Page 1



9th European Biotechnology Guide

European Biotechnology Guide Science & Industry

ISBN 978-3-928383-71-4

European Biotechnology NET WORK

European Biotechnology Guide Science & Industry

© BIOCOM AG, Berlin 2019 European Biotechnology Science & Industry Guide 2019 (Volume 9) Published by: BIOCOM AG Luetzowstrasse 33–36 10785 Berlin, Germany Tel. +49-30-264921-0 Fax +49-30-264921-11 service@biocom.de www.biocom.de Executive Producer: Andreas Macht Production Editor: Benjamin Röbig Graphic Design: Michaela Reblin Printed at: H. Heenemann GmbH, 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: 978-3-928383-71-4


Bright light, but much remains to be done Voilà! There it lies on the table, the 9th edition of the European Biotechnology Science & Industry Guide. As usual showcasing brilliant science and excellent business from companies, universities, research institutes, and expert support providers. The European Biotechnology Network is proud to present this useful and colourful book once more. It is very encouraging that the international biotech industry is developing very well. Hardly a week goes by without a billion-dollar deal being announced, mostly from the pharmaceutical sector. More products, more turnover, more employees: The intensive research work of the past decades is now increasingly paying off. Nevertheless, sometimes thoughtful frowning is indicated. For example the whole world is discussing the global challenges caused by climate change. Rarely do the proposals go so far that our lifestyle is seriously questioned: Does anyone believe, for example, that it is possible in the long run for billions of human beings to drive back and forth every day in metal vehicles weighing tons? And it is particularly regrettable that biotechnological solutions have hardly been seriously considered in the climate crisis so far. There is a lot for us biotechnologists to do to meet these great challenges. In particular, the progress and achievements of industrial biotechnology need to be presented much more strongly to the public. The biologisation of industry must must no longer be an intangible vision, but has to become a real political and economic alternative. What’s the saying? “Do good and talk about it.” This book makes a modest contribution to this by providing an interesting cross-section of the European biotech scene. We wish all readers an interesting and useful reading – travel through the continent with the new European Biotechnology Science & Industry Guide 2019.

Brussels, February 2019

Andreas Mietzsch European Biotechnology Network www.european-biotechnology.net

9 th european biotechnology guide 2019


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


Sector Reports . . . . . . . . . . . . . . . . . . . . . .


Profiles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Lipotype GmbH. . . . . . . . . . . . . . . . . . . . . . . LYOCONTRACT GmbH. . . . . . . . . . . . . . . . .

. . . . 100 . . . . 102

Medicines for Europe. . . . . . . . . . . . . . . . . . . Merck Biodevelopment S.A.S.. . . . . . . . . . . . Mettler-Toledo GmbH . . . . . . . . . . . . . . . . . . MicroMol GmBH. . . . . . . . . . . . . . . . . . . . . . Microsaic Systems plc. . . . . . . . . . . . . . . . . . Microsynth AG. . . . . . . . . . . . . . . . . . . . . . . . MOLOGEN AG . . . . . . . . . . . . . . . . . . . . . . .

. . . . 104 . . . . 106 . . . . 108 . . . . 110 . . . . 112 . . . . 114 . . . . 116

New England Biolabs GmbH. . . . . . . . . . . . . Novaliq GmbH. . . . . . . . . . . . . . . . . . . . . . . . NSF Health Sciences Ltd.. . . . . . . . . . . . . . .

. . . . 118 . . . . 120 . . . . 122

OP2 Drugs SAS. . . . . . . . . . . . . . . . . . . . . . . OPIS s.r.l.. . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . 124 . . . . 126

Polpharma Biologics. . . . . . . . . . . . . . . . . . . ProBioGen AG. . . . . . . . . . . . . . . . . . . . . . . . PROGEN Biotechnik GmbH . . . . . . . . . . . . . ProJect Pharmaceutics GmbH. . . . . . . . . . .

. . . . 128 . . . . 130 . . . . 132 . . . . 134

Recipharm AB. . . . . . . . . . . . . . . . . . . . . . . . Redx Pharma Plc. . . . . . . . . . . . . . . . . . . . . . Rentschler Biopharma SE. . . . . . . . . . . . . . . Richter-Helm BioLogics GmbH & Co. KG. . . Roche Diagnostics GmbH. . . . . . . . . . . . . . . Rotoinox d.o.o. . . . . . . . . . . . . . . . . . . . . . . . RTC S.p.A.. . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . 136 . . . . 138 . . . . 140 . . . . 142 . . . . 144 . . . . 146 . . . . 148

Socorex Isba SA . . . . . . . . . . . . . . . . . . . . . . Swiss Biotech Association SBA . . . . . . . . . .

. . . . 150 . . . . 152

Talk Biotech Ltd. . . . . . . . . . . . . . . . . . . . . . . Technologiepark Heidelberg. . . . . . . . . . . . . Tissue Solutions Ltd . . . . . . . . . . . . . . . . . . . Tosoh Bioscience . . . . . . . . . . . . . . . . . . . . . TRIGA-S . . . . . . . . . . . . . . . . . . . . . . . . . . . . Trockle Unternehmensberatung . . . . . . . . . .

. . . . 154 . . . . 156 . . . . 158 . . . . 160 . . . . 162 . . . . 164

3P Biopharmaceuticals S.L. . . . . . . . . . . . . .

15 . . . . 20

Aglaris Ltd. . . . . . . . . . . . . . . . . . . . . . . . . . . AiCuris Anti-infective Cures GmbH. . . . . . . . AnaPath Services GmbH. . . . . . . . . . . . . . . . Apogenix AG. . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . .

22 24 26 28

BACHEM AG. . . . . . . . . . . . . . . . . . . . . . . . . Biaffin GmbH & Co KG . . . . . . . . . . . . . . . . . BIO.NRW. . . . . . . . . . . . . . . . . . . . . . . . . . . . BIOCOM AG . . . . . . . . . . . . . . . . . . . . . . . . . BIOTECON Diagnostics GmbH. . . . . . . . . . . Biotype Diagnostic GmbH. . . . . . . . . . . . . . . Boehringer Ingelheim . . . . . . . . . . . . . . . . . . BRAIN AG. . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

30 32 34 36 38 40 42 44

CellGenix GmbH. . . . . . . . . . . . . . . . . . . . . . China Bioengineering Technology Group . . . . co.don AG. . . . . . . . . . . . . . . . . . . . . . . . . . . Coriolis Pharma Research GmbH. . . . . . . . . CRS Clinical Research Services Andernach .

. . . . . . . . . . . . . . . . . . . .

46 48 50 52 54

datametrix AG. . . . . . . . . . . . . . . . . . . . . . . .

. . . . 56

EnginZyme AB. . . . . . . . . . . . . . . . . . . . . . . . Enzymicals AG. . . . . . . . . . . . . . . . . . . . . . . . EuroJobsites Ltd. . . . . . . . . . . . . . . . . . . . . . EuropaBio. . . . . . . . . . . . . . . . . . . . . . . . . . . Evotec AG. . . . . . . . . . . . . . . . . . . . . . . . . . . Exyte Central Europe GmbH. . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . .

FGK Clinical Research GmbH. . . . . . . . . . . . FILTROX AG . . . . . . . . . . . . . . . . . . . . . . . . . Fördergesellschaft IZB . . . . . . . . . . . . . . . . . Fondazione Ri.MED. . . . . . . . . . . . . . . . . . . .

. . . . 70 . . . . 72

. . . . 74 . . . . 76

Greenovation Biotech GmbH . . . . . . . . . . . .

. . . . 78

Heidelberg Pharma AG. . . . . . . . . . . . . . . . . Hezelburcht. . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . 80 . . . . 82

UBM – Informa Group. . . . . . . . . . . . . . . . . . University of Birmingham . . . . . . . . . . . . . . .

. . . . 166 . . . . 168

IBA GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . ibidi GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . in.vent Diagnostica GmbH. . . . . . . . . . . . . . . intravacc. . . . . . . . . . . . . . . . . . . . . . . . . . . . ITM Isotopen Technologien München AG. . .

. . . . 84 . . . . 86 . . . . 88

VAXIMM AG. . . . . . . . . . . . . . . . . . . . . . . . . . Veeva Systems . . . . . . . . . . . . . . . . . . . . . . . Vetter Pharma-Fertigung GmbH & Co. KG . .

. . . . 170 . . . . 172 . . . . 174

. . . . 90 . . . . 92

Wood. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . 176

Jennewein Biotechnologie GmbH. . . . . . . . . JPT Peptide Technologies GmbH. . . . . . . . .

. . . . 94 . . . . 96

X-act Cologne Clinical Research GmbH. . . . Xell AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . 178 . . . . 180

Kraeber & Co GmbH. . . . . . . . . . . . . . . . . . .

. . . . 98

YUMAB GmbH . . . . . . . . . . . . . . . . . . . . . . .

. . . . 182

58 60 62 64 66 68

9 th european biotechnology guide 2019


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Sector Reports

9 th european biotechnology guide 2019


Key economic figures of national biotech industries Reliable data describing national biotech industry are among the foundations pillar for evaluating the economic impact of the life sciences. BIOCOM AG has a long tradition of regularly compiling these key indicators for European countries. In 2018, new figures for Austria and Germany were released. Biotechnology is considered an important strategic field for future development and investment in most industrialised countries. This is demonstrated by key statistical numbers, which are regularly collected by the Organisation for Economic Co-operation and Development (OECD). Since 2003, all OECD countries have been called upon to carry out surveys on biotechnology, following the so-called Framework for Biotechnology Statistics. However, in the respective member states, the biotechnology definitions are interpreted differently, which leads to a distortion of results. In addition, the most recent comparable key facts date back to 2012. Within Central Europe, comparable statistics are consistently available for countries such as Germany and Austria, provided by the financial markets expert team at BIOCOM AG. In 2018, a large survey was conducted in Austria on behalf of the Austrian Federal Ministry of Digital and Economic Af fair s and Austria Wir tschaftsservice Gesellschaft mbH (aws). For the biotech sector, the collection of data followed the OECD guidelines, for the medtech industry the Global Medical Device Nomenclature (GMDN; medical devices section) was used.

Austria’s life science industry in figures According to the report, with 917 companies active in biotechnology, pharma or the medical devices business, life sciences are an important and constantly growing part of the Austrian economy. Eleven percent more businesses were located in Austria in 2017 compared to 2014. In 2017, these companies were responsible for a turnover of 22.4 billion euros. From 2014, revenues increased quite substantially by 17.2%. The life science companies also employ a large chunk of the Austrian workforce. In 2017, more than 55,000 people earned a living working for an Austrian life science company, which means an increase of 7.4% compared to 2014. The life science industry in Austria is fully diversified and essentially consists of two equally important subsegments: biotechnology and pharma on the one hand, and medical devices on the other. Although there are more companies in the medical device sector (554 companies) than in the biotech and pharma sector (363 companies), both employ a similar number of people. In terms of turnover, biotechnology and pharma is the stronger field with revenues of 13.97 billion euros in 2017, while the turnover in the medical devices industry was at 8.44 billion euros. In conclusion, the key figures show that the life sciences are an important pillar of the Austrian economy. Whether it is with respect to research, development and manufacturing or to suppliers, service providers, sales and distribution specialists – the sector has established itself as an outstanding driver of economic growth and innovation and a creator of jobs.

Key figures of the life science sector in Austria 2012, 2014, 2017 2012



Number of companies in the life science industry




Number of employees in the life science industry




€ 17.73 bn

€ 19.11 bn

€ 19.11 bn

Number of research and education institutions active in life sciences




Number of life science employees in research and education institutions




Turnover in the life science industry

Centres of the Austrian life sciences 239 242 8.774 3.440  Biotechnology and Pharma   Number of companies 

 Medical technology

 Number of employees 



 Research and education institutions active in life sciences

Upper Austria

41 92

200 633


1.880 2.250

21 60 1.727 2.611

14.040 8.890


Lower Austria

4 –9

– 150

– 420



780 3.460



12 28

30 59

852 594


2 20


2.520 2.300

10 130

7 Vorarlberg

Salzburg 519 410 780 3.460

15 40 1.804 450 5.400 2.590 Tyrol



4 16

88 129

Quelle: aws austria wirtschaftsservice

Strong foundation in research and teaching The healthy economic development of the life sciences is supported by a dense network of internationally renowned research and teaching expertise. A total of 55 institutions are fully dedicated to life science research or have significant activities in this field. Altogether, more than 21,000 life sciences related employees are working at 17 universities, 13 universities of applied sciences and 25 non-university research institutes, building the innovative foundation of the Austrian life science sector as a whole. Besides high-quality research, the academic institutions also provide the sector with well-trained people, representing a strong pillar in the country’s educational system. In 2017, the total number of life science students at universities and universities of applied science accounted to more than 67,000, and close to 7,750 students graduated. Within Europe, Austria has established a solid position. The central geographical position of the country, combined with the highly skilled staff available in Austria as well as the broad technical and scientific expertise has placed the Austrian biotech and pharma sector firmly on the European life science map.

450 570


These companies can play a pivotal role in developing the medicine of the future, be it a treatment for infectious diseases, vaccines or diagnostic tools. The Austrian biotechnology and pharma sector forms a hub for the whole continent and acts as an interface between east and west. Solid growth for biotech and pharma companies The Austrian biotechnology and pharma industry continues to grow steadily. In the last three years, the number of companies in the biotechnology and pharma sector has grown by 27. The dynamic rate of growth confirms the significance of biotechnology and pharma in Austria. With revenues exceeding 14 billion euros, the sector continues to be a significant economic factor and a driver for innovation in the healthcare field. According to the survey, a total of 363 companies are active in the fields of biotechnology and pharma – an increase of 8% compared to 2014. This figure includes the 207 ‘research, development or manufacturing companies’ that consist of ‘dedicated biotechnology companies’, ‘other biotechnology active’ and ‘pharma 9 th european biotechnology guide 2019


companies’ and the 156 specialised service providers, suppliers, and sales and distribution companies. The 363 biotechnology and pharma companies generated a total turnover of 13.97 billion euros in 2017, an increase of 20% compared to 2014. With revenues of 9.34 billion euros, the research, development and manufacturing companies contributed about twice as much as the supply, service and sales companies (4.63 billion euros) – a shift that is at least partly due to a change in methodology. For the first time in 2017, subsidiaries of the companies whose purpose is not only the distribution of products, but also the preparation and monitoring of clinical trials, are included as research, development and manufacturing companies. In past surveys, they were counted as sales companies. In 2017, the majority of staff employed by the biotechnology and pharma companies worked in the research, development or manufacturing companies: 23,080 of the 28,850 people earned their living in this field. Supply, service and sales companies had 5,770 employees. These figures illustrate the dynamic that exists in the Austrian biotechnology and pharma sector. The following chapters will shed a more specific light on the developments in the different parts of this sector. Given the large amounts of capital needed for research and development of biotechnological products, this

sector has a high demand for external financing: either through venture capital, institutional or private investors, public subsidies, loans or other contributions. However, most Austrian companies are not obliged to report all their financing proceedings. Thus, statistics in this area may remain somewhat incomplete. In addition, capital markets are a highly dynamic field, being dependent on both the overall financial environment, and the performance of individual companies. Tremendous interest from VC investors and stock markets In terms of financing, 2017 was an exceptionally good year for Austrian dedicated biotechnology companies. They managed to secure a total of 289.5 million euros. This is more than three times the amount raised in 2014 (86.8 million euros). Financings through venture capital and private equity, in particular, went through the roof: Austrian biotechs were able to raise 137.4 million euros this way. The tremendous interest from VC investors more than tripled the amount of money raised. In 2014, they supplied 41.6 million euros. Another big chunk of capital came from the stock markets. Fifty-one million euros came from a single 2017 IPO while investment in public equity brought in another 67 million euros. Another major IPO had already flushed 94 million euros into the sector in 2015, bringing the number of publicly listed Austrian biotechs to three. By and large, stock markets are still playing a minor part for the sector. Nonetheless, this illustrates that they can be a viable source of capital for biotech companies.

Key figures of the German biotechnology sector 2014–2017 2014




Number of dedicated biotech companies





Number of other biotechnology-active companies





Number of employees in dedicated biotechnology companies





Number of employees in other biotechnology-active companies





Turnover of dedicated biotechnology companies





R&D expenditure of dedicated biotechnology companies





The engagement of private investors and business angels in the Austrian biotech sector is subject to high fluctuations. In 2017, 15.4 million euros came from these sources – 24.2% more than in 2014 (12.4 million euros). Companies reported 15 million euros of fundings from federal and state resources in 2017. However, only a fifth of all companies provided this information. According to public figures, public funding into Austrian life science companies amounted to more than 44 million euros in 2017 alone. Additionally, companies can take advantage of governmental tax incentives such as the Forschungsprämie, which gives Austrian firms a 14% refunding for R&D expenses.

scene in Germany. All this contributes to the fact that in 2018, experts saw many smaller rounds in Germany in addition to the big ones. Furthermore, crowdfunding was popular again in 2018. The complete report on the state of the industry will be published by BIOCOM in the German BioTechnology Yearbook 2019 this summer.

Two funding sources also netting lower amounts than in previous years were loans (3.5 million euros as compared to 5.5 million in 2014) and unspecified forms of financing (0.2 million euros; 2014: 2.8 million). However, even combined, these two forms of financing only constitute a slim fraction of all capital raised (1.3%). German biotech industry at a glance Every year, BIOCOM is also conducting a national survey to explore the current state of the German biotech industry. In May each year a national report is released, available at the website www.biotechnologie.de. In early 2019, the most recent financing trends were analysed. Accordingly, in 2018, for the third year in a row, the industry has reached a new financing high. Both privately held and listed companies have benefited. BIOCOM AG’s current figures amount to 422 million euros (+80% compared to 2017) for venture capital financing and 889 million euros (+103%) for financing measures on the public capital markets. In 2017, the bottom line was 235 million euros and 438 million eurosrespectively.

Life Science Report Austria 2018 For more information: www.biocom.de/deroesterreichische-lifescience-sektor/


Life Science aws Life Science Austria Austria 2013 Life Science Report Austria 2018






BioTechnologie Jahrbuch 2018




BioTechnologie Jahrbuch 2018

Many German biotech companies are on the move with very good platform technologies and exciting approaches. This is very attractive for investors – also from abroad. Companies listed on US stock exchanges such     as Morphosys, Affimed, Pieris and Inflarx were able to raise significant amounts of money. In addition, there are many active investors in Germany, but also on a European level, who are keeping an eye on the biotech


BioTechnologie aws Science Life Science Austria Life Austria Life Science Report Austria 2013

Aus dem Inhalt www.lifescienceaustria.at Neuer Branchen-Report Industrielle Revolution? Assekuranz mit Health Apps Biotechnische Aromastoffe Genome Editing im Agrarsektor Allergen-Imuntherapie Preisfrage Orphan Drugs Digitalisierte Krebsdaten Huntington doch heilbar? Methanisierung mit Archaeen Multiple Sklerose + Mikrobiom Biotechnisches PET-Recycling Genetische Schaltkreise Insektenproteine in Aquakultur Chronik 2017/18 OECD-Firmenliste


For more information: www.biocom.de/ biotechnologie-jahrbuch

9 th european biotechnology guide 2019

10 | 11

Analysis of European biotech companies on the stock markets: US vs Europe Mixed Picture Biotech stock markets are still appreciated by investors; however, the second half of the year 2018 was very painful. This mixed picture is reflected in the overall numbers: Whereas the number of IPOs significantly decreased in 2018 compared to 2017, follow-on financings were three times as much. This is particularly true for European stock exchanges. However, nurtured by the further progress of breakthrough technologies such as CAR-T or gene therapies, listed biotech companies – be it from Europe or not – are an attractive target for investors. Biotech stock markets have presented a mixed picture in 2018, resulting in an overall growth trend. However, ups and downs have been significantly in 2018, but in the end, positive picture remains. According to this analysis, which also includes all European biotech firms listed on the US Nasdaq, key figures for 2018 so far indicate an upward trend. The 239 European biotech companies raised a total of €6.36bn in financial proceeds by 2018 – 23% more than in 2017 (€5.17bn) (see Fig. 1). When it came to IPOs and listings, however, 2018 yielded a lower activity. A total of six European biotech IPOs occurred, raising a total figure of €553m. This indicates a large decrease of 37% compared to 2017 (see Fig. 2). Four companies opted for one of the 14 European trading centres, and two companies floated on US Nasdaq.

Six IPOs in 2018 Whereas Swiss company Polyphor SA raised a very high volume of €130m and Swedish Calliditas Therapeutics AB also raised €72m, the other Europe-based IPOs plateaued at the lower end – Polish OncoArendi Therapeutics S.A. (€13.7m), and Danish ViroGates A/S (€10m). However, the Nasdaq IPOs, both from UK companies, were much higher: Autolus Therapeutics reached a total of €129.5m and Orchard Therapeutics, €198m. In addition to the IPOs, three new listings that did not raise additional funding took place on the Nasdaq Nordic Stock Exchange in Stockholm (Fluicell AB, Gabather AB, and CombiGene AB). With this activity, the list of the most attractive stock market locations shifted slightly. Paris (47) is still at the top, although it has had no biotech IPOs so far in 2018. Then, Stockholm follows in the second place (45), and London, in third (44). The shares of 38 European companies are currently traded on the US Nasdaq. In addition to the IPO, two secondary listings (MorphoSys AG and Biofrontera AG) occurred. Follow-on financings In 2018, investors spent even more money on European biotech companies, compared to 2017. A total of €5.81bn was invested into these companies via follow-on financings, a substantial increase of 35%, compared to 2017’s numbers (see Fig. 3). The average size of capital increase in 2018 was a bit higher (€49m), compared to €35m in 2017. Within Europe, Euronext and Alternext together demonstrated the most activity, with 37 financings and total proceeds of €1.1bn, followed by Zurich (9 financ-

Key facts of European listed biotech companies: US vs Europe Nasdaq US Number of European biotech companies



Total numbers





Capital raised via IPOs/listings in 2018

€ 327.5 m

€ 205 m

€ 2,838 m

€ 758.3 m

Capital raised via follow-on financings in 2018

€ 1,331 m

€ 1,433 m

€ 2,838 m

€ 5,602 m

Total proceeds in 2018

€ 1,658 m

€ 1,638 m

€ 3,064 m

€ 6,360 m

Oncology in the spotlight The vast majority of companies (85%) are active in the health sector, developing diagnostics or new therapies for which major investments and long-term financial strategies are required. All of the six stock market newcomers in 2018 can be assigned to this category. The most attractive field within the health area is oncology (see Fig. 4). A total of 74 companies operate in this field, followed by neurology (36), inflammatory (30) and metabolic diseases (30), as well as auto-immune diseases (26). Stock market less attractive for service providers and industrial biotech companies Service providers that offer biotech-based processes for others in the B2B environment have a completely different risk profile than companies focused on biopharma. Although mid- and large-cap companies such as bioMérieux and Eurofins fall into this category, only 14 companies overall operate in this field. Another area of listed European companies is industrial biotechnology. A

Total financial proceedings of European biotech companies €6.36bn €5.17bn

+23% © BIOCOM AG

ings, €735m), Nasdaq Nordic (27 financings, €470m), AIM in London (28 financings, €286m) and Frankfurt (18 financings, €131m). The US-listed companies garnered a total of €3bn in capital , with 29 financings, a 62% increase, compared to 2017 s numbers.



total of 21 firms are involved in the development of new enzyme-based processes or bio-based solutions for various industries. Lower activity at Euronext in 2018 With 14 different trading centres, the variety of stock exchanges relevant to European biotech companies is huge. Analysis of previous years has revealed that the cross-border stock market Euronext is especially attractive for European biotech players, as it clearly provides a

Overview of IPO activity and follow-on financings of European listed biotech companies since 2013 IPO activitiy and volumes in €bn since 2013  





118 15



4.30 0.56


123 14

2.75 1.21


141 21

5.08 1.25

2014 2013

Follow-on financings in €bn since 2013

126 16

2.21 0.11 1.91

109 5 92

9 th european biotechnology guide 2019

12 | 13

Fields of activity

no biotech company went public. But, the Euronextlisted companies succeeded with follow-on financings – in particular those with a double listing in the US (Cellectis, DBV Technologies and Galapagos).

 Health/medicine (203 companies)  Industrial biotechnology (21 companies)  Agribiotechnology (1 company)  Non-specific services (14 companies)

Nasdaq Nordic is catching up In addition, 2018 demonstrated that the other cross-over exchange in Europe, the Nasdaq Nordic, is catching up. In addition to the IPO of ViroGates A/S in Copenhagen, three new listings at Stockholm First North, and three Swedish companies changing from First North in Stockholm to Nasdaq Nordic Main (Nuevolution A/S, Immunovia AB, and Immunicum AB), significant activity transpired here in 2018.

0.4 % 5.6 %




critical mass of listed biotech firms, as well as a nurturing environment in terms of innovation and high-risk financing. However, in 2018, less activity took place here and

Well-received IPOs at SIX For IPO activity, another sign for sustained optimism in the European stock market springs from the two wellreceived IPOs in Switzerland and Poland. That the antibiotics developer Polyphor succeeded in raising €130m in its stockmarket debut on the Swiss Stock Exchange (SIX) demonstrated the high potential of life sciences capital available for attractive biotech stories, even in challenging markets, such as anti-infectives. At the same time, it underlined the strong position of SIX in 2018.

European biotech companies and the areas of indications* they address Autoimmune diseases


Cardiovascular diseases






Inflammatory diseases


Metabolic diseases






Respiratory diseases



47 *Several mentions possible


Number of IPOs and the capital raised Initial public offerings:

Total proceedings

Average volumes

Total number




€92m –37%


€872m €42m


Number of financing rounds and the capital raised Follow-on and other financings: 2018

Total proceedings

Average volumes

Total number €5,807m





€4,300m €35m

Reproductive health specialist ObsEva, already listed on Nasdaq, also issued a listing in Switzerland. New entry on WSE in Poland The IPO of Polish drug developer OncoArendi on WSE increased the number of listed companies in Warsaw to seven. The company, founded in 2012, focuses on novel therapeutics for neoplastic and inflammatory diseases. They have an asthma-treatment candidate in clinical Phase 1 and an immunotherapeutic approach – based on arginase inhibitors to be used as a combination therapy for the treatment of patients with colon, lung, skin, or brain cancer – in preclinical development. The IPO encountered significant demand from both institutional and individual investors, and the proceeds were aimed at encouraging licensing agreements and strategic partnerships on an international level.


Modest IPO activity on Nasdaq The year 2018 saw quite modest activity for new European biotech companies on Nasdaq. However, the two that took place raised significant funding: Cancer biotech Autolus Therapeutics plc from the UK went public in New York in June. The company, which is developing blood cancer therapies based on highly targeted CAR-T cells, succeeded in raising a total of €129.5m, with a share price at the upper end of the price range. In October, even Orchard Therapeutics, a cell therapy developer from UK, raised €198m in New York. In addition, two already-listed German companies decided to go for a secondary listing on Nasdaq this year: MorphoSys AG (€168m) and Biofrontera AG (€10m). Antibody specialist MorphoSys gained much interest due to its late-stage biotech drug candidate MOR208, for which market approval is within reach.

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Thus, overall activity for 2018 demonstrated a mixed picture. Some European biotech companies succeeded in raising comparable high IPO volumes, but in Q4, the stock markets experienced a real downward trend, and some planned IPOs had to be cancelled. However, the appetite of investors in biotech shares however, remained high, so that the total proceeds have passed the €6bn mark for the first time.

Development of follow-on financings in €bn since 2013 European exchanges  

US Nasdaq



total number

total number























Promising companies attractive for US investors Due to its broad spectrum of investors, the US Nasdaq continues to be an attractive stock market for European biotech companies, particularly when they are in latestage development or active in promising areas, such as immunotherapies or gene therapy. In 2018, Nasdaq saw two European biotech IPOs, two secondary listings from European companies, and strong follow-on financings, resulting in increased overall figures. IPOs and listings on Nasdaq are particularly interesting for companies which need a large amount of capital. This holds true for the field of CAR-T-focused companies at the beginning stage of clinical development, such as Autolus Therapeutics. The company was spun out from the University of London in 2014, has a pipeline of product candidates in development for the treatment of haematological malignancies and solid tumours, and in

Overview of trading centres with total numbers of European biotech companies 9






*Euronext, **Nasdaq Nordic

Helsinki **


Amsterdam *







Brussels *





Copenhagen **




Stockholm ** 2018


Paris *







New York



Comparison of capital raised via IPOs in €m and number of IPOs







5 14


3 21



2014 2013



4 506.9



9 5

59.4 47.0

1 5

110.1 94.0 European exchanges 


June 2018, achieved a successful IPO on Nasdaq, raising €129.5m in total at the upper share price range. Unbroken investors’ appetite The same applies to Orchard Therapeutics. The British company is developing a gene therapy for rare genetic diseases and raised €198m with the IPO on Nasdaq. The new funding was needed to manufacture Strimvelis, an EMA-approved gene therapy, which GSK sold to Orchard in April. Including these companies, in total, 38 European bio­tech firms were listed on Nasdaq in 2018. They raised total financial proceeds of about €3.3bn via IPOs, secondary listings, and follow-on financings. This means a 49% increase compared to 2017 (€2.2bn). For the second year in a row, capital investments show a growth trend, not only in numbers, but also in volumes. The development is particularly driven by the high potential investors see in new therapeutic approaches, such as gene therapy, CRISPR, or cancer immunotherapies. With regard to follow-on capital, the companies attracted a combined total of €2.97bn in 29 follow-on financings, which means a 62% investment increase, compared to the same time in 2017(€1.83bn). The numbers also include the two secondary listings of German bio-tech companies MorphoSys and Bio-frontera, which amounted to a total combined capital of €178.4m.


If you are interested to get the full version of the report for free, please visit: www.biocom.de/en/analysis2019 BIOCOM offers a broad spectrum of services to our clients from industry and the public sector: Customised consultancy services Surveys and market intelligence OECD data collections in biotechnology and life sciences For more information, please visit: www.biocom.de/en/consultancy-and-research

Contact: Sandra Wirsching Director Business Development BIOCOM AG +49(0) 30-26 49 21-63 s.wirsching@biocom.de

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HORIZON EUROPE Excellent R&D projects deserve excellent communication. With more than 30 years of experience in life sciences, BIOCOM is the perfect partner for your professional dissemination, communication and exploitation needs in EU-funded projects. ÂŽ

Project branding and preparation of communications materials Creation and maintenance of the project website Media work, incl. social media and project videos Organisation of conferences and workshops


Picture: rakchai/fotolia.com

For more information, just head to www.biocom.de/comdis or contact Dr. Boris Mannhardt at b.mannhardt@biocom.de


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Name · 3P Biopharmaceuticals Address/P.O. Box Postal Code/City Country Contact Person

· · · ·

Telephone Email Website Number of Employees Founded (year)

· · · · ·

Pol. Mocholí. C/Mocholí 2. 31110 Noáin Spain Elena Erroba (Director of Business Development) +34-948-34-64-80 elenae@3pbio.com www.3pbio.com >200 2007

 iotechnology Areas of Activity · | B |B  iomedicine

Company profile 3P Biopharmaceuticals is a European-based Contract Development and Manufacturing Organisation (CDMO) specialised in the process development and GMP manufacturing of biopharmaceutical and cell therapy products. People, passion, and precision come together in a unique method of working. A highly qualified team accompanies clients through the full life cycle of their products as a robust manufacturing partner: from cell line development to clinical and commercial manufacturing. 3P has a successful track record on a global scale, helping customers to bring their candidates from the early stages of development up to clinical phases and, ultimately, to commercialisation. In its state-of-theart biomanufacturing facilities, the company also offers a comprehensive range of analytical and development services as well as continuous regulatory support that improves the value of its client’s candidates.

GMP certified 3P Biopharmaceuticals offers GMP manufacturing services for biologics obtained from both mammalian and microbial expression systems. 3P is GMP certified by AEMPS* for: ·· API manufacturing (clinical trials & commercial phase) ·· QC and release of API and final products for clinical trials and commercial phases * Spanish Medicines and Sanitary Products Agency (equivalent to EMA)

Summary services ·· Cell line development ·· Analytical methods development, qualification, and validation ·· Process development ·· Scale-up and GMP manufacturing ·· Process characterisation ·· Process validation ·· Commercial supply Advanced therapies (cell therapy) for non-GMP/GMP processes ·· Cell therapy products

3P Biopharmaceuticals

·· Tissue-engineered products ·· Cell culture media ·· Biomaterials (scaffolds or membranes)

Biologics facilities & equipment Process development capacities for mammalian: ·· Bioreactor ambr ® 250 ·· Microbioreactor ambr ®, 24 vessels ·· Biostat Q 6x1L ·· Biostat B: 2x2L+1x5L ·· Biostat B twin 2x5L Process development capacities for microbial: ·· Biostat B twin 2x2L +2x2L ·· Biostat B DCU 2x2L + 1x10L GMP Manufacturing capacities for mammalian: ·· Single use bioreactors: 50L, 200L, 400L GMP Manufacturing capacities for microbial: ·· Stainless steel bioreactors: 2x10L, 2x100L, 1,000L

Track record 3P has been involved in GMP manufacturing projects starting from gene design up to commercial manufacturing involving technology transfers from several CMOs based in Europe, the United States, Argentina, and Australia. 3P has experience working with different expression systems: microbial (E. Coli, S. Cerevisiae, H. Polymorpha, P. Pastoris) and mammalian (CHO, BHK, HEK, Hybridomas) for the process development and GMP manufacturing of New Biological Entities (NBEs) including but not limited to fusion proteins, vaccines, monoclonal antibodies, and Fabs. Moreover, the company has extensive experience in biosimilars (development from bacterial and mammalian processes; innovator characterisation and comparability studies). Extensive experience, capacities, and capabilities in Project advancements all through the late stages of execution. Proven approach in execution of risk assessments, scale-down model validation, process characterisation execution to facilitate successful Process validation and market supply. Our clients are in the market and with others we are advancing a number of programmes for mammalian and microbial projects. 9 th european biotechnology guide 2019

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Executive summary

Name · Aglaris Ltd. Address/P.O. Box · Stevenage Bioscience Catalyst Gunnels Wood Road Postal Code/City · SG1 2FX Stevenage Country · United Kingdom Contact Person · David Horna Telephone · +44-14-3890-6785 Email Address · aglaris@aglaris.co.uk Internet Website · www.aglaris.co.uk Number of Employees · 20 Founded (year) · 2012 Areas of Activity · l Cell manufacturing automation l Bioprocesses design l Cell processing technologies development

Aglaris’s automated cell production system, Aglaris Facer 1.0, has the potential to revolutionise the world market for massive cell production; this system is designed for use in hospitals for cell therapy, biotechnology and pharmaceutical companies that use a large number of cells, and research centres. The Aglaris Facer 1.0 can grow a large number of cells in a completely automated process. This increases process efficiency by 10% and reduces cell production costs by 80%. Aglaris Facer 1.0 is designed to perform the entire cell culture process, as well as all of the necessary quality controls, to ensure cell growth within the strictest quality standards.

Introduction The demand for cell cultures is rapidly expanding. Every day more and more applications require a large number of cells as a starting point (for example cell therapy, tissue engineering, production and development of drugs). It is estimated that the market for cellular therapies will reach approximately £10bn in the next five years. To meet the needs that such processes require, a more affordable and reliable cell source will be needed. This can be achieved with the use of the Aglaris Facer 1.0 system.

Company history Aglaris Cell, S.L. was founded in February 2012 to develop a cell production system capable of solving the current problems in the cell culture process and to provide the market with tools that can meet the future demands of cell culture. The technologies used are Aglaris’s proprietary patents developed by the entrepreneurial team.

Member of

European Biotechnology NET WORK

In the strategic and scientific fields, Aglaris has collaborated closely with ISIS Innovation from the University of Oxford. An agreement with a major engineering centre has also been made to design and develop product components. To start its internationalisation process Aglaris Ltd. was set up in July 2014. Currently Aglaris has its headquarters in the Stevenage Bioscience Catalyst,


Aglaris Facer 1.0 Bioreactor

where conducts all its bioengineering developments as well as a subsidiary company in Madrid (Spain) where it develops the biomaterials needed for the cell expansion.

Technological advancement The Aglaris Facer 1.0 technology is being fully developed at Aglaris. This technology allows the culture of cells from a biopsy to the maximum number of cells allowed by each cell type’s proliferation capacity without any human intervention. The patent for this technology has already been granted in the USA and China, and has been submitted to the EU and Canada, (WO 2013/186318). After each culture, the system delivers both the required number of cells for the user, and all the additional samples necessary for final lot inspection. The system has two types of components, fixed equipment that is reused, and a set of consumables that is discarded after each culture. The consumables are where the versatility of Aglaris Facer 1.0 is demonstrated. Depending on the characteristics of the interior surface of the consumable, Aglaris Facer 1.0 can be used for any type of cell expansion.

Cell culture bioreactor

Iterative method

Make it easy

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Name · AiCuris Anti-infective Cures GmbH Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

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

LI 65 2006 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: multiresistant Gram-negative and Gram-positive hospital infections 3. Immune modulators External · Merck & Co. (MSD): Licensee of Collaborations AiCuris’s HCMV drug PREVYMIS™ (letermovir) Request for · AiCuris is interested in collaborations Further Collaborations with academic and industrial partners and pursues an active in- and outlicensing strategy

Company overview AiCuris was founded in 2006 as a spin-off from Bayer and focuses on the discovery and development of drugs targeting infectious diseases. SANTO Holding is the Company’s majority investor. The Company develops drugs for the treatment of viruses such as human cytomegalovirus (HCMV), herpes simplex virus (HSV), hepatitis B virus (HBV), and adenoviruses. In the field of antibacterials, AiCuris seeks to develop innovative treatment options for life-threatening, (multidrug)-resistant hospital-treated pathogens. PREVYMIS™ (letermovir), a first-in-class non-nucleoside cytomegalovirus (CMV) inhibitor acting via a novel mechanism of action was outlicensed to MSD and received market approval in the U.S., Europe, and Japan after a successful Phase 3. The head office and laboratories of AiCuris are located at the Life Science Park in Wuppertal, Germany. Biology laboratories (S2 and S3) as well as pharmacokinetic laboratories are available for the discovery and the support of the development of novel anti-infective agents. The founding CEO of AiCuris was Prof. Dr Helga Rübsamen-Schaeff. In 2015, Dr Holger Zimmermann, former CSO, took over CEO responsibilities. AiCuris’s 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 licensed its HCMV portfolio to Merck & Co., USA (MSD) and granted MSD worldwide rights to develop and commercialise it. Under the terms of the agreement with MSD, AiCuris receives milestone payments as well as royalties on net sales. This was one of the largest agreements of its kind in the European biotech industry. So far, AiCuris has received 260 million euros as upfront and milestone payments.


Foto: ©Ansgar Pudenz

Corporate strategy

AiCuris CEO – Dr Holger Zimmermann

AiCuris R&D Pipeline

AiCuris is dedicated to developing 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. For this AiCuris therapeutics are resistance-breaking by design. AiCuris follows a proof-of-concept strategy before out-licensing its development projects. Currently, the company runs multiple clinical development programmes: PREVYMIS™ (letermovir) is marketed by MSD for the prevention of CMV infections in adult recipients of an allogeneic hematopoietic stem cell transplant (HSCT). A Phase 3 trial in solid organ transplant recipients is ongoing. AIC649, a novel biological immune modulator, aims to provide patients with a curative treatment for hepatitis B virus (HBV). Positive Phase 1 clinical trial results were recently reported. Pritelivir, a helicase-primase inhibitor, is being developed to treat herpes simplex virus Type 1 (HSV-1) and Type 2 (HSV-2) infections. A Phase 2 trial in labial herpes (topical indication) has been completed; a Phase 2 trial in acyclovir resistant infections is ongoing. Other preclinical and clinical programmes include small molecules against HCMV, HBV, and adenovirus and resistance-breaking hospital antibiotics. AiCuris addresses high medical need areas within the anti-infectives market. One key growth driver is the growing resistance of pathogens to existing antiviral and antibacterial drugs, causing serious concerns among healthcare providers and regulatory authorities worldwide. In addition, the anti-infectives market shows significant growth in emerging countries. AiCuris is actively in-licensing preclinical projects that help make a real difference in the anti-infectives field. AiCuris’s key areas of interest are viral indications (in particular HBV, adenovirus) and life-threatening nosocomial bacterial infections, especially those caused by Gram-negative pathogens. In November 2018, AiCuris received the “Deutscher Zukunftspreis”, the federal President’s Award for Innovation and Technology. 9 th european biotechnology guide 2019

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

· · · · · · · · · · ·

Hammerstrasse 49 4410 Liestal Switzerland Dr Klaus Weber (CEO) +41-61-906-4000 info@anapath.ch www.anapath.ch

I > 30 2012 Pre-Clinical CRO

Areas of Activity · l Histotechnology l Toxicologic Pathology l Molecular Pathology l Developmental Pathology l Digital Pathology

AnaPath Services GmbH AnaPath is an independent, privately owned pre-clinical CRO specialised in histotechnology and pathology. Located in the centre of Europe, close to the pharmaceutical capital Basel, we serve the pharmaceutical, chemical, agrochemical, and biotechnological industries, academia, start-ups, and medical device companies all over the world with our GLP-compliant services. Our cross-disciplinary team of internationally recognised scientist, and engineers uses decades of experience and great dedication to meet any need in toxicological, molecular, and fetal pathology.

Our services at a glance As Europe’s largest provider of histopathology services, we routinely process up to 35,000 tissues per month for H&E staining. Moreover, we offer: ·· Special stains, e.g. PAS, Fluoro-Jade, and Alcian Blue ·· On-site necropsy training and support ·· Toxicologic pathology (GLP-compliant and SEND ready archive files) ·· Molecular pathology: Immunohistochemistry and in-situ hybridisation, biomarker ·· Tissue cross-reactivity studies (FDA/EMA compliant) ·· Plastic embedding for implants and neurotoxicology ·· Ecotoxicology (according to OECD guidelines) ·· Sperm staging, ovary/follicle counting ·· Bone marrow differentiation ·· Evaluation of inhalation studies ·· Digital pathology ·  Slide scanning (bright field and fluorescence) ·  Quantitative measurements (QuPath, CellSense) ·  Statistical analysis

Reproductive and developmental pathology We are one of the few CROs having extensive experience and know-how in mouse, rat, and rabbit developmental studies according to current OECD regulations. Results can be provided in GLP-compliant reports: ·· C-section and external examination (in house or at client’s facility) ·· Fresh visceral microdissection, craniofacial evaluation ·· Skeletal evaluation (single & double staining)


Special technologies for special challenges Our employees are distinguished by solving also unusual challenges in pathology. Within our facilities and/ or through our partners we can use a wide range of state-of-the-art technologies: ·· 3D confocal laser scanning microscopy e.g. to study surfaces at high resolution (up to 17'280x) ·· Hyperspectral microscopy (CytoVia) e.g. to localise the test item within the tissue section ·· Transmission electron microscope ·· Energy-dispersive X-ray spectroscopy (element mapping) ·· High resolution micro-CT e.g. to study the vasculature including finest capillaries ·· Laser Capture Microdissection (LCM) We have established a large variety of measurements. However, our experienced scientists and pathologists can also help making customised measurements, designed to demonstrate special endpoints specific to your test item/device.

Peer reviews AnaPath’s pathologists offer to diligently and independently review pathology reports. Moreover, we organise pathology working groups and provide you with expert statements by a board-certified pathologist.

Safety Alliance Together with our network of European mid-size CROs, the so-called Safety Alliance, we are able to lead, manage, and conduct your complex multisite Safety Assessment Package within budget and timeline. From proposal generation to contract management, we make sure your test item is evaluated by experts in regulatory strategy, toxicology, and pathology. We are highly experiences in all laboratory animals: rodents, non-rodents, and rarely used species including birds, fish, and invertebrates!

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

· · · · · · · · · · ·

Im Neuenheimer Feld 584 69120 Heidelberg Germany Juergen Gamer, PhD +49-6221-58608-0 +49-6221-58608-10 contact@apogenix.com www.apogenix.com 60 2005 S1

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

Company overview Apogenix develops innovative 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. Checkpoint inhibitor asunercept, Apogenix’s lead immuno-oncology candidate, is being developed for the treatment of solid tumours and malignant hematological diseases. Asunercept has been shown to prolong overall survival in a phase II trial in recurrent glioblastoma – the most frequent and aggressive brain tumour – and has demonstrated hematological improvements in a phase I trial in myelodysplastic syndromes (MDS) – a stem cell disorder that can lead to severe anemia. Apogenix has also developed a proprietary technology platform for the construction of novel TNF superfamily receptor agonists (HERA-ligands) which stimulate and enhance the anti-tumour immune response and have the potential for broad application in oncology.

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 ligand-mediated signaling, which plays an important role in the progression of solid tumours. 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 diagnostic test based on this biomarker, so that asunercept can be used as a personalised therapy. In 2017, asunercept was granted PRIME (PRIority MEdicines) designation by the European Medicines Agency for the treatment of glioblastoma, which will greatly facilitate the further clinical development toward 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 demonstrated a significant decrease in transfusion frequency in 40 percent of patients during the trial. In addition, an investigation of parameters involved in erythropoiesis revealed how asunercept stimulates the production of red blood cells in these patients.

HERA-ligand technology platform Apogenix has developed the proprietary HERA-ligand technology platform for the construction of novel fusion proteins that target different TNFSF-dependent signaling pathways. The specific molecular structure of Apogenix’s HERA-ligands induces a well-defined clustering of functional TNF receptors on the surface of target immune cells, thus offering clear advantages over other biologics such as antibodies. By stimulating different TNF signaling pathways, these HERA-ligands can enhance the anti-tumour immune response and have the potential for broad application in oncology. Apogenix’s HERA-ligands have shown strong anti-tumour efficacy in vitro and in vivo, with a benign safety profile. The company has successfully out-licensed its first programme based on this technology platform – HERA-TRAIL receptor agonist APG880 and derivatives – to AbbVie. AbbVie initiated clinical trials with HERA-TRAIL (ABBV621) in 2017. Apogenix is currently utilising its technology platform to develop CD40, CD27, GITR, HVEM, and 4-1BB receptor agonists for cancer immunotherapy.

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Name · Bachem AG Address/P.O. Box Postal Code/City Country Contact Persons Email Address Internet Website Social Media

· · · · · · ·

Hauptstrasse 144 4416 Bubendorf Switzerland Global Marketing Bachem Group marcom@bachem.com www.bachem.com


Americas: Bachem Americas, Inc. Telephone · Toll Free (USA and Canada): +1-888-422-2436 or +1-310-539-4171 Email Address · sales.us@bachem.com Asia Pacific: Bachem Japan K.K. Telephone · +81-3-4405-3141 Email Address · sales.jp@bachem.com Europe, Africa, Middle East, and India: Bachem AG Telephone · +41-58-595-2020 Email Address · sales.ch@bachem.com Number of Employees · >1,000 Founded (year) · 1971 Type of Laboratory · Contract manufacturing organisation Areas of Activity · Bachem specialises in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based APIs.

About BACHEM Bachem is specialised in the process development and manufacturing of peptide-based active pharmaceutical ingredients. A comprehensive catalogue of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US, and Asia, the group has a global reach. Bachem shows total commitment to quality, innovation, and partnership.

Research Bachem offers the world’s largest collection of amino acid derivatives, which are used by customers interested in manufacturing peptides. In addition, solid phase supports for peptide synthesis are available. Other essential product lines are bioactive peptides, enzyme substrates and inhibitors, as well as some organic molecules. New products are added to maintain an innovative touch. Strong emphasis is placed on quality.

Preclinical development During preclinical development, lead finding and lead optimisation require large panels of peptides. These are generated as custom-synthesised molecules for customers around the world. Frequent consultation with Bachem experts allows further refining of target compounds. This requires a clear partnering aspect to come up with pioneering concepts and molecules to bring into clinical development.


Clinical development When clients have selected their lead compound, they commence clinical trials. It is a decade-long process to approval of the drug. During this time, there is a close collaboration to learn more about the product. Each production step is scrutinised, and manufacturing reproducibility is strived for. Scale-up and full control of the process are the goal. Validation and control of the process result from an intense partnership.

Peptide drugs The responsibility for manufacturing sufficient drug substance rests on the shoulders of the Contract Manufacturing Organisation. This can only be done by being extremely reliable and by coordinating activities closely with our partners. Forecasting the quantity needed is extremely difficult, especially for new drugs where the commercial success has not yet been proven. Hence, responsiveness to customer needs becomes paramount.

Bachem. Pioneering Partner for Peptides.

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Name · Biaffin GmbH & Co KG Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Websites Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · ·

AVZ 2, Heinrich-Plett-Str. 40 34132 Kassel Germany Dr Bastian Zimmermann +49-561-8044668 +49-561-8044665 info@biaffin.com www.biaffin.com www.proteinkinase.biz

· FIQ · 8 · 2001 · Analytical, ISO 9001:2015 certified

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

· · · · · · · · · · · ·

Merowingerplatz 1 40225 Dusseldorf Germany Dr Nils Schrader +49-211-385-469-9200 +49-211-385-469-9220 bio.nrw@bio.nrw.de www.bio.nrw.de

L 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 companies, research institutions, Collaborations 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-touse, these resources are valuable tools for identifying business partners. More information on www.bio.nrw.de Fairs, exhibitions and conferences Companies and academic institutions can generate awareness of their activities locally, nationally and internationally by being a part of the BIO.NRW common stands at fairs, exhibitions and conferences. BIO.NRW also organises a series of workshops and symposia, called BIO.NRW.academy. Support of young professionals BIO.NRW takes a special interest in supporting young professionals in biotechnology. We participate in conventions and exhibitions to bring graduates in contact with 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.

NRW – Germanys most international business location

Home to 20,000 foreign companies

North Rhine-Westphalia

USA 1,700* China 1,100* Japan 600* France 1,100* Great Britain 1,500* Switzerland 1,500* Netherlands 4,100* *Number of foreign companies in NRW (selection)


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 4.5% of the European GDP (EU-28). If classified as an independent nation, NRW would rank 19th in the world, just between Netherlands and Saudi Arabia. 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 500 life science companies, among them 126 core biotechnology firms that together account for 51.6% 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 three Helmholtz research centres, five Fraunhofer Institutes and six Leibniz Association facilities. 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 2017, some 49% 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 2018, the drug pipeline of all companies combined contained 97 products and candidates. 17 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. 9 th european biotechnology guide 2019

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The information specialist

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

· · · · · · · · · ·

Luetzowstr. 33–36 10785 Berlin Germany Dr Boris Mannhardt +49-30-264921-0 +49-30-264921-11 service@biocom.de www.biocom.de 34 1986

 onsulting Areas of Activity · | C |P  ublishing | E vents

Biotechnology, life sciences, knowledge-based bioeconomy, medical technology: experienced industry and scientific specialists at BIOCOM have been tracking the development of life sciences from research to market for more than 30 years – content-driven and resultsoriented, enthusiastic about the subject and always committed to the customer. To be close to its clients across Europe and optimally suppor t the media, event and ser vice activities, BIOCOM runs its headquarters in Berlin and has further offices in Brussels, Vienna and Zurich.

Consulting and studies As a leading information specialist in ­Europe, BIOCOM has extensive knowledge and experience in all life science areas, be it medtech, pharmaceutical development or the bioeconomy including agricultural innovation and industrial biotechnology. Building on this, the project management division offers a comprehensive range of services for companies and the public sector – wherever state-of-the-art biotechnology calls for specialised information and communication processes. BIOCOM prepares market, financial and technologyspecific studies with the highest user value for its clients. It conducts qualitative and quantitative analyses, developed closely with customers and delivering focused, accurate data. The result is clear, informative dossiers with highest quality information to effectively support professionals in industry and politics.

Industry surveys

Member of

European Biotechnology NET WORK

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


Publishing The unique feature of printed or electronic media published by BIOCOM is their relevance in practical work. From magazines like European Biotechnology, up-to-date books, directories, internet platforms to videos, they are fact-based and strongly content-related – simply a must on many desks or screens.

Events Proprietary conferences, conventions and congresses have long been part of the company’s successful activities. BIOCOM events are a perfect example of content relevance and superb organisation. BIOCOM’s event management team also organises large and small events on behalf of customers: from focused workshops to large professional congresses and exhibitions with thousands of attendees and visitors.

Communication + dissemination In all research projects funded under the European Commission’s framework programme Horizon 2020, the work package of communication and dissemination is a key element. Progress of the project and relevant research results need to be published through various channels to make the project – and European funding activities as such – more visible. Under the COMDIS label, BIOCOM offers these services to research consortia across Europe. To inform all stakeholders in a consortium as well as the interested public including policy makers about the objectives and results of the project, a coherent and clear communication strategy is essential. This is particularly true for large collaborative projects that involve many partners including universities and SMEs across Europe in a complex scientific approach over a long period of time. BIOCOM’s tasks in these projects comprise in particular: ·· Branding of the project and preparation of communication material ·· Creation and maintenance of the project website ·· Videos ·· Media work ·· Organisation of conferences and workshops 9 th european biotechnology guide 2019

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

· · · ·

Telephone Fax Email Website Social Media

· · · · ·

Hermannswerder 17 14473 Potsdam Germany Dr Kornelia Berghof-Jäger (CEO) Alois Schneiderbauer (CBO) +49-331-2300-200 +49-331-2300-299 bcd@bc-diagnostics.com www.bc-diagnostics.com

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. These 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 and ELISA.

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 RoboPrep Fusion® system, represents a set of fully automated DNA-extraction and PCR setup systems validated and certified for the food and beverage industry. The RoboPrep+ Series provides solutions 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 optimised especially for the food industry and are applicable for the detection of all food-related organisms in various food and environmental samples. The 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 robots for different food-testing applications. For example, the RoboPrep 32® isolates DNA from bacteria, GMO, or allergens within 45 minutes for up to 32 samples.

microproof ® products For environmental testing and water quality control, BIOTECON Diagnostics‘ real-time PCR-based microproof ® LyoKits play a trusted role in the detection and quantification of pathogens such as Legionella in environmental samples and water, and offer reliable analysis with high sensitivity and specificity.

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 customised contract development. With close contacts to 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 customised MALDI Biotyper reference libraries (e.g. D-MASS) for fast microorganism identification, microarrays, and sequencing. For MALDI-TOF MS the company provides own databases for specific food categories like dairy and works in a close cooperation with a leading provider of this technology. BIOTECON Diagnostics is thus able to provide flexible solutions to production and processing companies through new, tailored, and economical approaches. 9 th european biotechnology guide 2019

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Name · Biotype Diagnostic GmbH Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Address Internet Website

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

· · · · · · · ·

Moritzburger Weg 67 01109 Dresden Germany Dr Kathleen Clauß +49-351-8838-400 +49-351-8838-403 Info@biotype.de www.biotype.de www.custom-solutions.biotype.de https://molecular-diagnostics-group.com

· LI Q · 60 · 1999 · l Molecular biology l cGMP ready l ISO 13485 & ISO 9001 certified

Areas of Activity · l Molecular diagnostics l Companion diagnostics l Contract development l Contract manufacturing External · Member of the Molecular Diagnostics Collaborations Group (MDG); contributing solutions for healthcare, personalised medicine & digitalisation

General information Biotype develops, produces, and sells molecular diagnostic kits for the detection and quantification of RNA and DNA targets. Aside from assays, we provide premium OEM-services to cover all challenges, ranging from the idea up to manufactured marketable products on various platforms.

Product line Our portfolio of diagnostic kits is used in routine laboratories in the field of oncology, haematology, dermatology, pathogen detection, and forensics. Proprietary Modaplex technology Biotype offers a unique PCR benchtop system that simplifies the complexity of molecular diagnostics. With little hands-on time and simple workflow, the Modaplex platform can ·· Quantify up to 50 DNA & RNA targets in a single well ·· Measure up to 48 samples simultaneously ·· Detect all types of genetic aberrations simultaneously in a 3.5-hour run A selection of tests on the Modaplex platform: ·· Gene Expression ·· Mutations ·· Polysomy ·· Copy Number Variations ·· Methylation ·· Gene Fusion ·· Micro RNA ·· Splicing Variants The Modaplex System is available for co-development and out-licensing.


biotype diagnostic

OEM-Services Biotype provides development, manufacturing, and validation of PCR-based molecular diagnostic tests for the biotech industry. Our teams are specialised in the development of CE-IVD certified diagnostic tests for oncology and pathogen detection. However, we also develop and manufacture non CE-IVD test for agro, food, veterinary, and forensic companies. The following points characterise Biotype’s OEMservices: Assay development & validation ·· 20 years of experience in the development, validation, and manufacturing of CE-IVD tests ·· Experts on all PCR platforms, including qPCR, digital PCR, capillary gel electrophoresis, Modaplex ·· CE-IVD test-development according to FDA Design Control Guidance ·· ISO 13485 and ISO 9001 certified Assay manufacturing ·· Manufacturing in flexible batch sizes ·· Production under clean-room conditions ·· QC and & long-term stability tested ·· Customised formulation & packaging Regulatory affairs & registration services ·· QM/technical documentation ·· Assay validation on multiple platforms ·· Regulatory service and IVDR support Laboratory services ·· Sample testing for clinical studies ·· Development of custom QC tests ·· (CE-)Validation of existing in-house assays

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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

· · · · · · · · · · ·

Binger Strasse 173 55216 Ingelheim Germany Matthias Reinig +49-6132-77-0 +49-6132-72-0 bioxcellence@boehringer-ingelheim.com www.bioxcellence.com ~50,000 in 2017 1885 in Ingelheim, Germany S1

Areas of Activity · Focus on human pharmaceutical and animal health business Net Sales · €18,100 million in 2017 Relevant R&D Budget · €3,100 million in 2017 (net sales of Boehringer Ingelheim GmbH) 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 181 affiliates and around 50,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing, and marketing novel medications of high therapeutic value for human and veterinary medicine. In 2017, Boehringer Ingelheim achieved net sales of about 18.1 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 30 biopharmaceutical products products to market. Boehringer Ingelheim BioXcellenceTM offers tailormade 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 285,000 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 more than 30 biopharmaceuticals to the market and an outstanding track record of >150 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 · BRAIN AG Biotechnology Research And Information Network AG Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · ·

Darmstädter Str. 34–36 64673 Zwingenberg Germany Dr Martin Langer (EVP Business Development) +49-6251-9331-0 +49-6251-9331-11 public@brain-biotech.de www.brain-biotech.de

· · · · · LI · >300 · 1993 · S1, S2, L1, L2

Areas of Activity · l Customized enzymes, bioactive natural compounds, high-performance microorganisms based on a unique BioArchive l Cell-based screenings l Strain development l Protein engineering l Production scale-up l Off-the-shelf products Biological Patents · More than 350 patents in metagenome technologies, enzymes, enzymelibraries, bioactives, technical proteins, microorganisms, processes External · BASF, Bayer, Evonik, Henkel, Nutrinova, Collaborations RWE, Sandoz, Schering, Südzucker, Symrise (D), CIBA (CH), Clariant (CH), Diana (F), DSM (NL), Roquette (F), Genencor (USA), and others; global academic R&D network Request for · Joint developments of novel tailorFurther Collaborations made biological ingredients for Nutrition & Health, Cosmetics & SkinCare, and Industrial BioSolutions markets

BRAIN is a pioneering international company with a world class industrial biotechnology toolkit. Our innovations are based on biological solutions including extensive gene libraries. The consolidated capabilities of the BRAIN group companies uniquely focus on driving innovation to deliver value from concept to commercialisation and beyond. BRAIN is providing disruptive solutions to benefit our partners and a sustainable bioeconomy. We help to accelerate the biologisation of industries and commodity worlds with the aim of preserving sensitive raw materials and replacing unfavourable manufacturing processes and products. The unique approach of the BRAIN Group allows us to work in collaboration with our customers in a highly efficient way. We use our biotechnology toolkit to select the most appropriate technology to ensure that the solution delivers the maximum value throughout the product lifecycle and value chain. Our aim is to support our customers to innovate and differentiate themselves from their competitors, explore previously unobtainable solutions, and speed up time to market. Unlike other companies, we do this by first focusing on the challenge rather than the technological solution. This enables us to find the perfect solutions for our business partners and to deliver rapid, cost-saving innovations from sample identification to production scale-up and supply. At BRAIN we also understand that the key to any successful innovation is the right business model. Early commercialisation discussions are the key to ensuring a profitable partnership and the BRAIN Group’s ability to deliver market products is essential for this. BRAIN delivers fast and reliable results in customised R&D collaborations for joint product development and exclusive strategic partnerships including licensing agreements. BRAIN Group develops and brings to market novel biological ingredients for the improvement of product applications in B2B markets for Nutrition & Health, SkinCare & Cosmetics, and Industrial BioSolutions. Key R&D activities include the identification and production of bioactive compounds, tailor-made enzymes, and high-performance microorganisms.


Pioneering Bioproducts Team up with the BRAIN Group to innovate next-generation bio-based products to leverage your products and processes to competitive market advantage. → www.brain-biotech.de

Nutrition & Health

Skin Care

BRAIN can look back on more than 100 successfully concluded collaborative projects. Key success factors of BRAIN are many years of experience in the arenas of sustainability, biodiversity, and industrial biotechnology and its exceptional global network and innovation culture. BRAIN develops innovations based on the latest discovery and screening platforms for the natural diversity of species as well as 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. The BRAIN group of companies, including BRAIN AG, AnalytiCon Discovery GmbH, WeissBioTech GmbH, Biocatalysts Ltd. (UK), BRAIN LLC (US), SolasCure (UK), as well as L.A. Schmitt GmbH, and Monteil Cosmetics International GmbH bring together top-notch research and development work, specific production expertise, and attractive access to markets all under one roof. BRAIN AG in Zwingenberg is fully dedicated to scientific R&D. The other group companies complete the network, each acting as an independent entity in the areas of R&D, process development, manufacturing, or as product vendors in specific markets. BRAIN’s headquarters is located in Germany’s Rhine Main Neckar Metropolitan region near Frankfurt. As part of a business and growth strategy, BRAIN AG has been listed on the Prime Standard of the Frankfurt Stock Exchange since February 2016.

Industrial BioSolutions

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

· · · · · · · · · · · ·

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

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

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

High-quality GMP reagents for cell and gene therapy manufacturing CellGenix is a leading global supplier of high-quality raw and ancillary materials for the expanding market of cell and gene therapy as well as regenerative medicine. We develop, manufacture, and market human cytokines, growth factors, and other recombinant cell culture components in preclinical and GMP quality, as well as proprietary serum-free media for further manufacturing of ATMPs. Our products are used by academia and industry partners in clinical trials and commercial manufacturing throughout the world. As an ATMP developer and manufacturer we have acquired in-depth cell culture knowledge and superior regulatory expertise. With this unique background we understand the high requirements our customers face during product development and the regulatory approval process. CellGenix is headquartered in Freiburg, Germany and operates a subsidiary near Boston in Portsmouth, NH, USA.

Our mission & vision Our mission is to enable and accelerate safe and efficient transition of cell, gene, and tissue-engineered products from preclinical to post-approval clinical applications for the benefit of patients worldwide. We foster this by providing premium ancillary products, reagents, tools, and expert regulatory support to our academic and industry partners worldwide. We aim to be a key provider in the fight against disease, the preferred supplier of raw materials and tools, and a trusted partner for large-scale manufacturing in cell and gene therapy as well as regenerative medicine.

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






and regenerative medicine. The company was founded in 1994 as a spin-off of Freiburg University Medical Center and was the first European company to obtain a GMP manufacturing authorisation for cell processing in 1995. CellGenix’s current Quality Management (QM) system was established for the manufacture of recombinant protein investigational products (patient-specific idiotype vaccines and recombinant tumour vaccines) in compliance with GMP under manufacturing authorisation from German regulatory authorities. The QM system has been adapted for the manufacture of recombinant raw materials and has been ISO certified since 2012 (currently DIN EN ISO 9001:2015).


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


Regulatory excellence





iotechguide_BioCom.indd 1



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

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Name · China Bioengineering Technology Group Limited Address/P.O. Box · Rm 202, Premier Centre, Lai Chi Kok, Kowloon Postal Code/City · Hong Kong Country · China Contact Person · Dr Jay Liang Telephone · +852-2208-7900 Email Address · info@cbtgene.hk Internet Website · www.cbtgene.com.hk Number of Employees · 20 Founded (year) · 2015 Areas of Activity · l Gene testing l Single molecular assay l Disease risk testing

Introduction China Bioengineering Technology Group Limited (CBT), situated in Hong Kong, is a high-tech, professional, and well-recognised body working on biomedical science and precision medicine, as well as big data access, statistics, and analysis. Our company possesses Independent Intellectual Property Rights for our genetic-testing technology and biomedical data analysis platform. In addition, we are the pioneer in Hong Kong in using the Simoa HD-1 Analyzer to detect proteins and nucleic acid in serum and plasma. It is a fully automatic instrument for running immunoassays with ultrahigh sensitivity.

Products & services CBT is introducing new genetic applications that have the potential to aid in daily personal medication, disease prevention, nutrition & exercise, intelligence development, and other related domains in Hong Kong and mainland China. Simoa technology can facilitate early diagnosis of cancers, infectious diseases, immune inflammations, neurological diseases, and cardiovascular diseases. It also contributes to the development of new biomarkers for in vitro and concomitant diagnoses. Combining genetic data with biomarker data, CBT could produce more valuable and comprehensive research results.

Whole genome test The CBT GeneHealth Whole Genome Test includes detection of genes associated with disease susceptibility, individual traits, drug response, nutrition, and other areas. Utilising internationally recognised gold standard sequencing technology and high-throughput gene chips together with a high-volume database and analysis system, we provide customers with premium whole genome detection services and immediate results delivered directly to you. The CBT GeneHealth Whole Genome Test consists of 500+ items including 120+ risk factors for disease, 110+ characteristics, and 270+ drug reactions.

Single molecular assay (Simoa) Member of

European Biotechnology NET WORK

We are on a mission to change the way in which healthcare is provided by giving researchers the ability to closely examine the continuum from health to disease.


Oncology Measuring biomarkers at every stage of tumour development: The ability to detect oncology biomarkers at ultra-low levels has the potential to enable new options for diagnostics and treatment in cancer research. Simoa assays have the potential to be used to monitor cancer risk, identify early-stage cancers, and discriminate between benign and malignant cells. Neurology Advancing CNS (central nervous system) biomarker detection: The ability to detect neurological biomarkers, which have traditionally only been detectable in cerebrospinal fluid, at ultra-low levels has the potential to transform the way brain injuries and diseases are diagnosed. Simoa assays can detect neurological biomarkers associated with brain injury and disease at much earlier stages to understand the long-term effects and disease pathology. Cardiology Powering advancements in heart health: The ability to detect cardiac biomarkers at ultra-low levels is advancing the future of heart health. Simoa assays have the potential to detect cardiac biomarkers, which are instrumental for predicting major adverse cardiovascular events, development of heart failure, or transition to endstage kidney disease, earlier than ever before. Inflammatory markers Measuring inflammatory markers in normal and disease samples: Simoa assays can measure inflammatory and anti-inflammatory molecules in serum and plasma with unprecedented sensitivity, enabling new discoveries into the role of inflammation in the biology of health and disease. Infectious disease Powering epidemic prevention: The ability to detect infectious disease biomarkers before the onset of an immune response, while a virus is most contagious and multiplying rapidly, is critical for controlling the spread of disease.

Our vision Reveal the secret to a healthy life â&#x20AC;&#x201C; let China excel in the world of precision medicine. 9 th european biotechnology guide 2019

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Name · CO.DON AG Address/P.O. Box · Warthestr. 21 (headquarters) Postal Code/City · 14513 Teltow Country · Germany Ernst-Reuter-Platz 2 10587 Berlin Germany Contact Person · Matthias Meißner, MA (Director Corporate Communications / IR / PR) Telephone · +49-30-240352 330 Fax · +49-30-240352 309 Email Address · info@codon.de Internet Website · www.codon.de Number of Employees · 120 (2018) 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 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 (international) as well as for the development of product lines.

The company CO.DON AG develops, produces, and markets autologous cell therapies for the minimally invasive repair of knee cartilage defects following trauma or degeneration. The medicinal product is a cell therapy product that uses only the patient’s own cartilage cells (“autologous chondrocytes”). The method has been used for more than 10 years in over 200 clinics to treat more than 14,000 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: Ralf M. Jakobs. 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 rehabilitation 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 – 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. In 2018, the company initiated the setup of a second production site in Leipzig. With this, CO.DON is entering a new dimension: once all the work is finished the production site will be one of the world’s largest and most modern plants for the industrial-scale production of human cells. It will enable the company to ensure the supply of the highest quality cell therapy products to their customers in Germany and Europe going forward. CO.DON’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 from pain therapy to endoprosthetics, with the aim of becoming 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, meaning that there is currently no European competitor in market segment. With that, and with its promising product pipeline stem cell strategy, CO.DON has the chance to open up a market that is worth millions and to raise its company value. CO.DON has founded subsidiaries in the UK (2017) and the Netherlands (2018) as first steps to developing this promising market in line with the company’s strategy.

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

· · · · · · · · · · · · ·

Fraunhoferstr. 18 b 82152 Martinsried Germany Dr Jörg Müller +49-89-41-77-60-111 +49-89-41-77-60-222 joerg.mueller@coriolis-pharma.com www.coriolis-pharma.com

I 110+ 2008 Contract research and development Formulation excellence for biopharmaceuticals l Liquid and lyophilised formulation development l Lyophilisation process development l 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 1,000+ 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 (AUC), Resonant Mass Measurement (RMM), quantitative Far- and Near-UV circular dichroism spectroscopy (CD)). 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. Most recently we also offer polysorbate analytics such as quantification and characterisation of degradation products. 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. For gene therapy and viral based vaccine products Coriolis is equipped with state-of-the-art analytical equipment to support particle morphology, aggregation, size distribution, and purity analysis using e.g. AUC, transmission electron microscopy (TEM), nanoparticle tracking analysis (NTA) and dynamic light scattering (DLS).

coriolis pharma research

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 ·  Lyophilisation cycle optimisation ·  Scale-up and transfer studies ·· Support in container closure system selection ·· In-use stability studies ·· Stability testing including forced degradation studies ·· R&D and GMP-compliant contract analytical services ·· Orthogonal analysis of subvisible aggregates and particles ·· Testing of S1 and S2 GMO material ·· Polysorbate analytics ·· 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 Country Subsidiaries

· · · ·

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

Rennweg 72 56626 Andernach Germany | Kiel | Berlin | Wuppertal | Mönchengladbach | Mannheim Dr Volker Menschik (Chief Business Officer) +49-30-859-949-401 +49-151-526-416-33 volker.menschik@crs-group.de www.crs-group.de

· · · · · IQ · 300 · Merger 2006, Foundation of Legacy up to 1977 Type of Company · Full-Service CRO Areas of Activity · | Consultancy | Project Management | Clinical Conduct | Quality Assurance | Clinical Trial Supply Management | Clinical Data Management | Statistics | Medical Writing | 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 more than 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. Each CPU has access to a large database with more than 50,000 healthy volunteers and special patient populations. In addition, CRS has built up close collaborations with numerous clinical sites and family doctors to optimise reliable access to patients. These clinical and scientific collaborations offer CRS a powerful and efficient recruitment in several major 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 provides 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 authorities (FDA, EMA, BfArM, AFSSAPS, ANVISA, etc.).


Special Fields of Expertise Dr Torben Thomsen Partner, President & Chief Executive Officer

Dr Atef Halabi Partner, Managing & Medical Director

Prof. Dr Thomas Forst Chief Medical Officer

Ekkehard Herrmann Chief Financial Officer

CRS has experience in all kinds of trial designs and indications, especially in: ·· Renal & hepatic impairment ·· NASH ·· Diabetes ·· Obesity ·· Men’s & women’s health ·· Dermatology ·· Medical devices ·· Respiratory/inhalative devices ·· Vaccines ·· CNS ·· Biosimilars ·· FIM

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. Dr Volker Menschik Chief Business Officer

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.

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turning data into information.

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

· · · · · · · · · ·

Faubourg de l’Hopital 3 2000 Neuchatel Switzerland Irina El-Ali +41-32-511-4575 Irina.el-ali@datametrix.ch www.datametrix.ch

I 10–50 2003

Areas of Activity · We close the gap between data and information by bridging science with data, advanced analytics, and expert knowledge – to deliver beyond expected results External · Pharmaceutical and biotech Collaborations companies Request for · l Data analytics, including real-world data and big data Further Collaborations l Biostatistics l Data management l HEOR l Medical community platforms l Specialised medical records

Turning data into information Founded in 2003, datametrix is a Swiss data analysis company with a strong heritage in biostatistical analysis and programming, data management, and data modeling. With more than 15 years of experience, we are a well-established alternative to top tier CROs. We believe “what’s possible” can always go further. We do not restrict ourselves to the same tools as everyone else. We are convinced that high-quality services can also be cost-effective, that professionalism and expertise are the key to business success, and that attention to the client’s needs is the ground for long partnerships. Our expertise is based on deep knowledge, strong domain expertise, advanced data analytics, and customer appreciation. We know the challenges of each product development phase. We have extended knowledge across different therapeutic areas. Our customers value datametrix reliability and the high quality of our on-time delivery. Over 90% of our customer are satisfied or very satisfied with our services and will consider using datametrix services again in the future. (Customer Survey 2017). We shape our services around your business needs!

Services Data analysis We enable you to make data-driven business decisions by leveraging information. We combine data analytics with deep human insight to extract as much valuable information from the data as possible. Biostatistical analysis Our 15 years of experience and unparalleled flexibility, combined with our biostatisticians’ desire for quality, enable us to implement the best approach to your project to ensure correct analysis without a complex process.


HEOR Our experts in Health Economics and Outcome Research have a wealth of experience in different health economic modeling methodologies and can help you to unlock the optimal and fastest way to provide patients access to your innovating product. Data management We offer full data management services, including our fast easy-to-use EDC system to streamline data collection and monitoring process. Registries and medical communities We have set up online collaborative platforms open to healthcare professionals sharing a common scientific interest. We have also gained a strong reputation with investigators and medical sites in the performance of Real World registries. In addition to helping our customers save time, enhance productivity, and improve cost-effectiveness we offer all our analytical services via the datametrix adaptive, value-based FSP model.

Experience the difference with datametrix!

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

· · · · · · · · ·

Tomtebodavägen 6 171 65 Solna Sweden Robin Chatterjee +46-707822563 info@enginzyme.com www.enginzyme.com 14 2014

Areas of Activity · l Biocatalysis l Green chemistry l Flow processes l Enzymes

Your biocatalyst development partner EnginZyme’s technology platform converts any enzyme into an efficient heterogeneous catalyst to make enzyme reactions more cost efficient. By fast development of biocatalytic reactions in aqueous, organic, and biphasic environments in flow (packed bed) without extensive need of enzyme engineering we enable the use of enzymes within the time frames required for pharma.

EnginZyme differentiation Proprietary immobilisation technology (EziG™) EziG, a material based on controlled pore glass, can immobilise any enzyme type with a standardised and quick procedure, achieving high catalyst loading, retaining high enzyme activity and enabling efficient reuse of enzymes. The result is a catalyst exceptionally well suited for transformations in packed bed reactors, usable in aqueous as well as organic reaction conditions – ready for scale-up and cost-efficient biocatalysis operation. Automated optimisation The plug and play immobilisation system has allowed EnginZyme to develop standardised procedures for producing immobilised enzymes which can be automated to quickly design an optimised biocatalyst for a specific reaction. World-class biocatalysis expertise We employ some of the world’s top biocatalysis experts. No matter what level of expertise you have or what stage in your project you’re at, we’ll work with you to find the right enzyme and get an optimised preparation for your reaction — all in a fraction of the time you’re used to.


Enhancing traditional biocatalysis ·· Enable enzymes to remain active in organic solvents ·· Achieve higher throughput, lower capital and lower operating costs by operating in continuous flow ·· Efficient operation of enzyme cascade reactions in continuous flow in a single reactor ·· Circumvent the need for extensive enzyme engineering ·· Speed up development process

Synthesis of novel compounds through cascade reactions Combining enzymes in a series of reaction steps can enable the synthesis of novel compounds in an efficient way. When immobilising these enzymes on EziG, it is now possible to perform multi-step cascade reactions in flow in a single packed bed reactor. The EziG cascade technology is a versatile tool which can be employed to produce a broad range of valuable products, similarly to fermentation but with a more targeted process. Low capital and operating costs are achieved through enzyme reuse and flow operation of the highly active biocatalysts.

EnginZyme’s biocatalyst design services Our collaboration starts with a Proof Of Concept study to evaluate the efficacy of the immobilisation, impact on the reaction, and the development path forward. Armed with this quick early information one can easily determine the feasibility of developing a suitable solution without spending a long development programme on immobilising an enzyme. Following this proof of concept, the biocatalyst can be further designed and optimised to develop an immobilised enzyme ready for pilot testing.

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

· · · · · · · · · · ·

Walther-Rathenau-Str. 49a 17489 Greifswald Germany Dr Ute Liebelt +49-3834-515470 +49-3834-515473 info@enzymicals.com www.enzymicals.com 17 2009 l Chemistry l Genetic engineering l S1 Biotech lab l access to S2 Biotech lab

Areas of Activity · l Development and scale up of chemoenzymatic processes incl. DSP l Customer specific solutions in enzyme technology and biotransformation l Development and production of enzymes l Tailor-made fine chemicals, intermediates, and APIs Biological Patents · IP protected by international patent applications and granted patents External · l BBG Braun Beteiligungs GmbH Collaborations l BRAIN AG l Herbrand PharmaChemicals GmbH l National and international enterprises of the fine chemical and pharmaceutical industries l Broad international academic R&D collaboration

Enzymicals AG Enzymes I Chemicals I Solutions Enzymicals is your experienced partner for biocatalytic synthesis. An interdisciplinary team of 17 scientists and technicians is currently engaged in providing integrated solutions for industrial biocatalysis. The focus of the independent SME is the development and scale-up of robust chemo-biocatalytic processes for the production of fine and specialty chemicals as well as the development and production of enzymes and the chemo-biocatalytic synthesis of fine and specialty chemicals on customer demand. These core areas are combined to realise tailor-made solutions for custom development and manufacturing. Our continuous activities in academic partnering and industrial collaborations results in the delivery of state-of-the-art concepts which are applicable at commercial scale.

Products & Services Individual process solutions, tailor-made enzymes and customised chemicals Dedicated to designing, developing and implementing innovative, cost-effective, and scalable chemo-biocatalytic routes to fine chemicals & APIs, Enzymicals offers recognised expertise in the use of enzymatic processes for complex chemical synthesis. We develop scalable strategies for the synthesis of your desired compound, which includes feasibility studies as well as development and scale-up of the process, inclusive DSP. For this we are able to combine efficient enzymatic and chemical synthesis steps. Enzymicals is an outstanding resource of enzymes suitable for diagnostics, research, and development as well as for commercial production. Our enzyme portfolio contains a continually expanding biocatalytic toolbox, with innovative biocatalysts from the class of e.g. transaminases, monooxygenases, halohydrin dehalogenases, imine reductases, and hydrolases at desired quality grades to solve customer-specific demands at best performance. Selected products are incorporated in our online-catalogue.


We deliver concept-to-completion comprehensive solutions to create high-performance protein-based products and processes. For this, we discover and produce enzymes based on the demands of our customers and partners. Our technology platform covers the identification of suitable catalysts from strain or enzyme collections, databases, or metagenome libraries as well their functional expression in a range of microbial host systems. This enables us to offer tailor-made protein expression and optimisation as a service. Thus almost any biocatalyst of interest can be supplied on an analytical and commercial scale. A catalyst suitable for the production of your target compound can be optimised via our protein engineering technology to provide the best performance available. Together with our network partners, we have expanded our service to ASMF filing, regulatory affairs, cGMP production, and bulk scale supply. The combination of best catalysts with optimised chemistry and the integration of processing aspects have enabled us to increase the speed of delivery of effective solutions and expand our business along the whole value chain of the white biotechnology industry.

Management Dr Ulf Menyes (CEO)

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Name · EuroJobsites Ltd. Address/P.O. Box · Unit 8, Kingsmill Business Park, Chapel Mill Rd. Postal Code/City · KT1 3GZ Country · United Kingdom Contact Person · Lars Peter Svane Telephone · +44-20-3608-8800 Fax · +32-2-790-32-00 Email Address · info@eurojobsites.com Internet Website · EuroJobsites.com Social Media · FL I Number of Employees · 20 Founded (year) · 2003 Areas of Activity · Research Scientist and Pharma Expert Jobsites

EuroScienceJobs Since 2007, EuroScienceJobs has been advertising hundreds of job opportunities for scientific researchers and postdocs. Universities, research centres, companies, government and international organisations recruit scientists through EuroScienceJobs. International science researchers and other experts who can work in English are often willing to move abroad for the right opportunity in precisely their field. Every week, we send the EuroScienceJobs Newsletter to over 27,000 subscribers. Over 12,000 job alerts subscribers receive over 30,000 alerts every week. These highly specialised jobseekers often share the extremely targeted e-mails with colleagues, friends from university, and others with the same skills. Nearly 70% of EuroScienceJobs’ users have a PhD in science, in areas such as biochemistry, molecular biology, microbiology, biotechnology, biostatistics, and bioinformatics, as well as in medicine, immunology, toxicology, and pharma. This is one of the reasons we also launched EuroPharmaJobs six years ago. With over 3,500 LinkedIN followers, around 4,500 Facebook followers and over 1,000 Twitter followers, your job ads are also shared through EuroScienceJobs social media. EuroScienceJobs has advertisers ranging from international organisations like the European Patent Office (EPO), the European Molecular Biology Laboratory (EMBL), national centres of research such as the Austrian Academy of Sciences’ Ce-M-M-Centre for Molecular Medicine, and Belgium’s CISTIM – Center for Innovation and Stimulation of Drug Discovery to hundreds of European universities announcing their PostDocs on EuroScienceJobs. Pharmaceutical and biotech companies ranging from Abbott, to Astellas, GSK, Janssen/Johnson & Johnson to Novo Nordisk also use EuroScienceJobs to find researchers through job ads and CV searches. Over 5,000 research scientists are registered in the EuroScienceJobs CV database, plus thousands of other STEM candidates.

eurosciencejobs europharmajobs

EuroPharmaJobs EuroPharmaJobs is focused on Regulatory Affairs, Clinical Trials, Biotechnology, Pharmacovigilance, Quality Assurance, as well as many other types of pharma industry jobs. EuroPharmaJobs reaches candidates all over Europe working in the pharmaceutical industry. Candidates have technical skills such as Clinical Research, Clinical Trials, Medicine, Regulatory Affairs, Quality Assurance, Market Access, and more general business competencies. Advertisers include pharmaceutical and biotech companies such as Fresenius KABI, Astra Zeneca, ThermoFisher Scientific, GSK, Roche, MSD, Novo Nordisk, and Astellas, as well as organisations such as the European Patent Office (EPO) and the European Directorate for the Quality of Medicines and Healthcare. EuroPharmaJobs has over 15,000 visits every month, over 6,000 weekly newsletter subscribers, and every week more than 12,000 job alerts are sent to subscribers. The EuroPharmaJobs Facebook group has over 7,500 followers, plus hundreds of twitter and LinkedIn followers, so your job ads will be shared widely. Thousands of candidates are registered in the CV database.

EuroScienceJobs â&#x20AC;&#x201C; Areas of interest Biology Chemistry Biotechnology Molecular Biology Engineering Medicine Biochemistry Environment Pharmaceutical Nano-Technology Physics Microbiology Earth Science 0%







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Name · EuropaBio, the European Association for Bioindustries Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · ·

Avenue de l’Armée 6 1040 Brussels Belgium Clément Robijns (Communications & Events Manager) +32-2-739-11-76 +32-2-735-49-60 c.robijns@europabio.org www.europabio.org

· · · · · FL I · 16 · 1996 · EuropaBio is the European Association for Bioindustries and was created in 1996 to give a recognized voice to the European biotech community championing world-class solutions for society’s challenges, to improve quality of life, prevent, diagnose, treat and cure diseases, improve the quality and quantity of food and feedstuffs and move Europe towards a bio-based and zero-waste economy. Our membership is composed of 79 corporate and associate members and bio regions, and 15 national biotechnology associations representing over 1,800 European SME biotech companies. Last year, The Guardians quoted EuropaBio as “the largest and most influential biotech industry group in the EU”. EuropaBio was also ranked by Cambre Associates in the top 10 of ‘Digital Champions’ among 600 other associations. Request for · We welcome cooperation with Further Collaborations stakeholders from industry, European and national policymakers, media, academia and civil society to promote and advance the benefits of biotechnology for European citizens.

The leading voice for biotech in Europe No other industrial sector enhances quality of life, knowledge, innovation, productivity and environmental protection like biotechnology, while also being beneficial for the economy. From new drugs that can address unmet medical needs and fight epidemics and rare diseases, to industrial processes that use renewable feed stocks instead of crude oil, to drought-resistant crops that allow farmers around the world to feed more people under ever-harsher climatic conditions, promoting and investing in biotech pays economic, social and environmental dividends. For such reasons biotechnology has been a cornerstone of Europe’s competitiveness in terms of research and innovation as well as in terms of industrial growth, number of jobs and new companies created in Member States for numerous years. EuropaBio’s purpose is to ensure this will continue, and that Europe not only remains the world’s biotech research hub, but that European citizens also reap the benefits of innovative biotech products derived from that research.

Driving and sharing industry insights What is required firstly to realise biotech’s potential for and in Europe is sound policy that supports innovation and entrepreneurial risk-taking, together with regulatory structures that reward long-term investment in research and development over short-term gain and quick consumption. To support such policies and structures, EuropaBio set out key recommendations around research and development, assessment and approval, and market access in the 2017 EU State of the Union Evaluation available online at europabio.org/cross-sector/ publications/biotech-industry-state-union-evaluation).

Fostering biotech awareness Secondly, familiarisation of all parts of society with biotech and how it is helping to create a healthier, greener, more productive, and more sustainable economy is paramount. To this end, EuropaBio showcases these benefits through a wide range of activities and events

org): a yearly weeklong series of events, activities = $1.>;89.*728=.,1'..4 @@@+28=.,1@..4 org): a yearly in weeklong events, activities and initiatives Memberseries Statesofexplaining and cel8;0*B.*;5B@..45870<.;2.<8/.?.7=<*,=2?2=2.< and initiatives in Member States explaining and celebrating biotech across Europe. *7-272=2*=2?.<27.6+.;#=*=.<.A95*27270*7-,.5 ebrating biotech across Europe. ¡ The EuropaBio BeneďŹ ts Event features short pres350 million patients Seeking to relieve ¡ .+;*=270+28=.,1*,;8<<>;89. 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*<<8,2*=.6.6+.;<*7-28;.0287<*7-  soil erosion national biotechnology associations, who in turn repreLess toxins 6% to 30% sent than 1800 small and medium sized biotech cietalmore challenges. 7*=287*5+28=.,178580B*<<8,2*=287<@1827=>;7;.9;. Less in foodtoxins 6% to 30% more yield sent more than 1800 small and medium sized biotech companies in Europe. Members of EuropaBio are inLess in foodtoxins 6% to 30% more yield <.7=68;.=1*7  <6*55*7-6.-2>6<2C.-+28=.,1 companies in Europe. Members of EuropaBio are involved in research, development, testing, manufacturin food ¡ ¡ The European Forum on Industrial Biotechnology and more yield ,869*72.<27>;89..6+.;<8/>;89*28*;.27 volved in research, development, testing, manufacturing commercialisation of biotechnology products the and Biobased Economy (EFIB, www.efibforum.com): ?85?.-27;.<.*;,1-.?.5896.7==.<=2706*7>/*,=>; ing and commercialisation of biotechnology products and processes. Our corporate members have a wide an event providing insight in the exciting and rapidly 270*7-,866.;,2*52<*=2878/+28=.,178580B9;8->,=< and processes. Our corporate members have a wide range of activities: human and animal health care, evolving industrial>;,8;98;*=.6.6+.;<1*?.*@2-. biotech landscape that has be-di*7-9;8,.<<.< range of activities: human and animal health care, diagnostics, bio-informatics, chemicals, crop protection, come a part of the process of building a stronger, ;*70.8/*,=2?2=2.<1>6*7*7-*726*51.*5=1,*;.-2 INDUSTRIAL BIOTECH agnostics, bio-informatics, chemicals, crop protection, agriculture, foodEuropean and environmental products and more sustainable bio-based economy. INDUSTRIAL BIOTECH *078<=2,<+2827/8;6*=2,<,1.62,*5<,;899;8=.,=287 agriculture, food and environmental products and services. INDUSTRIAL BIOTECH *0;2,>5=>;./88-*7-.7?2;876.7=*59;8->,=<*7- services. Spares 33 million tonnes Greener transport EuropaBio also welcomes associate members such as Spares 33 million tonnes <.;?2,.< Greener transport thanks to biofuels, of CO2 emissions. EuropaBio also welcomesďŹ nancial, associateasset members such as international commercial, management rubber tyres, Spares 33 million tonnes Being part of EuropaBio story Greener transport thanks to biofuels, emissions. of CO2Equivalent >;89*28*5<8@.5,86.<*<<8,2*=.6.6+.;<<>,1*< to the energy use international commercial, ďŹ nancial, asset management bioplastic parts rubber to tyres, and other service-providing companies, regional biothanks biofuels, of CO2Equivalent ofemissions. 2.5 million per use year to homes the energy Members of EuropaBio are involved in research, devel27=.;7*=287*5,866.;,2*57*7,2*5*<<.=6*7*0.6.7= bioplastic parts and other service-providing companies,and regional biorubber tyres, of 2.5 million per use year technology development organisations scientiďŹ c Equivalent to homes the energy opment, testing, manufacturing and commercialisation bioplastic parts *7-8=1.;<.;?2,.9;8?2-270,869*72.<;.0287*5+28 of 2.5 million homes per year Materials technology development organisations and scientiďŹ c More effective detergents institutes. The products commonand denominator all our of =.,178580B-.?.5896.7=8;0*72<*=287<*7-<,2.7=2, biotechnology processes.among Our corpoMaterials More allow effective to save detergents up to 30% (including plastics) made institutes. 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'.5.*-*72778?*=2?.*7--B7*62,27-><=;B*7-6.6 ropaBioâ&#x20AC;&#x2122;s main biotech as sector councils agri-food and industrial), well as in other (healthcare, expert com- bers have the opportunity to play an active role in Eu;89*28E<6*27+28=.,1<.,=8;,8>7,25<1.*5=1,*;. agri-foodworking and industrial), ascommunications well as in other expert com- +.;<1*?.=1.8998;=>72=B=895*B*7*,=2?.;85.27> mittees, groups, initiatives 5 EUROPEAN BIOTECHNOLOGY GUIDE 2015 EuropaBio also welcomes associate members such as *0;2/88-*7-27-><=;2*5*<@.55*<278=1.;.A9.;=,86 mittees, working groups, communications initiatives 5 EUROPEAN BIOTECHNOLOGY GUIDE 2015 and in developing EuropaBio policy agenda as well international commercial, financial, asset management and 62==..<@8;42700;8>9<,866>72,*=287<272=2*=2?.<  %" ! $  (%  and in and developing EuropaBio policy agenda as well events networking opportunities. other service-providing companies, regional biotechnol*7-27-.?.589270>;89*289852,B*0.7-**<@.55 events and networking opportunities. ogy development organisations and scientific institutes. .?.7=<*7-7.=@8;42708998;=>72=2.<

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We lead an innovative and dynamic industry and members have the opportunity to develop EuropaBioâ&#x20AC;&#x2122;s policy agenda and to play an active role in our main biotech sector councils (healthcare, agri-food and industrial), expert committees, working groups, and communications initiatives including events and networking opportunities.

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Name · Evotec AG Address/P.O. Box · Manfred Eigen Campus Essener Bogen 7 Postal Code/City · 22419 Hamburg Country · Germany Contact Person · Gabriele Hansen (VP, Corporate Communications & Investor Relations) Telephone · +49-40-56081-255 Fax · +49-40-56081-222 Email · info@evotec.com Website · www.evotec.com Social Media · L I Number of Employees · >2,500 Founded (year) · 1993 Type of Laboratory · Chemical, Biological, Cell culture S1, S2 Areas of Activity · Drug discovery and development solutions as well as proprietary research with focus on CNS/neurology, diabetes and complications of diabetes, pain and inflammation, oncology, fibrosis, respiratory diseases and infectious diseases, iPSC, IND-enabling studies (INDiGO), PanOmics, artificial intelligence Annual Turnover · €257.6 million (2017) Relevant R&D Budget · €17.6 million (2017) Biological Patents · A broad portfolio of patent families relating to compounds, targets, and assays. External · Evotec is working with more than 750 Collaborations pharma and biotech companies, notfor-profit organisations, academia, and foundations on a global basis. Request for · Our team of business development Further Collaborations managers are happy to discuss our R&D solutions, in- and out-licensing opportunities, and how we can assist you in meeting your drug discovery and development needs. For more information, please contact us at info@evotec.com.

Evotec company profile Evotec is a globally operating drug discovery alliance and development partnership company headquartered in Hamburg, Germany. The publicly listed stock corporation provides comprehensive one-stop drug discovery solutions with a large pool of highly experienced scientists, state-of-the-art technology platforms and first-class scientific operations. The Company has key therapeutic expertise in the areas of neuronal diseases, diabetes (including complications), pain and inflammation, oncology, infectious diseases, respiratory diseases, and fibrosis. Evotec aims to identify and develop first-in-class and best-in-class differentiated therapeutics for collaborators or for its own pipeline development. With sites in France, Germany, Italy, Switzerland, the UK, and the USA, Evotec drives research and development projects in numerous alliances and partnerships with Pharma and biotech companies as well as academia and foundations. Its strategy follows a clear goal: to become the leading drug discovery solutions provider by building a partnered product pipeline based on both scientific and operational excellence. Building on its expertise in the field of drug discovery services, Evotec has evolved into a drug discovery engine in its own right with its two business segments EVT Execute and EVT Innovate. These segments effectively process various project types operating from one common drug discovery and development platform.

EVT Execute – speed, expertise, and new technologies Evotec’s drug discovery platform and development services deliver an industrialised, cutting-edge, comprehensive, and unbiased infrastructure to meet the industry’s needs for innovation in drug discovery and for accelerated population of its drug development pipelines. The EVT Execute segment provides stand-alone or integrated drug discovery and development solutions on a typical fee-for-service basis or through a variety of commercial structures including research fees,


milestones, and/or royalties. EVT Execute contributes efficiency, project management, and speed to the drug discovery and development process. The Company continuously upgrades its platforms and has recently expanded its offerings along the drug discovery value chain to include INDiGO, a unique efficient process for Investigational New Drug (“IND”) submission, as well as high-end CMC manufacturing processes.

EVT Innovate – source of new pipeline entries The EVT Innovate segment focuses on building a longterm co-owned pharmaceutical pipeline. Evotec’s programmes focus on first-in-class and best-in-class projects based on innovative biology or chemistry. Through its EVT Innovate segment, Evotec builds BRIDGEs with academia such as LAB282 (Oxford, UK), LAB150 (Toronto, Canada), LAB591 (Seattle, USA), and LAB031 (Toulouse, France) which identify and translate promising projects out of academia through access to Evotec’s industrial-scale discovery platforms and expertise. Additionally, Evotec expands its EVT Innovate segment through equity participation in selected companies.

Paradigm shift in drug discovery To continue operating at the forefront of drug discovery and development, Evotec invests in technologies with game-changing potential, such as induced pluripotent stem cells (iPSCs), PanOmics data, as well as artificial intelligence and machine learning. Evotec’s ultimate goal is to connect these technology platforms to improve the predictivity of tests at early development stages, lowering overall cost, and significantly increasing innovation efficiency.

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Name · Exyte Central Europe GmbH Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Website Number of Employees Founded (year)

· · · · · · · · ·

Löwentorbogen 9b 70376 Stuttgart Germany Katrin Neuffer +49-711-8804-1800 info@exyte.net www.exyte.net 4,800 1995

Areas of Activity · | Consulting | Design | Engineering | Construction | Qualification & Validation | Commissioning | Technical Facility Management

Company profile Exyte Central Europe GmbH, a wholly owned subsidiary of the Exyte Group, is one of the leading engineering and construction companies for the life sciences, chemicals and other high-technology industries. Clients include both large and medium sized enterprises as well as startup 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 Exyte 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. Exyte Central Europe customers gain individual full services in complete process and facility solutions from concept to construction of production facilities.

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 design & built (EPCQ) or an EPCMQ execution of a new production facility, laboratory and/or the conversion or extension of an existing facility, Exyte Central Europe will find the best and most economical solutions to meet your deadlines.





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exyte Central europe

Your requirements are our focus. Experienced project teams are your local professional partners delivering benefit across Europe.

GMP certified Exyte Central Europe will realise your entire project under best quality demands – based on current EUGMP/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, Leverkusen, Marburg, Nuremberg, Penzberg Austria: Vienna Switzerland: Allschwil/Basel, Schlieren/Zurich Belgium: Melsele/Antwerp Poland: Gdansk, Wroclaw, Warsaw UK: Chippenham/London Russia: Moscow France: Aix-en-Provence

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

· · · · · ·

Heimeranstr. 35 80339 Munich Germany Dr Edgar Fenzl, Martin Krauss +49-89-893-119-0 edgar.fenzl@fgk-cro.com martin.krauss@fgk-cro.com Internet Website · www.fgk-cro.com www.fgk-pv.com www.fgk-rs.com Number of Employees · 120 Founded (year) · 2002 Areas of Activity · Full service CRO (contract research organisation) offering a complete range of clinical development and consulting services: l Regulatory Affairs l Project Management and Monitoring l Medical Safety l Data Management / Biostatistics l Medical Writing l eSolutions for Clinical Trials l Quality Assurance FGK Clinical Research has two daughter companies: “FGK Pharmacovigilance” and “FGK Representative Service”, enabling us to offer our clients pharmacovigilance services including services of QPPV and PMSF management as well as legal representation for non- European customers conducting clinical studies or seeking marketing authorisation within the EU/EEA.

Company overview FGK Clinical Research is a Europe-based CRO of an ideal size for cooperation with smaller and mid-sized biotech, pharmaceutical, or medical device companies. FGK was founded in 2002 and currently has 120 employees – most of them located in our headquarters in Munich, Germany. Covering all phases and areas of clinical development, our focus is on phase II and III trials. We have experience in all important medical indications, including in particular in oncology, cardiology, neurology, dermatology, and gastroenterology. Broad knowledge in alternative therapies completes our expertise. Besides our services for drug development, we also help to guide all kinds of innovative medical devices through the increasingly demanding framework of clinical investigations.

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

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

fgk clinical research

Services Consulting ·· Advice for drug and device development ·· Biostatistical support Regulatory Affairs ·· Submission ·· All communication with competent authorities and ethics committees Project Management and Monitoring ·· Development of study documents ·· Study set-up ·· Feasibility ·· Investigator meetings ·· Site management & monitoring ·· TMF handling Medical Safety Data Management / Biostatistics ·· CRF design ·· Data collection, review, and analysis Medical Writing ·· Generation and review of entire spectrum of regulatory documents eSolutions for Clinical Trials ·· eCRF with integrated IWRS ·· eTMF Quality Assurance ·· Regularly reviewed and updated set of SOPs ·· Quality system audited on a regular basis ·· Audits on behalf of sponsors ·· Assistance during inspections Since 2017, we have been participating in an independent “GCP Qualification Programme”, offering our clients the possibility to obtain an all-encompassing audit report from a third party. Visit our website www.fgk-cro.com to learn details about our complete portfolio. 9 th european biotechnology guide 2019

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

· · · · · · · · · · ·

Moosmühlestr. 6 9000 St. Gallen Switzerland Ralph Daumke +41-71-272-9236 +41-71-272-9100 r.daumke@filtrox.ch www.filtrox.com

I 300 1938

Areas of Activity · l Microfiltration and treatment of high-value liquids l Depth filtration l Single-use cell removal l Activated carbon filter External · l ZHAW Wädenswil, Switzerland Collaborations l FH Trier, Bioverfahrenstechnik, Prof. Kampeis, Germany l HES-SO, Institut of Life Technologies, Prof. Kalman, Switzerland l Partners for business and product 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 training, seminars, audits, and customised training. 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 worldwide rapid product availability. For more information, please visit our website.

Products FILTRODICS™ BIO SD FILTRODISC™ BIO SD is the first depth filter using the advantages of the well-established method of alluvial (cake or precoat) filtration technology in a disposable format. FILTRODISC™ BIO SD is used e.g. for singleuse cell removal, 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 characterised by their extremely low levels of ions and pyrogens. PURAFIX® PF-P sheets, reinforced with plastic fibres, are typically used when a very high wet strength or stability is required. The new PURAFIX® PF-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 precoating 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 potentials for API manufacturers around the world to optimise their process. CARBOFILTM



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. With the DISCSTAR™ H, we have the newest generation of lenticular module housing, which is much safer to operate and easier to handle due to its horizontal working position. The enclosed system allows 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 are manufactured here. FILTROX France s.a.r.l., Sales office FILTROX North America USA, Sales office FILTROX Latinoamerica S.A. de C.V., 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 9 th european biotechnology guide 2019

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

· · · · · · · · · · ·

Am Klopferspitz 19 82152 Planegg/Martinsried Germany Dr Peter Hanns Zobel +49-89-5527948-0 +49-89-5527948-29 info@izb-online.de www.izb-online.de 28 1995 S1 and S2 labs

Areas of Activity · | 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 Helmholtz Zentrum Munich Hematology Unit and the following institutes of the LMU: the Biology Faculty, the Clinical Center Grosshadern, the Pharmacy and Chemistry Faculty, the Neurological Research Center, the Center for Neuropathology and Prion Research (ZNP),


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 50 start-ups ·· Business development support ·· In-house estate management ·· Center of an impressive research campus ·· Access to an international network ·· Flexible lab and office structures ·· Close contacts with investment partners ·· Joint location marketing ·· Attractive, modern conference rooms, also for external booking ·· 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) 9 th european biotechnology guide 2019

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

External Collaborations

· · · · · · ·

Via Bandiera 11 90133 Palermo Italy Giovanna Frazziano +39-091-6041111 +39-091-6041122 info@fondazionerimed.com gfrazziano@fondazionerimed.com · www.fondazionerimed.eu · I · 54 · 2006 · Biomedical Research · l Drug discovery l Computer-aided drug design l Medicinal chemistry l Bioinformatics l Structural biology and biophysics l Regenerative medicine l GMP production l Immunotherapy l Proteomics l Magnetic resonance imaging l Tissue engineering l Biomedical devices · We are collaborating with over 50 research organisations, SMEs and pharma, including: l University of Pittsburgh l University of Pittsburgh Medical Center l Italian National Research Council l IRCCS ISMETT l Children’s Hospital of Philadelphia l DRI Foundation l Institute de La Vision l Sterling SpA l TES Pharma Drug Discovery Innovation l ATeN Center – University of Palermo l Istituto Zooprofilattico Sperimentale della Sicilia l University of Messina l University of Catania

The Ri.MED Foundation is a non-profit private research organisation; its mission is to develop biotechnological and biomedical translational research approaches, disseminate scientific knowledge, and train highly qualified professionals in the Life Sciences sector. Ri.MED is currently involved in the realisation in Carini, near Palermo, of the Biomedical Research and Biotechnology Center (BRBC) that will become a centre of reference for researchers worldwide, placing Sicily in the forefront of biotechnology and biomedical research. Thanks to the instrumental role and the powerful strategic alliances with its partners (Italian Governement, Region of Sicily, University of Pittsburgh, University of Pittsburgh Medical Center, Italian National Research Council, and Mediterranean Institute for Transplantations and Advanced Therapies), the Ri.MED business model covers the entire process of preclinical research through an integrated approach, translating the progress of biomedical research into patient care. Ri.MED’s research is focused on three therapeutic areas: organ insufficiencies, oncology, and age-related diseases, and is developed through the following main approaches: drug discovery; regenerative medicine and immunotherapy; tissue engineering and medical devices development. Ri.MED has a diversified and balanced project portfolio, led by a multidisciplinary team with clear milestones related to product development objectives from a bench-to-bedside perspective: Small molecules ·· Design of selective inhibitors of targets involved in oncological, inflammatory, and age-related diseases ·· Molecular mechanism of protein misfolding diseases ·· Steroid-unresponsive inflammation in chronic obstructive pulmonary disease

fondazione ri.med

Biologics ·· Rebuilding liver and kidney in ectopic sites ·· Immunotherapy against colonisation by multidrugresistant bacteria ·· Probiotic yeasts as novel vaccination vectors ATMP (Advanced Therapy Medicinal Products) ·· NK cell-mediated therapy in cancer & chronic infection ·· Adoptive transfer of virus-specific T cells ·· MSC-based therapy for skin and liver diseases Biomarkers ·· Prediction of ischaemic lesions associated with cardiovascular diseases ·· Clinical risk stratification of cardiovascular pathologies Medical devices and artificial organs ·· Development of novel cardiovascular devices ·· Tissue-engineered cardiac valves, patches, and grafts ·· Development of osteochondral bioreactors and scaffold matrices We have also developed know-how and several technology platforms to support R&D projects: ·· Computer Aided Drug Design ·· Bioinformatics ·· Structural Biology and Biophysics ·· Proteomics ·· Magnetic Resonance Imaging ·· Bioengineering Ri.MED research activity is strongly patient-oriented: for this reason, in order to facilitate the translation of scientific discoveries into clinical solutions, in 2017 we have created the “Intellectual Property&Technology Transfer” Office and today we have over 20 patents. The enhancement of IP is a fundamental value for us, in order to develop an innovative model of research sustainability. Ri.MED is seeking further opportunities for collaboration with public and private research organisations, clinical institutes, and the biotech and pharma industries.

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

· · · · · · · · · · ·

Hans-Bunte-Str. 19 79108 Freiburg im Breisgau Germany Karin Heidenreich +49-761-470-99-0 +49-761-470-99-191 bd@greenovation.com www.greeenovation.com

Corporate strategy Greenovation is dedicated to developing moss-based biopharmaceuticals for orphan diseases by using the advantages of BryoTechnology.

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

LI 30 1999

Areas of Activity · l Lysosomal Storage Disorders l Fabry Disease l Pompe Disease l Complement related diseases l C3G 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.


Pipeline Greenovation has established a pipeline of proprietary drug candidates for orphan diseases like Fabry disease (Moss-aGal), C3 glomerulopathy (Moss-FH), and Pompe disease (Moss-GAA). Moss-aGal and Moss-GAA are subsitutes for human lysosomal enzymes, developed for enzyme replacement therapy (ERT), i. e. compensation for a genetically determined lack of the respective enzyme by regular infusion of biotechnologically produced substitute. In order to reach their cellular destination, the lysosomes, these biopharmaceuticals need to dock on specific receptors which recognise and bind terminal mannose sugars of N-glycans. Being produced in moss, Greenovationâ&#x20AC;&#x2122;s ERT products exhibit > 95 % uptake of mannose-terminated N-glycans. Moss-FH is a recombinant protein in development as a treatment for C3 Glomerulopathy (C3G). The structure is identical with human factor H, a regulator of complement activation. As a central regulator of the alternative complement pathway (AP), it is capable of re-establishing complement balance from the dysregulated state of complement diseases such as C3G, aHUS and PNH.

Clinical trials Greenovation successfully completed its moss-aGal phase I clinical safety study in 2017 and plans to start the clinical phase II soon. Moss-aGal will be the first enzyme replacement treatment of Fabry disease produced in moss that exhibits optimized N-glycosylation patterns of the protein alpha-galactosidase A. Preclinical studies indicate a potentially enhanced cellular uptake and favorable organ distribution.

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

· · · · · · · · · · ·

Schriesheimer Strasse 101 68526 Ladenburg Germany George Badescu, VP Scientific Affairs +49-6203-1009-0 +49-6203-1009-19 info@hdpharma.com www.heidelberg-pharma.com 66 1997 (as WILEX) l Chemistry l Molecular biology l Pharmacology l Bioanalytics

Areas of Activity · l ADC technology platform l Drug research and development l Preclinical services provider External · l German Cancer Center (DKFZ) Collaborations l Heidelberg University l Magenta Therapeutics l MD Anderson (Texas) l Takeda Pharmaceutical Company 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 for 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 (ADCs), work by inhibition of tubulin or binding to DNA, which makes them dependent on cell division. By contrast, Amanitin works in a cell-cycle independent manner and has a range of other unique properties that can be harnessed to develop highly effective, innovative drugs to provide new options in cancer therapy. ·· Unique and novel mode of action – never used in oncology ·· Ability to overcome drug resistance ·· Kills dividing AND quiescent (non-dividing) tumour cells ·· Kills the dormant tumour cells associated with metastasis & relapse ·· Favourable physicochemical properties – it is hydrophilic

ADC technology partnering 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 has successfully completed the technology transfer for the production of the Amanitin and the other basic building blocks from the Heidelberg Pharma Research laboratories into an industrial plant. According to Heidelberg Pharma, this is the first and only industrial source of chemically produced Amanitin worldwide. 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,

ndd 10

Heidelberg pharma

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 for exclusive targets.

ATAC third-party collaborations 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.

Proprietary lead ATAC HDP-101 In addition to collaborating with partners, Heidelberg Pharma is increasingly focused on developing its own ATAC candidates. Its lead ATAC candidate HDP-101 is being prepared for clinical development in multiple myeloma. In a preclinical study conducted with the Heidelberg University and the German Cancer Research Center (DKFZ), non-dividing cancer cells taken from multiple myeloma patients were examined with HDP-101. A strong cytotoxic effect was observed even at low doses of HDP-101 and with low target expression on the cell surface. This is the first time that the efficacy of Amanitin on primary human cancer cells was demonstrated. Heidelberg Pharma also uses its ATAC platform to collaborate with other companies to create ATAC molecules based on antibodies from those partners.

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. 9 th european biotechnology guide 2019

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Hezelburcht | Grant consultancy

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

· · · · · · · · · ·

High Tech Campus, 10 Eindhoven 5655 CM The Netherlands Petra Dijkman, PhD. +31-6-21-99-37-52 p.dijkman@hezelburcht.com www.hezelburcht.com/en/

LI 95 1995

Areas of Activity · l Grant identification l Feasibility assessment l Grant writing l Review l Consortium building l Project management External · Hezelburcht has an extensive track Collaborations record regarding European subsidies, in terms of writing applications and consortium building as well as strategic consulting, project management, and compliance. Please see our profile for examples of testimonials from some of our clients. l Eindhoven University of Technology – H2020 Marie Skłodowska-Curie project Photo4Future l Omnigen B.V. – H2020 Eurostars l PROMINENT by University Medical Centre of Groningen (UMCG) and the Faculty of Science and Engineering of the University of Groningen – H2020 Marie Skłodowska-Curie COFUND Request for · Researchers and innovative entrepreFurther Collaborations neurs from both industry and academia are welcome to contact us for an informal introduction to our support for grant acquisition.

Member of

European Biotechnology NET WORK

For over twenty years Hezelburcht has provided grant support to assist our clients in achieving their strategic, financial, and innovative ambitions. In addition to providing service in the Netherlands, we are experienced in applying for grants at the regional, national, and European levels for clients throughout Europe and beyond. Our headquarters in Nijmegen works closely with the offices in Brussels, The Hague, Amsterdam, Eindhoven, and Apeldoorn, all of them forging strong links between numerous academic and industrial parties and (regional) funding bodies.

Life Sciences, Health & Food team The Life Sciences, Health & Food team consists of ambitious and entrepreneurial consultants with highquality backgrounds and provides support for both fundamental scientific research and commercial R&D. Their scientific backgrounds range from biomedical engineering, health & nutrition, oncology, biology, and eHealth to neuroscience. Besides a solid scientific background, most of them have extensive, practical, sector-specific experience.

Supporting world-class universities & innovative companies with funding Hezelburcht has an extensive track record regarding European subsidies, in terms of writing applications, consortium building as well as strategic consulting, project management, and compliance. Our knowledge of grants as well as our experience in both the public and private sectors enable us to offer a full spectrum of services related to grants and incentives. Our specialists have broad experience in supporting every step of the grant application process for European programmes such as Eurostars and the H2020 Health programme, SME Instrument, and Fast Track to Innovation.


What our customers say Eurostars for market-oriented R&D: Omnigen B.V. focuses on both scientific research and services within the fields of genetics and bioinformatics. Using just a little saliva, Omnigen can analyse your DNA. Omnigen has received funding from the European grant programme Eurostars to initiate a clinical decision-making and support platform for pancreatic cancer, called IMedFrame. Hezelburcht coordinated the grant application for Omnigen and its partners. “We have experienced the collaboration with Hezelburcht as pleasant. Thanks to the scientific background of the grant experts, we have been able to submit a high quality project application. We recommend working with Hezelburcht for grant advice and acquisition!”  Omnigen B.V. Horizon 2020 MSCA international trainings network (ITN): The project Photo4Future focuses on photochemistry, has received funding from the Marie Sklodowska-Curie subsidy programme, and is coordinated by the Eindhoven University of Technology (TU/e). In 4 years, 10 doctoral students have developed new photochemical applications through multidisciplinary research to provide energy-efficient and green alternatives to the chemical industry. In order to be able to focus on the project’s primary activities, the TU/e is outsourcing the project management to Hezelburcht. “Working with Hezelburcht allows the researchers to focus on the real work, namely the research. This means that we can work more efficiently and results-oriented. As coordinator, I am therefore extremely pleased with the smooth collaboration with Hezelburcht!”  Dr Timothy Noël, TU/e.

More information? Should you have any questions or like to receive more information about grant opportunities for academia or industry, please contact us.

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

· · · · · · · · · · · ·

Rudolf-Wissell-Str. 28 37079 Göttingen Germany Dr Wolf Jockusch +49-551-50672-0 +49-551-50672-181 info@iba-lifesciences.com www.iba-lifesciences.com

FL I  G ~50 1990 S1

Areas of Activity · l Cell Selection & Expansion l Protein Production & Assays l Custom Oligos & Predefined DNA/RNA Biological Patents · l Strep-Tactin®XT 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. IBA’s portfolio includes tools for Cell Selection & Expansion, Protein Production & Assays as well as Custom Oligos & Predefined DNA/RNA.

Product portfolio Cell selection & expansion The Fab-TACS ® technology ensures automated cell selection directly from whole blood employing IBA’s design awardwinning FABian ® device. Customised protocols depending on cell type, sample volume, and 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 af finity purification, providing exceptionally pure proteins. Recently, the third generation of the Strep-tag ® system was launched, based on the new Strep-Tactin®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 high affinity 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 · ibidi GmbH Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Am Klopferspitz 19 82152 Martinsried Germany Dr Susanne Seifert +49-89-520-46-17-0 +49-89-520-46-17-59 info@ibidi.de www.ibidi.com

FL I I  75 2001 S1

Areas of Activity · l Functional (phenotypic) cell-based assays l Systems that simulate the native environment for analysing living cells l Cell biochips, reagents, and equipment for analysing living cells Biological Patents · 31 patent families (around 130 documents)

Company profile ibidi ® GmbH is a leading supplier of functional cellbased assays and advanced products for cell microscopy. Based in Martinsried, near Munich, ibidi develops cutting-edge solutions for classic cell culture, as well as complex assays (e.g., angiogenesis, chemotaxis, and wound healing). The ibidi product lines are sold worldwide to customers in scientific institutions, industrial pharmacology, and biotechnology, helping researchers to understand the mechanisms behind various diseases, resulting and leading to development of novel therapies. In 2001, ibidi GmbH was founded as a spin-off from the Technical University Munich and the Center for Nanoscience at the Ludwig-Maximilians-University Munich. The primary business idea was to produce microfluidic cell chambers for use in microscopy. With unique cell biochips made from high-performance polymers, ibidi has pioneered the use of plastic as a material for bio-slides that can be used to simulate an organ-like environment. Over the past 18 years, ibidi has managed to become the leading international provider of disposables for cell-based microscopy assays – a fact that has been acknowledged in more than 10,000 scientific publications. Also, in June 2016, ibidi was recognised as one of Germany’s collaborative leaders, receiving the prestigious “Germany Land of Ideas 2016” award. ibidi’s R&D team is comprised of physicists, chemists, and biologists with extensive experience in the fields of cell biology, surface chemistry, and fluidics. Their collective knowledge enables them to work together to create a variety of specialised slides and instruments, as well as integrated systems.


Products and applications The ibidi product lines include various Âľ-Dishes, Âľ-Slides, and Âľ-Plates for the cultivation and highresolution microscopy of cells, and also cell-based assays for investigating angiogenesis, chemotaxis, wound healing, and cells under flow. All of the products are designed for imaging cells with high-resolution microscopy. The high optical quality of the ibidi labware allows for high-end microscopy techniques, such as phase contrast, DIC, widefield fluorescence, confocal, and super-resolution microscopy. ibidi also specialises in developing and producing instruments, such as heating and incubation units for live cell imaging under physiological conditions, plus a unique perfusion system that provides continuous flow for the simulation of blood vessels. To complete the ibidi product family, the company also offers reagents and cell lines for live cell imaging. For example, the exclusive F-actin marker, LifeAct, makes it possible to keep track of the development and movement of F-actin structures in living cells. The ibidi Fuse-It reagents allow for the efficient and biocompatible transfer of mRNA, siRNA, dyes, and proteins directly into the cytoplasm in only a few minutes. ibidi places a special emphasis on simulating physiological processes of endothelial cells in blood vessels for studying arteriosclerosis and hypertension. Additionally, ibidi focuses on investigating the anti-angiogenetic effect of drugs that combat solid tumours.

Intellectual property ibidi currently holds 31 patent families (26 patents granted in the EU, 18 granted in the USA, and 5 granted in other countries). Over 7 applications are currently pending.

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

· · · · · · ·

Website Number of Employees Founded (year) Areas of Activity

· · · ·

Neuendorfstraße 17 16761 Hennigsdorf Germany Dr Jörg-M. Hollidt +49-3302-55199-0 +49-3302-55199-10 info@inventdiagnostica.de jm.hollidt@inventdiagnostica.de www.inventdiagnostica.de 40 1999 l Supply of Human Bio-Materials l Clinical & Analytical Performance Studies according to IVDR 2017/746 l Standards & Controls l Enhanced Biobanking

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

Company profile in.vent is Europe’s leading supplier for Human Bio-Materials. The company was founded 1999 and located in Hennigsdorf, nearby Berlin. With our highly qualified and well trained team we guarantee excellent quality, ethically impeccable conduct of all our operations and highest customer satisfaction. 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 in.vent Clinical Studies – Clinical & Analytical Performance Studies ·· In-Vitro-Diagnostics ·· Companion Diagnostics ·· Patient-Near-Diagnostics Project planning | Cost calculation Study Design & Preparation | Sample Procurement Medical Monitoring | Data Management Biostatistics | Reports according to IVDR 2017/746 in.vent Study Site in.vent ICS runs an own study site in Hennigsdorf, nearby Berlin. Our fully equipped Study Site allows donations of all kinds. Depending on customer’s projects, we recruit for both healthy and diseased donors according to your specifications: Various matrices ·· Processing specifications (e.g. time, speed, temperature) ·· Blood Drawing Specifications (e.g. circadian rhythm, food intake, blood drawing systems) ·· Donor Specification (e.g. BMI, gender, age) Standards and Controls pre-manufactured | individually produced lyophilised | fresh frozen native | spiked | depleted

in.vent diagnostica

kit-internal controls | kit-external controls routine laboratory surveillance applicable for proficiency testing

Dr Jörg-M. Hollidt Founder & CEO

Enhanced Biobanking ·· project-focused procurement of Human Bio-Material Samples ·· all variations of quality, numbers and volumes of samples single donations | consecutive donations panels | pools throughout the whole value chain of IVDs. Human Bio-Materials – Disease State and Normal Whole Blood | Blood Products Sera | Plasma | Other Matrices Human Tissues Faeces | Lavage Fluids | Swabs Single Donations | Consecutive Donations Sample Collections | Cohorts Bulks | Pools Small Volumes | Large Volumes | Very Large Volumes Autoimmunity | Allergy | Infectious Diseases Alcohol Abuse | Liver Diseases | Hormones Oncology | and more

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

Strategic outlook in.vent is already one of the major affiliates in the field of Human Bio-Materials. We are constantly adopting to market needs and to front end techniques in biobanking, sample storage and biomarker development. In 2019 in.vent is going to intensify its international cooperations in the Asian Market. 9 th european biotechnology Guide 2019

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innovating vaccines

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

· · · ·

Telephone Email Address Internet Website Number of Employees Type of Laboratory

· · · · ·

Antonie van Leeuwenhoeklaan 9 3721 MA Bilthoven The Netherlands Dr Ivo Ploemen (Business Development Manager) +31-30-7920300 businessdevelopment@intravacc.nl www.intravacc.nl 150 ML-II BSL-2 BSL-3

Areas of Activity · l Vaccine development l Process and assay development l Animal models l (Pilot) Production, QC & QA l Clinical and regulatory affairs External · l Academia Collaborations l Public health organisations (WHO, BMGF) l Biotech and pharmaceutical companies

Intravacc Intravacc is a renowned, not-for-profit R&D organisation with 100+ years’ experience in vaccine development. We optimise vaccines, vaccine processes and vaccine technologies. Intravacc reduces the risks and costs involved with developing vaccines by bridging the gap between concept and late-stage clinical studies.

Viral vaccine technology For new viral vaccine development, we use established blue-prints and scalable platform production processes, including those based on an available scale-down process for IPV. Our proven technologies are based on Intravacc’s long-standing experience with oral and inactivated poliovirus vaccines and include virus seed strains recovery from synthetic viral genomes, cell and virus culture technology, virus harvest and clarification, purification, formulation, and freeze-drying, with all analytical assays required for in-process controls and product release. Our viral vaccine platform makes use of Intravacc’s established WHO pre-qualified Vero cell line. In this way, we can demonstrate fast-track proof-ofprinciple of a pilot process for various viral vaccines, as recently shown for Sabin-IPV, OPV, RSV, EV71, CVA16, and Rota vaccine concepts, using a science-based quality-by-design approach.

Bacterial vaccine technology For the development of vaccines against bacterial pathogens, Intravacc has designed and developed, in addition to conjugate vaccine technologies, a unique platform based on outer membrane vesicles (OMVs) – spherical particles with natural adjuvant properties that harbour many antigens. Using genetic engineering, the OMVs can be decorated with the desired antigen(s) in the required amounts that maintain their native conformation. Heterologous OMVs are a suitable alternative for pathogens that require a high containment, are difficult to cultivate, or contain viral and/or parasitic proteins. The antigens of choice are placed in an “empty” OMV. We have developed genetic tools to increase yield, reduce toxicity, and achieve the desired antigenic com-


position. A robust, scalable GMP production process is operational.

Vaccine design Our broad technological capabilities including (physico) chemical analyses, molecular biology, proteomics, immunological read-out, and mass spectrometry allow us to guide your innovative vaccine concept through the development chain. Advanced LC-MS analysis allows us to provide state-of-the-art knowledge and know-how in protein characterisation. As a front-runner in applied research on mucosal and intradermal delivery we can create value for promising delivery technologies. Our formulation team can help to produce safe, affordable vaccines by using the right excipients. The production of combination vaccines, lyophilisation and spray-drying, stabilisation, and the use of proprietary adjuvants (like modified aluminum and our detoxified LPS mutants) can serve to complement your concept.

Animal models and 3Rs Intravacc has three state-of-the-art animal laboratory facilities for housing different species of experimental animals, e.g. (transgenic) mice, rats, cotton rats, ferrets, guinea pigs, and rabbits. Moreover, it is Intravaccâ&#x20AC;&#x2122;s ambition to replace the use of animals for routine lot release testing of vaccines with innovative animal-free techniques and to improve the scientific substantiation of these methods. Therefore Intravacc has developed several methods based on the 3Râ&#x20AC;&#x2122;s (reduction, refinement & replacement). You can find more information on www.intravacc.nl.

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Name · ITM – Isotopen Technologien Muenchen AG Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · ·

Lichtenbergstrasse 1 85748 Garching Germany Nicola Scharrer (Head of Marketing) +49-89-329-8986-600 +49-89-329-8986-66 info@itm.ag www.itm.ag

· · · · · LI · 140 · 2004 · Radiopharmaceutical Company

Areas of Activity · 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® (no-carrier-added 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. In May 2018, TOCscan® (68Ga-Edotreotide), the diagnostic radiopharmaceutical for the treatment of neuroendocrine tumours, was registered in Germany, France, and Austria. 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 tumours 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 24–48 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. In 2017, our lead product Solucin ® 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: www.itm.ag

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

· · · · · · · · · · ·

Maarweg 32 53619 Rheinbreitbach Germany Dr Stefan Jennewein +49-2224-9894501 +49-2224-9880854 stefan.jennewein@jennewein-biotech.de www.jennewein-biotech.de

FL 96 2005

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

· · · · · · · · · · · ·

Volmerstrasse 5 12489 Berlin Germany Holger Wenschuh (CEO) +49-30-6392-5500 +49-30-6392-5501 info@jpt.com www.jpt.com

F  LI Q

90 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 Prioritisation & Immune Collaborations Monitoring (BioNTech AG), The Human Proteome Peptide Library (TU Munich), Cancer Proteomics (MSKCC), Deep Viral Pathogen Detection (FriedrichLoeffler-Institute) 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. 9 th european biotechnology guide 2019

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Est. 1980

Name · Kraeber & Co GmbH Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Address Internet Website Number of Employees Founded (year) Type of Production QS-Standards

· · · · · · · · · · · ·

Waldhofstr. 14 25474 Ellerbek Germany Franziska Faber +49-4101-3053-0 +49-4101-3053-90 info@kraeber.de www.kraeber.de 27 1980 Filtration and separation GMP ISO 9001:2015

Areas of Activities · Ingredients, specialities and niche products for the pharmaceutical and cosmetic industries

Established in 1980 Kraeber focused from this very beginning until today on the production and the sale of niche products and specialities. During nearly 4 decades we specialised on separation and filtration processes of natural ingredients for the pharmaceutical and cosmetic industry. The family-owned company is located in the north of Germany and, thanks to its proximity to the trading hub Hamburg, enjoys the advantages of operating globally. The products produced in Ellerbek are mainly used in diagnostics and vaccine production. At the same time, we provide our process expertise in customer projects and produce substances for various applications in ·· ·· ·· ··

wound healing, dermatology, in-vitro diagnostics and cosmetics.

We produce in defined production areas in accordance with ·· GMP ·· ISO 9001:2015 and can flexibly integrate new production lines into the existing production landscape within our QS systems. This allows our customers to have niche or small products produced in accordance with the applicable regulations. Our qualified teams from quality assurance, quality control and production will successfully implement your projects! Please explore our company history, our philosophy and goals, our products and partners on www.kraeber.de


Kraeber’s production portfolio All types of plasma and sera are produced with various filtration and separation processes e.g. according to customer’s requirements ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ··

Bovine Plasma Bovine Serum Albumin, Fraction V Bovine Serum Chicken Plasma Chicken Serum Equine Plasma Equine Serum, donor Equine Tendons Gammaglobulin from various species Goat Serum Hemin Hemoglobin Plasmasubstrate R1, lyophilised Plasmasubstrate R1, EP Porcine Plasma Porcine Serum Rabbit Plasma Rabbit Serum Sheep Plasma USP Sheep Plasma USP, lyophilised Sheep Plasma Sheep Serum

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

· · · · · · · · · · · ·

Tatzberg 47 01307 Dresden Germany Dr Oliver Uecke +49-351-796-5345 +49-351-796-5349 sales@lipotype.com www.lipotype.com

FL I  16 2012 Analytical laboratory

Areas of Activity · l Lipidomics l Lipid analysis for biotech and pharma l Clinical research l Academic research l Food industry l Cosmetics industry

Lipotype delivers comprehensive, absolutely quantitative lipid analysis services for clinical and biological samples on a high-throughput scale. Drawing on many years of cutting-edge research experience, 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, claim support for the cosmetics industry, as well as for the small-scale profiling needs of academic researchers. Lipotype is a spin-off company from the Kai Simons and Andrej Shevchenko labs of the world-renowned Max-Planck-Institute of Molecular Cell Biology and Genetics in Dresden, Germany.

Customers and applications ·· Biotech and Pharma industry, clinical research – Drug discovery (mode-of-action, target validation, effect on lipid metabolism), biomarker identification (pharmacodynamic, pharmacokinetic, CDx), clinical screening, diagnostics ·· Food industry – Development of functional food/ nutraceuticals, intervention studies, lipid composition of food products ·· Cosmetics and dermatology – Claim support, drug development and validation, personalised cosmetics ·· Academic research – Lipid analysis of cells, tissues, and body fluids from various model organisms in a plethora of experimental setups

Lipotype Shotgun Lipidomics – Ultra-broad coverage The Lipotype Shotgun Lipidomics Technology provides a broad coverage of membrane, 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) – more than 2,300 individual lipids in total.

Absolute quantification The quantification is achieved using lipid class-specific internal standards that allow for unbiased and direct quantitation of individual lipids directly from their mass spectra intensities. Therefore, we deliver results ex-


pressed in absolute and not in relative values, which provides the basis for a direct comparison of different samples and experiments.

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 sample extraction, processing and data analysis. In this way, our exquisitely standardised technology allows for the analysis of hundreds of samples per day, offering an unprecedented delivery time of weeks instead of months for complete results and associated reports.

Highest quality


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Lipotype Shotgun Lipidomics Technology is highly reproducible, robust, and reliable. This performance is ensured by a rigorous quality control system. The high standards of Lipotype operations are based on years of research experience on lipids and lipidomics technology. This is reflected in numerous scientific publications from different fields, as well as in industry-oriented applications and patents.

At a glance ·· Lipotype Shotgun Lipidomics covers more than 2,300 individual lipids in 30 different lipid classes ·· Identification of lipids at the structural level of lipid subspecies ·· Absolute quantification of lipids with class specific internal standards ·· High-throughput allows results delivery within 2 weeks ·· Proven experience with various sample types ·· Minimal sample amount required (e.g. 1 μl of blood plasma) ·· Lipotype Shotgun Lipidomics technology is highly reproducible, robust, and reliable, with a technical variation of < 10 % ·· Extensive know-how in data mining, machine learning, and multifactorial regression analyses for identification and interpretation of lipids ·· LipotypeZoom and advanced statistical reports access in-depth lipidomic data 9 th european biotechnology guide 2019

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

· · · · · · · · · ·

Pulverwiese 1 38871 Ilsenburg Germany Dr Helmut Wolf +49-39452-4829-0 +49-39452-4829-199 helmut.wolf@lyocontract.de www.lyocontract.de 52 2009

Areas of Activity · aseptic filling and freeze-drying of parenterals in vials

Smart pharmaceutical development and manufacturing All too often, the one-stop-shop experience at a socalled development and manufacturing organisation fails to offer a state-of-the-art, quality-by-design approach for product development. Lacking expert knowledge and pilot-scale equipment, and/or driven by the need to fill manufacturing slots, such organisations frequently end up offering a non-guideline-compliant, trial & error development approach. It is our experience that development is often short-changed if managed by experts in manufacturing alone. Instead, research & development ought to be in the hands of development experts (CROs), and manufacturing and batch supplies are better off in the hands of manufacturing experts (CMOs). We understood early on the vital importance of seamless technology transfer from one expert partner to the other, thus combining the competencies of each. LYOCONTRACT GmbH and ProJect Pharmaceutics GmbH (p. 134) have taken on the task of providing such high-quality expert development and expert manufacturing services to the pharmaceutical industry. LYOCONTRACT is a state-of-the-art pharmaceutical manufacturing organisation (CMO) with the capabilities to manufacture liquid and freeze-dried parenteral drugs in vials for clinical trial and market supply. ProJect Pharmaceutics, one of the leading European contract research and development (CRO) service providers, has perfected the art of developing smart fit-for-purpose formulations and efficient and robust freeze-drying cycles in pilot plants that work under large-scale manufacturing. We have managed to achieve the smooth transfer of technology from ProJect Pharmaceutics’s CRO pilot plant to LYOCONTRACT’s manufacturing site by a) process robustness testing and definition of a design space, and b) using manufacturing plants from the same technology leader. At LYOCONTRACT, the machines for clinical manufacturing are the identical ones used for commercial manufacturing, without the need for any additional technology transfer for scale-up or change of equipment. In this way, technologies are easily aligned from small- to large-scale production.


LYOCONTRACT, as state-of-the-art contract manufacturing experts, and ProJect Pharmaceutics, as state-of-the-art development experts for formulations and processes, have teamed up to provide the pharmaceutical industry with high-quality parenterals from pre-clinical to clinical and large commercial scale. Both companies act as separate partners in their field, taking advantage of their mutual competencies: the CMO partner taking advantage of the elaborated development abilities and the CRO partner taking advantage of the technologically compatible manufacturing equipment. This close collaboration of contract manufacturer and developer, each an expert in their respective area, leads to an extraordinary benefit supporting smart, seamless pharmaceutical development and manufacturing. LYOCONTRACT (CMO) at a glance: ·· Aseptic filling into vials ·· Liquid filling up to 900 litres ·· Lyophilisation up to 250,000 vials ·· Development / optimisation of freeze-drying programmes ·· Clinical and commercial manufacturing ·· Stability testing acc. to ICH guidelines ·· Secondary packaging, serialisation ProJect Pharmaceutics (CRO) at a glance: ·· Development. Formulation. Process. Packaging. ·· Biologics, cytotoxics, vaccines ·· Guideline-compliance ·· Pre-formulation ·· Fit-for-purpose formulation ·· Fit-for-scale lyophilisation ·· Pre-clinical manufacturing ·· Design space, compatibility, technology transfer

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Name · Medicines for Europe Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Address Internet Website Number of Employees

· · · · · · · ·

50 Rue d’Arlon 1000 Brussels Belgium Trudy Beks +31-6-41190824 trudy@medicinesforeurope.com www.medicinesforeurope.com 20

Areas of Activity · l Generics l Biosimilar medicines l Value-added medicines

About Medicines for Europe Medicines for Europe began over 20 years ago as the European Generics Medicines Association (EGA) with the goal of representing the emerging generic industry, later growing to include biosimilar medicines in its portfolio. As the pharmaceutical industry and the healthcare environment within which it operates have evolved, so has our Association. When the EGA was first launched back in 1993, generic alternatives to branded medicines made up a fraction of the market. As more of these medicines have come off-patent, and the benefits and value of generics to both patients and healthcare providers have become clearer, the provision of generic medicines has increased dramatically. Our members provide the essential medicines that European patients, healthcare professionals, and healthcare systems rely on to treat the most acute and chronic conditions covering a wide range of diseases, from cardiovascular, to diabetes and cancer. Better access to the most effective therapies means millions more patients are getting better and living longer, while healthcare inequalities are being reduced. We now supply over 67% of all medicines in Europe, and over the last ten years, generic drugs have increased access to medicines by over 100% in 7 key therapeutic areas. For the treatment of high blood pressure alone, almost 50 million patients are taking generics each day, and 20 million people across Europe are now being treated for diabetes with generics. (See our IMS infographic on the Role of Generic Medicines in Sustaining Healthcare Systems.) Technological advances and innovation have had a massive impact on the pharmaceutical industry, including the development of new and highly innovative biologic medicines – medicines whose active substance is produced by or extracted from a biological source. We have responded to this opportunity with biosimilar medicines – medicines that are highly similar to existing biological medicines, with no meaningful difference in terms of

medicines for europe

efficacy. With more than 10 years of positive patient and treatment experience in the market, the first biosimilar medicine was approved by the EU in 2006, and the use of biosimilar medicines is expected to result in savings of up to â&#x201A;Ź33.4 billion for 8 EU countries by 2020. More recently, we have expanded into value-added medicines aimed at optimising, rethinking, and reinventing existing medicines based on known molecules, addressing unmet medical needs of patients through improved care delivery systems. Value-added medicines deliver relevant additional improvement for patients, healthcare professionals, and/or payers. Benefits include improved efficacy, safety, and tolerability profile, better adherence, better quality of life, greater convenience of use, and/or patient preference. As a novel contribution to the prevention of therapeutic escalation, the rational use of medicines, and improving equity, value-added medicines are expected to play a key role in improving efficiencies in Europeâ&#x20AC;&#x2122;s health care system. Medicines for Europe organises several industry-related conferences, with a highly valued reputation worlwide! For more details on the different events, visit: www.medicinesforeurope.com/events/

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Name · Merck Biodevelopment SAS Address/P.O. Box · 1 rue Jacques Monod Site Montesquieu Postal Code/City · 33650 Martillac Country · France Contact Person · Dr Sébastien Ribault Telephone · +33-5-57-960-960 Fax · +33-5-56-64-99-56 Email Address · Sebastien.ribault@merckgroup.com Internet Website · www.merckmillipore.com/end-to-end Number of Employees · Approx. 300 Founded (year) · 1987 Type of Laboratory · Biodevelopment center Areas of Activity · l Cell line development l Cell banking l Process development l Analytical development l GMP clinical supply l Regulatory advice l Process validation l Scale-up and transfer Request for · BioReliance® End-to-End Solutions Further Collaborations offers adaptive contract development and manufacturing for start-ups and small biotechs who need support and expertise for their biologic drug development from DNA to market.

Many parameters along your journey No two drug developments are ever the same. We understand you need to adapt to an unpredictable journey with changing priorities along the way. Whether you have never brought a product to market before or need a CDMO that can build upon your experience, we help you make the critical decisions that will impact your drug development journey, conscious of time and cost.

Adaptive CDMO solutions We offer CDMO solutions adapted to your project’s needs, even if your needs are continuously changing. Because we are a small and flexible organisation of 300 people backed by Merck’s more than 52,000 employees, we bring you a wealth of in-house expertise. We are the CDMO within Merck that helps biotechs develop their biologic drug candidates from DNA to market. We are BioReliance® End-to-End Solutions.

BioReliance® End-to-End Solutions We are an adaptive contract developer and manufacturer that helps start-ups and small biotechs reach their next milestone with the right balance between cost, risk, and speed to clinic and offers tailored solutions and expertise from pre-clinical to commercial: ·· Cell line development ·· Cell banking ·· Analytical development ·· Process development ·· GMP clinical manufacturing ·· Product characterisation ·· Lot release testing ·· Process validation, scale-up, and transfer

Our history Our biodevelopment centre in Martillac started in 1987 as a CDMO, which was acquired by Serono to become an in-house discovery, development, and manufacturing function for Merck Healthcare. Since 1995 the Martillac site has been GMP certified. The site was upgraded to a fully single-use platform in 1992, when we again began offering services externally and creating GMP batches for clients. Biodevelopment centres were opened in Boston, USA and Shanghai, China in 2018 for non-GMP clinical production.


Our experience ·· 31 years in process development, 23 in GMP production ·· 230+ biologics (antibodies, hormones, fc-fusion and recombinant proteins) ·· 70+ GMP drug substance batches released since 2012 ·· 65% fed batch, 35% perfusion ·· 100% scale-up success rate ·· 97% clinical GMP production success rate ·· Built our own single-use PD/GMP facility in <1 year

How we work with you We start with helping biotechs establish their strategy and offer tailored solutions that take into account our clients’ project needs. How fast do you need to go? What is the level of risk you are willing to take? These are questions we address and based on our experience we help our clients balance cost, risk and speed to clinic without ever sacrificing quality and patient safety. Our regulatory advisers represent our clients in front of regulatory bodies to show that patient safety is guaranteed throughout the process. Our dedicated project managers allow us to function like an extension of your team. We emphasise transparency and connect you directly with our experts. When you decide to transfer your process, we support your tech transfer to your facility or to any partner.

What you can expect ·· A flexible approach to balancing cost, risk, and speed to clinic ·· In-house expertise that helps you take informed decisions ·· Complete end-to-end or à la carte services ·· No upfront payment or booking fees ·· Freedom to tech-transfer at any stage, to any partner ·· Optionality through access to the latest technologies and deep development expertise Did you just get funding? Or are preparing to get to clinic and IND filing? Contact us today and let’s talk about your next steps.

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Name · Mettler-Toledo GmbH Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · ·

Ockerweg 3 35396 Gießen Germany Carmen Wiederuh +49-641-507401 Carmen.Wiederuh@mt.com www.mt.com

FL I  15,400 (worldwide) 1989

Areas of Activity · Manufacturer and marketer of precision instruments and services for many applications in research and development, quality control, production, logistics and retail to customers around the world.

UV/VIS Micro-Volume Spectrophotometry with Rainin specialised high-quality tools OneDrop UV/VIS Spectrophotometry, the Life Science Specialist The UV5Nano micro-volume spectrophotometer from METTLER TOLEDO stands out with its innovative technology and intuitive usability coupled with modern design. FastTrack™ technology combines a long-lasting light source with state-of-the-art array technology and enables very rapid, accurate, and precise measurements. Only a minimal amount of sample is required for accurate measurements. Wide concentration ranges from 6 ng/µL to 15,000 ng/µL of dsDNA can be measured without further dilutions. Large volumes of up to 3 mL are measured in the cuvette slot. Spectrophotometry with LockPath™ Technology ·· Wide concentration ranges without further dilutions ·· Automatic or manual pathlength selection ·· Secure locking of the arm during measurement minimises errors ·· No drying out of sample during measurement for increased repeatability ·· Convenient sample pipetting from either right or left side Predefined Bio-Applications The One Click user interface includes many predefined applications for the analysis of bio-molecules. Nucleic acids, such as dsDNA, ssDNA, RNA or can be easily tested for purity or concentration. For protein analysis, the One Click user interface provides direct determination at 280 nm, indirect determination with dyes, or the commonly used assays following, for example, the Lowry, Bradford, Biuret, or BCA protocols. Advanced liquid handling solutions Through its Rainin brand, METTLER TOLEDO is a leading provider of advanced liquid handling solutions for life scientists worldwide. We offer a wide selection of ergonomic manual pipettes, electronic pipettes, multi-

mettler toledo

channel pipettes, BioClean Ultra LTS, and universal pipette tips, as well as expert pipette services. It is a complete pipetting solution that we call Pipetting 360°. Our commitment to quality, innovative design, and stateof-the-art production results in superior pipette products that deliver years of reliable operation. Rainin developed the LiteTouch System (LTS) to increase the accuracy and precision of pipettes while decreasing friction, making Rainin pipettes a leader in pipetting ergonomics. The risk of repetitive strain injuries (RSI) is greatly reduced when using ergonomic Rainin LTS pipettes and tips. High-quality pipettes, professionally serviced and maintained, are crucial to scientific success and compliance with regulatory requirements. Together with the new EasyDirect asset management software, the SmartStand pipette station enables efficient monitoring of the entire pipette inventory. All tasks related to monitoring the pipettes are comprehensively met and the requirements of users, lab managers, quality control, and purchasing are also served. All service-relevant status data about the manual or electronic pipettes on the stand is displayed directly to the user, and charging is provided for up to four electronic pipettes. Reading the RFID chip in each Rainin XLS and XLS+ pipette, SmartStand immediately displays its service status. All pipette information is available to the next user without restriction, which significantly increases transparency and efficiency in the lab. All pipettes and relevant process steps can be monitored in real time with the EasyDirect software. With just a few clicks, the user knows immediately which pipettes need service and calibration over the next month, quarter, or year. It is immediately possible to determine whether pipettes are SOP-compliant, whether a pipette can even be used for a given task, or whether it needs to be recalibrated. Using SmartStand, you can identify the workstation where pipettes are located, the service-relevant data assigned, and whether work can be carried out in accordance with SOP. This is especially important for quality management. 9 th european biotechnology guide 2019

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

· · · · · · · · · · ·

Am Hubengut 3 76149 Karlsruhe Germany Dr Wolfgang Rudy +49-721-9415213 +49-721-9415214 wolfgang.rudy@micromol.com www.micromol.com 20 1996 CRO

Areas of Activity · l Preclinical cell and immune analytics l Pharmaceutical microbiology l Biocompatibility testing of medical devices and cosmetics

MicroMol focuses on defiened topics within the field of risk assessment of biologicals and biological safety in general. The section of in vitro Toxicology concentrates on the analysis of medical devices (ISO 10993), biologics, and pharmaceuticals, in detail on the: ·· Determination of in vitro cytotoxicity (ISO 10993-5) ·· Pyrogen determination: Monocyte Activation Test (EP 2.6.30) / LAL-Test (EP 2.6.14) ·· Determination of irritation to skin and eye (ISO 1099310 / OECD guideline 439 / 460 / 492) ·· Determination of skin sensitisation (ISO 10993-10 / OECD 442 d/e ·· Determination of genotoxicity (ISO 10993-10 / OECD guidelines 471 / 476 / 487) ·· Determination of bioburden (EP 2.6.12) Focussing on the field of cell bank safety / biological contamination, MicroMol concentrates on the risk assessment of bacterial and eukaryotic cell banks as well as the evaluation of biological samples in general, including: ·· Cell bank purity ·· Bacteriophage detection and determination ·· Plasmid stability ·· Viral contamination (retro-, human, animal virus) ·· Determination of biological contamimantion (mycoplasma, DNA, RNA, host cell protein)


This platform is supplemented with a sophisticated unit for Protein- / Immune- and DNA- analytics, focussing on the: ·· Antibody-based protein determination / identification ·· Protein determination by size ·· Protein determination by amino acid composition ·· Immunoprofiling and immunomonitoring of cell samples (PBMCs, cell lines) ·· Implementation, validation, and performance of PCR assays MicroMols offers a professionally equipped testing facility: Mesoscale Quickplex SQ120, AYOXXA Lunaris protein multiplexing platform, Merck Guava EasyCyte Flow Cytometer, Berthold FL / ECL ELISA work station, AID iSpot ELISpot reader, Protein Identification (high speed AA analyser, SDS-PAGE / Western Blotting work station), RT PCR work station (Applied Biosystems / BioRad). MicroMol is GMP certified and accredited according to the ISO 17025. All customised projects are strictly performed according to international valid protocols and guidelines (ICH, FDA, Pharm Eu, USP).

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Name · Microsaic Systems Address/P.O. Box · GMS House Boundary Road Woking Postal Code/City · GU21 5BX Surrey Country · United Kingdom Contact Person · Glenn Tracey Telephone · +44-1483-751577 Email Address · info@microsaic.com Internet Website · www.microsaic.com Social Media · L I Number of Employees · 20+ Founded (year) · 2001 Areas of Activity · l Mass spectrometry l Real-time point-of-need analysis l Product characterisation l Quality-by-Design strategy l Biopharmaceutical process control

Microsaic Systems plc (AIM: MSYS) develops point-ofneed mass spectrometry (MS) detection for biopharma, bioprocessing, and process analytical technology.

Miniaturised MS technology for point-of-need analysis Using micro-engineering principles, Microsaic is the first to miniaturise MS for point-of-need use. This reduces MS into a single box, while still delivering powerful analytical performance. Our patented chip-based technology enables analytical detection and characterisation where and when it is required, for a broad range of on-line, at-line, and off-line applications. Easy to use, with no prior knowledge of MS required, our technology gives users and process operators access to continuous MS detection data at any step in their workflow.

Reaction monitoring An essential part of an efficient Quality-by-Design (QbD) strategy, point-of-need MS added to a bioprocessing environment allows the user to promptly characterise important Critical Quality Attributes (CQA) of the biologic products and monitor Critical Process Parameters (CPP) within the bioprocess itself. This enables timely decisions to be made about how best to intervene in the workflow in real-time. As a result, our miniaturised MS system safeguards the biologics manufacturing process so that the product is of the desired quality and type, which ultimately leads to more robust yet agile bioprocessing. Our systems can interface with a whole range of equipment, including LPLC, HPLC, preparative chromatography, and more direct introduction methods from your workflow. We also support general analytical interfaces with TLC, CE, and Nano-LC.


Work with us We are working on a number of collaborations to further develop and broaden the commercial applications of our real-time MS solutions. Collaborators can work with us on a broad spectrum of workflow elucidation. Our capabilities include: ·· Detection and characterisation of large and small proteins (for example intact monoclonal antibodies, insulin). ·· Monitoring specific CQA parameters such as glycosylation. ·· Monitoring nutrients, metabolites, and other small molecules in the cell media, which can be used for monitoring critical process parameters (CPP). Our expertise is in the development, integration, and application of chip-based MS technology and we are always interested in hearing new ideas or in potential collaborations and partnerships. Contact us via info@microsaic.com to start the dialogue.

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Name · Microsynth AG Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Address Internet Website Founded (year) Type of Laboratory

· · · · · · · · · ·

Schützenstrasse 15 9436 Balgach Switzerland Christof Wunderlin +41-71-722-83-33 +41-71-722-87-58 info@mirosynth.ch www.microsynth.ch 1989 S1/S2, GMP/GLP

Areas of Activity · l Oligonucleotide Synthesis l Sanger Sequencing l Next Generation Sequencing l DNA/RNA Isolation, qPCR, ddPCR, Genotyping l Contract research/outsourcing Contract Research · l Contract Manufacturing (e.g. ASOs, probes) l Assay Development l Assay Validation (ICH Guidelines) l GxP(-like) analysis of customer test items (Sanger, NGS, qPCR & dPCR) l Process outsourcing l Genomics research

The Company Microsynth is a leading European company in the field of nucleic acid synthesis and analysis. Its main activities are oligonucleotide synthesis, DNA/RNA analysis and sequencing, as well as contract research and outsourcing. For three decades, the company’s objective has always been to serve its customers by delivering products and services of the highest quality, on time and with outstanding service – and all this at competitive prices. Microsynth employs approximately 50 people at its headquarters in Balgach, Switzerland. Microsynth also has subsidiaries in Germany (Microsynth Seqlab GmbH), Austria (Microsynth Austria GmbH), and Switzerland (ecogenics GmbH).

Products and Services Oligonucleotide Synthesis Broad range of different backbones (DNA, RNA, 2’-MOE, 2’-OMe, LNA, PTO), modifications (>250) and purifications. From small scales for primers over probes for molecular diagnostic kits up to pilot scale for therapeutic oligonucleotides, Microsynth is your total solutions provider in the area of oligonucleotide synthesis. DNA/RNA Analysis With more than 25 years of experience in DNA Sanger sequencing, Microsynth has become one of the leading sequencing suppliers in Europe. Having established Sanger sequencing labs in Switzerland, Austria, and Germany, we can offer this service with unmatched speed and environmentally friendly pickup service in these countries. Microsynth’s decentralised approach results in shorter sample delivery distances and thus in the predominant use of bicycle- and train-based courier logistics. Microsynth offers a broad spectrum of high-quality next generation sequencing applications. The in-house developed bioinformatics analysis pipelines provide reliable and ready-to-use results. The fast turn-around times and the top-notch consulting separate Microsynth from the competition.

microsynth AG

Beyond DNA sequencing, Microsynth has built up critical expertise in related analytical areas such as nucleic acids isolation, PCR (from classic over qPCR to digital PCR) and genotyping (e.g. STR DNA profiling, genotyping by sequencing). Together with other areas we can assist you as a full-service provider starting from whatever material you send us to the final result. Contract Research / Outsourcing Microsynth has vast experience in running many different research projects for its customers, including the development of new protocols. Successful projects in basic, preclinical, and clinical research range from one-month projects to projects lasting several years. Experienced researchers with strong track records in microbiology, genomics, molecular biology, and bioinformatics help you define the best strategy to address your research questions. A broad portfolio of validated techniques and protocols is available at Microsynth. Professional project management expertise, high-throughput sample logistics, and close interaction with the customer ensure that each outsourced project is carried out cost-efficiently and on time.

Quality Management System Microsynth puts every effort into constantly improving the underlying production processes. All branches of Microsynth are EN ISO 9001:2015 certified. The NGS and Sanger sequencing department as well as the paternity testing services of Microsynth AG are additionally ISO/ IEC 17025:2005 accredited (STS 0429). Microsynth AG is also authorised by SwissMedic to perform quality control of medicinal products using GMP Sanger sequencing. Further, Microsynth AG is EN ISO 13485:2016 certified for the analysis, production, and distribution of nucleic acids, in-vitro diagnostic (IVD) assays, and applications.

People Dr Markus Schmid, Christof Wunderlin (Co-CEOs) Dr Christoph Grünig (Head of Contract Research) 9 th european biotechnology guide 2019

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

· · · · · · · · · ·

Fabeckstraße 30 14195 Germany Claudia Nickolaus +49-30-84-17-88-0 +49-30-84-17-88-50 info@mologen.com www.mologen.com ~50 1998

Areas of Activity · Clinical drug development in the areas of cancer and infectious diseases Annual Turnover · ± €3m Relevant R&D Budget · €14m (FY 2017) Biological Patents · Comprehensive international patent protection for our product candidates External · Leading international scientific and Collaborations clinical centres, e.g.: I Aarhus University Hospital, Denmark I The University of Texas MD Anderson Cancer Center, USA I ONCOLOGIE Inc., USA/China Request for · Partnering opportunities for our Further Collaborations compounds

MOLOGEN AG – Technology leader in targeted immunotherapies With innovative and unique drug candidates, MOLOGEN is one of the pioneers in the field of immunotherapies. Our product development helps to fight some of the most threatening diseases. Apart from the core focus on oncology, we also develop immunotherapies for the treatment of infectious diseases. Our approach concentrates on drug candidates for which there is high medical need. As a biopharmaceutical company, MOLOGEN is oriented toward closer-to-market proprietary product candidates that have advanced beyond the basic research stage. Our foremost objective is the successful out-licensing and marketing of our products via partnerships with established pharmaceutical companies, particularly our lead compound lefitolimod (MGN1703). Our scientific approach is always based on the same premise: activation of the human immune system to combat the disease itself. It 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 the immunotherapeutic agent lefitolimod and its follow-up molecules EnanDIM ®. Lefitolimod is the company’s lead compound and regarded as the best-in-class TLR9 agonist. Treatment with lefitolimod triggers a broad and strong activation of the immune system. Because of this action mechanism, lefitolimod could potentially be used in various indications. Lefitolimod is currently being developed within the framework of a pivotal study for first line maintenance therapy for colorectal cancer with availability of the top-line data expected between summer and year-end 2019. Furthermore, it was investigated


in a phase II IMPULSE study in small cell lung cancer. Key data educate and support further development in this indication. In August 2017, the announcement of key data from the expansion phase of the Ib/IIa TEACH study in HIV-patients triggered further evaluation of lefitolimod in HIV. The TITAN study ,which will test our lead compound in combination with monoclonal antibodies in HIV patients, is expected to start in Q1 2019. In addition, lefitolimod is currently being investigated in a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy®) in various cancer indications. First results from this study have recently been presented and underscore the potential of our lead candidate in IO combination approaches.

Cell-based therapeutic vaccine Our product portfolio includes another proprietary cellbased therapeutic vaccine MGN1601 to treat advanced renal cancer. For the time being, we have shelved this candidate, but – depending on available funds or partnering opportunities – further development could be resumed.

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 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 EnanDIM ® – with the option for flexible cooperation arrangements.

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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 Country Contact Person Telephone Fax Email Website Social Media Founded (year)

· · · · · · · · · ·

Brüningstr. 50 – Geb. B852 65926 Frankfurt am Main Germany Dr Thomas Möllenkamp +49-69-305-23140 +49-69-305-23149 info.de@neb.com www.neb-online.de

FL I  H 1981

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

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

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

new england biolabs

student interns, and PhD students engaged in research projects. With this dual focus on both basic and applied research, NEB’s culture is collaborative and academic.

Latest innovation in enzyme technology Our outstanding expertise in protein engineering and evolution has led to the creation of unrivaled enzymes and unique workflows in the library preparation for the NGS space. These products set the benchmarks for optimal performance and ease-of-use in modern molecular biology laboratories. Moreover, NEB’s specialised offerings for alternative DNA Assembly & 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.

Customised products/OEM

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

Competent Cells Gene Expression



NEB’s OEM business unit has been delivering customised manufacturing, tailor-made enzyme formulations, and packaging solutions to customers for over 25 years. Relying on this extensive experience, we have established a new GMP-compliant manufacturing facility to offer a select set of tailor-made products enabling OEM customers to use NEB’s top-class products directly in their specific applications, or to bring them to regulated markets.

New England Biolabs in Europe 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. Customers in the UK/Ireland and France benefit from direct support through our subsidiaries in Hitchin/UK and Evry/France, respectively. Learn more at www.neb.com or www.neb-online.de 9 th european biotechnology guide 2019

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

· · · · · · · · · · ·

Im Neuenheimer Feld 515 69120 Heidelberg Germany Dr Christian Roesky +49-6221-502590 +49-6221-5025921 info@novaliq.com www.novaliq.com 60 2007 l Chemical l Pharmaceutical

Areas of Activity · l Specialty pharma l Ophthalmology Biological Patents · 42 patent families with a total of 106 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 is a pharmaceutical company focusing on the development and commercialisation of first- and bestin-class ocular therapeutics based on EyeSol ®, the worldwide first water-free technology for ophthalmology products. With an initial focus on dry eye disease (DED), Novaliq offers an industry-leading portfolio addressing today’s unmet medical needs of millions of patients with eye disease.

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 technology called EyeSol®.

Water-free 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 several NovaTears® and CyclASol® trials.

Product pipeline Novaliq offers an industry leading pipeline in DED. Novaliq’s tiered Dry Eye family addresses unmet medical needs in dry eye patients.

NOV03 NOV03 (100% perfluorohexyloctane) is a preservativefree ophthalmic solution and the first drug developed to treat DED associated with Meibomian Gland Dysfunction (MGD). NOV03 is a potential breakthrough in DED therapy: The drug effectively treats clinical signs and patientreported symptoms in an underserved and visual function impacting indication.


CyclASol® As a clear ophthalmic solution of 0.1% cyclosporine A in EyeSol®, CyclASol® is an anti-inflammatory and immunomodulating drug for the treatment of DED. CyclASol® unfolds the full potential of cyclosporine A for the first time in eye drops: It combines unprecedented efficacy, a fast onset-of-effect with an excellent tolerability profile.

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 and evaporative barrier for improved tear film. 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.

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

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Name · NSF International Address/P.O. Box · The Georgian House, 22/24 West End, Kirkbymoorside Postal Code/City · YO62 6AF, York Country · United Kingdom Contact Person · John Johnson Telephone · +44-1751-432-999 Email · johnjohnson@nsf.org Website · www.nsfpharmabiotech.org Social Media · I Founded (year) · 1944 Areas of Activity · l Auditing l Consulting l Training

The Company Pharmaceutical and biotech companies are challenged by more complex supply chains, ever-changing regulations and a volatile and uncertain global environment where patients and healthcare providers expect affordable, high quality medicines. At NSF International Pharma Biotech, we have over 30 years’ industry experience so understand your challenges. Our training is designed to change behaviours and improve workplace practices, not just to pass on information. Our consultancy and auditing services have one objective in mind: to help improve your productivity (efficiency and profit) and regulatory compliance. Unless you achieve both, you will go out of business.

Consulting Contact us if you want to be proactive and drive improvements, or if you require guidance on a specific issue. What we offer: ·· Development and implementation of cost-effective, compliant pharmaceutical quality systems ·· Advice on design, qualification and validation of new facilities, equipment, computerised systems and processes ·· Legal and regulatory issue guidance ·· Assistance with responses to regulatory inspection reports ·· Simplification of quality processes, SOPs and batch records ·· Benchmarking against best industry practices, beyond the regulations

Auditing Taking a close look at your facilities and operations. Standards | NSF can perform audits against Good Manufacturing Practice, Good Distribution Practice, Good Pharmacovigilance Practices and Good Clinical Practice international regulations. Audits | We can audit active pharmaceutical ingredients, excipients, medicinal product manufacturers, distributors, investigational medicinal product manufacturers, QC laboratories and more.

NSF International

Our processes can be tailored to your specific needs, including due diligence audits, compliance auditing against standards, inspection readiness audits and auditing your supplier and internal audit processes. Outputs can include efficiently reaching compliance.

Training and Education Providing you with customised on-site training, residential courses and eLearning. Examples of education offered annually include: ·· Pharmaceutical GMP, including clinical trials ·· Sterile and biotech products manufacture ·· Legislation updates and regulatory affairs ·· Auditing and self-inspections (A CQI and IRCA certified course) ·· Human error prevention and behavioural GMP ·· Quality risk management ·· Qualified Person training We have also expanded our European course offering with courses in Hamburg, Amsterdam and a practical hands-on GMP for Biological and Biotechnology products course held at NIBRT’s award-winning biotech facility in Dublin, Ireland. Visit www.nsf.org/info/pharmatraining for more information.


Martin Lush Global Vice President

Mike Halliday Executive Vice President

John Johnson Vice President

What Makes NSF Different?

Peter Gough Executive Director

·· Relationships matter. We care about you, our clients, which is why over 85% stay with us because we care about your future. ·· We will help you simplify and become more risk smart. ·· We don’t believe in off-the-shelf solutions, we provide customised solutions and improvements that work. ·· We measure our success by how quickly we leave you. Our focus is to improve your internal skills and competences, so you can thrive without us. ·· Global access. With offices around the world, we offer you services regardless of your location. For more information on our services, visit www.nsfpharmabiotech.org, email pharmamail@nsf.org or call +44-1751-432-999.

Rachel Carmichael Executive Director

Lynne Byers Executive Director

Catherine Kay Director

David Waddington Director

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2 Name · OP2 Drugs SAS (“OP2”) Address/P.O. Box · PTIB, Hôp. Xavier Arnozan Av. du Haut Lévêque Postal Code/City · 33600 Pessac Country · France Contact Person · Fred Marin Telephone · +33-685-833-905 Email Address · Fred@op2drugs.com Number of Employees · 4 Founded (year) · 2015 Areas of Activity · Drug development until registration, repositioning, cardiology, diabetes

Persons collapses every 40 sec in the US, felles by a heart attack. And their heart muscles will never recover their original contractility, leading to death or heart failure, one of the major causes of expenses for the US and EU healthcare systems. OP2 Drugs SAS (“OP2”), founded in 2015 by cardiologists and entrepreneurs who believe that energy deregulation is key in the development of heart dysfunctions, designs, develops, and seeks to register and market breakthrough drug therapies for cardiac disorders, characterised in collaboration with the LIRYC Institute (FR) and the Buck Institute for Aging (US).

Cardioprotection, a still unmet need after 50 years of drug candidate failures

External · IHU LIRYC (FR) Collaborations

Myocardial infarction (MI) is an irreversible necrosis lesion starting with the obliteration of a coronary artery due to a blood clot, leading to a loss of the contractility of the lesion area in the muscle. The necrosis area develops in two phases; the final, called the reperfusion phase, after removal of the clot, is due to the release of large amounts of reactive oxygen species (ROS) from muscle cells, leading to their death. Our first market is made of the 300,000 MI patients yearly treated by angioplasty, the MI reference emergency treatment. Indeed, our lead product, called Myosave*, is perfused as an add-on to the angioplasty procedure after reperfusion, during the hospital stay of the patient, and dramatically protects against reperfusion damage.

Member of

European Biotechnology NET WORK


1st active ingredient to specifically modulate mito-ROS production OP2 has been working over the last 3 years on a firstin-class molecule, OP2113, which has been shown to inhibit the main source of ROS release from the mitochondria. On a large animal model of MI, OP2113 has been generating impressive preclinical results. That molecule also benefits from 70 years of marketing in the EU in a chronic clinical setting, in an oral formulation, and has been shown to be extremely safe.

1st ever in silico clinical development for NDA With the aim of supplying the first cardioprotective drug in MI to the US market by 2023, OP2 is innovating with the FDA to develop and validate modeling and simulating algorithms to secure Myosave* clinical development, increase the success rate at registration, and speed up access to the US market.

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Name · OPIS s.r.l. Address/P.O. Box Postal Code/City Country Telephone Fax Email Address Internet Website

· · · · · · ·

Via Matteotti 10 20832 Desio Italy +39-0362-6331 +39-0362-633-633 office@opiseurope.com www.opiseurope.com www.clinical.net

Social Media · I Number of Employees · ~240 Founded (year) · 1998 Areas of Activity · Premium support for clinical drug and device development Annual Turnover · €24m External · Pharma Collaborations Request for · l Biotech Further Collaborations l Medical device l Food supplements

Our organisation OPIS is a European clinical CRO providing premium clinical trial management for multi-country trials. In addition to phase I-IV drug-related trials, OPIS also manages pre- and post-marketing clinical investigations for medical and diagnostic devices and nutraceutical/food supplement studies. Founded in 1998, OPIS is the number one Italian CRO, with roughly 240 employees. The company operates from its Italian headquarters and eight offices located in Europe (Spain, France, Germany, UK, Belgium, Sweden, Poland, and Switzerland).

Our expertise In 20 years of combining medical, regulatory, statistical, and technological expertise, OPIS has assisted over 40 different clients with interventional and observational trials. Full service projects in a wide range of therapeutic areas include various rare disease indications as well as pediatric studies. Currently, over 40% of trials managed by OPIS are oncology or onco-hematology trials. Other major therapeutic areas include ophthalmology, neurology, and cardiology. OPIS has established collaboration with numerous international sponsors on multi-country trials.

Our mission We draw on our know-how, experience, professionalism, and ethical values to assist our partners in developing drugs quickly and in compliance with laws and regulations. Our strength lies in the passion for what we do and in the quality with which we do it. We believe that clinical studies, particularly those incorporating scientific and methodological innovation, can significantly contribute to medical progress and a better quality of life.


Our core business


OPIS provides clinical research services and drug development consultancy to pharma, biotech, and medical device clients. From early phase clinical trials through proof of concept and up to late phase and post-market research, projects are executed in compliance with regulatory requirements, ICH-GCP E6 guidelines, and with therapeuticspecific attention. Operational staff that include medical writers, regulatory experts, project managers, monitors as well as data managers, biostatisticians, and SAS programmers assist sponsors with full-service study management of multi-country trials. The clinical trial data handling solution Clinical.net is fully FDA 21 CFR Part 11 compliant and modular in design to digitally manage EDC, protocol deviations, patient randomisation, safety reporting, and study drug handling.

Study types


·· ·· ·· ·· ·· ·· ·· ··

Early phase trials Phase II and III studies Post-market studies Observational research Real World Evidence studies Investigator Initiated Trials Medical Device Clinical Investigations Nutraceutical studies



·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ··

Medical Affairs and Medical Writing Regulatory Trial Start-Up Data Management Pharmacovigilance Quality Assurance e-Clinical Platform Project Control Statistical Analysis and Consultancy Study Management and Monitoring Preclinical and Drug Development Consultancy Training 9 th european biotechnology guide 2019

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Name · Polpharma Biologics S.A. Address/P.O. Box · Gdansk Science and Technology Park Trzy Lipy 3 bld A Postal Code/City · 80-172 Gdańsk Country · Poland Contact Person · Guenter Stempfer Telephone · +48-885505390 Email Address · guenter.stempfer@ polpharmabiologics.com Internet Website · www.polpharmabiologics.com Social Media · I Number of Employees · 300 Founded (year) · 2013 Type of Laboratory · State-of-the-art biopharmaceutical development centre for process development and optimisation; production of clinical trials materials as well as commercial supply of DS and DP. Areas of Activity · l Cell line development based on proprietary CHOBC® platform l Full analytical methods and process development l Process optimisation, scale-up and characterisation l GMP DS production out of mammalian cell culture at up to 2,000L scale l GMP DS production in microbial systems at up to 350L scale l DP formulation development l F&F (vials, pre-filled syringes, lyophilisation) External · Bioceros Holding B.V. (Utrecht, The Collaborations Netherlands) – cell line development; bioeq (Munich, Germany) – our centre of excellence for Clinical Development, Regulatory Affairs, and Patent Analysis; Polish universities and research institutes Request for · l Contract development and manufacturing of biopharmaceuticals Further Collaborations l Out-licensing and co-development of biosimilars and novel biological entities

From Discovery through to commercial Polpharma Biologics is a rapidly expanding biopharmaceutical company dedicated to improving patients’ lives by providing affordable, high-quality biologics. We operate four state-of-the-art facilities across Europe, located in Utrecht, Gdańsk, Warsaw, and Munich. Through working on our own biosimilars and new biologic entities pipeline, we have gained invaluable expertise, insights, and experience. Just a few months ahead of submitting our first biosimilar product to the US FDA, we are well positioned to efficiently and expertly support your entire project at all stages of biopharmaceutical development. Our dedicated team strives to tailor unique, customised solutions that fit our clients’ needs, bringing their products to market faster. Our flexible approach, reliability and in-depth knowledge means we are suited for a wide range of collaborations, from fee-for-service contract development and manufacturing projects to more complex long-term partnerships.

Your biopharmaceutical one-stop-shop We offer a truly integrated biopharmaceutical one-stopshop, which encompasses all required services from cell line development all the way to sterile fill & finish, thereby shortening your time to market, reducing managerial complexity and eradicating risky handovers between multiple service providers. Our proprietary CHOBC® expression platform enables rapid generation of high-quality cell lines at the highest titres for both protein-based innovative molecules and biosimilar products. By applying cutting-edge analytical methods and powerful process optimisation techniques, we are able to fully characterise your product and start tailoring process development towards your targeted profile in order to maximize final commercial production yield from the very beginning.

Polpharma biologics

We perform high-quality, GMP-compliant manufacturing of drug substance for both clinical and commercial supply using either mammalian cell culture (fermentation scale of up to 2,000L) or microbial expression systems (fermentation scale of up to 350L). Our flexible approach includes the exclusive use of disposable equipment, ensuring your demand is met on time, to the highest possible standard.


Global demand for biopharmaceuticals is growing. To serve this, we have included into our network the new Polpharma’s Group commercial-scale GMP production facility for drug substance manufacturing and sterile fill & finish, 20 km from Warsaw. The facility will become operational in 2021 and will have a total capacity of 12 x 2,000L cell cultures for drug substance production as well as 30 million vials and pre-filled syringes for sterile fill & finish.

Expertise and experience you can rely on Polpharma Biologics’ is led by a team with decades of international experience and a proven track record in biologics development, clinical and commercial production, registration and commercialisation.


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Our dedicated and skilled scientists and engineers provide invaluable expertise and insightful advice, and our Project Management Team ensures complete transparency, providing you with access to all the information you may require to drive your project forward on your terms. Polpharma Biologics brings expertise and flexibility to every project. Rely on us to partner with you and tailor solutions that fit your needs, bringing your high-quality biologics to market faster and improving patients’ lives.

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

· · · · · · ·

Goethestr. 54 13086 Berlin Germany Dr Wieland Wolf (CEO) +49-30-924-006-0 +49-30-924-006-19 info@probiogen.de cmo@probiogen.de · www.probiogen.de · FIQ · 125 · 1994 · S1, S2

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

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

Experience & client feedback Over 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. 9 th european biotechnology guide 2019

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

· · · · · · · · · · · ·

Maaßstraße 30 69123 Heidelberg Germany Caroline Odenwald +49-6221-8278-14 +49-6221-8278-24 odenwald@progen.com www.progen.com

FL I 22 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 · €4.7m 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.

Progressive 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 serves a well-diversified clientele in research institutes and universities, pharmaceutical and biotech companies, and clinical laboratories. PROGEN’s antibodies are among the most published antibodies in biomedical and cell biology literature while its ELISA kits aim at niche markets. Building on its extensive core competency in immunochemistry, the company offers recombinant antibody engineering, phage display technology, density gradient media, and AAV test kits for gene therapy research. Based on its 800+ antibody portfolio, PROGEN now intends to become a driver of innovative antibody technologies for protein detection, quantification, and purification – in different formats and for new applications to accelerate workflows in research and development.

Next generation protein detection, quantification, and purification With the new protag product line, the company provides a selection of recombinant single-domain antibodies, (sdAbs) that outperform conventional antibodies especially in tissue permeability and access to target proteins. Protags are labeled with a choice of fluorescent dyes for advanced microscopy applications or immobilised on agarose beads for effective protein purification and mass spectrometry. Furthermore, PROGEN has built a unique pipeline of ELISA kits for the correct assessment of adeno-associated virus (AAV) titres for safe and effective gene therapies. Some of these assays have already earned reference standard status in gene therapy centres around the world.


passion for research Ultimate commitment to quality, validation, and service PROGEN specifically serves the urgent need of today’s customers for premium antibody quality. As a DIN ISO 13485 certified company, PROGEN has established multi-level validation for many products: every new lot of antibodies for immunohisto-/cytochemistry undergoes independent quality control on relevant tissue sections or cells by external institutions. Antibody performance on western blot is evaluated, and sample sizes as well as positive controls are provided to customers for internal validation and assay calibration. Furthermore, PROGEN utilizes a novel method for antibody validation by epitope mapping in collaboration with PEPperPRINT GmbH. This innovative approach, which generates dependable data on antibody selectivity, specificity, and cross-reactivity, was “highly commended” in the 2018 CiteAb validation award.

Antibodies AAV-Tools Phage display technology ELISA Density gradient media

PROGEN’s longstanding success is based on well trained and highly experienced personnel that provides competent, individual technical and pre-/post-sales support.

Collaborations to meet existing and future demands Since 2012, PROGEN has been a 100% subsidiary of R-Biopharm AG, based in Darmstadt/Germany, a developer of test solutions for clinical diagnostics and food & feed analysis. This corporate affiliation offers new possibilities for the growth of PROGEN’s product & service portfolio. In addition, PROGEN is expanding the stable network in academia and industry that has been established over the past 35 years: the company is reaching out to potential partners in its endeavor to further expand its research reagents business.

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

· · · · · · · · · · ·

Fraunhoferstrasse 22 82152 Martinsried Germany Dr Daniela Woide +49-89-45-22-89-700 +49-89-45-22-89-717 info@project-pharmaceutics.com www.project-pharmaceutics.com

LI 2010 l Contract research and development l Chemistry l Cytotoxics l BSL-1 l BSL-2

Areas of Activity · l Biologics, cytotoxics, virus vaccines l Formulation development, liquid or lyophilised l Lyophilisation process development l Guideline-compliant quality-bydesign development l Physico-chemical characterisation l Manufacturing of pre-clinical supply l Technology transfer l Clinical trial supply Biological Patents · Several patents in freeze-drying and formulation External · Competence network player as Collaborations formulation specialist with LYOCONTRACT GmbH, Lyomark Pharma, and Bendalis GmbH. Crosscountry competence hub with business partners in Asia. Credited laboratory for Wyatt Technology in Europe. Request for · We partner with small biotechnology, Further Collaborations mid-size pharma as well as large top players in pharma/biotechnology – from DSP development to early and late drug product phases up to life cycle management.

Development. Formulation. Process. Packaging. ProJect Pharmaceutics is one of the leading European contract research and development (CRO) service providers, helping its worldwide clients to develop a consistently high-quality pharmaceutical product. Taking the ICHQ8 guideline as our credo, we pursue consistency of manufacturing by building quality into formulation and process. The high quality we build comes from a deep scientific understanding of a compound’s comfort zone in solution during the manufacturing process. Using guideline-compliant development we develop stabilisation concepts towards process-relevant manufacturability of each drug product. We transform biologics, cytotoxics, live virus vaccines, and other delicate molecules into pioneering drugs. Innovative, qualityby-design based, rational concepts of pharmaceutical development are increasingly requested by regulatory authorities. ProJect Pharmaceutics has already applied these requested DoE concepts exclusively throughout the development of stable formulations and manufacturing processes. Formulation development ·· pre-formulation, fit-for-purpose formulation ·· liquid or lyophilised formulation ·· early-state and late-phase formulation ·· high-throughput stability predictive technologies ·· concentration (mock-up) using UF/DF ·· process-relevant stability testing, forced degradation/challenge testing ·· aseptic manufacturing of pre-clinical supplies High protein concentration formulations ·· stable, convenient-use, and syringe-able formulations ·· eligible processes for pre-filled syringe/dual chamber technology ·· acceptable in-syringe shelf-life ADC / cytotoxic drug development ·· tailored formulation development ·· enhancement of solubility and stability ·· freeze-drying from solvent systems up to liposomal encapsulation

project pharmaceutics

Live virus vaccine ·· GMO S2 and BSL-2 biological products, protective and therapeutic vaccines ·· smart QbD-based formulation and manufacturing processes ·· stabilisation of quarternary virus capsid structure ·· avoiding virus aggregation, maintaining biological activity ·· safe distribution of viral vectors, safe long-term storage Downstream process development ·· QbD at earliest stage of development ·· rational design of purification steps incl. UF/DF ·· focused & accelerated DSP development ·· maximizing yield, decreasing loss ·· … ideally results in a common formulation for drug substance and drug product Lyophilisation process development ·· rational design of robust & efficient lyophilisation cycles ·· vials, (dual chamber) syringes, bulk trays ·· containers in nest & tub configuration ·· organic solvents ·· ADCs and other cytotoxic drugs ·· live virus vaccines ·· process robustness, definition of design space ·· process compatibility, seamless technology transfer ProJect Pharmaceutics has perfected the art of developing efficient and robust freeze-drying cycles that work under large-scale manufacturing. Using best-in-class pilot freeze dryers from technology leader and high-quality manufacturer of freeze drying systems ensures seamless technology transfer to smart commercial manufacturing. One-stop-shop solutions team up ProJect Pharmaceutics, as state-of-the-art development expert, and LYOCONTRACT (p. 102), as state-of-the-art contract manufacturing expert, to provide the pharmaceutical industry with high-quality parenterals from pre-clinical to clinical and large commercial scale.

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Name · Recipharm Address/P.O. Box Postal Code/City Country Telephone Email Website Social Media Number of Employees Founded (year)

· · · · · · · · ·

Box 603 10132 Stockholm Sweden +46-8-602-52-00 info@recipharm.com www.recipharm.com

I 6,000 1995

Areas of Activity · l Drug substance development l Drug product development l Analytical chemistry l Clinical trial material l Contract manufacturing for clinical trial material and commercial supply

Recipharm is a leading contract development and manufacturing organisation (CDMO) headquartered in Stockholm, Sweden. We operate development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK, and the US, and are continuing to grow and expand our offerings for our customers. Employing around 6,000 people, we are focused on supporting pharmaceutical companies with our full service, taking products from early development through to commercial production. For over 20 years we have been there for our clients throughout the entire product lifecycle, providing pharmaceutical expertise and managing complexity, time and time again. Despite our growing global footprint, we conduct our business as we always have and continue to deliver value for money with each customer’s needs firmly at the heart of all that we do. We provide support to pharmaceutical companies of all sizes with their outsourcing requirements, with our company operating in two core areas.

Contract development services

Member of

European Biotechnology NET WORK

Our development & technology segment offers clients a comprehensive range of services, with the aim of supporting the customer from the initial product concept to the approved pharmaceutical drug, in some cases, through various forms of risk sharing. We can offer both experience and expertise in various services including: ·· Medicinal chemistry ·· Custom synthesis ·· Radiochemistry ·· ADC and bioconjugates ·· Drug product development ·· Recipharm Pathway to Clinic® ·· Extractables & leachables testing ·· Impurity identification ·· Stability studies ·· Inhalation development ·· Tablet formulation ·· GLP bioanalytical services


·· Clinical supply ·· Project management ·· Regulatory support

Contract manufacturing services Recipharm’s largest business stream is manufacturing services. Our pharmaceutical manufacturing expertise means we can deliver a large number of pharmaceuticals in a variety of dosage forms requiring the use of a broad range of technologies, including: ·· Solids ·· Semi-solids ·· Liquids ·· Inhalation ·· Injectables ·· Ophthalmics As part of our manufacturing services, we also provide our customers with a comprehensive packaging service in a large number of variants. We also help our customers by simplifying their processes and managing complexities. We do this by offering additional services such as quality assurance, regulatory services, and logistics solutions, including Vendor Managed Inventory (VMI). For many of our clients that utilise our manufacturing capabilities, it is important that we have a solid foundation in drug development. We are proud to possess a broad pharmaceutical expertise that is essential in developing and supplying drug products. Within this business area, there is also a portfolio of product rights, which forms the basis of distribution through external partners. Through an integrated knowledge exchange between Recipharm’s manufacturing and development units, the skills and experience we have are used to improve the development organisation. Furthermore, this operating model helps to achieve a degree of efficiency and ensures quality when a pharmaceutical drug transitions from the development phase through to the manufacturing phase. That’s the Recipharm way. 9 th european biotechnology guide 2019

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Name · Redx Pharma Plc Address/P.O. Box · Block 33F Mereside Alderley Park Alderley Edge Postal Code/City · SK10 4TG Macclesfield Country · United Kingdom Contact Person · Mark Craighead Telephone · +44-16-2546-9929 Email Address · m.craighead@redxpharma.com Internet Website · www.redxpharma.com Social Media · I Number of Employees · 50 Founded (year) · 2010 Type of Laboratory · l Medicinal Chemistry l Pharmacology l DMPK Areas of Activity · l Fibrosis l Immuno-Oncology External · l AstraZeneca Collaborations Request for · Small molecule agents with potential Further Collaborations activity as anti-fibrotics or in the area of immuno-oncology

Redx is focused on the development of novel medicines to validated anti-cancer and fibrosis targets in areas of unmet need. Redx Pharma uses its proven drug discovery expertise to generate development candidates that it will take into the clinic and then partner. Our main programmes include:

RXC004 Porcupine is a key enzyme in the Wnt signalling pathway and plays a key role in immune resistance to treatment with immuno-oncology agents such as anti-PD-1 checkpoint inhibitors. Our Porcupine inhibitor, RXC004, is a potent inhibitor of this enzyme and the Wnt-ligand pathway. RXC004 could be used as a combination partner in immuno-oncology treatment paradigms with immunooncology agents such as anti-PD-1 checkpoint inhibitors. Additionally, RXC004 has potential as a biomarkerguided, targeted therapy in genetically defined cancers, such as colorectal, pancreatic, biliary, and gastric cancers.

RXC004 – Phase I trial update Clinical data from the first patient confirmed significant Wnt pathway inhibition and indicated that RXC004 exposure was higher than predicted from preclinical studies. Following a positive scientific advisory meeting with the MHRA, a protocol amendment incorporating a lower dose and additional safety monitoring will be submitted to the regulatory agency, with the aim of treating the next patient in the first half of 2019.

Member of

European Biotechnology NET WORK

In the remaining Phase I component of the clinical programme, we will establish the optimal dose of RXC004 to use going forward. As a part of this, we will look at side effects of the drug as well as the pharmacokinetics of the drug in cancer patients.

redx pharma

ROCK2 (Rho-associated protein kinase 2) inhibitors for the treatment of fibrosis ROCK2 is an intracellular kinase with multiple cellular functions. ROCK2 signalling plays a key role in both the inflammatory component and the tissue re-modelling that drives disease progression. ROCK2 has been shown to be up-regulated in acute inflammatory injury and in chronic diseases such as diabetes. The interaction with key molecular pathways leads to the subsequent activation of cells in the fibrotic organ. By selectively targeting ROCK2, we can avoid the hypotensive side effects typically associated with systemic pan-ROCK inhibitors. We aim to develop an orally administered selective ROCK2 inhibitor, to treat NASH/ liver fibrosis. Recent studies in animal models of lung, kidney and liver fibrosis, have shown that our lead ROCK2 compound, dosed therapeutically once fibrosis is initiated, was able to suppress collagen deposition and pathways associated with fibrosis, indicating that selective ROCK2 inhibition can have an impact on established fibrosis. The data from separate studies suggest that Redxâ&#x20AC;&#x2122;s compound possesses a suitable pharmacokinetic profile for an orally bioavailable drug and has a low propensity to inhibit key drug metabolising Cytochrome P450 enzymes, making it less likely to interact with other drugs.

RXC006 Porcupine is a key enzyme in the WNT signalling pathway. WNT signalling has been implicated in fibrogenesis, and therefore inhibition of WNT signalling is likely to prevent several mechanisms important for fibrotic disease progression. Current treatments for fibrosis are of limited benefit and there is an urgent need to develop new therapies to treat fibrotic conditions. Several recent publications have shown that Porcupine (PORCN) inhibitors can be beneficial in the treatment of fibrotic indications, including renal, heart, lung and skin conditions. Our team of scientists have demonstrated potent efficacy in mouse models of kidney, liver and lung fibrosis, and our candidate RXC006 is progressing through pre-clinical IND enabling studies. By targeting this pathway, we aim to prevent progression or reverse fibrosis in patients with these devastating diseases. 9 th european biotechnology guide 2019

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

· · · ·

Erwin-Rentschler-Str. 21 88471 Laupheim Germany Federico Pollano, Senior Vice President Business Development +49 7392 701-0 +49 7392 701-300 info@rentschler-biopharma.com www.rentschler-biopharma.com

· · · · · FIQ · 850 · 1927 · S1

Areas of Activity · l Contract development and manufacturing organisation (CDMO) for biopharmaceuticals l Focus on mammalian cell culture External · Strategic Alliance with Leucokare AG, Collaborations located in Munich, formulation development Strategic Partnership with Rentschler Fill Solutions GmbH, located in Rankweil, Austria, aseptic filling Request for · Rentschler Biopharma offers Further Collaborations bioprocess development and cGMP manufacturing solutions from gene to vial and from concept to market for pharma and biotech companies in long-term collaborations and strategic cooperation settings

A world-class biopharmaceutical CDMO Rentschler Biopharma is a leading CDMO focused exclusively on client projects. The company’s clients include innovative biotech companies and major pharmaceutical companies around the world. Rentschler Biopharma has long-standing experience and proven excellence as a solution partner of choice. A topnotch quality management system, well-established operational excellence, and advanced technologies ensure product quality at each development and manufacturing step. In January 2019 Rentschler Biopharma completed the acquisition of a U.S. production facility in Milford, MA.. Rentschler Biopharma is a family-owned company with over 850 employees. One-stop solutions from gene to vial and clinic to market Rentschler Biopharma’s end-to-end offering includes biopharmaceutical process development and manufacturing as well as related consulting activities, including project management and regulatory support. With a focus on mammalian cell lines, Rentschler Biopharma is highly experienced in the development and cGMP manufacturing of monoclonal antibodies, fusion proteins, and other therapeutic proteins in compliance with international standards (EMA/FDA). Working collaboratively with its clients, Rentschler Biopharma provides customised solutions with optimised work packages for each development stage. State-of-the-art cGMP facilities and cell culture processes allow manufacturing for both, clinical studies and commercial supply. To offer optimal solutions across the entire value chain, Rentschler Biopharma has partnered with Leukocare AG and Rentschler Fill Solutions GmbH.

rentschler biopharma

Bioprocess development ·· Proprietary cell expression platform TurboCell™ ·· Fast and efficient supply for multiple candidate screening ·· Robust and scalable CHO cell lines for cGMP manufacturing ·· Efficient cell culture and purification processes ·· Well-established analytical methods ·· Advanced formulation development using Leukocare’s SPS® technology Best-in-class formulation provides significant competitive advantages Rentschler Biopharma’s strategic alliance with Leukocare offers full-service development and manufacturing from gene to vial, fully integrating the patented SPS ® formulation technology at every step of the biopharmaceutical development and manufacturing process, resulting in products with superior formulations and administration routes. This innovative approach provides clients significant competitive advantages, enabling them to exploit the full commercial potential of their products. cGMP biomanufacturing ·· Multiple stainless steel bioreactor lines, including a twin system with 2x 3,000 L ·· Flexible single-use bioreactor lines up to 2,000 L ·· State-of-the-art purification processes ·· Liquid aseptic filling in vials as well as lyophilisates in collaboration with Rentschler Fill Solutions ·· Guaranteed product quality and purity in accordance with cGMP guidelines Best-in-class facilities for aseptic filling and lyophilisation Rentschler Biopharma, together with Rentschler Fill Solutions, provides one-stop solutions and best-inclass facilities for aseptic filling and lyophilisation. Their collaboration unites two centres of excellence for fast and efficient process development, manufacturing, and filling and enables drug product production for clinical and commercial supply.

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

· · · · · · ·

Suhrenkamp 59 22335 Hamburg Germany Dr Kai Pohlmeyer +49-40-55290-430 +49-40-55290-888 k.pohlmeyer@ richter-helm-biologics.eu Internet Website · www.richter-helm.eu Number of Employees · ~190 Founded (year) · 1987 Areas of Activity · Contract development and manufacturing of biopharmaceuticals derived from microbial systems Biological Patents · Several patents on manufacture of recombinant proteins 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 manufacturing company specialised in GMP-compliant microbial production, with a proven 30-year track record. 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 with a strong focus on the supply of material for late clinical studies and commercial demand. Count on us to provide a comprehensive range of services and customised solutions. Our seasoned, 190-strong team supports you with process development, supply of products for clinical trials, and commercial production. We operate two GMP-compliant production plants with bioreactor capacities of up to 1,500 litres, enabling GMP manufacturing for phase I to III up to commercial supply. Our large equipment fleet and extensive experience with many product types enable us to very flexibly meet your needs. As a biopharmaceutical manufacturer we are keenly aware of our responsibility towards patients. To meet the high quality requirements, Richter-Helm consistently works to the highest standards of pharmaceutical quality. This has been verified by major regulatory bodies including EMA, FDA, ANVISA, PMDA, and MFDS, as well as by numerous customer audits.


Products and services The highly motivated and experienced teams at RichterHelm have excellent expertise in development and GMP-compliant production of biopharmaceuticals. To ensure efficient and transparent work, we apply professional project management methods. Our process development team possesses extensive experience in developing and optimising fermentation and purification processes. For initial strain development, a variety of proprietary E. coli expression systems is available to support strain selection. Small scale models of existing processes provide helpful tools for trouble shooting, process characterisation, and validation. Furthermore, small scale models also ensure a smooth scale-up to large-scale GMP-compliant manufacture. The quality system at Richter-Helm meets the strictest standards of quality in biopharmaceutical production. Our in-house QC testing covers development and validation of a variety of analytical methods (incl. biological assays), performance of stability studies, and characterisation of reference standards. Richter-Helm offers a full range of biopharmaceutical manufacturing services, including: ·· Establishment of cell banks (MCB/WCB) ·· GMP manufacturing for phase I to III ·· Commercial GMP manufacturing Thanks to the broad knowledge of Richter-Helm’s experts and many years of experience gained from different kinds of projects, Richter-Helm works out tailor-made solutions for its worldwide customers, which include large pharmaceutical companies as well as advanced biotech companies. We treat each of our customers’ projects individually and with the highest flexibility – guaranteeing a successful partnership.

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Doing now what patients need next Name · Roche Diagnostics GmbH Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · ·

Nonnenwald 2 82377 Penzberg Germany Dr Johannes Ritter +49-8856-60-2600 +49-8856-60-3417 penzberg.allgemein@roche.com www.roche.de 6,200 1896 (Group) S1–3

Areas of Activity · Biotechnology based research, development, production of diagnostics and raw materials (including Custom Biotechs), active pharmaceutical ingredients Annual Turnover · CHF 56.8 bn (Group) Relevant R&D Budget · CHF 11.0 bn (Group) External Collaborations · > 200 Request for · www.roche.com/partnering.htm Further Collaborations

Company profile Penzberg is the Bavarian location of Roche Diagnostics GmbH. Situated south of Munich on 434,000m2, and with a workforce of around 6,200 employees, it is one of Europe’s largest biotech centres for research, development and the production of active pharmaceutical ingredients and diagnostics. With more than 45 years of experience, this site is a pioneer in the industrial scale of the biotechnology discipline. At the same time, Roche at Penzberg is the largest employer with significant economic impact in the region. Roche continues to expand the biotechnology competence in Penzberg. This is how the site has been strongly expanded over the past four years. Investments focused on production capacities for active pharmaceutical ingredients, diagnostics and overall infrastructure. This well exceeds a total of €3.5bn that Roche has invested in the Greater Munich biotechnology.

Personalised Healthcare The Penzberg Biotech Center is the only Roche location in the world that performs research, development and production for both Roche Divisions: Diagnostics and Pharma. This results in extensive synergetic crossnetworking between the two divisions and thus Roche is uniquely positioned to drive Personalised Healthcare (PHC) forwards. PHC is about providing the right treatment for the right group of patients. Roche’s strengths in pharmaceuticals and diagnostics along with advances in science and technology have made fitting treatments for patients possible. Previously, only five out of ten patients, on average, benefited from their treatment. Today, up to 80% of patients respond to their targeted therapies. Targeted treatments are based on the molecular causes of disease. That means treatments are based on the presence of biomarkers and through companion diagnostic tests indicating mutations or genetic expressions in the patients’ tissue. For example, in the past, nonsmall cell lung cancer (NSCLC) was just diagnosed as NSCLC. Today, over a dozen gene mutations are known to play a role in this type of cancer. The detection of biomarkers via diagnostic tests allows for a more targeted treatment that patients can benefit from.

Roche Diagnostics

Diagnostics For the Roche Professional Diagnostics business unit, Penzberg performs research, development and production of systems reagents and control sera for automated analysers in a professional lab environment or hospital related use. Growth drivers are immunological tests, the development of new biomarker tests and enzymatic clinical chemistry tests. Examples are thyroid parameters, lipid analysis, glucose metabolism, osteoporosis markers, cardiovascular diseases, womenâ&#x20AC;&#x2122;s health and fertility, infectious diseases and tumour markers. All components of the immunological tests and control sera are manufactured on site. Operations in Penzberg therefore produce over 800 different raw materials for all Diagnostics business units. It is safe to say that nearly all Roche Diagnostics tests contain components from Roche Penzberg. Furthermore, Roche is a renowned partner for custom biotech solutions in various fields.

Pharma The Greater Munich site also stands for units of Pharma Research and Early Development. The Roche Innovation Center Munich focuses on therapeutic proteins, including next generation monoclonal antibodies. The portfolio comprises Rocheâ&#x20AC;&#x2122;s five major focus areas: oncology, immunology, infectious diseases, ophthalmology and neuroscience. Biological and preclinical research for immuno oncology, biomarkers, the identification of tissue markers and histopathology are also located here, as is the management of clinical studies up to phase II. The department Technical Development establishes and optimises processes for the manufacture of active pharmaceutical ingredients and supplies proteins for the early phases of clinical development. As an important link between pharmaceuticals research and production, this unit recently underwent massive expansion. And finally, Roche at Penzberg in the Greater Munich area is a large scale biotechnological production facility of active pharmaceutical ingredients (API), including monoclonal antibodies. Therapeutic APIs made in Penzberg target disease areas like cancer, anemia and hepatitis. 9 th European biotechnology guide 2019

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Name · Rotoinox d.o.o. Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · · ·

Prvomajska ulica 39 5000 Nova Gorica Slovenia Mr Blaz Pavsic +386-5-330-63-55 +386-5-330-63-56 blaz.pavsic@rotoinox.com www.rotoinox.com

Engineering and manufacturing company Rotoinox is specialised in producing and designing innovative solutions and high-quality products for the pharmaceutical, chemical, and biotechnology industries. With a proven track record of 40 years, Rotoinox works with the most renowned biotechnology, chemical, and pharmaceutical companies on everything from preclinical development to commercial projects.

I 34 1979

Areas of Activity · Engineering, manufacturing, and assembling systems and equipment for pharmaceutical, chemical, and biotechnology companies. Core products: l Bioreactors l Fermentors l Process vessels l Process systems l CIP/SIP units External · Collaborations with pharmaceutical, Collaborations chemical, and biotechnological companies, process engineering companies, and universities. Request for · Our business development team is Further Collaborations happy to discuss your project and find tailor-made solutions for your challenges. Please do not hesitate to contact us at info@rotoinox.com.

Services and solutions Whether you need consulting, are planning to put in place a pilot plant or process system, or are looking for a custom-made service, Rotoinox will find the best solution for your needs and will provide you high-quality and reliable solutions that will meet your deadlines and exceed your expectations. Rotoinox covers a full range of services: ·· Consulting (best technical solutions, audits, quality control) ·· Design (concept, basic, detail) ·· Process Engineering ·· Customised Process Systems ·· Realisation and Construction ·· Qualification and Validation

Core products ·· ·· ·· ·· ··

Bioreactors Fermentors Process vessels Process systems CIP/SIP units


Quality statement Rotoinox has been ISO 9001 certified since 2005, demonstrating its commitment to consistently providing high-quality products and innovative services that meet the needs and expectations of its clients. All facilities, equipment, and critical materials are under control and cGMP and ASME BPE-compliant. Other key quality certificates include the Quality Welding Management System certified according to EN 3834-2 and manufacturing pressure equipment according to the Pressure Equipment Directive 2014/68/EU and AD 2000.

References Over the last four decades the company has designed, manufactured, and commissioned innovative solutions for the largest pharmaceutical companies worldwide and has set standards in the industry on every level.

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Name · RTC S.p.A. Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Address Internet Website Number of Employees Founded (year)

· · · · · · · · ·

Via Tito Speri 12/14 00071 Pomezia (Rome) Italy Danilo Bucci +39-06-91095-696 dbucci@rtc.it www.rtc.it 150 1972

Areas of Activity · Toxicology and safety assessment of: l Pharmaceuticals (Small molecules, biologicals) l Medical devices l Veterinary drugs l Biosimilars l Food products (Novel food, food additives and food ingredients) l Chemicals l Agrochemicals l Bioscides

Research Toxicology Centre RTC is a Contract Research Organisation specialised in non-clinical safety studies for product registration according to current international regulatory requirements. RTC is a leading CRO in Europe with more than 40 years of worldwide experience, providing high quality in non-clinical research management to national and international pharmaceutical companies and other health-related organisations. RTC offers a full range of experimental and consultancy services, performed by skilled professionals, for the development and safety assessment of: ·· Pharmaceuticals ·   Small molecules ·   Biologicals ·· Medical devices ·· Biosimilars ·· Food products ·· Chemicals ·· Agrochemicals ·· Biocides For each class of products, studies are performed according to international guidelines and regulations. RTC high-standard quality is guaranteed through the approval of European, American, and Japanese authorities. Scientific and technological expertise, combined with skills in project management and communication, together with the ability to provide clients with competitive, fast, and reliable service, qualify RTC as the partner of choice for product development.


Why RTC? Competence The quality of the services offered by RTC is assured by personnel highly specialised in their respective disciplines and with excellent communication skills. Our facilities and equipment are regularly updated in response to scientific, technical, and regulatory demands. We constantly improve our methods and techniques to meet current standards, thus providing the best up-to-date solutions for our clients. Our organisation is committed to ensuring efficient communication and timely, reliable, and high-quality services.

Experience People are our most important resource and we have succeeded in recruiting professionals of the highest competence. Our senior staff represents many years of industrial and/or contract research experience and therefore fully understands the specific requirements of our clients. The international scientific background and the diverse cultural and linguistic origins of the key personnel contribute to adding value to our services.

Reliability Serving our clients is our utmost priority. That is why RTC is deeply committed to meeting your needs and attending to every detail of your project. We will guide you during the selection of the experimental design and provide tailored solutions. RTC will ensure close monitoring of each study phase to respect quality and timing. Furthermore, our staff will constantly keep you informed of progress, every step of the way, since communication and collaboration are essential to achieving success.

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Name · Socorex Isba SA Address/P.O. Box Postal Code/City Country Contact Person

· · · ·

Chemin de Champ-Colomb 7a 1024 Ecublens Switzerland Yves Lachavanne (Marketing & Sales Support Manager) Telephone · +41-21-651-6000 Email Address · socorex@socorex.com Internet Website · www.socorex.com Social Media · FL I  Number of Employees · 55 Founded (year) · 1963 Areas of Activity · Liquid handling instruments

Your partner in precision volumetry Socorex Isba SA is a Swiss manufacturer of highly reliable laboratory instruments used for measuring, dosing, transferring, dispensing, and injecting liquids in a large number of applications. Manual and electronic micropipettes, single and multichannel pipettors, repeater pipettes, dispensers, pipette controllers, and re-usable syringes, together with pipette tips, consumables, and accessories, constitute the heart of the programme. The company is committed to manufacturing the most reliable products and to offering the best services. “A to Z” Quality Management includes quality checks and individual instrument performance control in the metrology laboratory, attested by an individual ISO 8655 certificate. Warranty coverage is three years on all manual pipettors and two years on electronic pipettes, dispensers, and repeaters. The efficient service centre offers a global maintenance programme in its Ecublens-accredited laboratories. The selection ranges from basic checks to ISO 17025 accredited calibrations of all micropipettes and dispensers – whatever their brand. Selected amongs the best laboratory equipment suppliers, an international network of distributors carries a stock of products and provides technical support, repairs, and calibration services.

Key products for biotech labs Acura® manual micropipettes – exceptional ergonomics The adequate shape of the finger rest maintains the micropipette in position without hand stress. The adjustment button allows easy volume setting, even when using a glove. Located at the front of the instrument, the display window is visible at all times during pipetting. The soft springs and tightness ring with PTFE sleeve reduce friction and make plunger activation smoother than ever. Ergonomically positioned, the large-surface, soft-padded ejector button allows low-pressure activa-

Socorex Isba

tion. In addition, JustipTM shaft height adjustment system allows a wide selection of tips to tightly fit the nozzle. Qualitix® – pipette tip programme Made from virgin polypropylene and free from DNAse, RNAse, pyrogens/endotoxins, and ATP, the tips provide for a very high purity degree. In addition, sterile tips are certified free of human DNA. Intended for accurate liquid delivery, the new Qualitix® ideally combines with Socorex® and all major micropipette brands. The tipfill rack filling system enables easy rack loading. Each insert is instantly transferred into an empty rack without risk of contamination. Its simplicity of use makes tipfill a convincing choice. The handling of viscous liquids is facilitated when using low-protein binding tips. Certified protease free, they are well adapted in the proteomic field. Sterile tip users now have the choice between models with and without a protection filter. Bottle-top dispensers – excellent chemical resistance Intended for safe and reproducible liquid distribution, the CalibrexTM dispenser line includes 7 different sizes: 0.1–1 / 0.25–2.5 / 0.5–5 / 1–10 / 2.5–25 / 5–50 / 10–100 mL. ·· CalibrexTM organo 525 suited for organics and noncrystallising solutions. ·· CalibrexTM solutae 530 for trouble-free distribution of salt solutions, weak and strong acids, and bases. Volume setting with a spring-loaded sliding cursor, softly moving up and down along the dual scale. Thanks to the optional flow control stopcock for priming dispenser, reagent is recycled without loss or contamination. Valves, plunger, barrel, and delivery jet are removable in seconds for cleaning. The printed QR code allows instant access to the chemical resistance chart. Fully autoclavable at 121°C. Access to calibration mechanism is protected by a safety seal sticker. The integrated key is located under the plunger cap.

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Name · Swiss Biotech Association Address/P.O. Box Postal Code/City Country Telephone Email Address Internet Website Number of Employees Founded (year)

· · · · · · · ·

Stauffacherstrasse 16 8004 Zurich Switzerland +41-44-455-56-78 info@swissbiotech.org www.swissbiotech.org 2.5 (FTE) 1998

Areas of Activity · National cluster development powered by Swiss Biotech Association External · National and international Collaborations stakeholders of the Swiss Biotech industry

The central resource for the Swiss biotech industry The Swiss Biotech Association represents the interests of the Swiss biotech industry. To support its members in a competitive market, the Swiss Biotech Association works to secure favourable framework conditions and facilitate access to talent, novel technologies, and financial resources. To strengthen and promote the Swiss biotech industry, the Swiss Biotech Association collaborates with numerous partners and life science clusters globally under the brand Swiss Biotech™. The association’s core objective is to ensure that the value generated by the Swiss biotech industry continues to grow and that the industry contributes to the well-being of the socio-economic ecosystem, thereby enabling Switzerland to be a key player at the forefront of bioscience innovation. To this end, the Swiss Biotech Association is dedicated to supporting Swiss biotech companies by: Developing favourable and competitive framework conditions ·· Creating awareness of the biotech industry’s needs and interests with policy makers ·· Advocating a competitive tax system alongside lean and pragmatic regulations ·· Fostering life science education, technology transfer, and intellectual property Attracting talent, know-how, and financial resources to drive innovation and growth ·· Promoting and facilitating access to funding opportunities ·· Connecting investors and attractive biotech investment opportunities ·· Facilitating access to national and international talent

swiss biotech

Fostering networking through strategic, national, and international partnerships ·· Connecting industry stakeholders and life science clusters ·· Organising and co-promoting national and international life science events ·· Providing access to privileged information through industry platforms and working groups Promoting the accomplishments of the Swiss biotech industry ·· Disseminating the value-creation of Swiss biotech companies ·· Visualising the diversity and competitiveness of Swiss biotech companies ·· Presenting innovative products and technologies and their contribution to quality of life

United forces lead to the summit – We offer many paths to success Join the Swiss Biotech Association swissbiotech.org

Join the Swiss Biotech Association As a Swiss Biotech Association member you profit from our engagement with national and international stakeholders, receive privileged information, share knowledge, improve your network, and optimise business efficiency. You also gain more visibility and receive discounts at events, as well as favourable rates with business solution providers and for promoting your company. Become a member of the biotech community and apply now for a membership at www.swissbiotech.org.

1 Nation 1 Biotech Cluster

7x232-Bergsteigerkette-European Biotech Guide-2019-V2.indd 1

21.02.19 15:51

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About us

Name · Talk Biotech Ltd Address/P.O. Box Postal Code/City Country Contact Telephone Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · ·

Birkdale House CW2 6NY Cheshire United Kingdom Customer Care +44-1270-749196 customercare@talk-bio.com www.talk-bio.com


With a combined experience of over 30 years in the Life Sciences industry we thrive on putting you first with our ethos of customer care, collaboration, and support, listening to fully understand your needs. We provide the most appropriate human biospecimens & biomarker research services to help support your in-house teams and advance your human health research strategies.

Opti-OX technology

2 2017

Areas of Activity · l Biomarker Assay Services l Image Analysis l Opti-OX l iPSCs l Hypoxia Workstations l Human Biospecimens

We have an amazing new technology set to disrupt the drug discovery, cell therapy, and biomanufacturing markets. Application areas range from neurology to immuno-oncology, including CAR-T & allogenic cell therapies. Our technology directly reprogrammes iPSCs using a dual safe harbour strategy, allowing for unprecedented efficiencies and overcoming the common limitations of traditional iPSCs, including lack of consistency, purity, and scalability.

Opti-OX glutamatergic cortical neurons Available off the shelf and arriving within 48hrs of placing your order – once doxycycline is added, cells differentiate into pure, mature and functional cortical neurons. Suitable as models for research in cell-type specific biology, target validation and drug screening in pharmaceutical R&D, and toxicology. Applications include functional and general neurotoxicity assays and validated techniques include HTS, RT-qPCR, branchedchain ISH, ICC, Patch Clamp & MEA.

Opti-OX custom development service We generate mature and highly pure human cell types, ideal for biomedical research, drug discovery, and cell therapy. We can also generate custom disease models, ideal for picking up subtle phenotypes and large-scale screens.

Member of

European Biotechnology NET WORK

talk biotech

Personal hypoxia cell culture workstation Regulating the oxygen environment using the partial pressure of oxygen (mmHg or kPa), our pioneering, scientifically rigorous approach eliminates errors due to atmospheric pressure variations or geographical altitude & sets the benchmark for the most accurate hypoxia workstation available. A fully humidified, temperature and CO2-controlled hypoxia environment is achieved in less than 15 minutes from switch-on.

Biomarker imaging assay services From autoimmune diseases to the Zika virus, we provide assay development and optimisation, including partial validation of nucleic acid and protein biomarker assays for almost any human tissue sample type.

Digital pathology & image analysis services We provide image acquisition and analysis, from basic H&E annotations and measurements to bespoke identification, localisation, quantification, and spatial analysis algorithms for complex multimodality & multiplexed biomarker studies including immuno-oncology, neurology, and infectious disease panels.

We love to talk bio all day, but when weâ&#x20AC;&#x2122;re talking about your important projects, we keep the talk focused and with your end goal always in mind. We know you need results, we know you need them quickly, and weâ&#x20AC;&#x2122;re here to help!

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

· · · · · · · · · · · ·

Im Neuenheimer Feld 582 69120 Heidelberg Germany Dr André H.R. Domin +49-6221-50257-00 +49-6221-50257-11 technologiepark@heidelberg.de www.technologiepark-heidelberg.de

LI 9 1984 S1 standard, GLP, and GMP labs

Areas of Activity · l Biotechnology l Pharmaceuticals l Digital health l Medical technology l Bioinformatics l Organic electronics l Environmental technologies l IT External · l Association of University Research Parks (AURP) l BIO Deutschland e.V. l Biotechnology Innovation Organisation (BIO) l BioRN Network e.V. l Bundesverband Deutscher Innovations-, Technologie- und Gründerzentren e.V. (BVIZ) l Heidelberg Startup Partners e.V. l International Association of Science Parks and Areas of Innovation (IASP) Request for · l Biotechnology Further Collaborations l Pharmaceuticals l Digital health l Medical technology l Bioinformatics l Organic electronics l Environmental technologies l IT Collaborations

World-renowned life science site Heidelberg Technology Park is one of Germany’s premier sites for innovative high-tech companies. Heidelberg Technology Park offers flexible infrastructure for biotechnology, pharmaceuticals, digital health, medical technology, bioinformatics, organic electronics, environmental technologies, and IT. Researchers, developers, and producers alike find fitting working conditions, an outstanding network, and hands-on support for their activities.

Strong partners at your side Since 1984, Heidelberg Technology Park has been offering lab space, clean rooms, and offices to science and technology-driven companies. Today, more than 90 companies and over 2,800 employees share 80,000 sqm across five locations. Tenants leverage the close proximity to Heidelberg University, German Cancer Research Center (DKFZ), European Molecular Biology Lab (EMBL), and twelve university hospitals with more than one million patients per year.

Startup support office Heidelberg Technology Park operates an inter-institutional and inter-disciplinary startup support office. A dedicated team supports entrepreneurs in raising public funding, finding partners and investors, and starting a sustainable business. Various events like startup weekends, hackathons, fireside chats, talks, and seminars enable easy access to a thriving regional startup scene. The startup support office is also headquarters to the Heidelberg Startup Partners network, a joint initiative including Heidelberg’s leading research and educational institutes.

Accelerator programmes Two accelerator programmes at Heidelberg Technology Park offer a fast lane for life science and IT startups: the Life Science Accelerator Baden-Wuerttemberg is an exclusive twelve-month programme consisting of a series of seminars, workshop and mentoring by seasoned entrepreneurs and market experts. The Up2B Accelerator for IT startups with a business-to-business focus

technologiepark heidelberg

includes various programmes for business modelling, product development, and fundraising. Both accelerator programmes are non-diluting and free of charge.

International network Heidelberg Technology Park has been the root of BioRN, the regional life science research and industry cluster. Additional memberships include the Association of University Research Parks (AURP), BIO Deutschland e.V., Biotechnology Innovation Organisation (BIO), Bundesverband Deutscher Innovations-, Technologie- und Gründerzentren e.V. (BVIZ), and the International Association of Science Parks and Areas of Innovation (IASP). Active participation ensures optimal representation of our tenants and members.

Space to grow A newly built Business Development Centre will offer 7,000 sqm of wet lab, cleanroom, and office space from mid-2019. The new building will be part of the upcoming Heidelberg Innovation Park (HIP), Heidelberg’s latest area of innovation. The Business Development Centre will include a dedicated conference centre as well as co-working and acceleration areas.

Park – in brief ·· More than 80,000 sqm wet lab, cleanroom, and office space for startups and growing companies ·· Startup support office and Heidelberg Startup Partners network ·· Accelerator programmes for Life Science and IT / B2B startups ·· Business development support ·· Entrée to an international network ·· Central location ·· Flexible infrastructure ·· Kindergarten ·· Conference Center ·· Bistro/Canteen ·· Car and eBike Sharing station ·· International PartnerPort 9 th european biotechnology guide 2019

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Name · Tissue Solutions Ltd Address/P.O. Box · 1.2, Fleming Pavilion, Todd Campus, West of Scotland Science Park Postal Code/City · Glasgow G20 0XA Country · United Kingdom Contact Person · Dr Morag McFarlane Telephone · +44-141-299-0055 Fax · +44-141-299-0054 Email Address · enquiries@tissue-solutions.com Internet Website · www.tissue-solutions.com Social Media · F I Number of Employees · 20 Founded (year) · 2007 Type of Laboratory · Virtual Biobank Areas of Activity · Global virtual biobank and tissue provision services, sourcing ethically acquired, fully consented human tissue and biomaterials for pre-clinical and clinical research l Biomarkers, immuno-oncology, primary dissociated cancer cells l Frozen and FFPE tissues, blood, plasma, serum, bone marrow, urine, saliva, sputum, synovial fluid, CSF & Ascites l Primary cells, PBMCs and Cord Blood Mononuclear Cells, and highly purified monocytes, T-cells, and B-cell subsets with basic or enhanced characterisation l iPS cells & dissociated tumour cells Request for · The Tissue Solutions team will be Further Collaborations pleased to learn more about your research and help to source human biomaterial for your projects.

Member of

European Biotechnology NET WORK

Tissue Solutions is a well-established global virtual biobank sourcing ethically acquired, fully consented human tissue and biomaterials. We provide a customised tissue provision service, offering a single access point for a wide range of high-quality diseased and normal human biomaterials for pre-clinical and clinical research. Incorporated in 2007, Tissue Solutions was born when our founder, Dr Morag McFarlane, spotted a niche in the market after experiencing first-hand the difficulty of finding reliable sources of human biomaterials. We support scientific discoveries to develop new drugs, biomarkers, and companion diagnostics. In addition to early stage drug discovery, target identification, and validation, samples are also used in clinical trials for pharmacogenomic studies for new drug candidates. Other commercial users within the biomedical sector include medical devices, immuno-oncology, biotech, and CROs focused on bringing products to market.

Guaranteed compliance In order to work with confidence in a highly regulated area, we work only with sources that comply with stringent international ethical guidelines. Tissue Solutions is ISO 9001:2015 certified, and guarantees the quality and the compliance of all samples. Excellent customer service is at the core of our company values.

Global supply chain Tissue Solutions operates an international business, delivering to clients worldwide. Working in this way we can supply a greater variety of tissues than a single biobank, meeting stringent requirements and tight deadlines more efficiently. This approach means that the products supplied are not restricted to a specific disease or tissue type.

tissue solutions

Products & services Banked samples Frozen and FFPE tissues, blood, plasma, serum, bone marrow, urine, saliva, sputum, synovial fluid, CSF & Ascites from a wide range of disease areas. Primary cells, primary dissociated cancer cells, PBMCs and Cord Blood Mononuclear Cells, and highly purified monocytes, T-cells and B-cell subsets with basic or enhanced characterisation. iPS cells & dissociated tumour cells. Research tissue bank We have our own Research Tissue Bank Licence to collect and supply a range of samples from living donors including skin biopsies and fresh blood samples delivered within a few hours of collection. This status also allows researchers in the UK to work under our ethics if they do not have their own in place. Custom prospective collections Our Tissue Procurement Team is extremely experienced with a proven track record in the provision of â&#x20AC;&#x153;tough-tocollectâ&#x20AC;?-samples. We handle all aspects of the collection, including set-up at the clinical site, project management of the collection, storage, and delivery. Transport logistics We coordinate all logistics and paperwork, including expediting materials through customs. We can implement programmes anywhere in the world and guarantee sample integrity. Expansion of services Since our inception, we have grown year after year, gaining an international reputation as an ethical quality provider of human biospecimens. We recently acquired HistologiX Ltd, a leading GLP/GCP-compliant IHC and Histology lab. We can offer clients a single point of access to comprehensive integrated range of tissue procurement and tissue-related CRO services. Our continued expansion in 2019 will be to establish European subsidiary as part of our future growth plans.

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

· · · · · · · · · ·

Im Leuschnerpark 4 64347 Griesheim Germany Regina Roemling +49-6155-7043700 +49-6155-8357900 Info.tbg@tosoh.com www.tosohbioscience.de >20 1989

Areas of Activity · Supplier of chromatography media, HPLC and UHPLC columns Application support in analysis and purification of biomolecules.

Tosoh Bioscience is an acknowledged global leader in the field of liquid chromatography with a focus on bioseparations. For more than 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 and L for the capturing of antibodies – salt tolerant ion exchange media, and TSKgel size exclusion columns for highly efficient UHPLC analysis of antibody aggregation. In 2019, Tosoh introduced TSKgel FcR-IIIA-NPR, the first affinity HPLC column for assessment of ADCC activity and glycoform pattern of therapeutic antibodies. 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/DSP Bioseparation Conference (www.hic-dsp.org).

Tosoh Bioscience

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

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

· · · · · · · · · · · ·

Mühltal 5 82392 Habach Germany Dr Jens Hain +49-8847-695-78-45 +49-8847-695-78-29 jens.hain@triga-s.de www.triga-s.de

I 80 1989 S2 laboratory

Areas of Activity · Conducting clinical and analytical studies for manufacturers of diagnostics and medical devices according to IVDR and MDR, sample storage and clinical study logistics

TRIGA-S is a privately-owned clinical research organization and a well-established partner for the in-vitro diagnostic (IVD) and medical device (MD) industry since almost 20 years. We offer tailor-made solutions for clinical studies and laboratory service including analytical and clinical performance studies in our own S2-laboratory as well as sample testing/management, storage and study logistics. Our GCP/GCLP trained teams work according to IVDR, MDR and national regulations.

Scientific excellence TRIGA-S stands for scientific excellence in all aspects of clinical and technical studies. Our international team of experienced and dedicated researchers has decades of experience in the field of clinical contract research. With our client return rates of nearly 100 % we have shown in the past two decades that we are a renowned expert in the field of clinical studies.

Full service provider TRIGA-S works as a full-service provider. We not only offer the classical study monitoring and study management but go far beyond with our clients. We are an experienced partner in the field of sample management and sample storage. In our own laboratory we handle all necessary tasks ourselves to bring your product as quickly and successfully as possible to the market. In addition, we have the regulatory and bio-statistical experience and are part of all relevant networks to guarantee that your endeavor will be successful.

Clinical trial management and monitoring services ·· Project management for national and international clinical and technical trials ·· Planning study design and conduction, medical writing ·· Development of study protocol, CRFs and training materials ·· Submission to IRB/EC and regulatory authorities ·· Site assessment, selection and monitoring

udy nt St geme a an

·· Preparation and maintenance of the trial master file (TMF) ·· Supply of study material ·· (S)AE / (S)ADE Documentation and notification to the sponsor ·· Preparation of audits and inspections ·· Participation in publication writing

S Mon tud ito y rin




Laboratory services

Contract Laboratory

Sample Management

g is






Sa m

B pl e

·· 290 m² S2 laboratory for performing clinical studies and providing laboratory support ·· Planning of sample collections and providing sample collection kits ·· Sample preparation and processing ·· Application testing and analytical test validation ·· Tailor-made laboratory information system ·· Investigational site for exploratory/pilot/performance evaluation and post-launch studies (e.g. clinical chemistry, immunochemistry, serology)

Clinical trial logistic services for IVD and MD ·· Temperature-controlled storage of clinical specimen and study materials in 330 m2 temperature-controlled human sample and reagent storage at RT, 4°C, -20°C, -80°C. Real time web-based temperature monitoring of sample/reagent temperature. ·· Organization of study logistics and sample collection worldwide, transfer of shipping documentation and customs clearance

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

Address/P.O. Box Postal Code/City Country Telephone

· · · · · ·

· · · ·

Swiss Office Geimoosstr. 12 8712 Stäfa/Zurich Switzerland Susanne Simon, PhD +41-43-818-0334 simon@trockleunternehmensberatung.com Headquarters Am Buschhäuschen 9 42115 Wuppertal Germany +49-202-31-10-00

Further offices · Düsseldorf, Hannover Website Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · ·

trockle-unternehmensberatung.com 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 · UBM – part of Informa plc Address/P.O. Box Postal Code/City Country Contact Telephone Email Website Social Media Number of Employees Founded (year)

· · · · · · · · · ·

De Entreé 73, Alpha Tower 1101 BH Amsterdam The Netherlands Customer Service +31-20-708-1637 cphicustomerservice@ubm.com www.cphi.com/europe

FL I  200–500 1990

Areas of Activity · Pharmaceutical events

CPhI drives growth and innovation at every step of the global pharmaceutical supply chain, from drug discovery to finished dosage. Through exhibitions, conferences, and online communities, CPhI brings together more than 100,000 pharmaceutical professionals each year to network, identify business opportunities, and expand the global market. CPhI hosts events in Europe, Korea, China, India, Japan, South East Asia, North America, the Middle East and Africa, co-locating with ICSE for contract services; P-MEC for machinery, equipment & technology; InnoPack for pharmaceutical packaging; BioProcessing for biopharma; and Finished Dosage Formulation for every aspect of the finished dosage supply chain. CPhI provides an online buyer and supplier directory at CPhI-Online.com. For more information visit www.cphi.com/europe

About UBM, part of Informa PLC CPhI Worldwide is organised by UBM, which in June 2018 combined with Informa PLC to become a leading B2B information services group and the largest B2B events organiser in the world. To learn more and for the latest news and information, visit www.ubm.com and www.informa.com The UBM annual schedule of pharmaceutical events include: CPhI North America (30 April–2 May, 2019 at McCormick Place – Chicago, USA); CPhI and P-MEC China (18–20 June, 2019 at SNIEC – Shanghai, China). CPhI Korea (21–23 August 2019, COEX – Seoul, Korea); CPhI Middle East & Africa (16–18 September, 2019 at the ADNEC – Abu Dhabi, United Arab Emirates); CPhI Worldwide, ICSE, P-MEC, FDF, InnoPack, BioProduction (5–7 November, 2019 at the Messe in Frankfurt); CPhI & P-MEC India (26–28 November 2019 at the India Expo Mart, Greater Noida, Delhi NCR – Delhi, India); Pharmapack Europe (5–6 February, 2020 at the Paris Expo, Porte de Versailles – Paris, France); CPhI South East Asia (4–6 March, 2020, at BITEC – Bangkok, Thailand); and CPhI Japan, ICSE, PMEC, bioLIVE and InnoPack (16–18 March, 2020, at the Big Sight Exhibition Centre – Tokyo, Japan).


CPhI Worldwide is the biggest event in pharma and represents all aspects of the pharmaceutical ingredients market with exhibitors covering ingredients, APIs, excipients, finished dosage, and more. Other UBM brands include: ICSE connects the pharmaceutical community with outsourcing solution providers, offering a forum for business development, networking, and education. InnoPack brings together buyers and specifiers from the packaging and pharmaceutical industries, creating business opportunities through a dedicated worldwide forum. BioProduction attracts biopharma decision makers and global mammalian and microbial scientists actively seeking manufacturing technologies and services to accelerate their biologics and novel molecules towards commercial success. P-MEC delivers innovative pharmaceutical machinery, equipment, and technology to a worldwide forum of decision makers through face-to-face networking and education. Finished Dosage Formulation (FDF) is the first event to bring every aspect of the finished dosage supply chain together in one location. Pharmapack is Europeâ&#x20AC;&#x2122;s dedicated pharma packaging and drug delivery event: two days of innovation, networking, and education.

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Name · University of Birmingham’s OMICS Research Services & Training Centres

/, . #$("( Address/P.O. , - ,# Box · Edgbaston Postal Code/City · B15 2TT Birmingham Country · United Kingdom Contact Persons · Joint Centre for Environmental Omics (JCEO): Professor John Colbourne J.K.Colbourne@bham.ac.uk MRC-funded Phenome Centre Birmingham: Dr Scott Harrison HarrisoS@adf.bham.ac.uk NERC Biomolecular Analysis Facility – Birmingham: Dr Ulf Sommer U.Sommer@bham.ac.uk Birmingham Metabolomics Training Centre: Dr Cate Winder C.L.Winder@bham.ac.uk Telephone Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · ·

+44-121-414-3344 www.birmingham.ac.uk


23 2009 OMICS research (genomics, transcriptomics, metabolomics) Areas of Activity · Research Service & Training External · Key partners include:  GI-Shenzhen Collaborations | B |C  hina National Genebank |B  eckman Coulter | T hermo Scientific | T he international Consortium for Environmental Omics and Toxicology

Member of

European Biotechnology NET WORK

An overview of the University of Birmingham The University of Birmingham has been challenging and developing great minds for more than a century. Characterised by a tradition of innovation, research at the University has broken new ground, pushed forward the boundaries of knowledge and made an impact on people’s lives. We continue this tradition today and have ambitions for a future that will embed our work and recognition of the Birmingham name on the international stage. Universities are never complete. They develop as new challenges and opportunities occur. At Birmingham we innovate, we push the frontiers of understanding; we ask new research questions, we turn theory through experiment into practice – because that’s what great universities do. The Joint Centre for Environmental Omics (JCEO) is a partnership between the University of Birmingham, the China National GeneBank, and BGI (the first citizenmanaged, non-profit research institution in China). The JCEO is staffed and equipped to conduct uniquely challenging and large-scale molecular research projects that transform biology, and improve environment and health protection. The Joint Centre specialises in environmental genomics and biodiversity research, in molecular high-throughput toxicity testing, studies of natural populations, DNA meta-barcoding, and molecular screening to discover the function of genes and their regulation in response to environmental conditions. Together with Birmingham metabolomics facilities (below) the JCEO breaks new ground in multiomics research. Its main objective is to facilitate collaborative research projects among academic, government and industry scientists. The Phenome Centre-Birmingham (PC-B) is part of a UK Stratified Medicine initiative led by the Medical Research Council (MRC) to develop analytical capacity and capability to enhance the fundamental research into the molecular basis of the changes that occur during disease and aging. The PC-B conducts metabolic phenotyping (metabolomics) studies across the breadth of the MRC

University of Birmingham

remit. It provides a collaboration project environment for performing metabolomics analyses in health studies and for academic projects is run on a cost recovery basis. The Centre is staffed by experts in experimental design, analytical chemistry, bioinformatics and statistics to provide all required aspects of the study from conception to helping with biological interpretation. NBAF-Birmingham (NBAF-B) is one of the nodes of the NERC Biomolecular Analysis Facility (http://nbaf.nerc. ac.uk/). NBAF-B was established in 2009 to serve the metabolomics research needs of the UK environmental sciences community (http://nbaf.nerc.ac.uk/applyingto-the-facility/). We are embedded in a well-equipped and vigorous research environment at the University of Birmingham that, together with continuing developments in equipment and training, ensures we maintain a ‘state-of-the-art’ position. We support metabolomic analyses using both high-resolution mass spectrometry and NMR methods and a variety of statistical approaches. We provide training courses in collaboration with the Birmingham Metabolomics Training Centre. The Birmingham Metabolomics Training Centre (BMTC) provides training to empower the next generation of metabolomics researchers, by delivering training in both analytical and computational methods. The BMTC partners with both the Phenome Centre – Birmingham and NERC Biomolecular Analysis Facility – Birmingham to provide vocational training in clinical and environmental metabolomics. A combination of face-to-face and online courses are provided. The face-to-face courses include lectures, laboratory practicals and computer workshops, with significant hands-on training utilising state-of-the-art analytical instruments and software. The online courses are available to a wide audience and offer flexibility in time and study on a social learning platform.

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Name · VAXIMM AG Address/P.O. Box · Technologiepark Basel Hochbergerstrasse 60c Postal Code/City · 4057 Basel Country · Switzerland Operations: VAXIMM GmbH Address/P.O. Box · Harrlachweg 2 Postal Code/City · 68163 Mannheim Country · Germany Contact Person Telephone Email Address Internet Website Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · ·

Dr Heinz Lubenau, COO +49-621-8359687-0 info@vaximm.com www.vaximm.com 10 2008 R&D Oncology drug development Oral T-cell immunotherapies

External · Clinical collaboration with Merck KGaA Collaborations and Pfizer Inc. to evaluate VXM01 in combination with avelumab Development and commercialization agreement with China Medical System Holdings for China and other Asian countries (excluding Japan) Works with leading academic institutions in its development activities, e.g., National Center for Tumor Diseases Heidelberg (NCT) Request for · New development partnerships and Further Collaborations collaborations with both industry and academia for the proprietary oral T-cell activation therapy platform and product candidates are welcomed

VAXIMM AG is a privately held, clinical-stage, Swiss/ German biotech company developing oral T-cell immunotherapies for patients suffering from cancer. VAXIMM AG is headquartered in Basel, Switzerland. Its wholly owned subsidiary, VAXIMM GmbH, located in Mannheim, Germany, is responsible for the Company’s development activities.

Technology VAXIMM’s technology is based on first-in-class oral T-cell activators that can be readily adapted to target a wide range of cancer-related antigens. The platform is based on the live attenuated bacterial vaccine strain Ty21, which has been administered to millions of people as a prophylactic vaccine to temporarily protect them from typhoid fever. This strain has been proven to be very safe and well tolerated. All immunotherapies resulting from this platform are taken orally by the patient. After oral ingestion, the modified Ty21a bacteria, which contain the cDNA of the desired cancer target(s), pass the stomach and invade the patient’s Peyer’s patches located in the small intestine. Uptake of the bacteria in macrophages, the eating cells present in these lymphoid tissues, leads to strong expression of and subsequently to a specific cellular immune response towards the encoded cancer antigen(s). These so-called “killer” T-cells then destroy the respective antigen-expressing tumor or tumor stroma cells. The oral bacterial technology enables delivery to the most immunocompetent organ of the body, targeting the lymphatic tissue of the gut, and has been shown to generate robust T-cell responses against many different antigens in animals and humans in first clinical studies. The low therapeutic doses required for specific T-cell activation make this approach suitable for continuous dosing (prime and boost administrations), without raising anti-carrier immunity, and provide another safety margin for carrier-related toxicity.


The platform is suitable for addressing multiple targets with one treatment and can be combined with additional immune therapies. Other major advantages of this approach include the high modularity (plug and play), the low cost and robustness of the production process, and the rapid development timelines to take products from concept to clinic.

Product pipeline

Mode of Action Intra-lymphatic Delivery via Oral Administration

The Companyâ&#x20AC;&#x2122;s lead product candidate, VXM01, is an investigational oral T-cell immunotherapy targeting VEGFR2 that is designed to activate T-cells to attack the tumour vasculature, and, in several tumour types, attack cancer cells directly. A Phase I/II trial in advanced pancreatic cancer showed that VXM01 was well tolerated and led to the activation of VEGFR2-specific cytotoxic T-cells, which was associated with significantly improved patient survival. An additional clinical Phase IIa trial in metastatic colorectal cancer has been completed. Single-agent activity was shown in an ongoing trial in recurrent glioblastoma where two objective clinical responses and long-term survival compared to historical controls have been observed. Based on these data, VXM01 has received orphan designation from the European Commission and from the US Food and Drug Administration (FDA) for the treatment of glioma, a difficult-to-treat form of brain cancer. Additionally, VAXIMM has a collaboration agreement with Merck KGaA, Darmstadt, Germany, and Pfizer Inc. to evaluate avelumab, a human anti-PD-L1 antibody, in combination with VXM01. Under the terms of the agreement, VAXIMM has started an open-label Phase I/II trial in progressive glioblastoma patients. Preclinical data support that adding VXM01 to treatment with a checkpoint inhibitor may increase survival. VAXIMMâ&#x20AC;&#x2DC;s platform technology is ideally suited to develop a personal neoantigen approach. VXM NEO has already demonstrated immune proof of concept in animals and is planned to enter clinical trials in combination with checkpoint inhibitors.

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

· · · · · · · · · ·

Carrer de la Diputació, 303 08009 Barcelona Spain Sam Rolfe +34-931-87-02-00 eu_info@veeva.com www.veeva.com/eu

About Veeva Systems Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 700 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America.

FL 2,700 2007

Areas of Activity · Industry cloud for life sciences, content and data management, innovative technology

For more information, visit veeva.com/eu.

Veeva Development Cloud Veeva Development Cloud brings together applications for clinical, quality, and regulatory to help organisations eliminate silos and drive end-to-end business processes across product development. Today, product development applications are siloed and not well integrated. Multiple systems create inefficiencies and slow down critical business processes. Veeva is the first and only company to offer suites of unified applications on a single cloud platform across the entire product lifecycle. With all applications on the Veeva Vault Platform, companies can streamline product development information across regions and departments for greater efficiency and compliance.

Veeva Systems

Veeva Vault Clinical Suite Veeva Vault Clinical Suite is the industryâ&#x20AC;&#x2122;s first cloud platform that combines CDMS (including EDC and coding), CTMS, eTMF and study start-up to deliver the most comprehensive suite of clinical cloud applications. For the first time, life sciences companies can unify clinical operations and data management on a single platform to create a single source of truth, streamline end-toend processes, and help sponsors, CROs, and sites improve how they work together throughout the clinical trial process.

Clinical Data Management

Vault CDMS Vault EDC Vault Coder

Clinical Operations Vault CTMS Vault eTMF Vault Study Startup Vault SiteDocs

Veeva Vault Quality Suite


Seamlessly manage your quality processes and content with the Vault Quality suite of applications. All parties â&#x20AC;&#x201C; life sciences companies, contract manufacturers, and suppliers â&#x20AC;&#x201C; have access to a single authoritative source, enabling greater visibility and control. Vault Quality enables organisations to modernise quality management, assuring quality while driving compliance and operational innovation.

Vault QMS Vault QualityDocs Vault Training

Veeva Vault RIM Suite

Regulatory Vault Registrations Vault Submissions Vault Submissions Publishing Vault Submissions Archive

Veeva Development Cloud Veeva Development Cloud brings together applications for clinical, quality, and regulatory to help organisations eliminate silos and drive end-to-end business processes across product development.

The Vault RIM Suite provides fully integrated regulatory information management (RIM) capabilities on a single cloud-based platform, including submission document management, product registration management, health authority correspondence and commitments, and submission archiving, and comes with fully integrated IDMP capabilities. The visibility that results from a unified solution will streamline global processes and improve data quality, helping life sciences companies respond faster to business changes, and health authority requests.

For more information visit: veeva.com/eu

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

· · · · · ·

Eywiesenstrasse 5 88212 Ravensburg Germany Oskar Gold +49-751-3700-0 EU and other international inquiries: info@vetter-pharma.com US inquiries: infoUS@vetter-pharma.com Japan inquiries: infoJapan@vetter-pharma.com Asia Pacific inquiries: infoAsiaPacific@vetter-pharma.com Website · www.vetter-pharma.com Number of Employees · Approx. 4,500 Founded (year) · 1950 Areas of Activity · Development support, 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: ·· Process development ·· Clinical trial manufacturing ·· Analytical services ·· Regulatory support Vetter Commercial Manufacturing Filling your potential Precise manufacturing. Creative thinking. It takes both to succeed in a competitive marketplace. Vetter Commercial Manufacturing supports your injectable with more than 35 years of expertise in high-quality, state-

vetter pharma international



of-the-art aseptic filling – and experience-based solutions that add value and increase efficiency. Vetter Commercial Manufacturing provides: ·· Fill and finish ·· Analytical services ·· Regulatory support ·· 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 ·· Serialisation ·· Logistic services ·· Systems & Technologies

Fast facts: Vetter-at-a-glance


·· Headquarters in Ravensburg, Germany ·· Production sites in Ravensburg and Langenargen, Germany ·· Representative offices for Asia Pacific in Singapore and South Korea, as well as a subsidiary in Japan ·· Additional clinical development facility in Chicago, US ·· Approximately 4,500 employees ·· Worldwide specialist in the aseptic production of prefilled drug delivery systems ·· Global experience and expertise with regulatory authorities including FDA, EMA, PMDA (Japan), and RP (Germany) ·· Service offering for small and large pharma/biotech firms worldwide ·· Numerous patents including technologies for protection against tampering and counterfeiting ·· Lyophilisation (freeze-drying) and siliconisation specialist

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Name · Wood Address/P.O. Box · 15 Justice Mill Lane Postal Code/City · Aberdeen AB11 6EQ Country · United Kingdom Contact Person Telephone Fax Email Address

· · · ·

Marco Bolognini (Milan, Italy) +39-024486-6656 +39-024486-6604 marco.bolognini@woodplc.com

Contact Person Telephone Fax Email Address

· · · ·

Hendrik Pantlen (Basel, Switzerland) +41-61-227-9481 +41-61-283-2201 hendrik.pantlen@woodplc.com

Internet Website Social Media Number of Employees Founded (year)

· www.woodplc.com · FL I  · 60,000 · 1848

Areas of Activity · l Consulting l Engineering l Process systems l Project delivery l Commissioning l Qualification + validation l From feasibility studies to full EPCMQ

Who we are Wood is a global leader in the delivery of project, engineering, and technical services to energy and industrial markets, operating in more than 60 countries and employing around 60,000 people, with revenues of over $10 billion. We provide performance-driven solutions throughout the asset life-cycle, from concept to decommissioning across a broad range of industrial markets: life sciences, biotechnology, environment and infrastructure, oil & gas, chemicals, power & process, clean energy, mining, and general industrial sectors. We strive to be the best technical services company to work with, work for, and invest in.

A specialist in pharma solutions Wood provides a broad range of services for the pharmaceuticals, biotechnology, and healthcare markets: process design (URS preparation, process simulation, equipment specification); consultancy (GMP audit/GAP analysis, assistance with site selection, site master planning, feasibility studies, conceptual design); engineering & construction (basic design, detailed engineering, project management, project control, procurement, FAT, SAT, risk assessment, construction management) and qualification/validation, commissioning, and start-up.

provider Annual Turnover · Over $10 billion

The solutions that we offer meet stringent industry regulatory requirements, are economically and environmentally sustainable, and create value for our customers. We have successfully completed EPCMQ assignments from small-scale projects to major developments, in many countries around the world. Our ability to service the needs of our clients comes from our culture, which is focused on process-driven facilities. Our process engineers, working closely with our facility design, process automation, piping design, pharmaceutical systems, and validation groups, efficiently translate our customers’ needs into an optimal manufacturing process and facility design in compliance with all applicable cGMPs, codes, regulations,


and standards. We provide sound, cost-conscious engineered solutions for our customers’ processing and manufacturing needs. We work with several of the world’s top drug manufacturers, including AstraZeneca, Roche, GlaxoSmithKline, Pfizer, Novartis, MSD, Sanofi, Bristol Myers Squibb, TEVA, Regeneron, Bracco, Lonza, CSL, and others. We have designed, built, and validated facilities for compliance with the code of Good Manufacturing Practice (cGMP) in USA, in Europe (Germany, Switzerland, Belgium, France, Italy, Russia), Turkey, Egypt, Saudi Arabia, UAE, China, South Korea, Singapore, Malaysia, Thailand, Australia, and New Zealand. Our project and design documentation is tailored to suit pharma regulatory requirements, ensuring that compliance is maintained at all times.

An extensive track record We have an exensive and proven track record of successful project delivery in: ·· Bulk Chemical (API) plants (high potent APIs, antibiotics, herbal/animal sources extracts, sterile bulk APIs) ·· Biotechnology plants (viral/bacterial vaccines, recombinant therapeutic proteins, plasma fractions, transgenic proteins, antibiotics) ·· Formulation, fill/finish and packaging plants (sterile injectables (LVP/SVP), oral solids/liquids, topicals, freeze-dried forms, inhalations) ·· R&D and pilot plants (research labs, biocontained labs, kilolabs, pilot plants, animal houses, auditoriums/conference facilities, QA/QC labs) ·· Other production support functions, such as warehouses and material handling systems, utilities plants, etc. ·· Medical devices manufacturing plants

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

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

· · · ·

Rudi-Conin-Str. 4 50829 Cologne Germany Jasmin Atarodi (Managing Director) Ilka Strehlau (Head of Data Management) +49-221-55922-0 +49-221-55922-33 welcome@x-act-cologne.com www.x-act-cologne.com

· · · · · IQ · >20 · 1994

Areas of Activity · l Regulatory affairs l Project management l Monitoring l Data management l Biostatistical services l Medical services l Medical writing l Quality assurance l Audits on behalf of clients l Workshops for SOP development

X-act Cologne Clinical Research GmbH is an independent and privately-managed contract research organisation in Cologne, Germany. Clinical data management and biostatistical services have been our core competencies since the company’s foundation. Our clients in the pharmaceutical, medicaldevice, and biotechnology industry have valued our expertise for 25 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 about 300 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 offer the following services for the supervision and management of your project: ·· clinical development programmes ·· feasibility studies & recruitment ·· clinical study management (project management and clinical monitoring) ·· 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 Country Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Alte Verler Str. 1 33689 Bielefeld Germany Dr Frederik Walter +49-521-96989-200 +49-521-96989-201 info@xell.ag www.xell.ag


> 30 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 media and feeds Further Collaborations 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


Analytical 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. Further 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 Country · Germany Contact Person · Dr Linda Kirchner Telephone · +49-531-481170-0 Fax · +49-531-481170-17 Email Address · info@yumab.com Internet Website · www.yumab.com Social Media · I Number of Employees · 21 Founded (year) · 2012 Type of Laboratory · S1, S2 Areas of Activity · l Fully human antibody discovery & lead development l Antibody Libraries l Engineering & Humanization l Professional R&D services (CRO) l Optimised conditions for start-up, biotech & biopharma companies l Flexible entry & exit points at any project stage l Partnered innovation Request for · YUMAB seeks clients & partners in Further Collaborations biopharma, biotech, & diagnostic industry as well as partners with innovative research projects, who need a reliable partner in human antibody development

YUMAB is a contract developer of fully human antibodies for the global biotechnological and biopharmaceutical industry. Starting out in 2012 with the goal to bridge the gap between innovative research and novel therapies, the company has become an important driver of the general trend in immunotherapy toward the use of fully human antibodies. The versatile technology platform combined with a longstanding and proven expertise makes YUMAB the partner of choice for the development of novel antibodies for therapeutic applications, diagnostics, or vaccines tailored to the clients’ needs. R&D projects customised with flexible entry and exit points at any stage and for any immunotherapeutic strategy appeal to start-ups, biotech, or biopharma companies. In 2018, YUMAB moved its headquarters and labs to one of Germany’s life science hotspots, the Science Campus Braunschweig-Süd, to enable sustainable growth and high-level scientific partnering.

The YUMAB® platform: fast & reliable translation from innovation to drugs The YUMAB® platform delivers fully human antibodies, the closest to natural germline among those on the market, using fast and reliable in vitro discovery technologies. The company’s highly diverse, human antibody libraries contain 1011 natural antibody sequences and specificities to all types of antigens. Unlike animal-derived, chimeric, humanised, or synthetic antibodies, each YUMAB® antibody sequence has been shaped in the human body, which maximises epitope diversity and overcomes restriction by in vivo immune responses while minimising immunogenicity and potential adverse effects in clinical development. Our advanced in vitro selection technology is also efficient for rare and difficult target antigens and allows pre-design of epitope specificity, interspecies X-reactivity, affinity, stability, and other properties early



in the discovery and development process. First antibody candidates are identified swiftly within a few weeks and are highly developable into all types of antibody drug formats such as full-length IgGs, Fabs, scFvs, bispecifics, CARs, fusion proteins, and ADCs. YUMAB provides tailored service and partnering concepts to jump-start translation from research innovation to drug development with affordable entry costs, flexible licensing options, and no additional third-party obligations.



YUMAB at a glance Human antibody discovery platform ·· Natural fully human libraries for low toxicity & immunogenicity ·· Optimised in vitro selection to address difficult targets ·· Rapid discovery within weeks Direct link to lead development ·· Advanced antibody lead development & optimization ·· All antibody drug formats, all disease areas ·· Robust & fast process with high success rates YUMAB® platform ·· Fully integrated discovery & development platform from target to optimized lead ·· Customised project plans with flexible entry & exit points ·· Smooth translation from bench to bedside


Flexible services, collaborations & partnering ·· Contract R&D as fee-for-service & flexible licence options ·· No technology access fees ·· Partnered collaboration to translate research innovation into drug development

rapid. robust. reliable

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Join the European Biotechnology Network!

Š Rawpixel/Fotolia.com

Biotechnological Armenian Association

The European Biotechnology Network is dedicated to facilitating co-operation between professionals in biotechnology and the life sciences all over Europe. This non-profi t organisation brings research groups, universities, SMEs, large companies and indeed all actors in biotechnology together. Do you want to know more about the advantages of a (free) membership? Just have a look at our website.


European Biotechnology Network AISBL Rue de la Science 14b | 1040 Brussels, Belgium Tel: +32 (0)2 588 70 71 info@european-biotechnology.net www.european-biotechnology.net

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European Biotechnology



9th European Biotechnology Guide

European Biotechnology Guide Science & Industry

ISBN 978-3-928383-71-4

European Biotechnology NET WORK

Profile for BIOCOM AG

European Biotechnology Guide 2019  

European Biotechnology Guide 2019  

Profile for biocom