highly reproducible quality. Isolated cells are suitable for all further immunological or cell biological investigations, including cell-based diagnostics or assays, e.g. pharmacological analysis of drug levels in the isolated cell fraction. For convenient manual cell selection we offer Fab-TACS Gravity columns. For T cell stimulation, we offer completely novel reversible reagents, the Streptamers® for cell expansion, which provide unique flexibility for cell research. Protein production & assays The Strep-tag ® technology is IBA’s proprietary and versatile protein purification, detection, and immobilisation platform. It is one of the most widely used systems for affinity purification, providing exceptionally pure proteins. Recently the third generation of the Strep-tag® system was launched, based on the new StrepTactin ®XT and Twin-Strep-tag ®. Strep-Tactin ®XT is a further developed Strep-Tactin® with extra high affinity to Twin-Strep-tag®, which now enables the use of the Strep-tag® technology in applications where extra tight binding is a requirement. With this feature, the third generation Strep-tag® technology now enters the field of assay development and screening, opening new possibilities in the pharmaceutical and biotech sector


for, e.g. screening of new diagnostic targets and the development of diagnostic assays. Custom oligos & predefined DNA/RNA IBA’s nucleic acid division focuses on specialised nucleic acid custom services. The tailor-made DNA and RNA oligonucleotides, including modified and labelled nucleic acids, require particular care in synthesis and are of the highest quality. Applications can be found in e.g. real-time PCR, FRET, gene silencing studies, immobilisation, FCCS, or high-resolution microscopy. The innovative Click Chemistry enables additional dye combinations with unsurpassed labelling densities. More than 200 fluorescent labels and more than 80 modifications are available. With our expertise, we can also produce custom DNA and RNA aptamers according to your individual specifications.

Business model ·· Development and commercialisation of proprietary products that are marketed worldwide ·· Contract service activities based on IBA’s innovative technologies ·· Licensing products and/or technology for research and diagnostics ·· Serving international markets directly and through a network of distributors

People Dr Mike Rothe (Chief Executive Officer) Dr Joachim Bertram (Chief Scientific Officer) Dr Herbert Stadler (Head of the Advisory Board)

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Name · in.vent Diagnostica GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Emails

· · · · · · ·

Website Number of Employees Founded (year) Areas of Activity

· · · ·

Neuendorfstraße 17 16761 Hennigsdorf Brandenburg Dr Jörg-M. Hollidt +49-3302-55199-0 +49-3302-55199-10 40 1999 l Supply of Human Bio-Materials l Enhanced biobanking l Studies / Trials

Company profile in.vent is a medical diagnostics company founded in 1999 and located in Hennigsdorf, near Berlin. With our highly qualified and well-trained team we guarantee excellent quality, ethically impeccable conduct of all our operations, and the highest customer satisfaction. In 1999 in.vent started with only one product: Nowadays we are proud to be one of the world’s leading suppliers of Human Bio- Materials. Our products are intended for non-therapeutical use and are applicable for research, development, production, quality control, and marketing purposes in pharmaceutical companies as well as in in-vitro diagnostic companies.

Core competences Human Bio-Materials – Disease State and Normal

External · in.vent maintains contact with more Collaborations than 350 international IVD-, pharmaand biotech companies and organisations on a global basis.

Whole Blood | Blood Products Sera | Plasma | Other Matrices Human Tissues Faeces | Lavage Fluids | Swabs Single Donations | Consecutive Donations Sample Collections | Cohorts Bulks | Pools Small Volumes | Large Volumes | Very Large Volumes Autoimmunity | Allergy | Infectious Diseases Alcohol Abuse | Liver Diseases | Hormones Oncology | and more

Diagnostic Studies – Clinical Trials – Clinical Performance Evaluations In-Vitro Diagnostics Companion Diagnostics Patient-Near Diagnostics Study Design | Sample Procurement Clinical Performance | Data Management Biostatistics | Reports according to IVDR/247

in.vent diagnostica

Standards and Controls pre-manufactured | individually produced lyophilised | fresh-frozen native | spiked | depleted kit-internal controls | kit-external controls routine laboratory surveillance applicable for proficiency testing

Dr Jรถrg-M. Hollidt Founder & CEO

Protein Biochemistry Laboratory Analysis Sample Handling | Sample Management Purification | Spiking | Depletion Contract IVD Assay-Development

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

Strategic outlook in.vent is already one of the major affiliates in the field of Human Bio-Materials. We are constantly adapting to market needs and to front-end techniques in biobanking, sample storage, and biomarker development. In 2018 we are going to establish two new competence centres for blood donations and sample storage located in Hennigsdorf, near Berlin, which are going to strengthen our outstanding market position.

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Name · Indivumed GmbH Address/P.O. Box Postal Code/City State Contact Persons

· · · ·

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

· · · · · · · ·

Falkenried 88 – Bldg. D 20251 Hamburg Hamburg Prof. Dr Hartmut Juhl (CEO) Andrew Deubler (CBO) +49-40-4133-83-0 +49-40-4133-83-14 140 2002 L2, S1 Cancer Research and Development; Highly standardized collection; banking and processing of human biospecimens and patient data; prospective collection of clinical samples; clinical trial support; drug target and biomarker identification and validation services; drug profiling in human primary tumor explants; discovery of proprietary biomarkers and phosphoprotein profiling.

Biological Patents · INDIVUMED has been granted three patents relating to cancer biomarkers and their use in diagnostics. External · INDIVUMED has developed a unique Collaborations collaborative network with leading cancer clinics in Germany, India, Poland and the US, as well as with biopharmaceutical companies and academic institutions worldwide, including the US National Cancer Institute. Request for · INDIVUMED intends to enter into Further Collaborations strategic collaborations with industry partners for the joint development of cancer diagnostics and therapeutics.

Company overview Indivumed, an ISO-certified global oncology research company based in Hamburg, Germany, has established the world’s leading cancer database and biobank, retaining unique patterns of biomolecules such as RNA, DNA, and proteins as they existed in the human body. This cancer database makes multi-omics capabilities possible that will allow for characterization of samples and data such as whole genome gene expression analysis, expression analysis of cancer-relevant proteins, expression analysis of cancer-relevant phosphoproteins and bioinformatic solutions for integrating molecular, biological, and clinical information. Indivumed’s products and services allow for in-depth understanding of the underlying mechanisms of a patient’s cancer, addressing important demands in translational research and molecular diagnostics to support implementation of personalized health care.

Preclinical and clinical services INDIVUMED has established an outstanding, high-quality ISO 9001:2008 certified global biobank and data collection comprising more than 24,000 patient cases and an infrastructure of proprietary clinical and laboratory facilities. Accurate follow-up information and additional post-surgery samples are obtained on a regular basis. INDIVUMED enables the highest quality drug target and biomarker identification and validation by combining its biospecimen and clinical data collections with state-ofthe-art analysis technologies.

Laboratory services Immunohistochemistry INDIVUMED establishes highly validated immunohistochemical assays for antibody, target, and biomarker validation in a GCP-compliant environment. Standardised and reproducible staining procedures with the automated Ventana Discovery® XT or BenchMark staining platforms lead to excellent results for INDIVUMED’s customers. By also providing full histopathology evaluations using its in-house pathologists, Indivumed is able to realise a complete service portfolio for its clients as well as the pharmaceutical and biotech industries.


Phosphoprotein profiling INDIVUMED analyses phosphoproteins using the automated proteomic platforms Meso Scale Discovery (MSDÂŽ) and Simple Western Technology (Peggy SueTM and NanoProTM 1000). These technologies are capable of distinguishing between total and phosphorylated states of proteins from a huge variety of commercially available targets in oncology and other research fields.

Biobank products Ischemia time-controlled biospecimens For more than 15 years, INDIVUMED has been collecting the highest quality biospecimens through its own study nurses according to strictly enforced operating procedures. The routine collection of fully consented highquality tumour and matched normal tissues and fluids (frozen or formalin fixed, serum, plasma, PBMCs and urine) and guaranteed short ischemia times (on average 10 min) enable the investigation of the molecular realities of gene and (phospho-) protein expression patterns.

Management team Prof. Dr Hartmut Juhl Andrew M. Deubler Michael Gutsmann Gudrun Niewel Dr Heinz Joachim List Dr Hans Vanhooren Kevin Sullivan Frank Clausen

Leonidas D. Leondaridis Dr Frauke Kristin Koch Dr Nina Gabelia PD Dr. Kerstin A. David Dr Bernd Gromoll Dr Philipp C. Uhlig Antje Schmitt Dr med. Ronald Carter

Financing INDIVUMED generates revenue through the commercialisation of its products and services. It has been awarded several public grants and has received funds from private investors.

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Name · ITM – Isotopen Technologien Muenchen AG Address/P.O. Box Postal Code/City State Contact Person

· · · ·

Telephone Fax Email Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · ·

Lichtenbergstrasse 1 85748 Garching Bavaria Nicola Scharrer (Head of Marketing) +49-89-329-8986-60 +49-89-329-8986-66

LI 85 2004 Radiopharmaceutical Company l Oncology l Targeted Radionuclide Therapy l Nuclear Medicine

Targeted cancer diagnostics and therapies ITM Isotopen Technologien München AG is a privately held group of companies dedicated to the development, production, and global supply of innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals. Since its foundation in 2004, ITM and its subsidiaries have established GMP manufacturing and a robust global supply network of a novel, first-in-class radionuclides and -generator platform for a new generation of targeted cancer diagnostics and therapies. ITM’s isotope business is profitable and growing. In July 2016 the European Commission granted marketing authorisation for EndolucinBeta® of ITM’s subsidiary ITG Isotope Technologies Garching GmbH. EndolucinBeta® respectively no-carrier-added (n.c.a.) Lutetium (177Lu) chloride is a radiopharmaceutical precursor and is used in Targeted Radionuclide Therapy. The drug approval is an important milestone for ITM as a specialised radiopharmaceutical company. Furthermore, ITM is developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing a range of cancers, such as neuroendocrine cancers or bone metastases. ITM’s main objectives, together with its scientific, medical, and industrial collaboration partners worldwide, are to significantly improve outcomes and quality of life for cancer patients while at the same time reducing side-effects and improving health economics through a new generation of Targeted Radionuclide Therapies in Precision Oncology. ITM Isotopen Technologien München AG was founded in 2004 and is the holding company for its subsidiaries ITG Isotopes Technologies Garching GmbH, ITM P4 Diagnostics GmbH, and ITM Oncologics GmbH. ITM is privately held and is responsible for the management and administration of its wholly-owned subsidiaries, together with the administration of IP.


Since 2007 the name ITG Isotopes Technologies Garching GmbH has stood for the highest level of quality and reliability in the sourcing, processing, radiolabeling, and sale of radionuclides and for the marketing of devices. ITG’s unrivaled logistics network allows guaranteed shipment within 24 hrs (Europe) and 72 hrs (overseas) respectively. ITM Oncologics develops innovative product candidates in the field of Targeted Radionuclide Therapy in Precision Oncology. It aims to identify, either independently or in collaboration with partners, appropriate targets and targeting molecules, and to link these with radionuclides for cancer therapy. ITM Oncologics has a number of very interesting candidates in the early clinical or pre-clinical phase, for example in the field of bone metastasis. Our lead product Solucin® recently started a phase III clinical trial, known as COMPETE. COMPETE is an international pivotal multi-center Phase III clinical trial evaluating the efficacy and safety of n.c.a.177Lu-Edotreotide (Solucin®) compared to Everolimus in patients with inoperable, progressive, somatostatin-receptor positive neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET). The subsidiary ITM P4 Diagnostics connects ITM Oncologics with the development of next-generation precision diagnostics based on a proprietary biomolecule portfolio and the genetic fingerprints of targeted tumours. For more information about ITM, please visit:

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Name · Janssen-Cilag GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · ·

Johnson & Johnson Platz 1 41470 Neuss North Rhine-Westphalia Klaus Suwelack +49-2137-955-0

L 800 1959 | Pharma | Biopharma | Biotech

Advancing science for the benefit of patients We are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That’s why we at Janssen strive to provide access to effective and affordable medicines and related health care services to the people who need them. Partnering with academic researchers around the world, we bring innovative therapeutic solutions to key unmet needs. Our approach seeks to combine complementary skills. Building strong working partnerships with governments, patient groups, healthcare professionals, and other professionals from the global academic and business communities. Our mission is to make the most fundamental change in the way diseases are managed. We have a leading portfolio of solutions that can alleviate, contain or cure some of the world’s most serious conditions and diseases. But we go one step further in our commitment. We are building great healthcare solutions that will bring benefits to patients and add value to society and our company’s stakeholders. We want to develop innovative and integrated products and medicines to restore and extend the quality of life. We also want to provide a return on investment that reflects outstanding performance and to reward those who invest ideas and work in our company. To ensure that we can deliver our commitments to patients, customers and investors who rely on us, we work side-by-side with healthcare stakeholders and build on our people’s talent. Together, we are looking at a future where patients and their families gain a new sense of hope. Hope for a cure.

Our mission is to transform individual lives We are actively developing treatments for our patients in important therapeutic areas of healthcare: ·· Immunology (psoriasis, crohn’s disease, …) ·· Infectious diseases (HIV/AIDS, hepatitis C, tuberculosis, …) ·· Neuroscience (schizophrenia, dementia, pain, …) ·· Oncology (multiple myeloma, prostate cancer, …)


Immunology We have a strong history of delivering biological medicines for immunological diseases and we continue to build a pipeline of exciting, new biotechnological products, while expanding into small-molecule oral medications and broadening our disease focus in autoimmune, inflammatory and pulmonary diseases. Through our ongoing efforts in discovery, biomarkers, clinical research and external innovation, we are poised for continued leadership and growth, bringing transformational medicines to patients and healthcare providers around the world.

Infectious diseases World demand for antibiotics remains high due to escalating resistance and the increased risk of serious infections in both immune-suppressed patients and ageing populations. Our goal is to transform peopleâ&#x20AC;&#x2122;s lives and to improve public health by fighting infectious diseases worldwide. To that end we are leveraging solid foundations in science and innovative thinking to bring breakthrough solutions to key unmet medical needs such as HIV, tuberculosis, hepatitis C and antibiotics for serious infections.

Neuroscience Neuropsychiatric illnesses are the most significant disease burden in high income countries and are expected to grow substantially in other regions of the world as the standard of living increases. Our mission is to transform individual lives affected by disorders of the central nervous system. As a leader in Neuroscience, we at Janssen are focused on developing medicines in cognition, mood, psychosis and moderate-to-severe chronic pain.

Oncology Cancer claims over seven million lives every year and the number continues to rise. Deaths are estimated to reach 12 million by 2030. We aim to transform cancer into a preventable, chronic or curable disease by delivering extraordinary diagnostic and therapeutic solutions that prolong and improve patientsâ&#x20AC;&#x2122; lives. We are committed to delivering targeted therapies to fight the devastation of cancer. 19 th Guide to german biotech companies 2018

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Name · JenLab GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Email Websites

· · · · · · ·

Schillerstraße 1 07745 Jena Thuringia Frank Merten +49-171-9519985 Number of Employees · 20 Founded (year) · 1999 Areas of Activity · l Medicine l Pharma l Cosmetics

The future starts right now JenLab is the leading specialist in multiphoton tomography. Their innovative tomographs create scar-free and label-free optical biopsies and make it possible to detect skin cancer much earlier with subcellular resolution directly on the screen. The efficiency of anti-aging creams can be evaluated and skin modifications of astronauts during long-term space flights investigated. Usually practitioners assess an abnormal section of a patient’s skin with the naked eye. In most cases, a biopsy is carried out that causes pain and leaves a scar. The skin sample is tested in a laboratory, a process that is not only costly but might also take weeks, leaving the patient with uncertainty. JenLab can provide a revolutionary and much faster option. It develops medical equipment and laser microscopes, which are based on femtosecond laser technology. The multiphoton tomograph creates highresolution images of affected skin within seconds. With this non-invasive and painless procedure, the physician obtains optical biopsies with detailed information on living cells and tissue structures within their physiological environment. Dermatological disorders can be detected with submicron spatial resolution. This innovative method allows for the earlier detection of skin diseases such as malignant melanoma and dermatitis, and enables physicians to start treatment immediately. CEO Dr Karsten König explains: “JenLab equipment enables us to gain deep insights into the skin ‘in vivo’. This makes a physically invasive biopsy prior to the examination unnecessary. Chemical processes can be made visible even at a sub-cellular level, which is interesting for cosmetic research and the pharmaceutical industry.”


JenLab is amongst Germany’s top 100 innovative businesses and is partly funded by the European Horizon 2020 programme. This May, JenLab was named as the Most Innovative Medical Diagnostics System Europe 2017 by the CFI. Hospitals in major cities such as Los Angeles, Paris, London, Beijing, Brisbane and Berlin are already using JenLab’s equipment to detect black skin cancer and inflammation diseases. The tomograph has been employed during neurosurgery to define the exact borders of a brain tumour in situ. The Lions cornea bank in Homburg uses it for quality checks of donated human eyes prior to transplantation. CEO Dr König, who is also a professor at Saarland University, gets enthusiastic when it comes to space applications. European astronauts are monitored with JenLab’s technology to measure skin modifications during long-term space flights. The list of areas where JenLab’s tools can cause a little revolution seems endless. We are on board.

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Name · Jennewein Biotechnologie GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · · ·

Maarweg 32 53619 Rheinbreitbach Rhineland-Palatinate Dr Stefan Jennewein +49-2224-9894501 +49-2224-9880854

FL 68 2005 l Large-scale manufacturing l World-wide registration of products l Marketing and sales of mono- and oligosaccharides for food l Pharma and cosmetic applications

Request for · Jennewein seeks collaboration in the Further Collaborations field of carbohydrate drugs, functional food applications such as engineered microbiome, prebiotic, probiotics, symbiotics, weight reduction, allergy development, and medical food applications incl. general nutrition and infant formula development

Jennewein Biotechnologie GmbH, situated in Rheinbreitbach near Bonn, is the leading company specialised in the production of rare monosaccharides and functional oligosaccharides (in particular human milk oligosaccharides (HMOs)) for nutrition, pharmaceutical, cosmetic, and medical applications. Since the company’s foundation in 2005, it has developed several innovative manufacturing processes that allow the production of these carbohydrates in large industrial-scale quantities. These processes are based on scientific research in the field of metabolic engineering, fermentation, biocatalysis, bioorganic synthesis, and chemical engineering, in order to ensure a safe and high-quality product. In particular Jennewein’s human milk oligosaccharides are produced using the latest fermentation technology and are structurally and functionally identical to the HMOs known from human milk. The processes developed can be conducted at such a reasonable production cost, that for the first time, HMOs can be synthesised in amounts large enough to be used as ingredients in infant formula, or as medical foods, dietary supplements, and other food products. The portfolio of products from Jennewein Biotechnologie GmbH is extensive. The company produces rare monosaccharides such as L-Fucose and Sialic Acid, and HMOs such as 2'-Fucosyllactose, 3’-Fucosyllactose, Lacto-N-tetraose, Lacto-N-neotetraose, Lacto-N-fucopentaose, as well as acidic HMOs like 3’-Sialyllactose and 6’-Sialyllactose. Many scientific studies have demonstrated that HMOs provide several health benefits; for example, protection against bacterial and viral infections (such as protections against Norovirus and Rotavirus infection). Moreover, positive effects of HMOs on brain development and on an infant’s immune system have also been reported. Thus, the most important goal of Jennewein Biotechnologie GmbH is the general protection of health. Jennewein Biotechnologie manufactures HMOs on a multiple hundred tonne scale for customers world-wide. Jennewein’s products for the infant nutrition market are marketed under the brand name of Mum’s Sweet Secret.

Jennewein biotechnologie

In addition, Jennewein Biotechnologie also manufactures nucleotide-activated sugars, such as GDP-Fucose or CMP-Sialic acid. Besides being an established supplier for HMOs and rare monosaccharides to the food industry, Jennewein Biotechnologie also provides building blocks, and carbohydrate intermediates for the synthesis of carbohydrate drugs, for the pharmaceutical industry. Jennewein Biotechnologie is very active in the field of research and development related to the manufacture of difficult-to-synthesise or difficult-to-obtain monosaccharides and oligosaccharides, and their applications. In particular the physiological functions of complex oligosaccharides are still incompletely understood. Thus, Jennewein Biotechnologie is today very active in the field of human microbiome research, and in research on the role of glycans (carbohydrates) in bacterial, as well as viral infectious diseases. Jennewein cooperates with several leading German and international universities and research institutes world-wide, such as the German Cancer Research Center (DKFZ) and the Children Hospital in Mannheim (part of the University of Heidelberg). The Managing Director of the Jennewein Biotechnologie GmbH is Dr rer. nat. Stefan Jennewein.

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

· · · · · · · · · · · ·

Volmerstrasse 5 12489 Berlin Berlin Holger Wenschuh (CEO) +49-30-6392-5500 +49-30-6392-5501

F  LI Q

60 2004 Biochemistry, Organic Chemistry, Medicinal Chemistry, Biology, Immunology Areas of Activity · Peptide-based products, services and research collaborations for immunotherapy, immune monitoring, biomarker discovery, proteomics and drug discovery Biological Patents · PepStarTM – Custom peptide microarrays PepSpotTM – High-throughput peptide synthesis PepMixTM –

Antigen-spanning peptide pools SpikeTidesTM – Peptide standards for proteomics SpikeMixTM – Stable isotope-labeled peptide pools PepTrackTM – Flexible custom peptide libraries External · Neo-Epitope Qualification (BioNTech Collaborations AG, Germany); Proteomics Kits (TU Munich, Germany; MSKCC, USA); Chronic Fatigue Syndrome Biomarkers (Charité, Germany) Request for · Immunotherapy development, cellular Further Collaborations and humoral immune monitoring, seromarker discovery, neo-epitope prioritisation, peptide lead discovery and optimisation, immune diagnostics, biomarker quantification

JPT Peptide Technologies is an ISO 9001 certified and GCLP compliant service provider and R&D partner for peptide-related projects in immunotherapy development, proteomics and drug discovery. Together with our US subsidiary, we serve a worldwide customer base in the pharmaceutical and biotechnology industries as well as at universities, governmental and non-profit organisations.

Innovations for immunotherapy & proteomics JPT’s proprietary technologies and corresponding product portfolio have helped to advance research efforts in the development of new immunotherapies against infectious and autoimmune diseases, allergies and cancer. JPT’s high quality peptide arrays, peptide pools and GxP peptides enable the development of novel immunotherapeutic applications as well as sophisticated immune monitoring. For the first time, broad and epitope resolved analysis and correlation of the cellular and humoral immune responses of diverse patient populations is feasible. This provides a basis for neo-epitope qualification, monitoring of epitope spreading, patient stratification and development of novel immune diagnostics and therapeutic approaches. In addition, our SpikeMixTM platform permits multiplexed and differential quantification of protein targets from biological samples.

JPT’s core technologies PepSpot™ – ultra-high-throughput peptide synthesis PepStar™ – patented peptide microarray technology PepMix™ – peptide pools spanning entire antigens PepTrack™ – flexible peptide libraries for T cell assays GxP Peptides – high quality peptides for immunotherapy SpikeTidesTM – peptide standards for proteomics SpikeMixTM – stable isotope labeled peptide pools


Products, services & collaborations Services: ·· Fast & low cost peptide libraries for neo-epitope qualification ·· Custom antigen peptides & pools for clinical immune monitoring ·· Custom GxP synthesis of peptides and peptide pools ·· Serological profiling using biological and clinical samples ·· Customised peptide standards for proteomics ·· Profiling of enzymatic activities ·· Tailored proteome-spanning peptide libraries and microarrays Catalogue products: ·· PepMix™ peptide pools from hundreds of antigens ·· RepliTope™ peptide microarrays for pathogens and tumour associated antigens ·· Enzyme substrate sets and microarrays for kinases, proteases, acetyltransferases, phosphatases etc. ·· Histone code peptide sets and microarrays ·· SpikeTidesTM Sets & SpikeMixTM for biomarker quantification using mass spectrometry Collaborations: ·· Neo-epitope-based immunotherapies ·· Neo-epitope qualification ·· Peptide lead identification and optimisation ·· Seromarker and epitope discovery and validation ·· Development of affinity ligands for therapeutic protein purification ·· Enzyme substrate discovery and qualification ·· Development of peptide kits for multiplexed biomarker quantification

Strategic outlook JPT is a key player in the constantly evolving and dynamic world of immunotherapy, immune profiling and proteomics. In addition to high quality GxP peptides for clinical applications, our comprehensive peptide toolbox for neo-epitope qualification, epitope discovery and immune monitoring adds value to the most essential development phases of novel immune therapeutics and diagnostics. 19 th guide to german biotech companies 2018

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Name · LIFE & BRAIN GmbH Address/P.O. Box Postal Code/City State Contact Persons

· · · ·

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

· · · · · · · ·

Sigmund-Freud-Str. 25 53127 Bonn North Rhine-Westphalia Prof. Dr O. Brüstle (CEO), Prof. Dr M. Nöthen (CEO), Ira Herrmann (Head of Business Development) +49-228-6885-100 +49-228-6885-101 37 2002 S1, S2 | Development of novel strategies for the diagnosis and therapy of nervous system discorders | Automated stem cell-based applications | High throughput generation and interpretation of omics data | Electrophysiology Services | Neuroeconomics & Neuromarketing

Biological Patents · Several international patents filed or granted covering in-house technologies External · Strong network with academic and Collaborations industrial partners

LIFE & BRAIN is a biomedical enterprise and commercial hub of the University of Bonn Medical Centre founded in 2002 located in Bonn, Germany. As a centre of innovation, LIFE & BRAIN acts as a revolving door between academic research and industry. Innovative research results are recognised early and developed further into marketable biomedical products and services. Scientific excellence, market-orientated translational research and plans for spinoffs grow together in a network structure supported by creative external collaborations. Integrating a unique set of expertise in cellomics, genomics, transgenics and neurocognition research, LIFE & BRAIN aims at delivering the next generation of products for disease modelling and prediction, compound development and tissue regeneration. The combination of technological know-how and scientific excellence makes LIFE & BRAIN the perfect partner for academic and commercial research. LIFE & BRAIN is based on a 3-pillar concept where academic research groups, the staff of LIFE&BRAIN GmbH and an incubator segment are combined in one organisational structure and all located under one roof. This 3-pillar model facilitates the efficient transfer of academic know-how to commercial application.

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

Life & Brain

LIFE & BRAIN Cellomics provides market-ready stem cell-based cellular products, customised automated solutions for stem cell-based applications and stem cell-related genomic services. We address the unmet need of process standardisation and automation for the robust production of human iPS cell-based disease models with industrial scale and standards. In particular, we consult, develop and support customised solutions for the industrialisation of human pluripotent stem cellbased applications. Our proprietary technology enables the production of human pluripotent stem cell-derived neuronal, neuroglial and microglial cell types for cellbased disease modelling, identification of new drug targets and screening applications. LIFE & BRAIN offers complementary genomic services including molecular karyotyping and expression profiling of differentiated stem cell-derived cell types. Within LIFE & BRAIN Electrophysiology Services, we support preclinical R&D programmes in the area of neurodegeneration, neurocognition and functional connectomics by providing electrophysiological characterisation of small molecules with focus on target engagement, efficacy and potency in acute rodent and human brain slices, cultures, neurons and animal models. LIFE & BRAIN NeuroEconomics provides consulting and research services in the domains of marketing, risk management and health behaviour by building on insights into human decision-making processes. We apply state-of-the-art implicit and explicit methods, including functional MRI, eye-tracking and behavioural assessment, customized to the specific needs of our clients. Our results provide a comprehensive, neurosciencebased view on the effectiveness of measures in marketing, brand management, customer-relations or governance structures. We provide a perfect combination of internationally recognised scientific excellence and experience in commercial applications.

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

· · · · · · · · · · · · ·

Tatzberg 47 01307 Dresden Saxony Dr Oliver Uecke +49-351-796-5345 +49-351-796-5349

FL I  11 2012 Analytical laboratory l Lipidomics l Lipid analysis for Biotech and Pharma l Clinical research l Academic research l Food industry l Cosmetics industry

Lipotype is a spin-off company from the Kai Simons and Andrej Shevchenko labs of the world-renowned MaxPlanck-Institute of Molecular Cell Biology and Genetics in Dresden, Germany. Drawing on many years of cuttingedge research experience, Lipotype delivers comprehensive, absolutely quantitative lipid analysis services for clinical and biological samples on a high-throughput scale. Lipotype offers high-quality lipid analysis services for a wide range of customers and applications including biomarker identification for clinical researchers, Pharma and Biotech companies, functional food development for the food industry, and claim support for the cosmetics industry, as well as for the small-scale profiling needs of academic researchers.

Customers and applications ·· Biotech and Pharma industry, clinical research – Drug discovery (mode-of-action studies, target validation, effect of delivery system on lipid metabolism), biomarker identification (pharmacodynamic, pharmacokinetic, CDx), clinical screening, and diagnostics ·· Food industry – Intervention studies for development of functional food/nutraceuticals ·· Cosmetics and Dermatology – Cosmetic claim support, topical drug development, development of personalised cosmetics ·· Academic research –Lipid analysis of various model organisms

Advantages of Lipotype Shotgun Lipidomics – Ultra-broad coverage The Lipotype Shotgun Lipidomics platform provides a broad coverage of membrane lipids, but also of storage lipids. Our analysis routinely covers 30 different lipid classes (e.g. TAG or PC) on the level of lipid species (e.g. TAG 54:0) or subspecies (e.g. PC 18:0/16:0, including the fatty acid information) – in total more than 2300 individual lipids.

Full high-throughput Lipotype uses Shotgun Lipidomics Technology without time-consuming chromatographic separation of lipids before analysis. We utilise the advantages of cuttingedge mass spectrometry, combined with automated

Lipot ype

sample extraction, processing, and data analysis. In this way our exquisitely standardised platform allows the analysis of 200 plasma samples per day, offering unprecedented delivery time for complete results and associated reports.

Absolute quantification The quantification is achieved using lipid class-specific internal standards allowing unbiased and direct quantitation of individual lipids directly from their mass spectra intensities. Therefore, we deliver results expressed in absolute and not in relative values, which provides the basis for a direct comparison of different samples and experiments.

Highest quality Lipotype’s Shotgun Lipidomics Technology is highly robust and reproducible. This performance is ensured by a rigorous quality control system. The high standards of Lipotype operations are based on years of research experience on the role of lipids in cellular processes and on the development of lipidomics technology according to industry requirements.


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Summary of Lipotype Shotgun Lipidomics ·· Global lipidomics with coverage of more than 2,300 individual lipids in 30 different lipid classes ·· Absolute quantitation of lipids ·· Worldwide only lipidomics platform for which intersite reproducibility and full validation could be shown (Surma et al. 2015) ·· Robust technology with technical variation < 10 % ·· High-Throughput allows data delivery within 2 weeks ·· Minimal sample amount needed (e.g. 1 μl of blood plasma, 60,000 cells) ·· Identification of lipids at the structural level of lipid subspecies ·· Extensive know-how in data mining, machine learning, and multifactorial regression analyses for identification and interpretation of lipid biomarkers ·· Proven experience with various sample types from body fluids, organelles to organs 19 th Guide to german biotech companies 2018

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Name · Lonza Cologne GmbH Address/P.O. Box Postal Code/City State Contact Persons

· · · ·

Telephone Fax Email Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · ·

Nattermannallee 1 50829 Cologne North Rhine-Westphalia Dr Karl Clasen Dr Claus-Dietmar Pein +49-221-99199-0 +49-221-99199-111

FL I  108 1998 S1 | BioAssay Products and Services | Electrophoresis and Analysis | Mycoplasma Detection and Prevention | Pluripotent Stem Cells | Primary Cells and Media | Transfection | QC Testing Solutions

Company profile Following the closing of the Capsugel acquisition, Lonza further strengthened its position as one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. Lonza harnesses science and technology to create products that support safer and healthier living and that enhance the overall quality of life. An integrated solutions provider serving the healthcare continuum, Lonza offers products and services from the custom development and manufacturing of active pharmaceutical ingredients to innovative dosage forms for the pharma and consumer health and nutrition industries. In addition to drinking water sanitizers, nutraceuticals, antidandruff agents and other personal care ingredients, the company provides agricultural products, advanced coatings and composites and microbial control solutions that combat dangerous viruses, bacteria and other pathogens. Founded in 1897 in the Swiss Alps, Lonza today is a wellrespected global company with more than 50 major manufacturing and R&D facilities and nearly 14,000 fulltime employees worldwide.

Integrated solutions Lonza Pharma&Biotech provides the biotech market with the tools life science researchers use to develop and test therapeutics, from basic research to final product release. Lonza’s bioscience products and services range from cell culture and discovery technologies for research, to quality control tests and software to ensure product quality. Lonza Bioscience Solutions serves research customers worldwide in pharmaceutical, biopharmaceutical, biotechnology and personal care companies, as well as academic and government research institutions.

Research tools for biologically relevant results At the BioCampus Cologne, Lonza Bioscience Solutions develops and commercialises non-viral gene transfer products for primary cells and hard-to-transfect cell lines. Primary cells more accurately reflect the condition

Lonza Cologne

and behaviour of cells within an organism when compared to commonly used laboratory cell lines. Therefore, they are important model systems for both basic and clinical research. One of Lonza’s latest innovations, the RAFT™ 3D Cell Culture System (see picture 1), offers simple protocols that allow the set up of 3D cell cultures within an hour. The versatility of the RAFT™ System is beneficial in certain applications such as development of corneal models or blood-brain barrier models where a multilayer co-culture setup is difficult to achieve with conventional methods. Lonza’s CytoSMART™ System (see picture 2), an easyto-use and affordable live cell imaging system, enables researchers to take time-lapse videos and images of their cell culture without needing to manually inspect their cells . With all images being transmitted to the CytoSMART™ Connect Cloud, researchers have 24/24h access to their cell cultures via computer, tablet or smartphone. With Lonza’s Nucleofector™ Technology (see picture 3), the functionality of different genes can be analysed in biologically relevant cell types. These results help identify possible new pharmaceuticals and therapies, for example to fight cancer or cardiovascular diseases. Building on that standard, Lonza strives to ensure that all of the company’s products improve the biological relevance of scientific research results.

QC tests from people who use them Lonza is the trusted QC testing solution provider for the pharmaceutical and medical device industries. Lonza transforms its practical knowledge and technical expertise to deliver a portfolio of endotoxin, mycoplasma and microbial detection products, as well as paperless QC microbiology software and services that support the critical needs of regulated manufacturing environments in the Pharma&Biotech market.

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Name · M+W Central Europe GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Email Website Number of Employees Founded (year) Areas of Activity

· · · · · · · · · ·

Löwentorbogen 9b 70376 Stuttgart Baden-Wuerttemberg Ilga Palfner +49-711-8804-1800 750 1995 | Consulting | Design | Engineering | Construction | Process systems | Qualification & Validation | Commissioning | Technical Facility Management

Company profile M+W Central Europe GmbH, a wholly owned subsidiary of the M+W Group, is one of the leading engineering and construction companies for the pharmaceutical, life sciences, chemical and other high-technology industries. Clients include both large and medium sized enterprises as well as start-up companies. The needs and requirements of our customers are our key priorities – we are the right partner for you when it comes to biotechnology.

Facilities & equipment M+W Central Europe has the experience and the knowhow for planning, design and execution of all types of biotechnology production systems, providing expertise for research plants and industrial facilities, mono-product or multi-product plants, variable single-use systems and large-volume stainless-steel production units. M+W Central Europe customers gain individual or fullservice in complete process and facilities solutions from concept and design to construction of a new production facility.

Services & solutions The portfolio includes: ·· Consulting (EU-GMP, FDA, benchmarking) ·· Design (concept, basic, detail) ·· Process engineering ·· Customised process systems ·· Cleanroom technology ·· Building services ·· Construction management ·· Realisation/construction ·· Qualification/validation ·· Technical facility management ·· Computer system validation/Cyber security Whether you require a turnkey handover, design & build (EPC) or an EPCMV realization of a new production facility, laboratory and/or the conversion or extension of an existing facility, M+W Central Europe will find the best and most economical solutions to meet your deadlines.







M+w Central europe

Your requirements are our focus. Experienced project teams are your local professional partners delivering benefit on every continent.

GMP certified M+W Central Europe will realise your entire project under best quality demands – based on current EU-GMP/FDA guidelines and other international standards. Following analysis of the requirements, these are subsequently implemented in a pragmatic manner with the aid of risk analyses. Solid basis of our work is an implemented quality management and EHS system.

References (Selection) Abbott · Astellas · Aenova · AVON · AYANDA · Baxter · Bayer · Beiersdorf · Biogen · Biomm · Boehringer Ingelheim · B. Braun · Catalent · Chr. Hansen · CureVac · CSL Behring · Daiichi Sankyo · Danisco · Dr. Kade · DSM · Evonik · Ferring · Fresenius · Gambro · Gedeon Richter · GE Healthcare · GlaxoSmithKline · Hermes · Hexal · Innovacell · Inter vet · Kloster frau · Leon Nanodrugs · Lonza · Merck · Merckle · Merz · Nestlé · Novartis · Oxea · Pfizer · Polpharma · Qiagen · Roche · Salutas · Sanofi · Sandoz · Sanfarm · Solvay · Steigerwald · Takeda · TEVA · Unilever · Vetter Pharma · WDT · Ypsomed

Locations Germany: Stuttgart (HQ), Berlin, Biberach, Dresden, Ludwigshafen, Leverkusen, Marburg, Nuremberg, Penzberg, Schwarzheide, Schwedt Austria: Vienna Switzerland: Allschwil/Basel, Schlieren/Zurich Belgium: Melsele/Antwerp Poland: Gdansk, Wroclaw, Warsaw Russia: Moscow

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

· · · ·

Am Neuland 3 82347 Bernried Bavaria Dr Andrea Gräntzdörffer (Business Development) +49-8158-9981-34 +49-8158-9981-10

· · · · · I · > 100 · 1992 · S1/S2, GLP, GCP, 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/solid supports ·· Lateral flow test strips ·· Recombinant proteins/antigens ·· Antibodies ·· Antibody/protein conjugates ·· Liquid components ·· Dried/lyophilized components ·· Diagnostic kits


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 ·· Sample and reagent stabilisation

Laboratory services

B2B Diagnostics

In our GLP/GC(L)P certified facilities, we conduct a broad spectrum of services to support drug development starting from early development to post-marketing surveillance. As an independent contract research organisation and preferred provider we serve pharma and life science industries worldwide. In over 600 square metres of laboratory space, we house clinical analysers from the leading diagnostic suppliers. Sample panels can be analysed for routine IVD parameters, clinical chemistry parameters or for any ELISA or PCR parameter that is commercially available. Our services include: ·· Biomarker testing ·· Immunogenicity/PK assays ·· Biosimilars support ·· 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. 19 th Guide to german biotech companies 2018

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

· · · · · · · ·

Hannah-Vogt-Str. 1 37085 Göttingen Lower Saxony Dr Aaron M. Nuss +49-551-370-00-10 +49-551-370-00-12 Founded (year) · 1989 Type of Laboratory · ISO 9001:2015, ISO 17025:2005 (refers to NGS, Sanger and genotyping labs of Microsynth AG) GMP certified Sanger sequencing lab Areas of Activity · 1. Synthesis of DNA/RNA oligonucleotides 2. DNA sequencing (Sanger, NGS), DNA/RNA isolation, qPCR and genotyping analyses 3. Contract research/outsourcing Request for · Microsynth is looking for Further Collaborations collaborations in the field of molecular diagnostics where we will provide our DNA synthesis and analytics knowhow, while relying on the know-how of the partner(s) in medical and regulatory affairs. The company is open to any new collaboration with pharma/biotech companies, public or academic institutions with the objective of getting involved in innovative or challenging scientific projects (e.g. EU projects).

Company mission It is Microsynth’s mission to be a leading service and solution provider for molecular biologists who require either high-quality DNA/RNA oligonucleotides, sophisticated DNA/RNA sequencing & analysis solutions, or want to outsource entire research projects.

History Microsynth was founded in 1989 by Dr Tobias Schmidheini and is currently active in three different business areas. When Dr Schmidheini started to produce DNA oligonucleotides on behalf of Swiss academic institutes and the pharma industry in 1989, he became one of the pioneers in this area. Meanwhile the company is offering its worldwide customers any kind of DNA/ RNA oligonucleotides. By 1992, the company had entered the business field of DNA sequencing. Today, Microsynth is well-positioned also in this area, and is able to offer its customers both traditional Sanger sequencing services, as well as state-of-the art next generation sequencing (NGS) services. The third business area (contract research/outsourcing) is essentially a combination of DNA/RNA synthesis with DNA sequencing alongside other expert areas such as DNA/ RNA isolation, qPCR and genotyping. Customers can rely on application specialists with outstanding track records in academia as well as Microsynth’s expertise in high-throughput logistics. Microsynth has subsidiaries in Germany (Microsynth Seqlab), Austria (Microsynth Austria) and Switzerland (ecogenics) and serves more than 15,000 customers worldwide.

Products & services 1. Synthesis of DNA/RNA Oligonucleotides ·· DNA and RNA oligos for various research purposes (broad range of scales, modifications and purifications) ·· Antisense oligos with drug-like properties (e.g. 2’ MOE gapmers) for drug discovery ·· DNA oligos for molecular diagnostic applications

We Enrich Your Research

Microsynth seqlab

·· Large-scale synthesis for up to gram quantities of DNA/RNA oligos ·· Primers for NGS applications (e.g. Illumina primers)

The Best Thing That Can Happen to a DNA

Our Know-How For Your Success: Since 1989!

2. DNA/RNA Sequencing and Analysis ·· DNA Sanger sequencing services (single-tube & plate sequencing, primer walking) for various research purposes ·· GMP-compliant and GLP-like Sanger sequencing ·· NGS sequencing & bioinformatics with focus on ·· Small genome sequencing ·· Eukaryotic model organism re-sequencing ·· Transcriptome analysis (e.g. RNA-Seq) ·· Amplicon deep sequencing (e.g. CRISPR/Cas9) ·· Metagenomics sequencing (16S/ITS, shotgun) ·· Whole exome sequencing ·· PCR, qPCR and digital PCR assay development and testing ·· Food testing (species, allergens, GMOs etc.) ·· Vet. med. applications (e.g. eradication of BVD) ·· Gene expression, CNV and SNP detection ·· Genotyping of plants and animals (e.g. GBS) ·· Paternity and cell line authentication testing ·· DNA/RNA (high-throughput) isolation from diverse biological sources 3. Contract Research/Outsourcing ·· Design and execution of all kinds of DNA/RNA related research projects (see our website for project examples and customer references)

Management and personnel Dr Aaron M. Nuss (Site Manager Microsynth Seqlab) Dr Markus Schmid, Christof Wunderlin (Co-CEOs Microsynth AG) Microsynth employees a team of internationally trained scientists and technicians with strong backgrounds primarily in the area of molecular biology (almost half of Microsynth’s staff holds a PhD). Our specific expertise, in combination with our mission, makes us a qualified and reliable partner for empowering molecular biology research. 19 th guide to german biotech companies 2018

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Name · Miltenyi Biotec GmbH Address/P.O. Box Postal Code/City State Telephone Fax Email Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · ·

Friedrich-Ebert-Str. 68 51429 Bergisch Gladbach North Rhine-Westphalia +49-2204-8306-0 +49-2204-85197

FL I Approx. 2,000 worldwide 1989 l S1/S2 l L1/L2 l cGMP l clean room facilities A/B/C/ l fully automated laboratory (collaboration with Tecan® Group Limited)

Areas of Activity · l Sample preparation l Cell separation l Flow cytometry l Cell sorting l Cell culture and stimulation l Lentiviral vector transduction l Cell analysis l Cell processing l Therapeutic apheresis l Cryopreservation l Cellular therapy l Lab automation l Customized Applications

The company Miltenyi Biotec has around 2,000 employees in 25 countries providing products and services that advance biomedical research and cellular therapy. Since 1989, we have been developing and manufacturing innovative technologies for scientists and clinicians who depend on reliable methods of sample preparation, cell isolation, cell sorting, flow cytometry, and cell culture. Our extended range of tools now includes microchip-based, high-speed cell sorting, and lentiviral vector transduction of cells. These tools are applicable to immunology, stem cell biology, neuroscience, and cancer research, as well as to clinical fields that include hematology, graft engineering, tissue regeneration, and plasmapheresis. Our expertise in life science is complemented by an in-depth knowledge of polymer and surface chemistry, physics, engineering, informatics, and electronics.

MACS® Sample Preparation gentleMACS™ Dissociators and MACS ® Tissue Dissociation Kits enable standardised sample preparation from almost any tissue source.

MACS® Technology MACS Technology is the gold standard in manual and automated immunomagnetic cell separation with tens of thousands of publications proving its power in biomedical research and clinical settings. Frequently occurring cells, rare cells, and specific cell subsets can be isolated from blood or tissue samples, from virtually any species. In the clinic, CliniMACS® Cell Separation is used in the context of hematopoietic stem cell engraftment and is regarded as a potent means for reducing graft-versushost disease (GVHD) after allogeneic transplantation.

miltenyi biotec

MACS® Flow Cytometry The MACSQuant® Instruments include ultra-compact flow cytometers and the MACSQuant ® Tyto™, a microchip-based cell sorter, and provide unrivaled ease of use for multisampling and multiparameter analysis and sorting. Our large portfolio of antibodies, including REAfinity™ Recombinant Antibodies and Vio ® Dyes, comprise a family of conjugates with high fluorescence intensities and stain indices, perfectly suited for working with human, mouse, rat, and non-human primate cells.

MACS® Cell Culture and Stimulation Our cell culture media, cytokines, growth factors, and reagents for stimulation, expansion, and differentiation of a variety of mammalian cells, are also available up to GMP grade, thus enabling GMP-compliant, cellular product manufacturing. Our cell culture labware has been designed for cell-based assays that use direct imaging and high-resolution microscopy.

Clinical products Miltenyi Biotec’s comprehensive portfolio for advancing translational research and therapy includes the FDAapproved CliniMACS CD34 Reagent System as well as a range of CliniMACS Products, CryoMACS® Products, MACS GMP Products, and TheraSorb® Apheresis Products. The CliniMACS Cell Separation System has been used in more than 35,000 treatments of patients. The revolutionary CliniMACS Prodigy® is a unique cellprocessing instrument that enables the fully automated manufacture of a GMP-compliant cell product in a benchtop, closed environment. CryoMACS Freezing Bags possess unique design features that increase safety in cryopreservation of hematopoietic cells. Together with MACS GMP Products, they form the basis for GMP-compliant, cellular product manufacturing. TheraSorb Apheresis Products enable the selective removal of pathogenic components from patient plasma by immunoadsorption.

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

· · · · · · · · · · · · ·

Koepenicker Strasse 325 12555 Berlin Berlin Julia Hillebrand +49-30-2000-437-0 +49-30-2000-437-9

L 22 1999 Biotechnology l Contamination control reagents l Product release testing l Food analysis l Contract manufacturing of molecular biology kits and reagent, including IVDs

Minerva Biolabs is a globally operating original manufacturer of molecular biology kits and reagents for contamination control in cell cultures, water, and food. We supply mainly to molecular biology research and QC laboratories as well as OEM customers in academia and the biopharmaceutical industry. We lead in European Pharmacopoeia compliant contamination testing, especially for mycoplasma in ATMPs and cell cultures, meat identification testing, vegan food control, and PCR cycler qualification. All these products feature the latest PCR technology. We bring high-value solutions to our customers through our 18 years of expertise and experience reflected in our products and contract manufacturing services. We do not stop with single applications for detecting a contamination. We provide the integrated solutions that are required for handling cell cultures contamination-free with our elimination and disinfection reagents, or for operating PCR labs contamination-free with our DNA and RNA removal reagents as well as monitoring tools. We bring experiences and services to markets that are undersupplied by the major suppliers that mainly provide products without support. Customised guidance is our strength as we develop products and apply them routinely in our labs. Based on our experiences, we seek to constantly improve our products and develop new products to offer innovative solutions to our customers. We are highly committed to quality and implemented a quality management system that was certified according to ISO 9001 in the first business year. Since 2007, we have conduct our business according to ISO 13485, which enables us to manufacture IVDs according to the in-vitro diagnostic directive.

minerva biolabs

Minerva Biolabs: contract manufacturing As a contract manufacturer, we offer our service and experience in producing various molecular biological reagents and kits. Product design & production management ·· Our service includes the entire design process from assay optimisation and composition to kit development and final product appearance. ·· Our team of product development specialists, graphic designers, manufacturing professionals, as well as market and logistics experts, is looking forward to assisting you. ·· As an established contract manufacturer with a proven record of success, we will tailor your product to meet your expectations as well as that of your customers, including regulatory requirements. Lyophilisation and liquid handling ·· We operate state-of-the art freeze-dryers with capacities from 100 to 10,000 vials per day, allowing the highest flexibility for any batch size. ·· Our lyophilisation service is compatible with various formats, such as PCR tubes, 96-well microtitre plates, microfluidic disks, and microtubes. ·· The lyophilisation process can be engineered to fit various product components and requirements. ·· We use automatic and semi-automated devices to guarantee the highest quality and consistency, especially for liquid handling. Quality control ·· Our analytical services include incoming goods inspection and in-process controls, as well as product release testing. ·· We perform HPLC analysis, UV and IR-spectroscopy, microbiological batch monitoring, and qPCR analysis. ·· A collaboration with our GMP-certified partner Minerva Analytix enables us to perform further methods and analyses to meet your requirements. Packaging and logistics ·· If desired, we can organise the purchasing, storage, and logistics of your packing materials. 19 th Guide to german biotech companies 2018

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Name · MLM Medical Labs GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · · ·

Dohrweg 63 41066 Mönchengladbach North Rhine-Westphalia Dr Katja Neuer +49 2161 4642 102 +49 2161 4642 190

LI 48 1993 Central laboratory services for clinical trials

External · Cenetron Diagnostics, Austin TX, USA Collaborations

MLM Medical Labs is a Central Laboratory dedicated exclusively to clinical trials. We offer full laboratory services, including a whole range of analytics: standard safety profiles, such as blood counts, coagulation, urinalysis, and clinical chemistry, as well as analyses of biomarkers, drug compounds, metabolites, and molecular diagnostic parameters. Internationally active in over 40 countries, we’re located in Mönchengladbach, Germany. The MLM lab is on duty 365 days a year to ensure valid results with a quick turnaround time. Highly skilled and with extensive clinical lab experience, our 48-person team supports between 110 and 120 clinical studies, Phase I–IV, at any given time. MLM Medical Labs runs trials in a broad range of indications, including diabetes, cancer, infectious diseases, dermatology, and diseases affecting the cardiovascular, neurological, and immunological systems. All members of the technical staff are certified research or medical assistants. 50% of the team has degrees in chemistry, biochemistry, biology, or physiology and a third have completed PhDs in relevant fields.

Analytics ·· ·· ·· ··

Development and validation of analytical methods Broad portfolio of validated biomarker assays World-standard analytical methods Clinical chemistry, hematology, coagulation, serology, and urine analysis ·· Complete analytical study reports

Management and logistics ·· Global study setup and project management ·· In-house manufacturing of study-specific sampling kits: MLM Assembly ServicesTM ·· More than 2,400 m2 lab space ·· Worldwide transport of clinical samples, sampling kits, and supplies ·· Long term sample storage at –30 °C, –80 °C and cryoconservation

MLM Assembly ServicesTM mlm medical labs

Superior IT infrastructure ·· Online data-access and kit tracking: mlm onlineTM ·· Electronic data transfer according to client’s DTA specifications ·· Validated LIMS, digital SOP system, and ERP

Clinical logistics innovation MLM Safeguard BoxTM efficiently protects samples against thermal stress and therefore contributes in a valuable way to the quality of safety data.

Clinical lab services available 365 days a year

The main benefits ·· Protective: Temperature stabilised during entire transport ·· Complete: All supplies delivered in one box ·· Easy-to-use: Colour-coded and pre-labelled tubes ·· Traceable: Identification via barcode. Sampling kit tracking via mlm onlineTM 19 th Guide to german biotech companies 2018

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Name · MOLOGEN AG Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · ·

Fabeckstraße 30 14195 Berlin Berlin Claudia Nickolaus +49-30-841788-38 +49-30-841788-50 ~ 50 1998 Clinical drug development in the areas of cancer and infectious diseases

Annual Turnover · +/- 0 Relevant R&D Budget · ~ €17m Biological Patents · Comprehensive international patent protection for our product candidates External · I Freie Universität Berlin, Germany Collaborations I Aarhus University Hospital, Denmark I The University of Texas MD Anderson Cancer Center, USA Request for · Partnering opportunities for our Further Collaborations compounds

MOLOGEN AG – Technology leader in targeted immunotherapies On account of its unique active agents and technologies, the biopharmaceutical company MOLOGEN AG is considered a pioneer in the field of immunotherapy. Alongside a focus on immuno-oncology, MOLOGEN AG develops immunotherapies for the treatment of infectious diseases. Our approach concentrates on drug candidates for which there is a high medical need. As a biopharmaceutical company, MOLOGEN is orientated toward closer-to-market proprietary product candidates which have advanced beyond the basic research stage. Our foremost objective is the successful out-licensing and marketing of our products, particularly our lead product lefitolimod (MGN1703). All products are based on the same active principle: they activate the human immune system to combat the illness itself. This is a highly promising approach which we are driving forward with great confidence and from which patients who are reliant on innovative treatment options stand to benefit. Without exception, our products have demonstrated good efficacy and excellent tolerability, which is a particularly noteworthy characteristic for cancer therapies.

DNA-based TLR9 agonists The focus of our development work is on MOLOGEN’s proprietary platform technology: the product family of DNA-based TLR9 agonists. This includes our lead product, the immunotherapeutic agent lefitolimod, and its follow-up molecules EnanDIM®. Lefitolimod (MGN1703) is currently being developed within the framework of a pivotal study for first-line maintenance therapy for colorectal cancer. Furthermore, the phase II IMPULSE study in small cell lung cancer is showing positive results in two previously defined and clinically relevant patient sub-groups, even though the primary endpoint “Overall Survival” in the overall study population was not met in this very challenging indication. Detailed analyses of IMPULSE data and the recently published TEACH data of the extension phase are currently being conducted. In addition, lefitolimod (MGN1703) is currently being


investigated in a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy ÂŽ) in various cancer indications. Along with various checkpoint inhibitors, lefitolimod is one of the few near-to-market product candidates in the field of immuno-oncology.

Cell-based therapeutic vaccine Our product portfolio includes another proprietary cellbased therapeutic vaccine, MGN1601, to treat advanced renal cancer. The further development of MGN1601 has been shelved for the time being. It is anticipated that this will be re-initiated at a later date, for example following the successful out-licensing of lefitolimod.

Partnering We offer pre- and clinical drug candidates in the highly attractive field of immunotherapies. Due to their known or expected good safety profile they offer, as well, a tremendous potential for combination therapies to enhance the efficacy of other immunotherapies. MOLOGEN is primarily seeking licensing partners for the TLR9 family with its compounds lefitolimod and EnanDIMÂŽ â&#x20AC;&#x201C; with the option for flexible cooperation arrangements.

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Name · MorphoSys AG Address/P.O. Box Postal Code/City State Contact Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · · ·

Semmelweisstr. 7 82152 Planegg Bavaria Corp. Comm. & IR +49-89-89927-404 +49-89-89927-5404

L ca. 350 1992 l Biopharmaceuticals l Monoclonal antibodies

MorphoSys’s mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines, and are driven by a desire to make the medicines of tomorrow a reality. Success benefits all of our stakeholders. Based on our proprietary technology platforms, particularly in the field of fully human therapeutic antibodies, MorphoSys, together with its partners, has built a therapeutic pipeline of more than 110 programs in R&D, around a quarter of which are currently in clinical development.

Segments In the proprietary development segment, MorphoSys, alone or with partners, is developing new therapeutic candidates, mainly focusing on cancer and inflammation. In the partnered discovery segment, MorphoSys uses its technologies to discover new drug candidates for pharmaceutical partners and participates in the programmes’ further development success through success-based payments and royalties.


Recent developments TremfyaTM, the first antibody derived from MorphoSys’s antibody technology library HuCAL, entered the market in 2017. The partnered discovery program with Janssen/ J&J for the treatment of psoriasis received FDA approval and has been available to patients in the US since end of July 2017. MorphoSys’s licensee Janssen has also submitted a marketing authorisation application for this antibody to the European Medicines Agency (EMA). MOR208 was the first antibody from the proprietary portfolio to start a pivotal phase 3 development in 2017. MOR208 is an fc-enhanced monoclonal antibody directed against CD19, developed in diffuse large B-cell lymphoma (DLBCL) and CLL. In addition, MorphoSys conducts clinical trials with its proprietary assets MOR202, MOR106 and MOR107 in oncology and inflammation, respectively. Another antibody from the proprietary development segment, MOR103/GSK3196165, has been out-licensed to GSK and is in several phase 2 studies in rheumatoid arthritis and osteoarthritis.

Our future ·· Commercialising own products in selected geographies ·· Lucrative milestone and royalty streams from deep partnered pipeline ·· Innovative science and technology driving expansion of proprietary portfolio

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

· · · · · · · · · · ·

Am Haag 6-7 82166 Gräfelfing Bavaria Dr Christian Loss (CEO) +49-89-898888-0 +49-89-898888-16 approx. 150 2003 BioStoffV S3**, cGMP certified production facilities, EU (Annex 1 EU-MP guideline) up to grade A respectively ISO 5 (according to EN-ISO 14644-1)

Areas of Activity · l Transplantation Medicine l Haematological Oncology External · Academic research institutions and Collaborations undisclosed companies

The company Neovii Biotech GmbH (formerly Fresenius Biotech GmbH) is a globally operating company dedicated to delivering targeted biopharmaceutical treatment options in transplantation medicine and haematological oncology. The focus of its activities is the development and commercialisation of immunologically active biopharmaceutical therapeutics based on innovative antibody technologies. Clinical and development activities as well as manufacturing are located in Germany with an additional development unit in the USA. Since its inauguration Neovii Biotech has been manufacturing and commercialising Grafalon® (former brand name ATG-Fresenius S), a medicinal product for the prevention of graft-versus-host-disease after stem cell transplantation and prevention/treatment of acute organ rejection following solid organ transplantation. For further details please visit:

Transplantation: Grafalon® – a polyclonal antibody Grafalon® is an antibody-based medicine for the targeted suppression of immune responses (immunosuppressant); it is a polyclonal antibody composed of antihuman T-lymphocyte immune-globulin from rabbits. It suppresses immune responses by multiple mechanisms, such as immune cell depletion, inhibition of T-cell function, induction of regulatory immune cells. Its immunosuppressive properties are used mainly in solid organ transplantation and stem cell transplantation.


In solid organ transplantation (SOT), Grafalon® is indicated either for the prevention of organ rejection or to suppress active, acute rejection reactions. The rejection of a transplanted organ is primarily caused by immune cells of the recipient that start attacking the grafted organ, because it is recognised as foreign. By suppressing these immune reactions, Grafalon ® limits organ damage and prevents graft loss. In stem cell transplantation (SCT) Grafalon® is indicated for the prevention of graft-versus-host-disease (GVHD). GVHD is recognised as a severe complication following SCT that negatively impacts on patient’s quality of life and is a major cause of morbidity and mortality. In GVHD, transplanted immune cells attack the recipient’s body, causing tissue and organ damage. By suppressing these immune reactions, Grafalon ® significantly lowers the incidence of GVHD. Grafalon® has been approved for more than 30 years in more than 60 countries. More than 230,000 patients worldwide have already been treated with Grafalon®. In 2011, Grafalon® was granted the MMW Pharmaceutical Drug Award (MMW-Arzneimittelpreis) in recognition of its 30-year success story in transplantation medicine.

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Name · New England Biolabs GmbH

New England Biolabs – be Inspired | drive Discovery | stay Genuine

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

· · · · · · · · · ·

Brüningstr. 50 – Geb. B852 65926 Frankfurt am Main Hesse Dr Thomas Möllenkamp +49-69-305-23140 +49-69-305-23149

FL I  H 1981

Founded in the mid-1970s as a collective of scientists committed to developing innovative products for the life sciences industry, New England Biolabs is now a recognised world leader in the discovery, development and commercialisation of recombinant and native enzymes for genomic research.

New England Biolabs – putting science first Created “by scientists for scientists”, NEB is renowned for consistently providing exceptional product quality and unsurpassed technical support. For over four decades, NEB has been shaping the landscape of bioscience research by discovering, developing, and supporting superior research reagents. In addition to NEB’s commitment to scientific innovation and customer satisfaction, NEB notably ensures the environmental sustainability of the company’s business practices. Our passion is our promise. A supplier-of-choice for scientists across the globe, NEB offers the largest selection of recombinant and native enzymes for genomic research. While restriction enzymes remain part of our core product portfolio, our ever-expanding offering also includes products related to PCR and qPCR, gene expression, sample preparation for next generation sequencing, synthetic biology, and CRISPR/Cas9 gene editing as well as glycobiology, epigenetics, and RNA analysis. A recognised leader in the field of enzymes and reagents, NEB has earned a world-wide reputation for setting the highest standards for quality and value.

Basic and applied science New England Biolabs’ laboratories more closely resemble those of a research institute than a biotech company, and with good reason; NEB’s scientists are engaged in research in areas that include enzyme analysis and engineering, epigenetics, RNA biology, and parasitology. As a result, NEB researchers have authored or co-authored over 1,000 publications, many of which have been published in

new england biolabs

peer-reviewed journals. To foster science education, NEB scientists also supervise post-doctoral associates, student interns, and Ph.D. students engaged in research projects. With this dual focus on both basic and applied research, NEB’s culture is collaborative and academic.

Latest innovation in enzyme technology Our outstanding expertise in protein engineering and evolution has led to the creation of unrivaled enzymes and unique workflows in library preparation 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 offering for alternative DNA Assembly & Cloning methods as well as novel reagents for CRSIPR/Cas9-based Genome Editing makes us a first-choice supplier for today’s molecular biologists.

Quality, customer service, and the environment NEB is dedicated to providing research products of the highest quality. We are committed to processes that ensure the protection of the environment, and our integrated quality and environmental management systems are certified to meet the requirements according to the standards ISO13485, ISO9001, and ISO14001.

Enzymes & Reagents for: Sample Preparation for Genome Editing



qPCR Glycobiology

RNA Analysis

Synthetic Biology



Cloning PCR Modification

RNA Epigenetics Cellular Analysis

Protein Expression

Nucleic Acid Purification

Guide_2017.indd 1

Customised products/OEM Our expertise and large fermentation capabilities also make NEB an ideal partner for customers that have a need for bulk quantities of enzymes. Tailor-made enzyme formulations and packaging enable OEM customers to use NEB’s top class products directly in their specific applications, or bring them to market.

New England Biolabs GmbH


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

Competent Cells Gene Expression

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Name · Nordmark Arzneimittel GmbH & Co. KG Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · ·

Pinnauallee 4 25436 Uetersen Schleswig-Holstein Dr Jan Heyland +49-4122-712-907 +49-4122-712-545 ~ 500 1927 l Process development l Microbial fermentation l Mammalian cell culture

Annual Turnover · ~ €80m

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 more than 500 employees and generates revenues of around EUR 80 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 Biotech connects flexible partnerships with a unique expertise and know-how in developing and delivering drugs to market. As a family-owned business we work with maximum care and attention and with fast and simple decision-making processes. We are focused on success â&#x20AC;&#x201C; regardless of project size. Nordmark can refer to a significant track record in the industry with different successful process development and manufacturing projects in various stages of clinical development as well as approved and marketed products for more than 40 international partners. With nearly 90 years of excellence and commercial success, Nordmark is the ideal partner to bring your ideas to market.

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

· · · · · · · · · · ·

Im Neuenheimer Feld 515 69120 Heidelberg Baden-Wuerttemberg Dr Christian Roesky +49-6221-502590 +49-6221-5025921 60 2007 l Chemical l Pharmaceutical

Areas of Activity · l Specialty pharma l Ophthalmology l Drug delivery Biological Patents · 29 patent families with a total of 76 patents issued for all key pharmaceutical markets External · l University of Cologne Collaborations l Queens University Belfast l University of Auckland l Martin-Luther University Halle Request for · With its fast and proven drug Further Collaborations development process and its rich pipeline of differentiated products, Novaliq provides a unique opportunity for industry and academic partners.

The organisation Novaliq GmbH is a specialty pharmaceutical company focused on developing innovative products for ophthalmic indications. Founded in 2007 and based in Heidelberg, Germany, Novaliq develops first- and best-in-class ocular therapeutics based on EyeSol®, its disruptive water-free drug delivery technology.

Business strategy Novaliq’s mission is to transform Active Pharmaceutical Ingredients (APIs) into highly effective ocular therapeutics for both the front and the back of the eye. All product developments are based on Novaliq’s proprietary, water-free drug delivery technology called EyeSol®.

Mechanisms of action and technology EyeSol® is the first and only technology to overcome the limitations of water-based eye drops, creating novel drugs with added value such as better bioavailability, efficacy, stability, and tolerability. EyeSol® is clinically validated by NovaTears® (4 trials) and CyclASol® (2 trials).

Product pipeline Novaliq offers an industry leading pipeline in DED. CyclASol®, Novaliq’s most advanced DED pipeline product, has demonstrated better efficacy and tolerability versus current gold-standard Restasis® in a Phase 2 trial.

NovaTears® Novaliq’s first commercial product, NovaTears®, is on the market in selected European countries for the treatment of dry eye disease (DED). NovaTears® is a first-in-class, preservative-free eye lubricant and tear film stabiliser for evaporative dry eye disease. As the first of its kind, NovaTears® offers a new Mode of Action by acting as a lubricating lipid layer substitute and evaporative barrier for improved tear film stability.


NovaTears® is clinically validated by significant improvement in signs and symptoms in evaporative dry eye disease and MGD patients (NT-001 and NT-002). It is approved and marketed in Europe under the brand name EvoTears® by Ursapharm.

NovaTears®+Omega-3 NovaTears®+Omega-3 are the first eye drops containing highly concentrated Omega-3 of plant origin with superior stability at room temperature in a multi-dose bottle. The product is the first water-free lipid layer stabilizer containing Omega-3 fatty esters that improves signs and symptoms in patients with DED without causing blurred vision after administration. NovaTears ® efficacy and safety have been clinically validated by 4 prospective, post-market studies.

CyclASol® A pivotal-stage, anti-inflammatory drug to treat Dry Eye Disease (DED) CyclASol ® is a promising candidate with significant improvement in signs with earlier onset of action vs. the market gold standard in moderate/severe DED entering a pivotal US trial in 2017. Cyclosporine A has been proven to be the most successful API for the treatment of dry eye disease in the United States so far. In January 2017, Novaliq announced positive Phase 2 results evaluating CyclASol ® in 207 patients with moderate to severe dry eye disease (DED). The reported data confirmed that CyclASol® had demonstrated a superior outcome and an early onset of action when compared head-to-head with Restasis™.

Management Dr. Christian Roesky (CEO) Dr. Oliver Schlüter (CFO)

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

· · · · · · · · · ·

Merowingerplatz 1a 40225 Düsseldorf North Rhine-Westphalia Philipp Bürling +49-211-97532901 7 2017 I Biotechnology I Molecular Biology I S1

Areas of Activity · I Biosynthesis of recombinant peptides I R&D Request for · I Industry Further Collaborations I Academia

About NUMAFERM NUMAFERM has developed an efficient and effective biotechnology for the production of recombinant peptides. The drawbacks of available bioprocesses have been overcome – for example proteolytic damage, aggregation, and toxicity issues. Our technology serves as a reliable platform for peptides of any length. Our mission is to make peptides cheaper and their production more eco-friendly in comparison to predominantly chemical synthesis. With lower prices and a scalable process, they become accessible for nonpharmaceutical applications. Founded in 2017, NUMAFERM is a venture capitalbacked startup company headquartered in Düsseldorf, Germany.

Technology description Secretion technology We have developed the first-in-place secretion technology for Gram-negative bacteria. Peptides are transported out of the E. coli cells into the proteasefree environment immediately after biosynthesis. This protects them from being destroyed by proteases. Our technology is based on a Type 1 secretion system (T1SS) where a transport complex of three membrane proteins catalyses the transport. Requested peptides are genetically fused with a transport signal that is recognised by the nano-machinery. After transport, the transport signal remains attached to the peptide as a fusion partner, which is essential. First, the transport signal has been rationally designed in such a way that it increases the stability and solubility of peptides and counteracts aggregation. Second, the return of peptides to the production host is prevented by the transport signal – cells are protected from cytotoxic effects. Fusion peptides have high purity and can be efficiently extracted from the culture supernatant. The transport signal can be cleaved off during the DSP and pure peptides are produced.


Molecular switch In a second development we managed to overcome a major constraint working with an inclusion body approach. With our technology called “Molecular Switch”, we manage to renature inclusion bodies efficiently which allows us to obtain a functional product and to work with site-specific proteases in order to cleave off the fusion partner and to obtain the pure peptide of interest.

Key advantages ·· ·· ·· ·· ·· ··

Cost efficiency Scalability Short ramp-up Quick proof of feasibility Peptide length not limited Eco-friendly

Service offering R&D ·· Feasibility studies ·· Design of peptides with unique functionalities ·· Optimisation of peptide candidates ·· Product development ·· Process development Production ·· Small batches at research grade ·· Bulk supply and GMP material via sub-contracted CMO ·· Intermediates Licensing ·· Tailormade license opportunities

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Name · ORGANOBALANCE GmbH Address/P.O. Box · Gustav-Meyer-Allee 25 Postal Code/City · 13355 Berlin State · Berlin Contact Person · Prof. Dr Christine Lang, CEO Telephone · +49-30-46307-200 Fax · +49-30-46307-210 Email · Website · Social Media ·  Number of Employees · 30 Founded (year) · 2001 Type of Laboratory · l Microbiology l Molecular biology l Cell culture l Anaerobic culture l Biosafety level S1, L2 l Process development l Fermentation l DSP Areas of Activity · l New product developments based on natural & proprietary lactic acid bacteria and yeast strains l Production of Lactobacillus-based products and ingredients, e.g. Pylopass™ Biological Patents · Patents and patent applications on microbiological processes to produce functional compounds for health, food, feed, personal care, and in industrial biotechnology. Request for · ORGANOBALANCE works in Further Collaborations co-development projects with partners.

Company profile Organobalance GmbH is a biotechnology research and development and production company with facilities in Berlin and Flensburg. Founded in 2001, the firm develops and markets products based on probiotic bacteria cultures as well as yeast production strains for use in industrial biotechnology. One of its best-known products is Pylopass™, a natural lactobacillus agent able to bind Helicobacter pylori, a stomach bacterium. Among the company’s national and international customers are clients from the food, cosmetics, feed, agriculture, and health industries. The company owns an extensive collection of yeast and lactobacillus cultures, some of which date back to the 1920s. In September 2016, Organobalance was acquired by the world leader in bioinnovation Novozymes A/S. ORGANOBALANCE’s expertise in production includes the establishment and scale-up of fermentation processes and down-stream processes. A reliable network of toll producers has been established for large-scale production. ORGANOBALANCE is an active part of the life-science network, integrated in co-operations and networks between academic and industrial groups. ORGANOBALANCE is an active member of DECHEMA Society for Chemical Engineering and Biotechnology, VBU Association of German Biotech Companies, DIB German Association of Biotechnology Industries, BioDeutschland, IWBio, and IPA International Probiotics Association. Christine Lang, the company’s Managing Director, is also a Professor of Microbiology and Molecular Genetics at the TU Berlin and has received several business awards. She co-chairs the German Bioeconomy Council.


Exploring natural biodiversity Microorganisms are nature’s perfect problemsolvers. Although microscopic, they have the power to solve daunting global challenges and unlock new opportunities. That is why we look to a future powered by biology. ORGANOBALANCE exploits the potential of probiotic bacteria and yeasts for new product developments in food, feed, personal care, health, and for the production of fine chemicals. From a large number of lactic acid bacteria and yeasts, specific strains are selected to inactivate pathogenic microorganisms, add new activities to products, neutralise malodorous / toxic substances or produce high titres of valuable compounds.


Yeast metabolic engineering ORGANOBALANCE has a broad expertise in the field of yeast metabolic engineering. This includes the design and development of platform strains and new production strains for industrial biotechnology applications. Specific strains – based on the yeast Saccharomyces cerevisiae – are developed to produce protein compounds and to carry engineered biosynthesis pathways for the environmentally friendly production of carboxylic acids, terpenoids, steroids, and other lipid compounds. ORGANOBALANCE runs a state-of-the-art analytic facility ranging from q-PCR and FACS to HPLC and GC-MS.

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Name · PeproTech GmbH Address/P.O. Box Postal Code/City State Contact Persons

· · · ·

Telephone Fax Email Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · ·

Oberaltenallee 8 22081 Hamburg Hamburg Dr Bärbel Icheln, MD Dr Peter Bubeck +49-40-73435-777-0 +49-40-73435-777-9

FL I 9 (Germany), 125 (Worldwide) 2006 (Germany), 1988 (USA) S1, ADCF, GMP l Molecular biology l Cell culture l Stem cell and cell line development l Cell preparation l Fermentation l Protein purification l Antibody production l Kit development l Process development

Biological Patents · Vector and production patents External · Researchers from academia, industry, Collaborations and biotech companies Request for · PeproTech encourages researchers to Further Collaborations convey their particular needs, especially if they need ancillary products for cell, gene and tissue therapy.

Company profile PeproTech creates the building blocks of your life science research by manufacturing high-quality products that advance scientific discovery and human health. Since 1988, we have grown into a global enterprise with state-of-the-art manufacturing facilities in the US and offices around the world. With over 2,000 products PeproTech has developed and refined innovative protocols to ensure quality, reliability, and consistency. Our mission is to provide the highest-quality products and premium support that address the needs and demands of today’s scientists and researchers. Quality policy PeproTech is committed to supplying our customers with the highest-quality products and services to achieve customer satisfaction, as well as to ensure compliance with the requirements of the quality management system and its continuing improvement.

Proteins GMP PeproTech ensures that all aspects of our quality management system – from management of raw materials and equipment to facilities maintenance (environmental monitoring), manufacturing processes, internal audits and inspection processes – are in compliance with GMPs and all applicable regulatory and standards requirements. We perform extensive quality-control testings to verify that PeproGMP® Cytokines meet rigorous standards for purity, identity, safety, activity, and consistency. RUO Full-length and fully biologically active Research Use Only cytokines are developed in-house by our experienced protein scientists. The process starts in our molecular biology labs with gene design and expression, to cell banking, and continues to fermentation/cell culture, purification, QC testing, and finally QA review and release. Animal-Free product line PeproTech’s line of animal-free proteins is designed to minimize potential variables associated with the use of animal-derived manufacturing components.


The proteins listed in this category are produced in a dedicated animal-free facility under strict animal-free conditions. The production protocols have been modified to include only animal-free reagents and chemicals while maintaining identical high biological activity and purity to the corresponding proteins produced using standard techniques.

Antibodies & ELISA Kits Polyclonal antibodies PeproTech’s polyclonal antibodies are purified through the isolation of specific polyclonal antibodies from antiserum by antigen affinity chromatography. This procedure exploits the specificity of the antibody-antigen interactions and typically yields >95% pure specific antibodies. Biotinylated antibodies PeproTech’s biotinylated antibodies are produced from highly pure and specific antigen affinity-purified polyclonal antibodies, and are therefore ideal for use in any analytical procedures that require biotinylated antibodies. Monoclonal antibodies PeproTech’s monoclonal antibodies are raised against fulllength recombinant antigens and have been thoroughly screened for performance in a variety of applications. ELISA Development Kits PeproTech’s ELISA Development Kits contain the necessary key components for the quantitative measurement of natural and/or recombinant proteins in a sandwich ELISA format. Each kit contains a capture antibody, a biotinylated detection antibody, a calibrated antigen standard, the avidin-peroxidase conjugate, and a detailed protocol.

Media A comprehensive line of cell culture media products engineered by PeproTech and collaborators offers highquality options to support your culturing needs. Manufactured in state-of-the-art cell culture laboratories, these media products are designed around our high-quality recombinant growth factors and demonstrate comparable, if not superior, performance to other products on the market. 19 th Guide to german biotech companies 2018

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Name · Peptide Specialty Laboratories GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · ·

Im Neuenheimer Feld 515 69120 Heidelberg Baden-Wuerttemberg Dr H.-R. Rackwitz +49-6221-889612 +49-6221-889613 7 2000 Peptide Synthesis Customised peptide synthesis and peptide-specific antibodies

Peptide Specialty Laboratories GmbH Peptide Specialty Laboratories (PSL) GmbH was founded in August 2000 and is located in the Technology Park in Heidelberg, Germany. PSL is a spin-off laboratory of the German Cancer Research Center (DKFZ) in Heidelberg, where the co-founder and manager of the company, Dr H.-R. Rackwitz, has gained a long wealth of experience in peptide synthesis and antibody preparation. The main goal of PSL is based on the production of unmodified as well as modified peptides, from mg to gram amounts and with lengths between 5 and 75 amino acids, to a very high standard. PSL guarantees that peptides are all HPLC purified by preparative gradient purifications and analysed by mass spectrometry. PSL also offer the synthesis of peptides with rare amino acids, unnatural amino acids, peptides with fluorescent moieties and biotinylated peptides. PSL’s production facility allows syntheses of peptides with lengths of between 5 and 75 amino acids to a very high standard. Furthermore, PSL produces bio-conjugates between peptides and proteins as well as column matrices, and PSL is a main contributor of peptide specific antibodies for scientific and industrial research. PSL antibodies are primarily produced in guinea pigs or rabbits but immunisation of other animals is also available. Furthermore, PSL specialises in the production of phosphospecific antibodies.

Custom peptide sets PSL offers custom peptide sets of various lengths and quality controls. Peptide sets are important tools for the screening of epitopes, proteases, kinases, antibodies, or pharmacologically active peptides. For the most part, peptide sets can be used to save time and cost in comparison to using recombinant proteins.

peptide specialty laboratories

Peptide specific antisera service PSL offers a customised peptide specific antisera service. We have achieved a high success rate in the generation of specific antisera through the use of high-quality peptide-conjugates for the preparation of our antisera.

Special purpose research peptides PSL specialises in special purpose research peptides, and as a company we strive to assure high quality for our products. The company’s experience has demonstrated that only a qualitatively “good” peptide will result in a “good” antiserum or “good” results in research. Synthesis scale We provide peptide services in which you can select from different coupling prices. Peptides are available on four scales. To obtain a specific amount of a peptide you may choose between a minimum of 1–4 mg, 5–9 mg, 10–19mg, or 20–30 mg of an HPLC purified peptide. Higher quantities up to 1,000 mg are available upon request. Purification Unpurified peptides are not appropriate for immunisation or other research purposes. Therefore we do not provide unpurified peptides. Delivery It will take approximately two to three weeks to receive your product once the order has been confirmed. Modifications & special services We have the capacity to incorporate modified or special amino acids into peptides (i.e. acetylated, myristoylated, phosphorylated, stable isotope amino acids, etc.). We also provide labeling.

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Name · PlasmidFactory GmbH & Co. KG Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · · ·

Meisenstr. 96 33607 Bielefeld North Rhine-Westphalia Dr Marco Schmeer +49-521-29973-50 +49-521-29973-55 I 15 2000 l Contract Manufacturing of plasmid and minicircle DNA in different quality grades for research up to clinical applications l Analysis of plasmid topology l In Stock Service of AAV Helper & Packaging Plasmids (pDG/pDP) and of further plasmids

Biological Patents · US 9,382,552 B2 / DE 10 2013 220 859 and others Request for · PlasmidFactory is always happy to Further Collaborations collaborate with Pharma and Biotech companies needing plasmid or minicircle DNA for (pre-) clinical applications.

PlasmidFactory is the leading contract manufacturer of plasmid and minicircle DNA and the driving force in the development of gene vectors for gene therapy and genetic vaccination. PlasmidFactory’s research and development as well as the complete services are located in Bielefeld, Germany.

Customised plasmids and minicircles PlasmidFactory’s individual manufacturing service is frequently used by researchers from the fields of transfection and drug delivery, virus production, nano-biotechnology, gene therapy, cell or tumour therapy, and DNA vaccination. The company offers the production of plasmid 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 and viral vectors, and GMP Grade for clinical applications.

In Stock service Besides production of individual plasmids and minicircles, In Stock products that are deliverable immediately “off-the-shelf” – e.g. reporter genes (gfp, lacZ, luc), AAV Helper & Packaging vectors (pDG/pDP family, several serotypes) or pEPI plasmids (containing S/MAR elements) – are also provided.

Other services On request, plasmid DNA storage and logistics, following ICH guidelines, and delivery of requested amounts on dry ice by overnight courier service can be organized, supplementing the company’s service portfolio. PlasmidFactory’s proprietary method for quantification of the structural diversity of plasmid DNA by means of capillary gel electrophoresis (CGE) is the only reliable method able to determine the stability of plasmid DNA during storage.


Minicircle â&#x20AC;&#x201C; a safe vector system Minicircles (MC) are circular DNA molecules that are generated e.g. by an intramolecular (cis-) recombination from a parental plasmid (PP). The difference between MC and standard plasmid vectors for gene therapy or nucleic acid vaccination is that the MC contains neither the bacterial origin of replication (needed only in bacteria for the amplification of plasmids in cell division) nor the antibiotic resistance markers or other selection systems to keep the plasmid in high amounts within the producer cell. Hence, minicircles are the most promising tool 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 constructs, according to clientsâ&#x20AC;&#x2122; requirements.

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

· · · · · · · · · · · · ·

Weinbergweg 22 06120 Halle (Saale) Saxony-Anhalt Dr Konrad Glund, CEO +49-345-555990-0 +49-345-555990-1

I 14 1997 S1; chemical Life Sciences

Biological Patents · 43 patent families

Probiodrug AG (Euronext Amsterdam: PBD) is a biopharmaceutical company focused on the development of new therapeutic products for the treatment of Alzheimer’s disease (AD). Probiodrug has identified a new therapeutic concept linked to disease initiation and progression. Two complementary approaches are targeting a key neuro/synaptotoxic component of the pathology, pyroglutamate-Abeta (pGlu-Abeta, N3pG), as a therapeutic strategy. PQ912, Probiodrug’s lead product candidate, is a firstin-class, highly specific and potent small molecule inhibitor of Glutaminyl Cyclase (QC), which has shown therapeutic effects in AD animal models. In a Phase 1 study with healthy volunteers, both young and elderly, PQ912 was shown to be safe and well tolerated; the results revealed dose-dependent brain exposure reaching high QC inhibition as measured in the spinal fluid. PQ912 was evaluated in a Phase 2a randomised, double-blind, multi-centre, placebo-controlled trial (the SAPHIR study) that included 120 patients with early Alzheimer’s disease treated for three months with a high dose leading to about 90% QC-inhibition. The primary outcome was safety and tolerability. Although differences between treatment arms were observed regarding skin and GI effects, there is high confidence that the drug is safe and well tolerated in the AD population. In the next study, optimal dose will be defined in combination with a longer treatment duration. Significant improvement signals of secondary exploratory efficacy markers were obtained in the SAPHIR study, all pointing to a rescue effect on synaptic impairment. The positive effects strongly support the hypothesis of pGlu-Abeta being a synaptotoxic Abeta variant, and with this, the therapeutic concept pursued by Probiodrug. The study revealed a positive benefit–risk ratio for PQ912 and provides important guidance on how to move forward in the development of PQ912 as a disease-modifying drug for Alzheimer’s disease. Altogether, the results make the program highly attractive for further development.


PQ912 has demonstrated beneficial effects in a preclinical Huntington's disease (HD) model. There is currently no disease-modifying therapy for this condition. PQ912 clearly improved several signs of the disease in a wellcharacterised BACHD mouse model of HD. PBD-C06 is a monoclonal antibody, currently in preclinical stage. PBD-C06 targets pGlu Abeta, aiming to selectively clear the brain of pGlu-Abeta while leaving non-toxic forms of Abeta untouched. PBD C06 has been successfully humanised and also de-immunised to avoid detection by the patient’s endogenous immune system. For the first time for an anti-pGlu-Abeta approach, PBD-C06 has not only shown the ability to reduce Abeta/ plaques but also to significantly improve cognitive deficits in aged Alzheimer’s mice. Moreover, no evidence was found of increased microhemorrhages after treatment with PBD-C06. The development of the manufacturing process of this molecule is currently underway. PQ1565 is a second QC-inhibitor, currently in the preclinical stage. The product candidate has shown attractive drug-like properties in preclinical studies. The compound is ready for regulatory toxicology studies. Founded in 1997 by Hans-Ulrich Demuth and Konrad Glund, the company successfully developed a novel therapeutic concept for diabetes – the DP4 inhibitors – which provided the basis for a novel class of antidiabetics – the gliptins. Today, Probiodrug aims to become a leading company in the development of AD treatments and to thereby provide a better life for Alzheimer’s disease patients.

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

· · · · · · ·

Goethestr. 54 13086 Berlin Berlin Dr Wieland Wolf (CEO) +49-30-924-006-0 +49-30-924-006-19 · · FIQ · 115 · 1994 · S1, S2 · | Biopharmaceutical development and GMP Production Facility | Biopharmaceutical contract development and manufacturing | Technologies for improving product characteristics and process efficiency

Biological Patents · ProBioGen holds numerous international patents on technologies to improve product quality/potency and enhance cellular productivity. External · With many international companies Collaborations and research organisations, e.g. LTC, Boehringer-Ingelheim, Max-PlanckInstitutes, etc. Request for · ProBioGen works with biotech and Further Collaborations pharma companies developing complex therapeutic glycoproteins or viral vaccines. Services include cell line and process development, up to GMP-manufacturing, based on animal or human cell lines. In addition, proprietary product/process-improving technologies are out-licensed.

Intelligent biopharmaceutical solutions Internationally renowned specialist for developing and manufacturing complex therapeutic glyco-proteins; state-of-the-art service packages plus innovative platform technologies. Manufacturing authorisation for human biopharmaceuticals and operating to quality standards of the EMA and FDA.

Experience & client feedback Over 20 years a successful development partner for leading biotechs & pharmas on novel products, biosimilars, and biobetters, e.g. Fc-fusion proteins, clotting factors, enzymes, or others. Clients value our scientific expertise, excellent working relationships, and outstanding flexibility.

Services Quality development services Offer as true “one-stop-shop” complete service packages from early lead optimisation, rapid and integrated development of high-producer cell lines, processes and analytical methods, up to full GMP manufacturing programmes. Comprehensive analytics portfolio, incl. standard inprocess & release tests, and in vitro bioactivity assays. Innovative technology platforms to optimise yields, boost product potency, increase development speed, or cut manufacturing costs; all independently licensable. Integrated cell line and process development Pharmaceutical cell line development platform based on proprietary, royalty-free expression vector technology, various pre-selected CHO host cells, and own chemically defined media platform. Excellent reputation of cell line development skills based on fine-tuned, individually adjusted clone selection procedures and early integration of upstream and downstream selection parameters. This allows selecting the optimal expression strategy for each protein and enables rapid, economic upstream process development. Reliable and flexible contract manufacturing Offers GMP production in fully state-of-the art disposable systems in fed-batch and continuous processes in up to 1,000 L bioreactors, incl: ·· Downstream Process Development


We Wemake makeour ourexperience experienceyours. yours.

·· Cell Banking (MCB/WCB) ·· GMP Manufacturing ·· Analytical Development Cell-based activity assays An range of cell-based activity assays for potency and mode-of-action analyses is established.

Technologies GlymaxX® ADCC Enhancement Glyco-engineering technology preventing cellular fucose synthesis and thus antibody fucosylation for maximised ADCC cell-killing activity against tumour and infected cells. Works for novel and existing producer cell lines, external expression platforms, or can be licensed alone. Glyco-engineering Fucose, galactose, and sialic acid levels of glyco-proteins can each be adjusted, e.g. in biosimilar projects. Site-specific antibody drug conjugates A novel, site-specific, enzymatic ADC technology is available for licensing or in-house development, fully compatible with ProBioGen’s development platform. Productivity-boosting pathway modulator Stable introduction of an engineered cdc42 enzyme typically increases cellular productivity 2-fold. Just as GlymaxX® applicable to existing cell lines and expression platforms, independently licensable. Human artificial lymph node: immunofunction Fully human mini-bioreactor technology to test longterm drug effects on the immune system in vitro. Unique 3D-matrix-assisted system uses primary cells to mimic immune reactivity in vivo, to analyse immunogenicity, immune-modulation, and -toxicity. AGE1.CR® viral vaccine manufacturing platform AGE1.CR® duck cell line replaces primary chicken fibroblasts for GMP-compliant viral vaccine production, incl. highly attenuated ones, e.g. MVA and viral vectors. Chemically defined media platform and scalable suspension processes for industrial production. 19 th Guide to german biotech companies 2018

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

· · · · · · · · · · · ·

Maaßstraße 30 69123 Heidelberg Baden-Wuerttemberg Katja Betts +49-6221-8278-16 +49-6221-8278-24

F L I 21 1983 S1, S2, L2 class laboratories, DIN ISO 13485 certification for the production of in vitro diagnostic kits and research reagents.

Areas of Activity · Antibodies and reagents for biomedical research, in vitro diagnostics, ELISA, AAV gene therapy tools, antibody phage display technology, density gradient media. Annual Turnover · €3.0m 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 antibody-based products & services.

Research antibody pioneer Since 1983, PROGEN has been an established manufacturer and supplier of premium antibodies, in vitro diagnostics, and reagents for the global life science research community. The company’s portfolio attracts and serves a well-diversified clientele in research institutes and universities, pharmaceutical and biotech companies as well as private and clinical laboratories. While PROGEN’s antibodies are among the most published antibodies in biomedical and cell biology literature, its ELISA kits aim at niche markets in microbiology, infectious diseases and immunology. Building on its extensive core-competency and experience in immunochemistry, the company has expanded its product and service portfolio in recent years to include recombinant antibody engineering, antibody phage display technology, density gradient media, and AAV test kits for gene therapy research.

New areas of expertise: AAV-based tools and phage display technology Adeno-associated viruses are widely used for gene delivery in mammalian cells. Purification and capsid titer determination of AAV-vectors are critical steps for the assessment of correct AAV-concentrations, especially in the development of safe and effective gene therapies. PROGEN offers a unique range of AAV-titration ELISA kits that specifically recognise intact AAV particles. These ELISA kits have earned reference standard status in gene therapy centres worldwide. As the field of gene therapy advances, PROGEN continues to develop key tools for AAV-based research and development. The hyperphage technology has revolutionised the generation and engineering of specific monoclonal antibodies in recent years. It improves antibody presentation in phage display by dramatically increasing the number of antibodies displayed per phage particle, thus representing a leap forward in functional gene analysis and proteomics. In cancer research for example, hyperphage-packed libraries are used to discover new tumour markers. In order to meet the growing demand in


passion for research these research areas, PROGEN is offering hyperphage technology as an effective tool for the generation of recombinant antibodies, proteins or peptides.

Commitment to quality & service PROGEN’s longstanding success is based on premium products and individual services by trained and experienced personnel. The production area (S1, S2, L2 class laboratories) is qualified for manufacturing under quality assurance conditions according to DIN ISO 13485 for the production of in vitro diagnostic devices and research reagents. Rigorous quality management and quality control systems combined with reliable, individual pre- and post-sales support ensure high customer satisfaction.

Collaborations to meet existing and future demands

Antibodies AAV-Tools Phage display technology ELISA Density gradient media

Since 2012, PROGEN has been a 100% subsidiary of the R-Biopharm AG based in Darmstadt/Germany, a developer of test solutions for clinical diagnostics and food & feed analysis. This corporate affiliation offers new possibilities for the growth of PROGEN’s product & service portfolio. In addition, Dr Sven Kuhlendahl, PROGEN’s general manager since 2014, intends to expand the stable network in academia and industry that has been established over the past 34 years: the company is actively seeking strong collaborators to develop novel antibody-based technologies and applications in order to strengthen its pipeline of life science reagents. Together with its partners, PROGEN aims to support and extend existing markets as well as to enter new ones. 19 th guide to german biotech companies 2018

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

· · · · · · · · · · · ·

Fraunhoferstrasse 22 82152 Martinsried Bavaria Andreas Vogel +49-89-45-22-89-700 +49-89-45-22-89-717

LI 10 2010 l Chemistry l Cytotoxic l BSL-1 l BSL-2

Areas of Activity · l CRO l Parenterals l Biologics l QbD-based drug product development l Formulation and process development l Freeze-drying l Cytotoxics l Pre-clinical study supply l Technology transfer

ProJect Pharmaceutics, based in Martinsried/Munich, Germany, transforms promising compounds such as proteins, peptides, highly-concentrated proteins and antibodies, vaccines, ADCs, and other delicate cytotoxic molecules into pioneering drugs. We add value to our international clients’ biopharmaceutical products by applying innovative, QbD-based concepts of pharmaceutical development as increasingly requested by regulatory authorities. Amongst other concepts we are predominantly valued for our high throughput screening approach called “predictive formulation analytics”. ProJect Pharmaceutics is one of the leading CROs collaborating with its clients on the development of stable formulations and processes utilising DoE study designs for liquid and/or lyophilised parenteral drug product presentations. As a well-trusted development service provider operating with state-of-the-art technologies, ProJect Pharmaceutics designs optimised pharmaceutical formulations and parenteral/topical delivery systems for biologics that are stable, convenient, and safe. Unlike the prevalent trial-and-error approaches, we make it our business to design a quality product and its manufacturing process on a sound scientific rationale pursuant to ICH Q8 and other guidelines, thus truly supporting the establishment of a design space, specifications, and manufacturing controls. We pay particular attention to ensure processability of all our formulations under standard aseptic conditions. Our formulation and process excellence on biologics merges well with cytotoxic drug expertise towards an outstanding position within the pharmaceutical industry: we resourcefully develop tailored pharmaceutical formulations and lyophilisation processes for biologics including ADCs and other highly potent drugs in our expanded and technically upgraded safety laboratories. Notably in our innovatively implemented S2-safety laboratory we now offer these pharmaceutical development services also for e.g. the stabilisation of freezedried live vaccines.

project pharmaceutics

Tailored to these optimised systems the company develops cost-effective manufacturing processes and high-end freeze-drying cycles and transfers those from its own pilot labs to large-scale manufacturing. We make sure that investigational products are developed effectively and will run smoothly in clinical and commercialscale GMP manufacturing. ProJect Pharmaceutics is managed by leading experts in protein formulation and process development with many years of experience in (bio)pharmaceutics. The combined expertise and complementary set of qualifications enables our team to deliver the high-tech pharmaceutical services that are in increasing demand for the global pharmaceutical industry. We offer: ·· protein formulation using high throughput screening “predictive formulation analytics” (PFA) – a scientifically structured QbD-based algorithm to shift all kinds of protein stability towards its maximum ·· PFA-tweaked down-stream process optimisation ·· formulation development for cytotoxics and antibodydrug-conjugates ·· high protein concentration formulations (e.g. in prefillable syringes) ·· stabilisation of freeze-dried biological agents (up to BSL-2) e.g. live vaccine products ·· liposomal formulations and manufacturing processes ·· concentration (mock-up) studies using UF/DF for proteins and ADCs (pilot scale) ·· challenge testing and accelerated stability studies ·· robust and efficient lyophilisation process development and optimisation ·· lyophilisation in dual chamber prefilled syringes ·· process robustness testing and evaluation of design space according to ICH Q8 ·· compatibility studies on container closure material ·· manufacturing of pre-clinical study materials ·· process compatibility studies and technology-transfer including scale-up to GMP-manufacturing

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

· · · · · · · · · · · ·

Breisacher Str. 117 79106 Freiburg Baden-Wuerttemberg Dr Christoph Schächtele +49-761-769996-0 +49-761-769996-1781

I 37 2001 Drug discovery in oncology

External · Multiple collaborations with academic Collaborations institutions and biotech companies Request for · Together with experienced chemistry Further Collaborations providers, ProQinase offers collaboration for integrated drug discovery projects in oncology up to demonstration of efficacy in animal models

Company mission It is ProQinase’s mission to be a leading solution provider for drug discovery in oncology.

History ProQinase was founded in 2001 as a 100% subsidiary of the Tumor Biology Center Freiburg. In 2015 the company was acquired by Chinese investors. The company’s unique cancer drug discovery platform is ideal to develop novel therapeutic agents for tumour therapy. In the past, this platform has successfully been used for internal drug development projects. For some years now, ProQinase’s focus is on the fee-for-service business.

Products & services ProQinase offers a unique panel of tools and services for drug discovery in oncology: Recombinant Proteins ·· Recombinant protein kinases which can be used for biochemical kinase assays ·· Lipid kinases ·· Recombinant substrates for protein kinase activity assays ·· Other recombinant proteins Biochemical Assay Services Biochemical kinase assay services for identification and characterisation of small molecule kinase inhibitors ·· Radiometric assay technology ·· Totally flexible projects (any numbers of kinases, cpds., conc. and replicates) ·· Standardised whole kinase panel profiling with 400 protein kinases and 13 lipid kinases ·· Binding assays for protein-protein interaction


Cell-based Assay Services ·· Target-specific cellular phosphorylation assays ·· Cell proliferation assays ·· Soft agar assays ·· Cell migration assays ·· 3D Tumor spheroid assays ·· Cellular angiogenesis assay Syngeneic & Xenogeneic In Vivo Models ·· Subcutaneous tumour models ·· Orthotopic tumour models ·· Metastasis tumour models ·· In vivo angiogenesis model ·· Immuno-oncology platform ·· Proprietary syngeneic tumor models

Worldwide customers ProQinase offers its tools and services worldwide to pharmaceutical and biotech companies of any size, as well as to academic institutes. In 2015, 7 of the top 10 pharma companies used ProQinase’s services.

Business models ProQinase offers any product or single service module on a fee-for-service basis. In addition, ProQinase strives for long-term relationships with clients which are interested in integrated cancer drug discovery projects starting from hit identification up to proof of concept in animal models.

Personnel Our team of internationally trained scientists has more than 20 years experience in cancer drug development. The focus of our scientific experience is on protein kinase and angiogenesis research. We believe that this makes us a qualified and reliable partner for cancer drug discovery targeting protein kinases and other target molecules.

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Name · Protagen Protein Services GmbH Address/P.O. Box · Inselwiesenstr. 10 Postal Code/City · 74076 Heilbronn State · Baden-Wuerttemberg Branch:  Otto-Hahn-Str. 15 44227 Dortmund Contact Person · Martin Blüggel Telephone · +49-7131-74504-0 Fax · +49-7131-74504-299 Email · contact@ Website · Social Media · I Number of Employees · 82 Founded (year) · 1997 Type of Laboratory · Protein GMP Compliant Areas of Activity · | Biopharmaceuticals | Biosimilars | Protein Characterisation | Antibody Drug Conjugates | New Biological Entities | Host Cell Proteins | Analytical Method Development | Stability Testing | GMP Release Testing Strategic Partners · Member of The Biosimilars Group GmbH Vela pharmazeutische Entwicklung und Laboranalytik GmbH Vienna, Austria Charles River Biopharmaceutical Services US, Germany, Ireland, Scotland

Biopharmaceuticals Protagen Protein Services (PPS) is a leading provider of contract analytical services in protein science. Long experience of PPS in business and the comprehensive spectrum of validated analytical methods ensure the highest quality to the customers in the pharmaceutical, biotech and life science industry. PPS provides a strategic approach for characterising biopharmaceutical products. Analysis is performed in a GMP-compliant laboratory that fulfils the latest regulatory requirements. PPS provides state-of-the-art protein analytics for: ·· Comparability: Comparability studies should include characterisation, physicochemical properties, biological activity, purity, impurities and stability. ·· Stability:  These studies enable the assessment of shelf life for new drugs and also allow the study of possible degradation pathways in more detail. ·· Release  testing: Products entering the pharmaceutical market require cGMP testing to certify that they are released in accordance with regulatory standards. The analyses should be carried out according to sets of guidelines that describe the rules for showing product quality. ·· Process development: Determination of critical quality attributes support the development of up- and downstream processing ·· GMP/GLP:  Good manufacturing practice (GMP) is a set of guidelines that outline rules applying to the production and testing of drugs such as biopharmaceuticals. The main focus of GMP is to ensure the safety of drugs and to set up a rationale for the safe release of drugs onto the market. ·· ICH Q6B: This guidance document ICH Q6B provides a uniform set of internationally accepted specifications for the characterisation of biotechnological and biological products to support new marketing applications. The analysis of biopharmaceuticals is carried out for all biologics that are developed, such as Antibodies, Antibody Drug Conjugates, New Biological Entities and Biosimilars.

Protagen protein services

Biosimilars Besides a large number of new biological entities (NBE), PPS has successfully supported over two dozen different customers in multiple projects for developing biosimilars using state-of-the-art analytical methods. Typical studies include: ·· Detailed structural characterisation of originators and biosimilar candidates according to ICH Q6B ·· Analytical support in cell line and process development based on rational selected quality attributes ·· Biosimilarity/comparability exercise from single to multiple batch-to-batch comparison ·· Stability testing ·· Batch-to-batch consistency studies ·· GMP batch release testing The analytical reports on biosimilars and biobetters has been accepted by multiple regulatory bodies worldwide including e.g. FDA (USA), EMA (EU), ANVISA (Brazil) and MFDS (Korea) during all stages of development: scientific advice, phase I, phase III to marketing authorisation.

Protein characterisation PPS provides you with the full range of services, from drug discovery and development to release testing and regulatory compliance under ICH Q6B: ·· Protein quantification by means of amino acid analysis and extinction coefficient. ·· Protein primary structure analysis, which involves a combination of different techniques (i.e. peptide mapping, de-novo sequencing, intact mass, N/C-terminal sequencing and disulfide linkage) to allow for complete understanding. ·· Glycosylation analysis to identify common and biologically relevant modifications. Several techniques (i.e. N-linked glycosylation, O-linked glycosylation, sialic acid, site of modification, quantification, monosaccharide) can be applied. ·· Bioassays which are integral to quality assessment during the development and manufacturing of biological drugs. ·· Impurities analysis to assist with the purification of proteins and enable you to use them in research or medical applications. 19 th Guide to german biotech companies 2018

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

· · · · · · · · · · · · ·

Erwin-Rentschler-Str. 21 88471 Laupheim Baden-Wuerttemberg Dr Marion Schrader +49-7392-701-0 +49-7392-701-300

FIQ 750 1927 S1 l Contract bioprocess development and manufacturing partner for biopharmaceuticals l Focused on mammalian cell culture l Aseptic filling of biopharmaceuticals l Project management l Global regulatory support

External · l Strategic Alliance with Leukocare AG, Collaborations located in Munich, Germany, a Biotech company for formulation development l Strategic Partnership with Rentschler Fill Solutions GmbH, located in Rankweil, Austria, for aseptic filling Request for · Rentschler Biopharma seeks Pharma Further Collaborations and Biotech companies needing bioprocess development and cGMP manufacturing solutions and interested in long-term collaboration

Passion for performance Rentschler Biopharma is a biotechnology pioneer, specialising in mammalian cell culture with expertise in recombinant proteins. As a full-service Contract Development and Manufacturing Organisation (CDMO), the company is a proven outsourcing partner and one of the leaders in the industry. Focused on the bioprocess development and manufacturing of biopharmaceuticals, we support our global clients through to market approval of their products. The company’s clients include innovative biotech companies as well as major pharmaceutical companies around the world. Founded in 1927, Rentschler Biopharma is a familyowned company located in Laupheim, Germany employing approximately 750 people. Many years of experience and excellence in finding solutions as well as certified quality management and advanced technologies ensure Rentschler Biopharma, high-quality standards. Rentschler Biopharma provides an essential contribution to the global availability of biopharmaceuticals and thereby helps millions of people each day.

Full-service concept The full-service offering of Rentschler Biopharma covers all activities from bioprocess development through to manufacturing, from analytical characterisation to fill & finish. Our experience covers the manufacturing of recombinant proteins such as monoclonal antibodies, fusion proteins, cytokines, and enzymes in compliance with international cGMP standards (EMA/FDA). The state-of-the-art cGMP facilities and cell culture processes, allowing us to manufacture material for clinical phases and commercial supplies. Constant monitoring of regulatory environments and deep experience in the creation of approval documents at an international level ensures that each project is documented in accordance with regulatory requirements. The Alliance with Leukocare AG strategically aims to incorporate formulation development at every step throughout biopharmaceutical development and manufacturing. Working closely with the client, this will ensure

Rentschler Biopharma

that the end products will – from the very beginning – have an advanced formulation and administration mode. This innovative approach will provide clients significant competitive advantages, enabling them to exploit the full potential of their products and markets. The Strategic Partnership of Rentschler Biopharma and Rentschler Fill Solutions provides one-stop solutions with new state-of-the-art fill and finish facilities and unites two centres of excellence for the rapid and efficient bioprocess development, manufacturing, and filling of biopharmaceuticals with the Rentschler commitment to quality.

Bioprocess development ·· Development of production cell lines ·· Development and optimisation of cell culture and purification processes ·· Process characterisation and validation ·· Advanced formulation development ·· Development, qualification, and validation of analytical methods

cGMP manufacturing and aseptic filling ·· Clinical and commercial drug substance manufacturing ·· Stainless steel bioreactors up to 3,000 L ·· Single-use bioreactors with up to 2,000 L ·· Fed-batch and continuous processing ·· State-of-the-art purification processes ·· Production, testing, and storage of master and working cell banks ·· Aseptic liquid filling in vials and lyophilisates

Associated consulting activities ·· Detailed and reliable consulting and planning in every phase of client projects ·· Managing all aspects of the project, including monitoring the timeline, goals, and budget. ·· Regulatory support including advice and assistance with regulatory questions, and the generation of the complete documentation for approval (IND/IMPD CMC parts) 19 th Guide to german biotech companies 2018

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Name · Richter-Helm BioLogics GmbH & Co. KG Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email

· · · · · · ·

Website Number of Employees Founded (year) Areas of Activity

· · · ·

Suhrenkamp 59 22335 Hamburg Hamburg Dr Kai Pohlmeyer +49-40-55290-430 +49-40-55290-888 k.pohlmeyer@ 171 1987 Contract development and manufacturing of biopharmaceuticals derived from microbial systems

Biological Patents · Several patents on manufacture of recombinant proteins External · Richter-Helm is working with Biotech Collaborations and Pharma companies worldwide Request for · Richter-Helm’s Business Development Further Collaborations team will be pleased to learn more about your needs for development and GMP manufacturing services to bring your project one step further. For more detailed information please contact us.

German reliability and thoroughness Richter-Helm is a Hamburg, Germany-based contract development and manufacturing company specialised in products derived from bacteria and yeasts, with a proven 30-year track record. Count on us to flexibly provide a comprehensive range of services and customised solutions. Clients worldwide have already benefited from our commitment to good manufacturing practice and total transparency. Our work focuses on recombinant proteins, plasmid DNA, antibody fragments, and vaccines. Our seasoned, 170-strong team supports you with process development, supply of products for clinical trials, commercial production, in-house QC testing, and QP release. We operate two GMP-compliant production plants with bioreactor capacities of up to 1,500 litres. Richter-Helm consistently works to the highest standards of pharmaceutical quality. This has been verified by major regulatory bodies including EMA, FDA, ANVISA, and MFDS, as well as by numerous customer audits. In addition, Richter-Helm is the platform of its mother companies Gedeon Richter and Helm AG for worldwide licensing options as well as partnerships for co-development and marketing of microbial-derived biopharmaceutical projects.


Products and services The teams at Richter-Helm have excellent expertise in development and GMP-compliant production of biologicals and biosimilars. Therefore Richter-Helm offers a full range of biopharmaceutical services: ·· Strain development (e.g. E.coli) ·· Establishment of cell banks (MCB/WCB) ·· Process development (USP/DSP) ·· Process optimisation ·· Development of analytical methods (incl. biological assays) ·· Validation of analytical methods ·· In-house QC testing and release ·· GMP manufacturing for phase I to III ·· Commercial GMP manufacturing ·· Process characterisation ·· Process validation ·· Stability studies according to ICH ·· Regulatory support 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 customers. Each project is treated individually and with the highest flexibility from RHB’s side.

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Name · Roche Diagnostics Deutschland GmbH Roche CustomBiotech Address/P.O. Box Postal Code/City State Telephone Fax Email Website Areas of Activity

· · · · · · · ·

Sandhofer Strasse 116 68305 Mannheim Baden-Wuerttemberg +49-621-759-8580 +49-621-759-6385 l Enzymes, substrates, kits and kit components for the pharmaceutical and diagnostic industry l OEM reagents for diagnostics l Cedex Analyzers for monitoring of cell culture and fermentation processes The Roche CustomBiotech headquarter is located in Penzberg, Germany. Roche Penzberg Quality Management System (QMS) ist certified according to ISO 13485. Production is performed according to GMP guidelines on demand as well as aminal- and antibiotic-free production.

Company profile Building on over 30 years of industry experience, Roche CustomBiotech uses the powerful multidisciplinary skills found in Roche facilities throughout the world. The team offers products and solutions for manufacturers in the diagnostics and Pharma/Biotech industry, ranging from raw materials to system solutions for bioprocessing. Roche CustomBiotech facilitates access to products and technologies that Roche has developed over years. More than 1000 IVD and Pharma companies around the world already benefit from partnering with Roche CustomBiotech in numerous applications and processes.

Portfolio for manufacturers of immunology and clinical chemistry assays The clinical chemistry portfolio offers a comprehensive range of enzymes and substrates which are required in IVD reagents. The immunoassay portfolio is designed to meet customers’ needs and to save development time for diagnostic assays. High-quality enzymes are complemented by substrates, antibodies, marker enzymes, and immune interference blockers.

Portfolio for manufacturers of molecular diagnostics assays As a leading raw materials provider for molecular diagnostic assays, Roche CustomBiotech provides products for sample preparation, amplification, and detection. GMP production ensures extensive documentation for submission to regulatory authorities, the highest possible quality, performance, reproducibility, and supply security.


Portfolio for the pharmbiotech industry Our extensive product portfolio includes enzymes, cofactors, substrates, PCR-based kits for rapid microbiological methods, and our Cedex HiRes, Cedex Bio, and Cedex Bio HT Analyzers for cell growth and fermentation process monitoring. They allow the detection of subtle changes in nutrients, metabolites, or cell morphology and growth, enabling informed decisions and immediate response in process development as well as manufacturing. Further, our portfolio includes PCR-based kits for rapid monitoring of mycoplasma and host cell contamination of biopharmaceuticals. With our toolbox of in vitro glycoengineering enzymes and substrates, the glycan structure of proteins can be systematically optimised after fermentation.

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Name · Sartorius Stedim Biotech Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · · ·

August-Spindler-Str. 11 37079 Goettingen Lower Saxony Dominic Grone +49-551-308-0 +49-551-308-3289

I 4,725 (for 2016) 2007 Cutting-edge products, technologies, and services for biopharmaceutical applications

Annual Turnover · €1,051.6bn (fiscal year 2016)

Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. The company focuses on single-use technologies and valueadded services to meet the rapidly changing technology requirements of the industry it serves. Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America, and Asia and a global network of sales companies, Sartorius Stedim Biotech has a global reach.

Products and services Fermentation The widest range of bioreactors and fermentors from benchtop to process scale and from disposable to reusable technologies. Filtration A complete, scalable array of filter capsules and cartridges for all bioprocessing steps – backed by decades of experience in filter technologies. Purification A leading position in crossflow filtration, membrane chromatography, and virus removal technologies for state-of-the-art initial recovery and contaminant clearance in biomanufacturing.

sartorius stedim biotech

Fluid management Pioneer and leader in single-use systems, freeze-thaw processing and aseptic transfer systems, with the most extensive capabilities for creating fully integrated, single-use biomanufacturing solutions. Media Sales and marketing of cell culture media and buffer solutions for biopharmaceutical manufacture. Services Expert services for process development, process optimisation, validation, and regulatory support â&#x20AC;&#x201C; rapidly deployable and globally available.

Management â&#x20AC;&#x201C; executive committee of the board Dr Joachim Kreuzburg Chairman of the Board and Chief Executive Officer Volker Niebel Executive Vice President of Operations and IT Dr Oscar-Werner Reif Executive Vice President of Research and Development Reinhard Vogt Executive Vice President of Marketing, Sales and Services

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Name · Sartorius Stedim Cellca GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · ·

Erwin-Rentschler-Strasse 21 88471 Laupheim Baden-Wuerttemberg Birgit Schumacher +49-7392-96648-0 +49-7392-96648-193 90 2005 l Cell line development l Process development l Process transfer l Media

Sartorius Stedim Cellca is a leading provider of cell line development and upstream process development services for large-scale protein production of biopharmaceuticals in mammalian (CHO) cells and also licenses technologies for the production of proteins and offers cell culture media. For this purpose, Cellca has devised a unique, cost-effective, and reliable technology platform that consistently delivers well-characterised and stable research clones from DNA to Research Cell Bank in 4–5 months, with titres upwards of 3 g/L in an easily scalable fed-batch process. The technology platform is made up of 4 key components: ·· Expression Vector ·· Host Cell Line ·· CHO Media System ·· Upstream Process Design Together they deliver high-yielding, stable cell lines and robust, simple, fed-batch processes for the biopharmaceutical market. The Cellca CHO Expression Platform is an easily accessible, scalable, and robust system that takes your product from DNA to RCB in just 4 months. Cellca has a successful track record with more than 60 successfully completed customer projects.

Sartorius stedim cellca

Customers first As well as our unique technology platform, we consider our customers Cellcaâ&#x20AC;&#x2122;s greatest asset. To achieve our purpose of providing high-producing, stable cell lines to our customers, our dedicated cross-functional project teams work meticulously on the successful realisation of each project. We believe in a continuous dialogue between the customer and project team to ensure a steady effective flow of information during all project stages. Thereby, we guarantee competent responsiveness on all levels and manage your cell line and process development programme accordingly. Our satisfied loyal customers have repeatedly recommended Cellcaâ&#x20AC;&#x2122;s CHO cell line development and upstream process development services to their peers, enabling continuous growth of our global customer base, which currently includes about 30 large and small pharma or biotech companies from Europe, the USA, Asia, and Australia, with a customer retention rate of more than 80%. Industry references available on request. Contact our experts to discuss our cell line development services today! Founded in 2005, Cellca was acquired by Sartorius Stedim Biotech in 2015 and is located in Laupheim, Germany. More information on

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Name · SYNIMMUNE GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · ·

Alte Landstrasse 42 72072 Tübingen Baden-Wuerttemberg Dr Martin Steiner +49-7071-770-8382 +49-7071-770-8383 3 2011 l Drug development l Oncology l Immune oncology

Biological Patents · Granted patents in US and EU l FLYSYN l TACSYN l Bispecific antibody platform Request for · Synimmune is looking for development Further Collaborations and commercialisation partners for its FLYSYN and TACSYN and for R&D partners interested in applying SYNIMMUNE’s proprietary bispecific antibody platform for the development of new antibodies.

Company overview SYNIMMUNE GmbH is a biotechnology company dedicated to the development of innovative and effective mono- and bispecific anti-tumour antibodies for the treatment of patients suffering from life-threatening diseases, with a focus on orphan hematopoietic malignancies. SYNIMMUNE’s lead product candidate is the antibody FLYSYN, which is currently being evaluated in a first-in-human Phase I clinical study in acute myeloid leukemia (AML). SYNIMMUNE GmbH is a spin-off of the Department of Immunology of the University of Tuebingen. The Company is financed by grants from the German Ministry of Education and Research (BMBF) within its GO-Bio programme as well as with investments from the German KfW and private equity.

Lead product – FLYSYN The chimeric and Fc-optimised IgG1 antibody FLYSYN binds specifically and with high avidity to the human fms-like tyrosine kinase 3 (FLT3). An increased expression of this cell surface receptor is measured on leukemic blast cells in 70–100% of AML patients, while only low copy numbers of FLT3 are expressed on monocytes and progenitor stem cells, avoiding off-target binding and stem cell toxicity. Therefore, FLT3 is a suitable and highly selective target for SYNIMMUNE’s therapeutic antibodies to treat leukemia patients. FLYSYN contains a genetic optimisation of its Fc-part, resulting in optimised binding to cells expressing the Fc receptor, particularly Natural Killer (NK) cells, and thus in substantially improved antibody-dependent cell-mediated cytotoxicity (ADCC). FLYSYN is a monospecific antibody for the treatment of AML patients at a stage of minimal residual disease (MRD). Most AML patients achieve complete remission (CR) with MRD after regular chemotherapy, but the majority relapses to AML within several months, requiring additional courses of chemotherapy or stem cell transplantation. FLYSYN is intended to delay or prevent such relapse in AML patients with MRD. FLYSYN is currently being evaluated in 28 AML patients in a multicenter Phase I/II clinical study at the University hospitals of Tübingen, Ulm, and Heidelberg.


Bispecific antibody platform – TACSYN SYNIMMUNE focuses also on the development of antibodies which are based on its proprietary, patent protected platform technology for bispecific antibodies. These antibodies do not only bind to tumour cells and recruit and activate T-cells to kill tumour cells, but also induce proliferation of such T-cells and consequently amplify the immune response.










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SYNIMMUNE’s proprietary bispecific antibodies offer key competitive advantages including: ·· No aggregate formation, and therefore reduced offtarget activity ·· No binding to Fc receptors and therefore exclusive targeting of tumour cells and T-cells ·· Increased production yield and easy purification ·· Improved stability and increased half-life resulting in longer bioavailability of higher amounts of antibody ·· Applicability for multiple antibody combinations in broad disease indications ·· Protection by granted patents in US and EU. SYNIMMUNE’s lead product based on its proprietary antibody platform, TACSYN, is a bispecific antibody targeting FLT3 and CD3, a T-cell receptor exclusively expressed on the T-cells. TACSYN is indicated for the therapy of AML and acute lymphoblastic leukemia (ALL) in patients displaying a persistence of disease after chemotherapy or relapse of disease. SYNIMMUNE has completed the preclinical characterisation of TACSYN and has demonstrated high target specificity, no aggregate formation, no off-target activation and specific lysis of FLT3 expressing tumour cells. TACSYN is ready to enter preclinical development and GMP manufacturing.

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

· · · · · · · · · · · ·

Paul-Ehrlich Straße 15 72076 Tübingen Baden-Wuerttemberg Renate Burnet +49-7071-6397812 +49-7071-964326 50 2004 S1, S2 l Drug discovery l In vivo pharmacology l Medicinal chemistry l Analytical work l Immuno-oncology l Inflammation l Infection l NASH l Diabetes

Biological Patents · 21 External · l Diagnostics Collaborations l Formulations, NCEs for infection Request for · l Immuno-oncology Further Collaborations l Infection l Airway monitoring

Synovo is a drug discovery and services company focused on diseases related to inflammation. It was founded by Michael Burnet in 2004 and has operated profitably since. It now has 50 employees in Tübingen at two sites. Synovo has a well-trained team of chemists, biologists, biochemists, and pharmacists who together provide pre-clinical development services for pharma and biotech companies. Central to our offerings are: ·· ·· ·· ·· ··

In vivo disease models Pharmacokinetics and distribution Medicinal chemistry and formulation Analytics HPLC/MS/GC as standard services Medical writing

Synovo offers its services in well-equipped laboratories working under ISO 9001. Synovo is able to offer models, research, and medicinal chemistry with standard protocols and procedures. Synovo also develops protocols together with its clients under research conditions. Synovo has in house chemistry facilities, so that pharmacology can be coupled with compound formulation, galenics, and stability studies if necessary. Synovo has an in house testing system for quantification of clinical parameters in plasma and/or blood, using less than 2 µL sample volume. The disease areas we work on include: ·· Cancer – Immuno-oncology ·· Liver and metabolic disease (e.g. NASH) ·· GI – inflammation ·· CNS – Alzheimer’s/MS/pain


Discovery research Synovo also conducts discovery research together with public and private sector partners.

Diagnostics An innovative detection system for wound and airway infections has been developed by Synovo and its partner Qualizyme diagnostics. This was one of the top 3 finalists for the H2020 Prize “Better Use of Antibiotics” of the European Commission in 2017. This has been validated in clinical studies and is now being prepared for the market.

Therapeutics research Early stage research at Synovo has two main themes related to innate immunity: ·· modulators of myeloid cells for use in cancer therapy ·· novel anti-infectives that promote intracellular bacterial killing

Orphan designations Based on our research, we have two products with orphan designations. SYD003 is an immune modulator that breaks immune suppression around the tumour and allows both chemotherapy and immune cells to degrade the tumour. Indications: pancreatic cancer (orphan drug designated, EMA and FDA), lung, gastric, and liver cancers. CSY0073 is a broad spectrum anti-inflammatory. Indications: CF (Orphan drug designated, EMA), and COPD.

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

· · · · · · · · · · · ·

Neurather Ring 1 51063 Cologne North Rhine-Westphalia Monika Hahn +45-70-23-04-05 +45-69-80-35-99

FL I H 800 worldwide 1952 S1

Taconic Biosciences is a fully-licensed, global leader in genetically engineered rodent models and services. Founded in 1952, Taconic helps biotechnology companies and institutions acquire, custom generate, breed, precondition, test, and distribute valuable research models worldwide. Specialists in genetically engineered mouse and rat models, precision research mouse models, and integrated model design and breeding services, Taconic operates three service laboratories and six breeding facilities in the U.S. and Europe, maintains distributor relationships in Asia and has global shipping capabilities to provide animal models almost anywhere in the world. Taconic’s main goal is always to provide our customers with the best solution and this begins with superior products. From high-performance standard strains, to exclusive best-in-class models, to the most comprehensive genetic and health quality programme, Taconic sets customers up for success. In addition to offering superior products, Taconic also has the most comprehensive gene modification toolkit in the industry.

taconic biosciences

Aerial view of Taconic’s Germantown facility

Offering CRISPR gene editing, homologous recombination gene targeting, shRNAi silence targeted gene expression, pronuclear injection, and targeted transgenesis, Taconic’s model generation team is able to help customers find the right solution by being able to leverage all relevant technologies, in combination with 20 years of experience. Finally, Taconic is the only comprehensive and integrated model design and breeding services provider, allowing seamless planning and integration of model generation and breeding projects. With PhD scientists managing and dedicated to each project from start to finish, Taconic starts each breeding discussion with a clear understanding of the customer’s goals and then creates a custom breeding plan with defined milestones. From the routine to the highly customised, Taconic’s quality and dedication to helping customer’s succeed is what has made us an industry leader for over 60 years.

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Name · TIB MOLBIOL Syntheselabor GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email

· · · · · · ·

Website Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · ·

Eresburgstraße 22–23 12103 Berlin Berlin Olfert Landt +49-30-787994-55 +49-30-787994-99 45 1990 chemical, S1 l Nucleic Acid Synthesis (DNA, LNA, RNA) l Real-Time detection l Assay Development l LightMix® Real-Time PCR Kits l LightMix® Modular PCR Kits

Annual Turnover · €17.0m Relevant R&D Budget · €1.2m Biological Patents · l Protected RNA standards l Real-Time PCR Clamping technology External · l Charité, Berlin Collaborations l Chemicell GmbH, Berlin l Chipron GmbH, Berlin l Dyomics GmbH, Jena l DRFZ, Berlin l Epigenomics AG, Berlin l GenExpress GmbH, Berlin l Institute Pasteur, Dakar l IT-IS, Stokesley l Microbiologia, Genoa l Mayo Clinic, Rochester l MyDiagnostics, Berlin l MyPOLS, Konstanz l Replicon GmbH, Berlin l Roche Diagnostics GmbH

TIB MOLBIOL TIB MOLBIOL has been providing custom oligonucleotides to customers worldwide for more than two decades, covering applications from life science research to product quality assessment to medical diagnostics. Our products can be used in qPCR, sequencing, FISH, arrays, immune stimulation (CpG), and other applications. As one of the first suppliers of synthetic DNA in Europe, we have not only set industry standards for quality and service, but continue to lead in fulfilling the customer’s demanding requirements for high-quality products and services. Development and production are ISO 9001 and ISO 13485 certified. Oligonucleotides are an important tool in genomic research and molecular diagnostics. PCR has revolutionised the molecular biology laboratory and has triggered an explosive number of novel and exciting applications. A central feature of our custom synthesis is our awareness of the individuality of our products, respecting individual needs and requirements – our product is the “individual oligo”. Fluorescence. TIB MOLBIOL offers a broad spectrum of fluorophore-labeled products spanning the visible spectrum from UV to IR, including the classic ABI dyes, Cyanine dyes (GE Healthcare), MegaStokes dyes (Dyomics), LightCycler ® dyes (Roche), and BHQTM and BBQTM quenchers. Real-Time PCR with TaqMan ®, SimpleProbe ®, HybProbe ® or Scorpion® oligomers. TIB MOLBIOL manufactures DNA and LNA probes for use in qPCR quantification and genotyping. LNA-based probes strongly increase specificity and sensitivity of Real-Time PCR assays. We also offer synthesis of SimpleProbe ® oligomers under license of Roche, Scorpion® primers under licence of Qiagen (DxS) and LNA probes and kits under licence of Qiagen (Exiqon). Assay Design in qPCR. Our design team would be delighted to assist in the design of suitable primers and probes for quantification use or nucleotide polymorphism detections with Real-Time PCR or to recommend published assays – our team has designed more than

tib molbiol

20,000 customer-specific assays. Client and sequence data are treated strictly confidential. Please contact LightSNiP Assays. Since 2007 developed more than 2,300 SimpleProbe® based ready-to-use assays for SNP analysis of any Genbank-listed human polymorphism (to be ordered by rs-number), available with positive controls since 2017. LightMix® Kits represent our product line of Real-Time PCR kits designed to be used with Roche LightCycler ® Instruments. LightMix ® Diagnostic Kits. The number of CE-IVD marked kits is growing – including gene typing kits (FV, F2, MTHFR, HFE, lactose intolerance) and pathogen detections as well as KRAS testing. LightMix® Modular Kits. Combine six or more assays in one multiplex DNA or 1-step RT qPCR for use in highthroughput screening – with maximum flexibility through the option to exchange assays. ModularDx kits cover many fields such as Carbapenemase bacterial resistance, Tropical, Respiratory Virus, Atypical Pneumonia, Gastro Virus, Bacteria and Parasite testing, and are to be extended to cover some 100 common pathogens. Selected panels are CE-IVD marked. ModularDx kits are distributed through Roche Diagnostics. Arrays. For information on the Chipron low-density arrays please contact:

·· ·· ·· ·· ·· ··

1990 founded as a private company in Berlin since 1993 production in Genoa, Italiy since 1995 production sp z o o in Poznan, Poland since 2000 TIB MOLBIOL LLC in Adelphia, USA since 2009 production in Madrid, Spain since 2014 global distribution through Roche

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Name · Tosoh Bioscience GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · ·

Im Leuschnerpark 4 64347 Griesheim Hesse Regina Roemling +49-6155-7043700 +49-6155-8357900 >20 1989 Supplier of chromatography media, HPLC and UHPLC columns Application support in analysis and purification of biomolecules.

Tosoh Bioscience is an acknowledged global leader in the field of liquid chromatography with a focus on bioseparations. For more than 25 years, Tosoh Bioscience is providing cutting-edge solutions to meet the needs of customers developing and producing new biologics, biosimilars or biobetters, such as plasma products, monoclonal antibodies, recombinant proteins, vaccines and oligonucleotides. Our product portfolio encompasses SEC instruments and a comprehensive line of media and prepacked process development, HPLC, and UHPLC columns. These products are popular in the biotech and biopharmaceutical industry and used in R&D, downstream processing, and quality control. Typical applications comprise the purification of therapeutic proteins in lab, pilot, and commercial scale, as well as their characterisation by HPLC or UHPLC. Latest developments comprise TOYOPEARL rProtein A HC for the capturing of antibodies – the alkaline stable Protein A resin with the highest capacity available on the market, salt tolerant ion exchange and mixed-mode media, and TSKgel size exclusion columns for highly efficient UHPLC analysis of antibody aggregation. 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 is also the sole sponsor for the renowned HIC/RPC Bioseparation Conference (

Tosoh Bioscience

Tosoh Bioscience is part of the Tosoh Group, a Japanese chemical and speciality products and materials group, founded in 1935, which comprises over 100 companies worldwide and a workforce of more than 11,500 people. Our brands TOYOPEARLÂŽ and TSKgelÂŽ are renowned for their quality and reliability. The stationary phases cover all common modes of liquid chromatography, including ion exchange, hydrophobic interaction (HIC), mixed-mode, reversed phase, hydrophilic interaction (HILIC), size exclusion (SEC) and affinity.

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Name · Vetter Pharma International GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone

· · · · ·

Email ·

Website Number of Employees Founded (year) Areas of Activity

· · · ·

Eywiesenstrasse 5 88212 Ravensburg Baden-Wuerttemberg Markus Kirchner +49-751-3700-0 (for international inquiries) +1-847-581-6888 (for US inquiries) (for international inquiries) (for US inquiries) Approx. 4,300 1950 Aseptic contract filling and packaging of compounds into syringes, vials, and cartridges

A strategic partner focused on your success Vetter is an international specialist in the production of aseptically prefilled syringe systems, cartridges, and vials. We are a family-owned, independent company and do not manufacture our own drugs. Our focus is on providing highly skilled support and state-of-the-art manufacturing resources – from the initial phases of clinical development and the regulatory approval process to successful product launch, commercial manufacturing, and life cycle management. Vetter has extensive experience with biologics and other complex compounds. More than 80% of Vetter’s active projects are biologics, and Vetter currently manufactures five of the world’s top 10.

Resources for every stage of growth Vetter’s full portfolio of services includes dedicated resources for both clinical development and commercial manufacturing. In addition, we provide expert packaging technologies and solutions tailored to your product’s specific market needs. Vetter Development Service Planning for success Preclinical through Phase III is a pivotal and unpredictable period for new molecules. Vetter Development Service helps smooth the path to clinic with dedicated support for key stages of development, testing, clinical manufacturing, and regulatory approval. We also help you integrate thoughtful, efficient life-cycle solutions for long-term growth and success. Vetter Development Service provides: ·· Formulation support ·· Process development ·· Clinical trial manufacturing ·· Analytical services ·· Regulatory support Vetter Commercial Manufacturing Filling your potential Precise manufacturing. Creative thinking. It takes both to succeed in a competitive marketplace. Vetter Commercial Manufacturing supports your injectable with

vetter pharma international



more than 25 years of expertise in high-quality, stateof-the-art aseptic filling – and experience-based solutions that add value and increase efficiency. Vetter Commercial Manufacturing provides: ·· Fill and finish ·· Analytical services ·· Regulatory support ·· Product life cycle management Vetter Packaging Solutions Packaging matters Material compatibility. Patient convenience. Market differentiation. There are many factors to consider in the selection of your primary and secondary packaging materials. Which ones matter most to your compound’s performance and long-term potential? Vetter’s packaging experts help you find the right solutions throughout your product’s life cycle. Vetter Packaging Solutions provides: ·· Customised packaging development ·· Specialised technologies ·· Proven platform technologies ·· Packaging services ·· Serialisation services ·· Logistic services

Fast facts: Vetter-at-a-glance


·· Headquarters in Ravensburg, Germany ·· Additional clinical development facility in Chicago, US ·· A representative office for Asia Pacific in Singapore and a subsidiary in Japan ·· Approximately 4,300 employees ·· Worldwide specialist in the aseptic production of prefilled drug delivery systems ·· Global experience and expertise with regulatory authorities including FDA, EMA, PMDA (Japan), and RP (Germany) ·· Manufacturing products for the top 20 pharma/biotech firms worldwide ·· Numerous patents including technologies for protection against tampering and counterfeiting ·· Lyophilisation (freeze-drying) and siliconisation specialist

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Name · Vibalogics GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Email Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · ·

Zeppelinstr. 2 27472 Cuxhaven Lower Saxony John Shaw +49-4721-565-400

I 45 2006 Biologics CMO l Live bacteria l Live virus l GMP manufacture l Process development l BSL-2 fill and finish lyophilisation development l Formulation development l Immunotherapy l Gene therapy l Vaccines

Vibalogics is a privately owned contract development and manufacturing organisation (CDMO) offering services for companies developing therapeutic and prophylactic vaccines and biological products. With a specific focus on viruses and live bacteria, we work in full compliance with international GMP standards in our BSL-2 classified state-of-the-art facility in Germany. We place the greatest value on being a reliable partner and offering a high quality, highly flexible service to our customers. Our services include:

Virus production We offer state-of-the-art production of viruses tailored to our customers’ requirements. We perform process development, cGMP manufacturing, aseptic fill and finish including lyophilisation, batch-release testing and QP release. ·· Cell banking and characterisation ·· Virus seed stock generation and characterisation ·· Feasibility studies and productivity optimisation ·· Genetic stability studies ·· Assay development including infectious particle, genomic virus particle, and total particle ·· Primary cell culture (CEFs) suitable for viruses such as MVA ·· Production of oncolytic viruses and gene vectors ·· Production in roller bottle, Cell FactoryTM, T-flask, HYPERFlaskTM, and iCELLisTM systems ·· Single-use, scalable bioreactor technology

Live bacterial product manufacture We are experienced with the manufacturing of vaccine candidates from microorganisms such as Mycobacteria, Salmonella, and Listeria. We develop and optimise manufacturing processes and our comprehensive service covers every step from cell banking to fill & finish. ·· Cell banking and seed lot manufacture ·· Process development ·· cGMP manufacture of therapeutic and prophylactic vaccines ·· Single-use, scalable fermentation technology ·· Lyophilisation development and formulation development ·· Aseptic filling of liquid presentations and lyophilisation if required


Egg-based virus production We rely on our comprehensive knowledge of all aspects of egg-based virus production. Virus material can be harvested from allantoic and amniotic fluids or chicken embryos. ·· cGMP virus production on SPF eggs ·· Batches of up to 5,000 eggs ·· Expertise in the manufacturing of DNA and RNA viruses

cGMP fill & finish Our focus is the filling of liquid and lyophilised drugs in vials. Validated cleaning procedures are established to prevent cross-contamination. Routine media fills for standard formats are performed. ·· Liquid and lyophilised products up to BSL-2 ·· Development lyophiliser for non-GMP batches and formulation/lyophilisation cycle development ·· Grade A/B clean room for manual and automatic operations ·· Manufacturing batch scale: ·  Manual filling of up to 1,500 vials ·  Automatic filling of up to 30,000 vials ·  Lyophilisation of up to 3,000 vials ·· Validated processes in place ·· Semi-automatic visual inspection ·· Packaging and labelling

Quality control ·· Development, establishment, and cGMP-compliant performance of compendial and customer-specific tests ·· Microbiological methods such as sterility, monosepsis, identity testing, and determination of CFUs ·· Molecular biological methods such as restriction analysis and PCR ·· Physical testing such as residual moisture, pH, and vacuum testing ·· Potency testing such as TCID50 and EID50 ·· Stability testing according to ICH guidelines

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Name · Vita 34 AG Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · · ·

Perlickstraße 5 04103 Leipzig Saxony Dr Wolfgang Knirsch +49-341-48792-45 +49-341-48792-39

F 101 1997 Umbilical cord blood and tissue banking

In 1997, Vita 34 was founded as the first private umbilical cord blood bank in Europe and has more than 20 years of experience in the field. The core business of Vita 34 is the collection, processing, and long-term cryopreservation of cord blood and tissue and the delivery of stem cell products for the therapy of different diseases. With more than 200,000 stem cell deposits, Vita 34 is the market leader in the German-speaking countries and the second largest bank in Europe. We already provided cord blood for 30 successful applications in various diseases. The company is licensed to manufacture and distribute autologous and allogeneic cord blood preparations. Together with our European subsidiaries and partners (e.g. in Denmark, Spain, Italy, Austria, and the Balkan states) as well as in strategic alliances worldwide (e.g. in Chile, Mexico, and Vietnam), we continuously enhance the knowledge of private stem cell banking. Thanks to the existing sales and marketing alliance in the Balkan States, we cover Slovenia, Serbia and Montenegro, Macedonia, Bosnia-Herzegovina, Romania, and Croatia. Moreover, Vita 34 is involved in stem cell research and collaborates in many cases with renowned research institutes and clinics in order to investigate the practical and medical possibilities of using umbilical cord stem cells or developing new cryopreserved stem cell products. Vita 34 is the only private stem cell bank in Germany that is licensed by the Paul-Ehrlich-Institute (PEI), an Agency of the German Federal Ministry of Health, and the Federal Institute for Vaccines and Biomedicines to dispense umbilical cord blood transplants for therapeutic use in hematological/oncological and immunological diseases to siblings, and to help other people in case of illness by means of unrelated donations. Furthermore, Vita 34 is licensed to collect, process, cryopreserve, and store umbilical cord tissue. In January 2017, the European Patent Office granted the patent on the processing and cryopreservation of umbilical cord tissue and the contained cells. Our preparations are thereby applicable for hematopoietic and regenerative stem cell therapies.

vita 34

Vita 34 will continue to accelerate growth in the future by introducing new products, thereby remaining an innovation leader in Europe. In 2016, the company was recognised as one of the hundred most innovative companies of German small and medium-sized businesses and honoured as on of the â&#x20AC;&#x153;Top 10 Cord Blood Banks Worldwideâ&#x20AC;?. Vita 34 is able to provide the overall knowledge in establishing and operating the stem cell business according to the highest medical quality standards (Good Manufacturing Practice â&#x20AC;&#x201C; GMP). The developments at Vita 34 are made at a modern laboratory by a team of highly qualified employees in the Research and Development Department. The top priority is to guarantee the highest quality standards and the best possible storage of stem cell preparations. In order to ensure this, the research and development team of Vita 34 has developed a proprietary collection kit with temperature control and all the necessary equipment needed to ensure the safe collection of cord blood and tissue at the hospital. The kit is at the same time a storage and transport container for the umbilical cord blood and tissue from the maternity hospital to the Vita 34 laboratory. These processes are the result of intensive, targeted research and development and are already used by subsidiaries and partners in 28 European countries.

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Name · X-act Cologne Clinical Research GmbH Address/P.O. Box Postal Code/City State Contact Persons

Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · ·

Rudi-Conin-Str. 4 50829 Cologne North Rhine-Westphalia Jasmin Atarodi (Managing Director) Ilka Strehlau (Head of Data Management) +49-221-55922-0 +49-221-55922-33

· · · · · IQ · >20 · 1994 · l Data Management l Biostatistical Services l Medical Services/Medical Writing l Quality Assurance/Audits

X-act Cologne Clinical Research GmbH is an independent and privately-managed contract research organisation in Cologne, Germany. Clinical data management and biostatistical services have been our core competencies since the company’s foundation. Our clients in the pharmaceutical, medicaldevice, and biotechnology industry have been appreciating our expertise for 23 years. We are a team of seasoned as well as tech-savvy professionals providing valuable data management solutions, biostatistical services, medical services, and quality management support to the industry. Our wealth of experience enables us to tailor solutions to match your project-specific requirements with budget-consciousness and creativity. Since 1994, we have performed more than 280 interventional and non-interventional clinical studies in various countries with pharmaceutical products and medical devices, including investigator-initiated studies in over 25 therapeutic areas. Many of them were managed as full-service projects in the framework of our established partnerships. Full service: You have the choice to contract single services from our portfolio: ·· clinical data management ·· biostatistical services ·· medical services/medical writing ·· quality assurance services/audits, or to agree with us to manage your project starting from the planning phase to the final submission. In close collaboration with our standing cooperation partners, we are offering the following services to supervise and manage your project: ·· clinical development programmes ·· feasibility studies & recruitment ·· clinical study management ·· pharmacovigilance ·· regulatory affairs (legal notifications and submissions)

x-act cologne

Clinical data management: ·· consulting on data management strategies ·· EDC solutions ·· eCRF design and database development / CDISC CDASH standards ·· integration of external study data ·· development of data management documents ·· data review and query management ·· coding of medical terms with MedDRA and WHOGlobal ·· SAE reconciliation ·· CDISC SDTM mapping ·· lead data management on behalf of clients Biostatistical services: ·· statistical advice ·· sample size determination ·· randomisation schedules ·· development of statistical analysis plan ·· statistical evaluation with SAS™ ·· implementation of CDISC ADaM standards ·· SAS™ programming ·· reporting and interpretation of statistical results ·· publications/dossiers Medical services: ·· medical consulting ·· development of study synopsis ·· development of clinical study protocol ·· preparation of case narratives (safety narratives) ·· clinical study report writing Quality management support: ·· process analysis & improvement ·· problem solving & corrective and preventive action planning ·· SOP development ·· independent auditing ·  system, process, data, document ·  in-house, on-site, vendor

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

· · · · · · · · · · · ·

Alte Verler Str. 1 33689 Bielefeld North Rhine-Westphalia Dr Frederik Walter +49-521-96989-200 +49-521-96989-201


> 25 2009 Analytical and cell culture laboratory (S1) Areas of Activity · Biopharmaceutical solutions, processes and services with a focus on cell culture media and feeds External · Global network of pharma and Collaborations biotech companies as well as research institutes

Request for · l Contract development of cell culture Further Collaborations media and feeds l R&D collaborations and strategic partnerships

Company profile Xell is an innovative and agile partner for the biotech and pharmaceutical industry, providing highly efficient solutions in cell culture technology. Since our formation, we have had a dedicated focus on cell culture media development and have continuously strengthened our proprietary technology. A broad range of successful projects throughout different applications in biopharmaceutical production has helped us to gain a reputation as a reliable partner for the biotech industry. We have been working with recognised pharma companies, CMOs, as well as SMEs and research institutes, to improve their process efficiency, yields, and quality in biopharmaceutical production.

Customised media development As a leading company for cell culture medium and feed development, Xell offers targeted, efficient, and rapid services for the development and optimisation of culture media for customer cell lines. We utilise our proprietary approach based on metabolic models, powerful analytical tools, and a superior platform media technology to rationally design tailored solutions for our clients.

Ready-to-use products Besides customised formulations, Xell offers highperformance off-the-shelf media products and special application solutions. These media and feeds are available both as liquid formulations as well as powdered products for large scale manufacturing with certified quality. For various cell types … ·· CHO ·· HEK / human ·· BHK, MDBK, MDCK ·· Hybridoma … and for different applications: ·· Transient and stable gene expression ·· Biopharmaceutical and vaccine production ·· Batch, fed-batch and perfusion processes


Additional services Intensive work in the field of mammalian cell culture makes us an excellent partner to provide additional services and face our customers’ analytical and process-related challenges. From spent media to product analyses, Xell offers a complete range of analytical tools. Other services include cell studies, process development, media lot testing, and media stability studies. With a highly capable team of scientists, we generate comprehensive data sets for our customers’ cultures or samples, enabling them to better understand complex cell behavior and processes.

Quality statement Chemically defined and free of animal components, Xell’s culture media meet all necessary quality standards required by the regulatory authorities for GMP manufacturing. Our contract services provide reliable results with versatile experts, ensuring a successful transfer to the customer.

At a glance ·· Rational cell culture medium development ·· Off-the-shelf media and feed products for research and further manufacturing use ·· Reliable analytical services ·· Versatile process services ·· Efficient and flexible workflows ·· Dedicated and personal spirit

People ·· ·· ·· ·· ··

Stefan Northoff (CEO) Christoph Heinrich (COO) Prof. Dr Thomas Noll (Chairman Supervisory Board) Dr Sandra Klausing (Director Scientific Innovations) Dr Tim Beckmann (Director Strategic Development)

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Name · Yumab GmbH Address/P.O. Box · Science Campus Braunschweig-Süd Inhoffenstr. 7 Postal Code/City · 38124 Braunschweig State · Lower Saxony Contact Person · Dr Linda Kirchner Telephone · +49-531 3804 270 Fax · +49-531 3804 271 Email · Website · Social Media · I Number of Employees · 20 Founded (year) · 2012 Type of Laboratory · S1 | S2 Areas of Activity · l Discovery & development of recombinant fully human antibodies l Antibody libraries l Engineering & humanization l Drug development l Professional R&D services l Flexible licenses & license options with low entry costs for academic labs & biotech startups Request for · Yumab seeks collaborators and clients Further Collaborations in pharma, biotech, and diagnostic industry and research, who need a reliable partner in early stage antibody development and the benefits of fully human and recombinant antibodies

YUMAB provides discovery and development of fully human antibodies for clients and partners worldwide. In little more than five years, YUMAB has become a global player in human antibody discovery and development, and is now a driver of the general trend in the immunotherapy space toward the use of fully human antibody for therapeutic applications. The versatile technology platform and outstanding expertise make YUMAB the partner of choice for the generation of human antibodies optimized to the client’s needs in any kind of development program, at any stage, and with the properties needed for any immunotherapeutic strategy.

YUMAB® platform: fast & reliable The YUMAB® platform delivers fully human antibodies closest to natural germline among those on the market using fast and reliable in vitro discovery technologies. YUMAB’s highly diverse, human antibody libraries contain up to 1011 natural antibody sequences with specificities to all types of antigens. Unlike animal derived, chimeric, humanized, or synthetic antibodies – each YUMAB® antibody sequence has been shaped in the human body, which maximizes epitope diversity while minimizing immunogenicity and potential adverse effects in clinical development. Our vastly improved technology is also efficient for rare and difficult target antigens and directly optimizes properties such as affinity, stability, or interspecies X-reactivity during the early discovery process. First antibody candidates are already identified after only 4–8 weeks and are highly developable into all types of antibody drug formats such as full-length IgGs, Fabs, scFvs, bispecifics, CARs, fusion proteins, and ADCs. YUMAB provides tailored service and partnering concepts to jump-start translation from research to drug development by affordable entry costs, no additional third party obligations, and flexible licensing options.


YUMAB at a glance




Ultra-fast antibody discovery ·· Natural fully human antibody sequences from superior, universal, close-to-germline libraries ·· Direct, targeted in vitro selection on cells within 4–8 weeks ·· No unnecessary animal use, low toxicity & immunogenicity by design Efficient antibody lead development ·· Fully human, close-to-germline antibody candidates ·· All antibody drug formats, all therapeutic indications ·· Robust & fast process with high success rates Advanced research ·· Versatile, universally applicable technology ·· Smooth translation from bench to bedside ·· Innovative research & diagnostic tools Flexible services, collaborations & partnering ·· CRO: fee-for-service projects & flexible license options (low entry costs) ·· Collaborative & partnered development ·· Out-licensing of internal lead candidates


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Profiles of Service Providers

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Name · BIO.NRW Cluster Biotechnology North Rhine-Westphalia Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · · ·

Merowingerplatz 1 40225 Dusseldorf North Rhine-Westphalia Dr Bernward Garthoff +49-211-385-469-9200 +49-211-385-469-9220

FL  6 2008 | Technology transfer | Support of biotech companies, esp. SME | Support of biotech start-ups, coaching & financing | National and international fairs, exhibitions, and conferences | Analysis of biotechnology in North Rhine-Westphalia for location data | Marketing & PR for the biotech state of North Rhine-Westphalia | Promotion of young academics | Online jobfair

External · | EIT Health e. V; local to international Collaborations companies, research institutions, financiers and further biotech stakeholders | ChInValue – China-NRW-cooperation

BIO.NRW – Business for biotech BIO.NRW is the biotechnology cluster of North RhineWestphalia (NRW). We catalyse the sustainable development of the state’s biotech sector by building on NRW’s strengths in industrial and pharmaceutical biotechnology, and in enabling technologies. BIO.NRW is part of a state government initiative, named ‘Excellence NRW’, to position NRW as Germany’s number one state for innovation.

Our services include: Technology Transfer Tech transfer support is a key contribution from BIO.NRW. We organise events, working platforms and meetings to promote the dialogue between business, research, investors and policy-makers and to activate cooperation. Biotech business & sciences BIO.NRW compiles comprehensive and current online databases of academic institutions and companies active in the life sciences in NRW. Free to access and easy-to-use, these resources are valuable tools for identifying business partners. More information on Fairs, exhibitions and conferences Companies and academic institutions can generate awareness of their activities locally, nationally and internationally by being a part of the BIO.NRW common stands at fairs, exhibitions and conferences. BIO.NRW also organises a series of workshops and symposia, called Support of young professionals BIO.NRW takes a special interest in supporting young professionals in biotechnology. We organise conventions where graduates meet representatives from industry and academic science. The ‘Business Angel Network – BIO. NRW’ helps financing and funding biotech start-ups. In addition, the idea of an annual “BIO.NRW Business Angel Congress” is, to assist and to supply the highly divers investors’ community of business angels, venture capitalists, institutional investors and their potential clients, such as founders and SMEs with the most recent and updated finance and investment information.

Biotech in North Rhine-Westphalia Hyatt Regency Düsseldorf


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 4.4% of the European GDP (EU-28). If classified as an independent nation, NRW would rank 19th in the world, just above Switzerland. A multitude of successful start-up and spin-off companies have been launched in NRW, alongside a strong chemical and pharmaceutical presence. In total, the state is home to more than 470 life science companies, among them 129 core biotechnology firms that together account for 48.6% of the German biotech turnover. It is also Europe’s number one in patenting biotech inventions (according to OECD Biotechnology statistics). With 55 universities and research institutions that conduct life science research, NRW also enjoys the highest concentration of academic institutions within Europe. These include six Max-Planck-Society life science research institutes. There are four Helmholtz research centres, five Fraunhofer Institutes and six Leibniz Association facilities.

7th BIO.NRW Business Angel Congress March, 1st 2018 Hyatt Regency Speditionsstraße 19 Medienhafen, Düsseldorf

One notable strength of NRW’s biotech industry is industrial (‘white’) biotechnology, which benefits from the states strong chemical industry. The sector is connected by the Cluster of Industrial Biotechnology, named CLIB2021. Beyond ‘white biotech’, the pharmaceutical ‘red’ biotech sector is also strong e.g. especially in personalised medicine. In 2016, some 39% of the biotech companies in NRW were actively developing new drugs and diagnostics. Some, like the Bayer AG, Grünenthal and UCB are global players in the pharmaceutical sector. Same goes for diagnostics with e.g. Qiagen and Miltenyi Biotec. In Q3 2017, the drug pipeline of all companies combined contained 76 products and candidates. 13 of these were in clinical phases I–III. To support and develop pharmaceutical biotechnology, BIO.NRW founded in 2010 the strategic initiative BIO.NRW. red. The aim is to build a sustainable network that connects the major contributors to medicine, healthcare, the pharmaceutical industry and red biotechnology in the state. 19 th Guide to german biotech companies 2018

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

· · · · · · · · · · · ·

Franziskanerstr. 14 81669 Munich Bavaria Brigitte Ehret +49-89-444699-76 +49-89-444699-99

FL I  H > 100 2000 SaaS services for: | Secure Collaboration | Outlicensing | Due Diligence | Clinical Trials | IP Protection | Board Communication | Fundraising | Partnering etc.

External · Direct sales. Headquarters in Collaborations Munich (D) with subsidiaries in Vienna (A), Zurich (CH), London (UK) and Paris (F) as well as collaboration with international partners

Brainloop protects confidential information The Brainloop Solution is a web-based platform whose logic facilitates compliance with legal requirements and policies. The high-security workspace enables customers in the biotech industry to share confidential information – including clinical studies, dossiers and legal regulations – with internal and external people, while ensuring complete protection of ownership rights (such as for outlicensing and bidding processes). The documents are stored in a secure data room and users can only access them after entering a personal password and PIN texted to their cell phone. Depending on their individual permissions, they may also edit the documents. The documents are completely encrypted during transmission and while they are not in use. The system protects biotech companies’ intellectual property, which they need to share and work on within the company as well as with external people (IP protection). This enables them to collaborate securely on confidential documents.

Outlicensing, Due Diligence The Brainloop system ensures that processes related to outlicensing are both efficient and – most importantly – highly secure. The solution also enables the due diligence phase to be completed faster and supports bidders with the secure provision of electronic dossiers. The webbased information is accessible worldwide to several bidders simultaneously, facilitating the bidding process. Every document can be provided with a personalised watermark if required. Brainloop’s operator shielding protects sensitive information from unauthorised access by IT administrators and data centre staff. The integrated audit trail logs every action on the platform and ensures transparency and traceability for compliance purposes. This makes the information flows completely secure while remaining efficient and flexible.

Board communication Company boards also use the Brainloop platform for collaboration on highly confidential information. In this context, the tablet has become a very popular tool for board members who need to work while travelling. The


Brainloop app guarantees them protected access to confidential documents while they are on the road.

Business focus Licensing processes in which companies need to give internal and/or external staff access to highly confidential intellectual property, such as clinical studies, dossiers and legal regulations. Several bidders can be given simultaneous, web-based access to information while remaining invisible to each other. The secure and controlled environment ensures that ownership rights to all documents are protected.

Customers: leading biotechnology and pharmaceutical companies Brainloop’s customers include world-leading biotechnology and pharmaceutical companies that develop innovative products to improve and preserve human lives. The main asset of these companies is their intellectual property.

The benefits of Brainloop at a glance ·· H  ighest level of security – strong authentication as well as encryption of data transmission and storage ·· Protection of dossiers with a file size of several gigabytes ·· Provision of information simultaneously for bidding processes (outlicensing) ·· Document protection with personalized watermarks and rights management ·· Secure emailing by sending a secure document link ·· Integrated Audit-Trail with reports that show the history of each document and bidder ·· Prevention of unauthorised distribution of documents via download, printing or forwarding ·· End-to-end protection of confidential documents – right through to the user’s desktop ·· Ease of use – intelligent and intuitive interface ·· Operator shielding to protect against access by IT service providers and administrators ·· Secure mobile access with the Brainloop app for iOS devices and Windows tablets

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MANAGEMENT Your Expert-CRO since 1993

Name · CW-Research & Management GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · · ·

Konrad-Zuse-Platz 8 81829 Munich Bavaria Christian Wolflehner +49-89-20-70-42-600 +49-89-20-70-42-601

FI 15 1993 l Studies (Planning, Monitoring, Evaluation) l Data collection l Medical writing l Pharmacovigilance l Audit (GCP, GDP, GMP) l SOP (preparation, review, management)

CW-Research & Management GmbH is an independent Contract Research Organisation (Expert-CRO) operating in the pharmaceutical, biotechnology, medical device, and healthcare industry. Our expertise combined with many years of experience is the basis of our corporate philosophy and our success. The company was founded as Dr Robert Heinz & Partner GmbH 1993 in Vienna and has been successfully managed by Christian Wolflehner since 2007. Soon, the company expanded in Austria with the opening of a second geographically favourable location in Adlwang/Upper Austria. Mr Wolflehner has been the owner of the company since 2010. The expansion into Germany followed in 2013 with the establishment of the subsidiary CW-Research & Management GmbH in Munich. Since September 2017, the whole company has been operating under the mutual name CW-Research & Management GmbH. Over the past 25 years, our dedicated team of experienced specialists has been successfully managed numerous projects, especially in Germany, Austria, and Switzerland. Together with our contractors we contribute to projects all across Europe.

Experience our tailor-made solutions At CW-Research & Management, we believe in individuality rather than uniformity. Each project is different – unique in its structure, objectives and requirements. This requires the development of individually adapted solutions. The diversity of our service portfolio allows us to develop tailor-made solutions for each single company, comprising an allinclusive concept as well as individual services. We provide support throughout the entire development cycle of clinical and non-interventional studies, from the planning phase, through monitoring and assistance during the trial conduct, to a successful closure of the project. Clinical study data may be collected and managed either by the use of our in-house eCRF or manually imported to an individually designed data base for subsequent statistical analysis. Our medical writing service

cw-research & management

comprises not only study documents like protocols, information leaflets, patient diaries, or clinical study reports, but also publication manuscripts, meeting abstracts or posters, training documents, and many more. We know that during a clinical trial but also throughout the entire life cycle of a medicinal product or medical device, the main focus lies on patient safety. New legislations continuously demand more and more from pharmaceutical companies, thus we expanded our service portfolio with regards to pharmacovigilance in order to optimally support over-challenged houses. As we not only dedicated ourselves to quality, we help to enhance it whenever we can. We offer the conduction of audits (GCP/GDP/GMP) and help to establish, maintain, and improve a custom-tailored quality management system including the preparation, review, and management of SOPs and processes.


Our high-quality services are continually being further developed by our committed and experienced staff. All areas are regulated by SOPs and are subject to continuous monitoring and annual audits. Our quality management system has been certified since July 2010 according to the quality standard EN ISO 9001:2015 and is continuously subjected to surveillance and recertification audits. Use our experience and flexibility and increase your resources with the support of our professionals. â&#x20AC;&#x153;For us quality means taking over responsibilities in all areas. The offer of high-quality services and a constant striving for improvement represent our core objectives. All employees focus on achieving these objectives.â&#x20AC;?

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Name · Dentons Address/P.O. Box · NEXTOWER Thurn-und-Taxis-Platz 6 Postal Code/City · 60313 Frankfurt State · Hesse Contact Person · Peter Homberg Telephone · +49-69-450012-311 Fax · +49-69-450012-133 Email · Website · Number of Employees · More than 150 lawyers and professionals in Germany, approximately 8,500 lawyers and professionals worldwide Founded (year) · 2013 Areas of Activity · Full-service law firm providing legal advice on a national and international level with a specific focus on the Life Sciences sector in Dentons’ Frankfurt office

Company profile Driven to provide clients with a competitive edge, and connected to the communities where its clients want to do business, Dentons knows that understanding local cultures is crucial to successfully completing a deal, resolving a dispute or solving a business challenge. We proudly offer clients talent from diverse backgrounds and countries with a wealth of experience in every legal tradition in the world. We offer business solutions and measure our success by the service we provide. Regardless of the scale and scope of your business needs, you get the individual attention you need and deserve. Whether the matter is big or small, if it is important to you, then it is important to us. Dentons serves the local, regional and global needs of a broad spectrum of clients, including private and public corporations; governments and government agencies; small businesses and start-ups; entrepreneurs; and individuals. In our German offices, more than 150 lawyers are there to advise you in all key areas of business and commercial law.

Life Sciences Team Dentons’ Life Sciences lawyers in Germany advise on project-related transactions, or alternatively as an “outsourced legal department,” with deep industry-specific knowledge, creativity and years of experience to ensure our clients’ success. Whether license agreements or regulatory issues relating to the drug advertising law, as part of a team of more than 150 lawyers in Germany, Dentons provides companies in the areas of pharmaceuticals, diagnostics, biotechnology and medical devices with future-oriented and interdisciplinary legal advice. Peter Homberg – Head of the German Life Sciences Practice – is an expert in advising on a broad range of legal matters. He focuses on licensing deals and cooperation agreements, M&A transactions, R&D contracts, regulatory issues and the implementation of practice standards.


Dentons. Now the world’s largest global elite law �irm.* *Acritas Global Elite Law Firm Brand Index 2013�2016.

Legal services Our Life Sciences team provides a wide-ranging portfolio of services and experiences regarding issues, including: Mergers and Acquisitions, Corporate and Commercial ·· Negotiation and drafting different types of agreements (cooperation, co-promotion, manufacturing, supply, distribution, sponsoring, sub-contracting, research and development agreements) Public and Regulatory Law ·· Certification of medical devices; procedures for establishing prices of pharmaceutical specialties and conditions for their reimbursement, etc. Intellectual Property and Patent Advice ·· License agreements ·· Management of intellectual property rights/know-how ·· Trademarks and anti-counterfeiting matters Dispute Resolution ·· Litigation and all forms of alternative dispute resolution representation before civil, commercial and criminal courts and institutions relating to: product liability, counterfeiting of products, intellectual property, unfair competition and charges of bribery, distribution agreement issues, breach of contract and wrongful termination, contract liability, etc. ·· Litigation under specific regulations applicable to healthcare products and activities before administrative courts (market authorisations, advertising prohibitions, financial sanctions, medical promotion, drug category decisions, professional and ethical sanctions, reimbursement, etc)


Head of the German Life Sciences Practice: Peter Homberg, Partner, Frankfurt

© 2017 Dentons. Dentons is a global legal practice providing client services worldwide through its member �irms and a�iliates. Please see for Legal Notices.

2-German Advert Biotech Companies 2017.indd 1

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Name · Evosciences Leasing GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Email Website Number of Employees Founded (year) Areas of Activity

· · · · · · · · · ·

Lorenz Huber Straße 25 85540 Haar Munich Manuela Habeker +49-178-4016873 12 2006 l Financing solutions l Remarketing capatibilities

Request for · Companies needing vendor finance Further Collaborations

Evosciences Leasing GmbH is the German member of the international Evosciences Group, which is headquartered in France. EVOSCIENCES is present in, DACH, Benelux, F, UK, I, E, P, and the Nordics. Our core competence is individual, flexible, and tailormade financing solutions in our specialist areas of analytics, measurement, and laboratories of all kinds (research, biotech, quality assurance, production, medical, etc.). We have deep knowledge of the equipment and remarketing capabilities. Because we are independent of banks and leasing companies, we are not tied to a particular lender and have access to a wide range of financial products when planning and implementing funding concepts and vendor financing solutions. We work with both international leasing companies and banks, as well as with local lending partners. In addition to financing solutions we also offer global factoring and trade financing products. Our services are available and can be implemented either as a vendor leasing solution in cooperation with suppliers or manufacturers, or for projects with end-users.

Solutions for manufacturers – vendor finance Evosciences partners manufacturers and stockists of laboratory equipment, analytical instruments, and medical devices with our independent sales promotion advice. This includes developing individual strategies and structuring contracts. A dedicated advisor is available at all times. The Evosciences team have experience in the sale of laboratory and analytical equipment and speak the same language as their clients. In the course of these partnerships we take care of all the necessary documentation and thus optimise workflows, quality, quantity, and flexibility. By working with various leasing companies we can achieve a high degree of customisation. This enables us to find the right funder for every one of your customers. Not every leasing company or bank will finance every customer or every asset; our skill is to match the customer with the right funder! We can also reach an agreement on how to manage leases during their term and when they come to an end, as well as remarketing and disposal of your lease assets. Additionally Evosciences provides support with the


design of presentations, training material, and individual overviews of terms and conditions. We are happy to accompany our partners in person to trade fairs or training courses. Our support is further enhanced by accessing our online portal. Your benefits: ·· Individual financing solution for your customers (leasing, rental, hire purchase, extension of credit terms, start-up programme) ·· Personal, competent advice for your customers ·· Support for your customers when making an investment ·· Financing partner that understands your sector ·· Your sales force concentrates on closing the deal and we arrange the financing in cooperation with your back-office staff ·· Orders can be acquired faster, get paid quicker ·· Customer requests for longer payment deadlines can be enabled worldwide

Pictures: CUP Laboratorien Dr. Freitag GmbH

Solutions for end user Our financing solutions spread the acquisition costs of expensive equipment over time. This improves your cash flow. We respond to our clients’ different requirements with a variety of solutions. Not only do we offer the complete range of possible funding options; we also adapt to the requirements of very different clients. Our client base includes biotech companies, from start-ups to publicly listed businesses, as well as universities, research institutions, and pharmaceutical companies large and small. Depending on the situation, suitable solutions may involve, e.g. leasing, hire purchase, rental, borrowing, operating lease, or a pay-per-use structure. We have special programmes for start-ups from the biotechnology sector. To round off our service portfolio we help our clients to achieve payment terms of up to a maximum of 120 days. Your benefits: ·· Cash flow is improved ·· Obsolescence risk is reduced ·· Rates can be adjusted to your individual needs 19 th Guide to german biotech companies 2018

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Name · HealthCapital – Cluster Healthcare Industries Berlin-Brandenburg Address/P.O. Box Postal Code/City State Contact Person

· · · ·

Telephone Email Website Social Media Areas of Activity

· · · · ·

Fasanenstr. 85 10623 Berlin Berlin Dr Kai Bindseil, Clustermanager HealthCapital Berlin-Brandenburg +49-30-46302-463 L #HealthCapitalBB l Technology transfer between science and industry l Initiation and support of networks l Support for technology-oriented start-ups l Funding support for innovative project concepts l Providing and presenting regional life sciences information l Building and coordinating of scientific and interdisciplinary networks l Establishing contacts between experts from all disciplines l Organisation of events and seminars, Public Relations work for the life sciences region

External · l Member of the Council of European Collaborations Bioregions l ScanBalt and European Diagnostic Clusters Alliance l Cooperation Platform with the Region Cheongchungbuk-do, Korea (Chungbuk Technopark) l Member and contact point in Berlin for Enterprise Europe Network (EEN) l Collaborations with European Life Science clusters and SMEs in several FP6 and FP7 projects and other activities

The Berlin-Brandenburg BioRegion … … a Leading Hub for Life Sciences The Berlin-Brandenburg region is one of the leading, international locations for life sciences. The area concentrates on clinical research via a dense and compact healthcare network, and boasts a state-of-the-art IT infrastructure. It is no coincidence that the region is Germany’s ‘health capital’ as it is home to both the German government, as well as the centre for healthcare industries. The region’s distinction is anchored in its unique research and clinical landscape, as well as its ability to closely link the key players in the life sciences and healthcare. Biotechnology, in particular, is a strong driving force within the Berlin-Brandenburg healthcare industries cluster – HealthCapital – generating innovation and growth there and beyond. Through networking the pharmaceutical, diagnostics and medical technology sectors completely new fields of business are created. More than 240 biotechnology and around 30 pharmaceutical companies are located in the German Capital Region. They include market leaders like Bayer, Bausch & Lomb, B. Braun Melsungen, Berlin-Chemie, Pfizer, Sanofi and Takeda. Along with the sector’s many small and mid-sized companies, they benefit from close cooperation, both with science and with more than 130 hospitals – above all, one of Europe’s largest university hospitals: Charité – Universitätsmedizin Berlin. Customers from research and industry have access to patient cohorts of urban and rural populations of about 180 ethnicities, covering all medical indications. The many technology parks and networks in the various branches of modern biotechnology create the excellent infrastructure and technological support that characterize the Berlin-Brandenburg life sciences area. Focus of biotech activity within the region are biomedicine and diagnostics, therapeutics and regenerative medicine as well as industrial biotechnology.


… 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), ScanBalt and the European Diagnostic Clusters Alliance (EDCA).

… 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 Brandenburg Economic Development Corporation (WFBB) are responsible for managing the cluster.

Meet us 2018 at Deutsche Biotechnologietage, April BIO International Convention, June BioJapan, October BIO-Europe, November

See you in Berlin at BIONNALE 2018 June, 20

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Name · Innovation and Start-up Center for Biotechnology IZB Fördergesellschaft IZB mbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · ·

Am Klopferspitz 19 82152 Martinsried Bavaria Dr Peter Hanns Zobel +49-89-5527948-0 +49-89-5527948-29 28 1995 S1 and S2 labs | Biotechnology | Life Sciences

Number of Firms · over 60 companies External · Collaborations with the scientific Collaborations institutes on the Campus Martinsried

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 m 2, over 60 biotech companies with over 650 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 MaxPlanck-Institutes für Biochemistry and Neurobiology.

Magnet for biotech start-ups Since 1995, the Planegg-Martinsried location, now covering 23,000 m2, has accommodated Start-ups focusing on medical biotechnology. Since 2002, the IZB in Freising-Weihenstephan with 3,000 m2 of space offers optimal conditions for establishing companies in the sector of life sciences. Here, young entrepreneurs and company founders come upon an optimal infrastructure for transforming their products or services into business propositions, within a competence cluster for life sciences that is one of the best in the world. S1 and S2 labs for fair rental prices, internal property management, close contact to the venture capital scene, as well as joint location marketing are also factors for our success, as is the flexibility to adapt space requirements to the development of our tenants.

Top research at the Campus Martinsried Today the scientific and business Campus Martinsried is one of the largest centres in Europe where teaching, basic scientific and clinical research, as well as technology innovation are combined on one campus. Located in the direct vicinity are other institutes such as the MaxPlanck-Institutes for Biochemistry and Neurobiology, the HelmholtzZentrum Munich Hematology Unit and the following institutes of the LMU: the Biology Faculty, the Clinical Center Grosshadern, the Pharmacy and Chemistry Faculty, the Neurological Research Center, the Center for Neuropathology and Prion Research (ZNP),


the Gene Center and Institute for Biochemistry, the Biomedical Center, the BioSysM Bavarian Research Network for Molecular Biosystems and the Surgery Center of the Clinical Center Grosshadern. The close proximity of the scientific institutes around the Campus Martinsried confers a huge competitive advantage. Young scientists can profit from incorporating expertise in science and research into their own business enterprises; short distances promote interaction and cooperation between biotech companies – in terms of globalisation both factors are essential requirements for successfully entering world markets.

IZB Residence and Faculty Club G2B The 28-meter high IZB Residence CAMPUS AT HOME that opened in October 2014 is the architectural and communicative centre point of the Campus Martinsried. The sevenstorey building with 42 rooms and its own restaurant will accommodate visiting scientists from all over the world. The core element is the Faculty Club G2B. Its purpose is to promote the transfer of research results into marketable products and services, and intensify the dialogue between top class scientists.

IZB – in brief ·· 2  6,000 m2 laboratory and office space for start-ups and growing companies ·· Home for more than 60 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 ·· Competitive leasing rents ·· IZB Residence CAMPUS AT HOME (42 Rooms) ·· Faculty Club G2B ·· Restaurants: SEVEN AND MORE and Café Freshmaker ·· 2 day care centres (BioKids & BioKids2) 19 th guide to german biotech companies 2018

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Name · Life Science Nord Management GmbH Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · · ·

Falkenried 88 20251 Hamburg Hamburg Dr Hinrich Habeck (Managing Director) +49-40-47196-400 +49-40-47196-444

FQ 14 2004 Cluster Management

External · l BIO Deutschland e.V. Collaborations l Arbeitskreis der Deutschen BioRegionen l ScanBalt

Cluster profile The Life Science Nord Cluster in the federal states of Hamburg and Schleswig-Holstein embraces over 500 biotechnology, pharmaceutical, and medical technology companies, clinics, and research institutes. About 42,300 employees work in the health industry. In Biotech/Pharma, some 18,850 employees work within the Life Science Nord Cluster. Particular features of the cluster are the broad business base and the complete value chains from basic and applied research to clinical studies and the marketable end product. The good, close cooperation between researchers, clinicians, and industrial partners in many fields is reflected in innovative products, projects, and technologies.

Cluster management and the association The cluster management organisation Life Science Nord was set up by the Northern German federal states of Hamburg and Schleswig-Holstein to develop the cluster into a leading international life sciences network. The cluster agency Life Science Nord Management GmbH and the registered association Life Science Nord e.V. work together to achieve that goal. About 240 regional firms and institutions in the health industry are organised in Life Science Nord e.V. In a joint Life Science Nord partner programme, the agency and Life Science Nord e.V. offer their members numerous activities aimed at promoting regional networking, sharing experiences and know-how, and jointly representing the regional life sciences industry on a national and international level. In 2016, Life Science Nord was awarded the Gold Label of the European Cluster Excellence Initiative.

Life science nord

What Life Science Nord offers

Picture: Christina Körte, Torsten Kollmer

·· Comprehensive support in initiating innovative projects, arranging contacts to experts, and providing know-how ·· Fast and uncomplicated access to regional, national, and EU funding programmes ·· Admitting members to the network and helping them position themselves within the Life Science Nord Cluster ·· Extensive opportunities for collaboration within an international industry network ·· Participation in leading international and national industry trade shows ·· Providing data on business and technological capabilities in medical technology, biotechnology, and pharma in Northern Germany ·· Providing the latest information on developments in business and science ·· Access to platforms on which the cluster players can exchange information and which support the dissemination of new developments in the cluster. This also includes the online newsletter and the Life Science Nord print magazine, both of which can be subscribed to via the website free of charge.

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Name · Technologiepark Weinberg Campus Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website

· · · · · · · ·

Heinrich-Damerow-Straße 3 06120 Halle (Saale) Saxony-Anhalt Dr Ulf-Marten Schmieder +49-345-5583-5 +49-345-5583-601 Number of Employees · 13 Founded (year) · 1993 Type of Laboratory · | S1, S2, S3 | GMP areas | Greenhouses Areas of Activity · | Biotechnology and Biomedicine | Environmental and energy technology | Nanotechnology | Medical technology | Information and automation technology

Company profile Founded in 1993, the Technology and Business Incubation Centre Halle come together 1998 with the BioCentre Halle to run modern specialist research facilities for biotechnology, biomedicine, medical technology, environmental and process engineering, nanotechnology and also information and automation technology. Technology orientated start-up companies’ benefit from office space, laboratories, workshops, greenhouses, animal keeping facilities, GMP areas and clear space in a total of nine buildings. We provide not only classic building and facility management but also support and assistance with the planning and implementation of investment projects, with organising trade fair presentations and conferences. We offer project management for research and development projects and facilitate contacts to science and industry.

Technology Park Weinberg Campus The Weinberg Campus ranks within the Top 10 technology parks in Germany and is the number one in Central Germany. Its core competence is the close network between science and industry. The people involved here represent the entire value-added chain, starting with basic and applied research, going over to product and service development to the final production. Since 1990, more than €1 billion have been invested in expansion and restructuring the area. Currently more than 5,000 employees work here.

Technologiepark weinberg campus

Selection of resident biotech companies BioSolutions Halle GmbH Endomedica GmbH Heppe Medical Chitosan GmbH Icon Genetics GmbH Lipocalyx GmbH NH DyeAGNOSTICS GmbH Nomad Bioscience GmbH Okmed Biotech GmbH Ontochem GmbH Probiodrug AG Navigo Proteins GmbH Skinomics GmbH Wacker Biotech GmbH

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Name · TROCKLE Business Consultancy Address/P.O. Box Postal Code/City State Contact Person Telephone

· · · · ·

Am Buschhäuschen 9 42115 Wuppertal North Rhine-Westphalia Susanne Simon, PhD +49-202-31-10-00 +41-43-818-0334 Email ·

Swiss office Postal Code/City · 8712 Stäfa/Zurich Country · Switzerland Further offices · Düsseldorf, Hannover Website Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · 10 1991 Business Consultancy Recruiting and organisational consultancy in healthcare/life sciences (biotechnology, IVD, medical devices, diagnostics, Pharma) in DACH / Europe with a focus on German speaking markets

Successful executive recruitment requires industry insight, HR expertise, and a keen eye for market trends. Every consultant at TROCKLE Business Consultancy has the insight, expertise, and current market knowledge to deliver on our promise of successful placement of the right candidate for you.

Our organisation For over 25 years, TROCKLE Business Consultancy has supported European biotechnology, medical device, IVD, pharmaceutical, healthcare, and life sciences institutions in the challenging realm of executive recruitment. Our goal is to ensure that our clients have the optimum talent with the minimum burden on their management during the recruitment process. We also focus on giving candidates fair and transparent treatment.

Our team Our consultants have various academic backgrounds, including science, medicine, economics, and engineering, but all have spent at least 10 years in leadership positions in international healthcare companies. Coupled with our HR expertise, this helps us understand your business, position-specific challenges, and the opportunities that your new executive recruit can leverage for your continued success.

Track record Our track record speaks for itself, with candidate placements in life sciences and healthcare companies at all hierarchy levels, from specialists to CEOs, and all functions, including R&D, quality, regulatory affairs, operations, marketing and legal, but also Finance and HR.


TROCKLE Business Consultancy has: ·· Profound knowledge of the biotechnology, medical device, IVD, pharmaceutical, healthcare, and life sciences industries ·· An excellent applicant and client network, bolstered by memberships in medical and HR communities ·· A unique set of tools for direct searching ·· Well-developed methodologies for coaching and onboarding ·· A “one face, one project” approach to ensure close and continuous communication through the recruitment process

Our core business We identify managers and experts and inspire them to engage with new tasks. Our missing is to find the individual with the skills and career aspirations to meet the specific business needs of the role. Thanks to our detailed knowledge of the industry, we understand the challenges and opportunities specific to companies, roles and sectors.

Excellent leaders and specialists make the difference.

TROCKLE supports the entire process, from search and first contact through contract negotiations to integration into new role. Our many years of experience, extensive network and excellent contacts put us in the best position to perform the complex and difficult tasks involved. We will help you find the best available staff for your enterprise Contact us when you want to fill a vacant position with an appropriate candidate. We’ll be happy to partner you through the challenges of recruitment and find the right person for you.

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Name · TVM Capital Life Science Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media Founded (year) Areas of Activity

· · · · · · · · · · ·

Ottostraße 4 80333 München Bavaria Dr Hubert Birner +49-89-998-992-0 +49-89-998-992-55

TVM Capital Life Science TVM Capital Life Science is a group of independent investment advisories and fund managers for Venture Capital funds, investing innovative Biotech, pharmaceutical, and medtech companies in Europe, Canada, the USA, and Asia, with teams based in Munich and Montreal. TVM Capital Life Science was founded in Munich in 1984 and has grown to be a truly global VC, with a strong footprint in Germany and Europe, Canada, the USA, and Asia.

LI 1984 Venture Capital for Biopharmaceutical and Medical Devices Companies in Europe, North America, Asia

During last 30 years and within seven fund generations, TVM Capital Life Science has invested in entrepreneurial venture-backed companies. Over several fund generations, the investment strategy has included a multi-stage investment approach spanning discovery to market-ready companies, as well as profitable companies searching for growth capital. The investment focus has always been broad and includes investments in therapeutics, technology platforms, medtech, and diagnostics.

No road is long with good company Multiple strategic partnerships with Big Pharma, an innovative investment approach for developing pharmaceutical assets in a capital-efficient fashion, and a global reach have made TVM Capital Life Science the financing partner of choice in many of today’s promising biotechnology segments. TVM Capital Life Science’s investment professionals draw upon the experience, international approach, and demonstrated success of close to 100 exits from our portfolio. These exits include initial public offerings on the NASDAQ, and the London, Frankfurt, Zurich, and Vienna Stock Exchanges, as well as trade sales and mergers.

tvm capital life science

TVM Capital Life Science in numbers

Benefit from global hands-on experience With more than three decades of experience in picking promising entrepreneurs, concepts, and products for development, and building successful entrepreneurial companies, TVM Capital Life Scienceâ&#x20AC;&#x2122;s team is acutely aware of what it takes to build a category leader in its field, and has gained unrivalled international investment experience with their track record of dedicated board work, extensive global networks in the world of life science research and product development, and a direct knowledge of the local markets. TVM Capital Life Science provides investors, as well as entrepreneurs and innovation-seeking biopharmaceutical companies, access to global life science innovation and paths for successful tech transfer and commercialisation for the benefit of patients, innovators, and investors.

Selected Exits & IPOs, TVM Capital Life Science

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German Biotech Companies

300MICRONS GmbH, Karlsruhe 3B Pharmaceuticals GmbH, Berlin 4 Animals AlsterScience GmbH, Hamburg 4base lab AG, Reutlingen 4SC AG, Martinsried


A2M Pharma GmbH, Monheim AB Diagnostic Systems GmbH, Berlin AB Enzymes GmbH, Darmstadt (VBU) ABA GmbH & Co KG, Dortmund Abbott GmbH & Co. KG, Ludwigshafen Abbott GmbH & Co. KG, Wiesbaden Abbvie Deutschland GmbH & Co. KG, Ludwigshafen Abbvie Deutschland GmbH & Co. KG, Wiesbaden ABiTEP GmbH, Berlin ABT Armbruster Biotechnology GmbH, Bensheim Abviris Deutschland GmbH, Ammersbek Accelero ® Bioanalytics GmbH, Berlin acCELLerate GmbH, Hamburg Ackermann Saatzucht GmbH & Co. KG, Irlbach bei Straubing Acousia Therapeutics GmbH, Tübingen Across Barriers GmbH, Saarbrücken ACTILOR GmbH, Leuna Adhesys Medical GmbH, Aachen AdrenoMed AG, Hennigsdorf advanceCOR GmbH, Martinsried AESKU.DIAGNOSTICS, Wendelsheim Aeterna Zentaris GmbH, Frankfurt a. Main Affectis Pharmaceuticals AG, Dortmund Affimed GmbH, Heidelberg AGCT GmbH, Lübeck Agrobiogen GmbH Biotechnologie, Hilgertshausen-Tandern AgroProtect GmbH, Aachen AiCuris Anti-infective Cures GmbH, Wuppertal aj Roboscreen GmbH, Leipzig Alacris Theranostics GmbH, Berlin Albutec GmbH, Rostock Aldevron Freiburg GmbH, Freiburg Alere Technologies Jena GmbH, Jena Algenol Biofuels Germany GmbH, Berlin Algiax Pharmaceuticals GmbH, Erkrath Allecra Therapeutics GmbH, Weil am Rhein ALLERGOPHARMA GmbH & Co. KG, Reinbek Almirall Hermal GmbH, Reinbek altona Diagnostics GmbH, Hamburg Alvotech Germany GmbH, Jülich (VBU) Amal Therapeutics SA, Berlin amcure GmbH, Eggenstein-Leopoldshafen Amedrix GmbH, Esslingen AMGEN GmbH, München Amgen Research (Munich) GmbH, München AMINO GmbH, Frellstedt AMODIA Bioservice GmbH, Braunschweig AMP-Therapeutics GmbH, Leipzig AmplexDiagnostics GmbH, Gars Bahnhof Amptec GmbH, Hamburg AMSilk GmbH, Planegg amYmed GmbH, Martinsried AnaKat Institut für Biotechnologie GmbH, Berlin Analyticon Biotechnologies AG, Lichtenfels AnalytiCon Discovery GmbH, Potsdam (BIOD, VBU) Analytik Jena, Jena (VBU) Anchor Diagnostics GmbH, Hamburg AnDiaTec Division, Kornwestheim

AngioBiomed GmbH, Hennigsdorf ANiMOX GmbH, Berlin Aokin AG, Berlin apceth Biopharma GmbH, München (BIOD, VBU) Apogenix AG, Heidelberg (BIOD, VBU) AptaIT GmbH, Planegg/Martinsried Aptarion Biotech AG, Berlin arrows biomedical Deutschland GmbH, Münster Artemiflow GmbH, Potsdam ARTES Biotechnology GmbH, Langenfeld (BIOD, VBU) ASA Spezialenzyme GmbH, Wolfenbüttel Asbach Medical Products GmbH, Obrigheim Ascendis Pharma GmbH, Heidelberg Assay.Works GmbH, Regensburg Astra Biotech GmbH, Berlin ATG:biosynthetics GmbH, Merzhausen ATLAS Biolabs GmbH, Berlin Atriva Therapeutics GmbH, Tübingen ATTO-LAB GmbH, Lübeck Attomol GmbH, Bronkow, OT Lipten AudioCure Pharma GmbH, Berlin Auto Tissue Berlin GmbH, Berlin Autodisplay Biotech GmbH, Düsseldorf (VBU) AVA Green Chemistry Development GmbH, Karlsruhe AVENTRA Gesellschaft für biologische Diagnostik mbH, Osnabrück Avergen Pharmaceuticals GmbH, Martinsried Avitop GmbH, Berlin Axiogenesis AG, Köln Axolabs GmbH, Kulmbach AYOXXA Biosystems GmbH, Köln


BAG Health Care GmbH, Lich baseclick GmbH, Neuried BASF Personal Care and Nutrition GmbH, Monheim BASF SE, Ludwigshafen Baumschulen Oberdorla GmbH, Vogtei OT Oberdorla Bavarian Nordic GmbH, Martinsried Baxalta Deutschland GmbH, Unterschleißheim Baxter Oncology GmbH, Halle/Westfalen Bayer AG, Berlin BAYER CropScience AG, Monheim Bayer CropScience Biologics GmbH, Malchow/Poel Bayer HealthCare, Bergkamen Bayer Pharma AG, Wuppertal (VBU) BBT Biotech GmbH, Baesweiler Beckman Coulter Biomedical GmbH, München Beiersdorf AG, Hamburg BELANO medical AG, Hennigsdorf Berlin Cures GmbH, Berlin Beroceutica GmbH, Potsdam Biaffin GmbH & Co KG, Kassel (VBU) Biametrics GmbH, Tübingen BianoScience GmbH, Zwickau BIBITEC Gesellschaft für Prozessentwicklung mbH,   Bielefeld (VBU) Bicoll GmbH, Planegg/Martinsried bifa Umweltinstitut GmbH, Augsburg BIOASSAY GmbH, Heidelberg Bio-Mar GbR, Düsseldorf Bio-Protect GmbH, Konstanz Bio-X Technologies GmbH, Berlin BioCheck GmbH, Münster BioControl Jena GmbH, Jena BioCrea GmbH, Radebeul

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BIOCYC Gesellschaft für Biotechnologie und Recyclingverfahren   mbH & Co. Entwicklungs KG, Potsdam-Golm BioEcho Life Sciences GmbH, Köln Bioenergy CellTec GmbH, Lübeck bioeq GmbH, Holzkirchen Biofidus AG, Bielefeld Biofrontera AG, Leverkusen BioGenes GmbH, Berlin (BIOD, VBU) Bioglobe GmbH, Hamburg BioKryo GmbH, Sulzbach Biolog Life Science Institute Forschungslabor und Biochemica  Vertrieb GmbH, Bremen (VBU) Biomax Informatics AG, Martinsried (BIOD, VBU) Biomedro Biomedizinische Forschung & Entwicklung Rostock   GmbH, Bad Doberan biometec GmbH, Greifswald BIOMEVA GmbH, Heidelberg (BIOD, VBU) BioNTech AG, Mainz BioNTech Cell & Gene Therapies GmbH, Mainz BioNTech Diagnostics GmbH, Mainz BioNTech Innovative Manufacturing Services, Idar-Oberstein BioNTech Protein Therapeutics GmbH, Mainz BioNTech RNA Pharmaceuticals GmbH, Mainz BioNTech Small Molecules GmbH, Martinsried Biontex Laboratories GmbH, München BioNukleo GmbH, Berlin BIOPHARM GmbH, Eppelheim Biophotonics Diagnostics, Jena Bioplant Biotechnologisches Forschungslabor GmbH, Ebstorf BIOPRACT GmbH, Berlin Bioresources Technology & Engineering GmbH, Gießen Bioron Diagnostics GmbH, Ludwigshafen BIOSERV Diagnostics GmbH, Rostock Biosilu Healthcare AG, Frankfurt BioSolveIT GmbH, Sankt Augustin BioSphings AG, Frankfurt BioSpring Gesellschaft f. Biotechnologie mbH, Frankfurt/Main (VBU) biosyn Arzneimittel GmbH, Fellbach (VBU) biotechrabbit GmbH, Hennigsdorf BIOTECON Diagnostics GmbH, Potsdam (VBU) Biotest AG, Dreieich BioTeSys GmbH, Esslingen BioTeZ Berlin-Buch GmbH, Berlin BioTissue Technologies GmbH, Freiburg Biotype Diagnostic GmbH, Dresden Biotype Innovation GmbH, Dresden BioVersal Deutschland GmbH, Delitzsch Bioviotica Naturstoffe GmbH, Dransfeld Bioworx, Berlin (VBU) bitop AG, Witten (BIOD, VBU) bj-diagnostik GmbH, Göttingen Blue Biolabs GmbH, Berlin BlueBioTech GmbH, Büsum Bock Bio Science GmbH, Bremen Böhm-Nordkartoffel Agrarproduktion OHG, Hohenbrünzow Boehringer Ingelheim Biopharmaceuticals GmbH, Biberach a.d. Riss Boehringer Ingelheim Biopharmaceuticals GmbH, Ingelheim Boehringer Ingelheim Veterinary Research Center GmbH & Co. KG,   Hannover botiss medical AG, Berlin BRAIN AG, Zwingenberg (BIOD, VBU) Brandenburg Antiinfektiva GmbH , Borstel BromMarin GmbH, Freiberg BSL BIOSERVICE Scientific Laboratories Munich GmbH, Planegg BSV Bioscience GmbH, Baesweiler Burgwedel Biotech GmbH, Burgwedel


c-LEcta GmbH, Leipzig (VBU) CAG GmbH – Center for Animal Genetics, Tübingen Calico Biolabs GmbH, Berlin Cambrex IEP GmbH, Wiesbaden CAMPTON Diagnostics UG, Itzehoe caprotec bioanalytics GmbH, Berlin Cardior Pharmaceuticals GmbH, Hannover Carpegen GmbH, Münster

CASCAT GmbH, Straubing CCRP Therapeutics GmbH, Berlin CE-Immundiagnostika GmbH, Eschelbronn CeGaT GmbH, Tübingen Celares GmbH, Berlin Cell Concepts GmbH, Umkirch Cell.Copedia GmbH, Leipzig CellAct Pharma GmbH, Dortmund cellasys GmbH, München (VBU) Cellbricks GmbH, Berlin Cellendes GmbH, Reutlingen Celler Pflanzen- und Gewebelabor, Celle Cellex Treatment GmbH CPT, Dresden CellGenix GmbH, Freiburg (BIOD, VBU) CellServe GmbH, Berlin CellSystems Biotechnologie Vertrieb GmbH, Troisdorf (VBU) CellTrend GmbH, Luckenwalde Cellzome GmbH, Heidelberg CeMeT GmbH, Tübingen Centogene AG, Rostock Cevec Pharmaceuticals GmbH, Köln (VBU) Charles River Biopharmaceutical Services GmbH, Erkrath Charles River Discovery Research Services Germany GmbH, Freiburg Chembiotech – DNA Technologies, Materials and Reagents, Münster chevita Tierarzneimittel GmbH, Pfaffenhofen Chimera Biotec GmbH, Dortmund Chr. Hansen GmbH, Nienburg/Weser Chromatec GmbH, Greifswald ChromBios GmbH, Nussdorf am Inn ChromoTek GmbH, Martinsried Chronix Biomedical GmbH, Göttingen CIBUS Biotech GmbH, Rheda-Wiedenbrück Cilian AG, Münster CIRES cell & immune research services Ges. für Immunbiologische   Auftragsforschung mbH, Bochum Clariant Produkte (Deutschland) GmbH, Planegg CLS Cell Lines Service GmbH, Eppelheim co.don ® AG, Teltow Computomics GmbH, Tübingen Conaris Research Institute AG, Kiel CONGEN Biotechnologie GmbH, Berlin conoGenetix biosciences GmbH, Martinsried Corden BioChem GmbH, Frankfurt a. Main corlife OHG, Hannover CPO Cellular Phenomics & Oncology Berlin-Buch GmbH, Berlin Crelux GmbH, Martinsried CropEnergies AG, Mannheim CSL Behring GmbH, Marburg Cube Biotech GmbH, Monheim Cultex Laboratories GmbH, Hannover Curetis NV, Holzgerlingen CureVac AG, Tübingen (BIOD, VBU) Cyano Biotech GmbH, Berlin Cysal GmbH, Münster cytena GmbH, Freiburg Cytobox UG, Konstanz Cytocentrics Bioscience GmbH, Rostock CytoPharma GmbH, Darmstadt


Danisco Deutschland GmbH, Niebüll Davids Biotechnologie GmbH, Regensburg DECODON GmbH, Greifswald Delta-Vir GmbH, Leipzig DermaTools Biotech GmbH, Darmstadt DiaPat GmbH, Hannover Diarect AG, Freiburg DIREVO Industrial Biotechnology GmbH, Köln Dispendix GmbH, Stuttgart Dr. Rölleke Labor für Genetische Analytik GmbH, Potsdam DRG INSTRUMENTS GmbH, Marburg DSM Nutritional Products GmbH, Grenzach-Wyhlen Dust Biosolutions GmbH, Martinsried Dynamic Biosensors GmbH, Martinsried Dynavax GmbH, Düsseldorf (VBU)


e.gene Biotechnologie GmbH, Feldafing e~nema GmbH, Schwentinental ecSeq GmbH, Leipzig Electrochaea GmbH, Planegg ElexoPharm GmbH, Saarbrücken Ella Biotech Gesellschaft für angewandte Biotechnologie mbH,   Martinsried EMC microcollections GmbH, Tübingen EMP Genetech, Ingolstadt Emsland-Stärke GmbH, Emlichheim Enza Zaden Deutschland GmbH & Co. KG, Dannstadt-Schauernheim Enzymicals AG, Greifswald EpiGene GmbH, Freising Epigenomics AG, Berlin EpiLogic GmbH, Freising Epiontis GmbH, Berlin Epomedics GmbH, Göttingen Ernst Benary Samenzucht GmbH, Hannover-Münden Eternygen GmbH, Berlin ethris GmbH, Planegg Eupheria Biotech GmbH, Dresden Eurofins BioPharma Product Testing Munich GmbH, Planegg Eurofins GeneScan GmbH, Freiburg Eurofins Genomics, Ebersberg EUROIMMUN Medizinische Labordiagnostika AG, Lübeck Evonik Industries AG, Essen Evonik Industries AG, Hanau Evonik Industries GmbH, Marl Evonik Nutrition & Care GmbH, Halle/Westfalen Evotec (München) GmbH, Martinsried Evotec AG, Hamburg Evotec International GmbH, Göttingen evoxx technologies GmbH, Monheim am Rhein Exosome Diagnostics GmbH, Martinsried Experimentelle Pharmakologie & Onkologie Berlin-Buch GmbH, Berlin


FERRING Arzneimittel GmbH, Kiel Filt Lungen- und Thoraxdiagnostik GmbH, Berlin Formycon AG, Martinsried Formycon Services GmbH, Martinsried Freeline Therapeutics GmbH, Martinsried FRIZ Biochem Gesellschaft für Bioanalytik mbH, Neuried FRUTAROM Savory Solutions GmbH, Stuttgart


GA Generic Assays GmbH, Dahlewitz GALAB Technologies GmbH, Hamburg GANYMED Pharmaceuticals GmbH, Mainz GATC Biotech AG, Konstanz GEMoaB Monoclonals GmbH, Dresden GEN-IAL GmbH, Troisdorf Genaxxon Bioscience GmbH, Ulm Gene Bridges GmbH, Heidelberg Genedata Bioinformatik GmbH, München GeneQuine Biotherapeutics GmbH, Hamburg Genewerk GmbH, Heidelberg geneXplain GmbH, Wolfenbüttel GenExpress Gesellschaft für Proteindesign mbH, Berlin (VBU) Genomatix GmbH, München Genotype GmbH, Wilhelmsfeld GenXPro GmbH, Frankfurt am2016 Main German Seed Alliance GmbH, Köln GewürzMühle Nesse, Loxstedt-Nesse GFE Blut mbH, Frankfurt a. Main GHG Saaten GmbH, Aschersleben GICON Bioenergie GmbH, Dresden GlaxoSmithKline Biologicals, Dresden Global Bioenergies GmbH, Leipzig Glycothera GmbH, Hannover Glycotope Biotechnology GmbH, Heidelberg Glycotope GmbH, Berlin GlycoUniverse GmbH & Co.KGaA, Berlin

glyXera GmbH, Magdeburg GNA Biosolutions GmbH, Martinsried GoodMills Innovation GmbH, Hamburg Green Sugar AG, Meissen Greenovation Biotech GmbH, Freiburg (BIOD, VBU) Grünenthal GmbH, Aachen GVG Diagnostics GmbH, Leipzig


Hain Lifescience GmbH, Nehren HealthTwiSt GmbH, Berlin Heidelberg ImmunoTherapeutics GmbH, Heidelberg Heidelberg Pharma GmbH, Ladenburg Henkel AG & Co. KGaA, Düsseldorf hepacult GmbH, Planegg/Martinsried HepaRegeniX GmbH, Ulm Heppe Medical Chitosan GmbH, Halle Heraeus Precious Metals GmbH & Co. KG, Hanau Herbrand PharmaChemicals GmbH, Gengenbach Hezinger Algaetec GmbH, Kornwestheim highQu GmbH, Kraichtal Hit Discovery Constance GmbH, Konstanz HMNC Brain Health, München Horizon Pharma GmbH, Mannheim HS Diagnomics GmbH, Berlin HUMAN Gesellschaft für Biochemica und Diagnostica mbH,   Magdeburg Human Gesellschaft für Biochemica und Diagnostica mbH,   Wiesbaden humatrix AG, Pfungstadt Hummingbird Diagnostics GmbH, Heidelberg Hybro Saatzucht GmbH & Co. KG, Schenkenberg Hybrotec GmbH, Potsdam Hyglos GmbH – a bioMérieux company, Bernried


IBA GmbH, Göttingen (VBU) ibidi GmbH, Martinsried Ibt – immunological and biochemical testsystems GmbH, Binzwangen Icon Genetics GmbH, Halle IdentXX GmbH, Stuttgart IDT Biologika GmbH, Dessau-Roßlau IFM Therapeutics GmbH, Bonn IGV Institut für Getreideverarbeitung GmbH, Nuthetal IIT – Institut für Innovationstransfer an der Universität Bielefeld   GmbH, Bielefeld IMAX Discovery GmbH, Dortmund IMD Natural Solutions GmbH, Dortmund ImevaX GmbH, München IMGM Laboratories GmbH, Martinsried immatics biotechnologies GmbH, Tübingen Immumed GmbH, München Immundiagnostik AG, Bensheim Immungenetics AG, Rostock Immunic AG, Martinsried immunoGlobe Antikörpertechnik GmbH, Himmelstadt Immunolab GmbH, Kassel ImmunoQure AG, Martinsried Immunservice GmbH, Hamburg imusyn GmbH & Co. KG, Hannover in.vent DIAGNOSTICA GmbH, Hennigsdorf INDIVUMED GmbH, Hamburg InfanDx AG, Köln InflaRx GmbH, Jena InnovaPlant GmbH & Co. KG, Gensingen InSCREENeX GmbH, Braunschweig Insilico Biotechnology AG, Stuttgart (BIOD, VBU) Institut für angewandte Zellkultur Dr. Toni Lindl GmbH, München Institut für Bioanalytik, Umwelttoxikologie & Biotechnologie Halle   GmbH, Halle Institut für Medizinische Molekulardiagnostik GmbH, Berlin Institut für Pflanzenkultur e.K., Schnega Institut Virion\Serion GmbH, Würzburg Intana Bioscience GmbH, Martinsried

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INVICOL GmbH, Berlin INVIGATE GmbH, Jena InVivo BioTech Services GmbH, Hennigsdorf (VBU) iOmx Therapeutics AG, Martinsried Ionera Technologies GmbH, Freiburg IPM Biotech GmbH, Hamburg Ipsen Pharma GmbH, Ettlingen Iris Biotech GmbH, Marktrewitz (VBU) Isarna Therapeutics GmbH, München ITM AG, München IVD Gesellschaft für Innovative Veterinärdiagnostik mbH, Seelze  Letter


Janssen-Cilag GmbH, Neuss Jena Bioscience GmbH, Jena JeNaCell GmbH, Jena Jenlab GmbH, Jena Jennewein Biotechnologie GmbH, Rheinbreitbach JPT Peptide Technologies GmbH, Berlin Juno Therapeutics GmbH, Göttingen


Kaesler Nutrition GmbH, Cuxhaven Klemm + Sohn GmbH & Co. KG, Stuttgart KreLo GmbH, Ulm KSK Diagnostics GmbH, Hamburg KWS LOCHOW GMBH, Bergen KWS SAAT SE, Einbeck


LABOR DR. MERK & KOLLEGEN GmbH, Ochsenhausen LABOR FÜR DNA-ANALYTIK, Freiburg Larova GmbH, Jena Laves-Arzneimittel GmbH, Ronnenberg Lead Discovery Center GmbH, Dortmund LEO Pharma GmbH, Neu-Isenburg LEUKOCARE AG, Martinsried LGC Genomics GmbH, Berlin Life & Brain GmbH, Bonn LifeCodexx AG, Konstanz LifeGlimmer GmbH, Berlin Ligandis GbR, Gülzow-Prüzen Limagrain GmbH, Edemissen Lionex GmbH, Braunschweig Lipid Therapeutics GmbH, Heidelberg Lipocalyx GmbH, Halle (Saale) Lipotype GmbH, Dresden Lisando GmbH, Regensburg Loewe Biochemica GmbH, Sauerlach LOGOPHARM GmbH, March Lohmann Animal Health GmbH, Cuxhaven Lohmann Tierzucht GmbH, Cuxhaven Lonza Cologne GmbH, Köln (VBU) Lophius Biosciences GmbH, Regensburg LXP Group GmbH, Marienwerder


m2p-labs GmbH, Baesweiler/Aachen MAB Discovery GmbH, Neuried MabTag GmbH, Friesoythe Magna Diagnostics GmbH, Leipzig Maribo Seed GmbH, Maintal Matricel GmbH, Herzogenrath MBBL Dr. Bartling GmbH, Bielefeld medac Gesellschaft für klinische Spezialpräparate mbH, Wedel Mediagnost GmbH, Reutlingen Medical Biomaterial GmbH, Neustadt-Glewe Medigene AG, Planegg/Martinsried (BIOD, VBU) Medigene Immunotherapies GmbH, Planegg MEDIPAN GMBH, Dahlewitz MEDIWISS Analytik GmbH, Moers MELEMA Pharma GmbH, Hamburg

MERCK KGaA, Darmstadt Merlion Pharmaceuticals GmbH, Berlin Merz GmbH & Co. KGaA, Frankfurt a. Main Merz Pharma GmbH & Co. KGaA, Dessau-Roßlau metabion international AG, Martinsried (VBU) Metabolomic Discoveries GmbH, Potsdam MetaHeps GmbH, Martinsried metanomics GmbH, Berlin Metanomics Health GmbH, Berlin MetaSysX GmbH, Potsdam MetaVi Labs GmbH, Bottrop miacom diagnostics GmbH, Düsseldorf MicrobEnergy GmbH, Schwandorf Microcoat Biotechnologie GmbH, Bernried MicroDiscovery GmbH, Berlin (BIOD, VBU) MicroMol GmbH, Karlsruhe Micromun Privates Institut für Mikrobiologische Forschung   GmbH, Greifswald MicroPro GmbH, Gommern Mikrogen GmbH, Neuried Milenia Biotec GmbH, Gießen MILTENYI BIOTEC GmbH, Bergisch Gladbach Miltenyi Biotec GmbH, Teterow Milupa GmbH, Bad Homburg Minerva Analytix GmbH, Berlin Minerva Biolabs GmbH, Berlin (VBU) MINITÜB GmbH, Tiefenbach Mireca Medicines GmbH, Tübingen MLM Medical Labs GmbH, Mönchengladbach MoBiTec GmbH, Göttingen MODAG GmbH, Wendelsheim Molecular Health GmbH, Heidelberg MOLOGEN AG, Berlin moloX GmbH, Berlin Molzym GmbH & Co.KG, Bremen Monsanto Agrar Deutschland GmbH, Düsseldorf Monsanto Saaten GmbH, Nienstädt Morphoplant GmbH, Bochum MorphoSys AG, Planegg Mosaiques Diagnostics and Therapeutics AG, Hannover MSD SHARP & DOHME GmbH, Haar multiBIND biotec GmbH, Köln multimmune GmbH, München Multiplexion GmbH, Friedrichshafen Mundipharma GmbH, Limburg/Lahn My Life Diagnostics GmbH, Hennigsdorf MyBiotech GmbH, Überherrn Myelo Therapeutics GmbH, Berlin MykoMax GmbH, Wuppertal myPOLS Biotec GmbH, Konstanz MYR GmbH, Burgwedel Myriad GmbH, Martinsried


N-Zyme BioTec GmbH, Darmstadt (VBU) nadicom Gesellschaft für angewandte Mikrobiologie mbH,   Karlsruhe (VBU) nandatec GmbH, Lübeck Nanion Technologies GmbH, München NanotecMARIN GmbH, Mainz NanoTemper Technologies GmbH, München nanoTOOLS Antikörpertechnik GmbH & Co. KG, Teningen (VBU) Naturin Viscofan GmbH, Weinheim Navigo Proteins GmbH, Halle (VBU) NEO New Oncology GmbH, Köln Neovii Biotech GmbH, Gräfelfing (BIOD, VBU) NeuroProfile GmbH, Regensburg NEUWAY Pharma GmbH, Bonn nextplant UG, Berlin nexttec GmbH, Hilgertshausen-Tandern NH DyeAGNOSTICS GmbH, Halle Nomad Bioscience GmbH, Halle Norbitec GmbH, Uetersen Norddeutsche Pflanzenzucht Hans-Georg Lembke KG, Holtsee Nordmark Arzneimittel GmbH & Co. KG, Uetersen (BIOD, VBU) Nordsaat Saatzucht GmbH, Langenstein

Norika Nordring-Kartoffelzucht- und Vermehrungs-GmbH,   Groß-Lüsewitz Northwest Biotherapeutics GmbH, Leipzig NovaBiotec ® Dr. Fechter GmbH, Berlin NOVAgreen GmbH, Vechta-Langförden Novaliq GmbH, Heidelberg Novartis Vaccines and Diagnostics GmbH, Marburg/Lahn NovaTec Immundiagnostica GmbH, Dietzenbach Novo Nordisk Pharma GmbH, Mainz NOXXON Pharma AG, Berlin NPZ Innovation GmbH, Holtsee NUMAFERM GmbH, Düsseldorf


OakLabs GmbH, Hennigsdorf Ocean Pharma GmbH, Reinbek oceanBASIS GmbH, Kiel Octapharma Biopharmaceuticals GmbH, Heidelberg Octapharma GmbH, Langenfeld Ohly GmbH, Hamburg OMEICOS Therapeutics GmbH, Berlin OmicScouts GmbH, Freising oncgnostics GmbH, Jena OncoLead GmbH & Co. KG, Karlsfeld Oncoprevent GmbH, Hennigsdorf Oncoscience AG, Schenefeld Oncoscreen, Jena Oncotrition GmbH, Leipzig OntoChem GmbH, Halle optiferm GmbH, Oy-Mittelberg ORGANOBALANCE GmbH, Berlin (VBU) ORGENTEC Diagnostika GmbH, Mainz origenis GmbH, Martinsried ORYX GmbH & Co. KG, Baldham Oxacell AG, Potsdam


P. H. Petersen Saatzucht Lundsgaard GmbH & Co. KG, Grundhof PAIA Biotech GmbH, Köln PAION AG, Aachen PAN-Biotech GmbH, Aidenbach PANATecs – a brand of Protagen Protein Services GmbH,   Heilbronn PELOBIOTECH GmbH, Martinsried PEPperPRINT GmbH, Heidelberg Peptide Speciality Laboratories GmbH, Heidelberg peptides&elephants GmbH, Potsdam perora GmbH, Heidelberg Pfizer Deutschland GmbH, Berlin Phadia GmbH, Freiburg PHARMA WALDHOF GmbH, Düsseldorf PharmaInformatic, Emden PHARMAPLANT Arznei- und Gewürzpflanzen Forschungs- und Saatzucht GmbH, Artern PharmaZell GmbH, Raubling Pharmbiotec GmbH, Saarbrücken Pharmedartis GmbH, Aachen PharmGenomics GmbH, Mainz Phenex Pharmaceuticals AG, Ludwigshafen Phenos GmbH, Hannover Phytolutions GmbH, Bremen Phyton Biotech GmbH, Ahrensburg Phytowelt GreenTechnologies GmbH, Nettetal (VBU) Pieris Pharmaceuticals GmbH, Freising PL BioScience GmbH, Aachen Planton GmbH, Kiel (VBU) PlasmidFactory GmbH & Co. KG, Bielefeld (BIOD, VBU) PLS-Design GmbH, München pluriSelect Life Science UG, Leipzig Polyquant GmbH, Bad Abbach (VBU) PortaCellTec biosciences GmbH, Göttingen Predemtec GmbH, Hennigsdorf PreOmics GmbH, Martinsried Prima BioMed GmbH, Leipzig PRIMACYT Cell Culture Technology GmbH, Schwerin

Probiodrug AG, Halle ProBioGen AG, Berlin PROGEN Biotechnik GmbH, Heidelberg ProJect Pharmaceutics GmbH, Martinsried Prolytic GmbH, Frankfurt am Main PromoCell GmbH, Heidelberg ProQinase GmbH, Freiburg (BIOD, VBU) Protagen AG, Dortmund Protagen Protein Services, Dortmund Protectimmun GmbH, Bochum Proteo Biotech AG, Kiel Proteome Factory AG, Berlin Proteome Sciences R&D GmbH & Co. KG, Frankfurt a. Main Proteros Biostructures GmbH, Martinsried Provecs Medical GmbH, Hamburg provitro AG, Berlin Purmin GmbH, Greifswald PXBioVisioN GmbH, Hannover (VBU) PZO Pflanzenzucht, Schwäbisch Hall


Q-bios GmbH, Mannheim QIAGEN Hannover GmbH, Langenhagen QIAGEN Leipzig GmbH, Leipzig QIAGEN, Hilden QITHERA GmbH, Düsseldorf Qlaym Healthcare AG, Göttingen Qualitype GmbH, Dresden quantiom bioinformatics GmbH & Co. KG, Weingarten


R-Biopharm AG, Darmstadt ravo Diagnostika GmbH, Freiburg ReliaTech GmbH, Wolfenbüttel Rentschler Biotechnologie SE, Laupheim (VBU) RESprotect GmbH, Dresden RHEACELL GmbH, Heidelberg Ribocon GmbH, Bremen RIBOLUTION Health GmbH, Leipzig Riboxx GmbH, Radebeul Richter-Helm BioLogics GmbH & Co. KG, Hamburg (BIOD, VBU) Ridom GmbH, Münster RIEMSER Pharma GmbH, Greifswald-Insel Riems Rigontec GmbH, Bonn RLP AgroScience GmbH, Neustadt Roche Diagnostics GmbH, Penzberg Roche Diagnostics Deutschland GmbH, Mannheim Roche mtm laboratories AG, Mannheim Rodos BioTarget GmbH, Hannover Roquette Klötze GmbH & Co. KG, Klötze


Saaten-Union BIOTEC GmbH, Leopoldshöhe (VBU) Saatzucht Fritz Lange KG, Bad Schwartau Saatzucht Josef Breun GdbR, Herzogenaurach Saatzucht Steinach GmbH & Co KG, Steinach Saatzucht Streng-Engelen GmbH & Co. KG, Uffenheim SaKa Pflanzenzucht GmbH & Co. KG, Windeby Salata AG, Ritschenhausen SanguiBioTech GmbH, Witten Sanofi-Aventis Deutschland GmbH, Frankfurt Sartorius Stedim Biotech GmbH, Göttingen Sartorius Stedim Cellca GmbH, Laupheim ScheBo ® Biotech AG, Gießen (VBU) SCIENION AG, Berlin Scientific Research and Development GmbH, Bad Homburg SciMab GmbH, Martinsried Sciomics GmbH, Heidelberg (BIOD, VBU) ScreenFect GmbH, Eggenstein-Leopoldshafen SeNostic GmbH, Hannover Senova Gesellschaft für Biowissenschaft und Technik mbH, Weimar SenseUp GmbH, Jülich Senzyme GmbH, Troisdorf SEQLAB Sequence Laboratories Göttingen GmbH, Göttingen

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SequentiX – Digital DNA Processing, Klein Raden sequiserve GmbH, Vaterstetten Seracell Stammzelltechnologie GmbH, Rostock Seramun Diagnostica GmbH, Heidesee OT Wolzig Seratec Gesellschaft für Biotechnologie mbH, Göttingen SeSaM-Biotech GmbH, Aachen (VBU) SGS M-Scan GmbH, Freiburg Sialotec GmbH, Mannheim Siemens Healthcare Diagnostics Products GmbH, Marburg sifin diagnostics gmbh, Berlin (VBU) Sigma-Aldrich Biochemie GmbH, Hamburg Signatope GmbH, Reutlingen Signature Diagnostics GmbH, Potsdam SILANTES GmbH, München Silence Therapeutics GmbH, Berlin sinYmed, Martinsried SIRION Biotech GmbH, Martinsried Sirius Fine Chemicals SiChem GmbH, Bremen SIT Biotech GmbH, Dortmund siTOOLs Biotech GmbH, Martinsried Sividon Diagnostics GmbH, Köln Soluventis GmbH, Bochum Source BioScience Germany GmbH, Berlin Sovicell GmbH, Leipzig SP Sourcon Padena GmbH & Co. KG, Tübingen SpheroTec GmbH, Martinsried sphingotec GmbH, Hennigsdorf SpinDiag GmbH, Freiburg Squarix GmbH, Marl STADA Arzneimittel AG, Bad Vilbel StarSEQ GmbH, Mainz StemVAC GmbH, Bernried sterna biologicals GmbH & Co. KG, Marburg SternEnzym GmbH & Co. KG, Ahrensburg STRATEC Molecular GmbH, Berlin Strube Research GmbH & Co. KG, Söllingen Subitec GmbH, Stuttgart (BIOD, VBU) Succinity GmbH, Düsseldorf Südzucker AG, Obrigheim Surflay Nanotec GmbH, Berlin SYGNIS AG, Heidelberg SymbioVaccin GmbH, Herborn Symrise AG, Holzminden Synaptic Systems Gesellschaft für neurobiologische Forschung,   Entwicklung und Produktion mbH, Göttingen Syngenta Agro GmbH, Maintal Syngenta Seeds GmbH, Bad Salzuflen Synimmune GmbH, Tübingen Synovo GmbH, Tübingen Syntab Therapeutics GmbH, Würselen Sysmex Inostics GmbH, Hamburg Sysmex Partec GmbH, Görlitz Sysmex Partec GmbH, Münster Systasy Bioscience GmbH, München


t2cure GmbH, Frankfurt Taconic Biosciences GmbH, Köln (BIOD, VBU) Takeda GmbH, Konstanz targenomix GmbH, Potsdam Taros Chemicals GmbH & Co. KG, Dortmund (BIOD, VBU) TECNARO GmbH, Ilsfeld TETEC Tissue Engineering Technologies AG, Reutlingen Teva Biotech GmbH, Ulm tgcBIOMICS GmbH, Bingen (VBU) The Medicines Company (Leipzig) GmbH, Leipzig TherapySelect Dr. Frank Kischkel, Heidelberg Therawis Diagnostics GmbH, München Therawis Pharma GmbH, München Thermo Fisher Scientific GENEART GmbH, Regensburg (VBU) Thermo Fisher Scientific, Hennigsdorf Thermosome GmbH, Martinsried Tib Molbiol Syntheselabor GmbH, Berlin TICEBA GmbH, Heidelberg TIGO GmbH, Wiesbaden Tinplant Biotechnik und Pflanzenvermehrung GmbH, Wanzleben

TissUse GmbH, Spreenhagen TolerogenixX GmbH, Heidelberg TOMCROP GmbH, Rostock Topas Therapeutics GmbH, Hamburg TOPLAB Gesellschaft für angewandte Biotechnologie mbH,   Martinsried (VBU) TraitGenetics GmbH, Stadt Seeland OT Gatersleben Transimmune AG, Düsseldorf Transinsight GmbH, Dresden trenzyme GmbH, Konstanz (VBU) TRION Research GmbH, Martinsried


UCB GmbH, Monheim UGA Biopharma GmbH, Hennigsdorf (BIOD, VBU) UGiSense AG, München uniQure GmbH, Heidelberg URSAPHARM Arzneimittel GmbH, Saarbrücken


Varicula Biotec GmbH, Teterow varionostic GmbH, Ulm vasopharm GmbH, Würzburg Vaximm GmbH, Mannheim Vaxxilon Deutschland GmbH, Berlin vaxxinova GmbH, Cuxhaven Ventaleon GmbH, Gemünden/Wohra vermicon AG, München vertis Biotechnologie AG, Freising Vibalogics GmbH, Cuxhaven Viramed Biotech AG, Planegg Viro-Immun Labor-Diagnostika GmbH, Oberursel VIROSCREEN & VIROFEM diagnostics GmbH, Wiesbaden VIROTECH Diagnostics GmbH, Rüsselsheim Vita 34 AG, Leipzig VivaCell Biotechnology GmbH, Denzlingen vivo Science GmbH, Gronau


W. von Borries-Eckendorf GmbH & Co. KG, Leopoldshöhe W42 Industrial Biotechnology GmbH, Dortmund Wacker Biotech GmbH, Halle (VBU) Wacker Biotech GmbH, Jena Wacker Chemie AG, München (VBU) WeissBioTech GmbH, Ascheberg WILEX AG, München


XanTec bioanalytics GmbH, Düsseldorf Xell AG, Bielefeld XL-protein GmbH, Freising (BIOD, VBU) YUMAB GmbH, Braunschweig


Zedira GmbH, Darmstadt zell-kontakt GmbH, Nörten-Hardenberg Zellkraftwerk GmbH, Leipzig Zellwerk GmbH, Oberkrämer OT Eichstädt Zentrum für Humangenetik und Laboratoriumsdiagnostik,   Martinsried Zimmer BioTech GmbH, Neu-Ulm ZytoVision GmbH, Bremerhaven (VBU)

Abbreviations: BIOD: BIO Deutschland VBU: Vereinigung Deutscher Biotechnologie-Unternehmen

19th Guide to German Biotech Companies 2018

19 Guide to German Biotech Companies th


In cooperation with: BIO Deutschland â&#x20AC;&#x201C; German Biotech Industry Organisation European Biotechnology Network ISBN 978-3-928383-64-6

VBU Association of German Biotechnology Companies

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19th Guide to German Biotech Companies 2018  

19th Guide to German Biotech Companies 2018  

Profile for biocom