European Biotechnology Guide 2022

VOLUME 12

2022

12th European Biotechnology Guide

European Biotechnology Guide Science & Industry

ISBN 978-3-928383-83-7

European Biotechnology Net work

European Biotechnology Guide Science & Industry

© BIOCOM AG, Berlin 2022 European Biotechnology Science & Industry Guide 2022 (Vol. 12) Published by: BIOCOM AG Jacobsenweg 61 13509 Berlin, Germany Tel. +49-30-264921-0 Fax +49-30-264921-11 service@biocom.de www.biocom.de Executive Producer: Andreas Macht Production: Martina Willnow 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).

The copyright for the printed photos is held by the presented companies.

ISBN: 978-3-928383-83-7

Editorial

The first climate war – and biotechnology as the key to the future In the battle noise of the first major war in Europe this millennium, the second assessment report of the Intergovernmental Panel on Climate Change (IPCC) was almost drowned out in the media. The Swedish scientist Johan Rockström put it in a nutshell: “The catastrophic consequences of climate change are coming faster than predicted, they are coming more frequently, and they are more serious than predicted.” In other words, the climate catastrophe is here! Instead of focusing all resources on keeping our biosphere habitable, we are now looking at a military conflict that seems out of time. “We don’t have time for that anymore”, say justifiably all those who feel a responsibility for the future. But the Russian dictator, who seems to be stuck in the very early 20th century, is not one of them.

Yet the war in Ukraine is closely linked to climate change. It has dawned on people in the rich industrialised countries, at least since the first report, “The Limits to Growth” 50 years ago, that our wasteful lifestyle based on the consumption of our planet’s natural resources can no longer be upheld. Global warming caused by greenhouse gases means that we must leave the fossil age behind as soon as possible. It is (unfortunately) human nature that such a major upheaval will not always be peaceful.

Andreas Mietzsch European Biotechnology Network, Brussels

And that brings us to Russia. The state is tiny in a global comparison, if you take the number of inhabitants and economic power as a yardstick. The huge country lives almost exclusively from the export of its fossil raw materials. This “business model” is very likely to fail in the very near future. Thus, Russia’s backward-looking dictator believes that it is high time to use the economic and military power he still has now to expand the empire, which will soon no longer have the opportunity to do so. Incidentally, the last European dictator to declare invading and plundering other countries as a “business model” was Adolf Hitler.

Of course, Putin will not stop the course of time. Instead of wreaking havoc, it is urgent to transform our entire economy so that it fits into the natural cycles of our planet. Nothing is better suited for this than biotechnology. It is high time to tackle the biologisation of industry worldwide. Young, well-educated people must take on this task. The solutions that industrial biotechnology already offers today will be on display at INDUSTRIA BIOTEC on 7 October in Berlin. european-biotechnology.net 12TH EUROPEAN BIOTECHNOLOGY GUIDE 2022

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European Biotechnology Net work

Let’s save the planet!

Join the European Biotechnology Network!

COVID-19, climate apocalypse, billions of people in turmoil. New strategies are desperately needed. Biotechnology creates confidence and solutions. The European Biotechnology Network is a non-profit organisation that aims to facilitate cooperation between all professionals in biotechnology and life sciences on the European continent.

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Find out about (free) membership on our website www.european-biotechnology.net

European Biotechnology Network AISBL Avenue Louise 65, Box 11 | 1050 Brussels Belgium | Tel: +32 (0)2 588 70 71 www.european-biotechnology.net info@european-biotechnology.net

Content

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

3

Introduction . . . . . . . . . . . . . . . . . . . . . . . . .

7

IBA GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . .

84

Immunic AG . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . .

86

Indivumed GmbH . . . . . . . . . . . . . . . . . . . . . .

. . . .

88

. . . .

90

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

15

Intravacc B.V . . . . . . . . . . . . . . . . . . . . . . . . .

10x Genomics B.V. . . . . . . . . . . . . . . . . . . . . .

16

invIOs GmbH . . . . . . . . . . . . . . . . . . . . . . . . .

. . . .

92

. . . .

94

. . . .

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

. . . .

18

iOmx Therapeutics AG . . . . . . . . . . . . . . . . . .

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

. . . .

20

IRBM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . .

96

22

ITM Isotope Technologies Munich SE . . . . . .

. . . .

98

. . . . 100 . . . . 102

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

. . . .

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

. . . .

24

KML Vision GmbH . . . . . . . . . . . . . . . . . . . . .

Altasciences . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . .

26

LIFE & BRAIN GmbH . . . . . . . . . . . . . . . . . . .

Maiwald Patentanwalts- und

ASKA Biotech GmbH . . . . . . . . . . . . . . . . . . .

. . . .

28

B Medical Systems S.a r.l. . . . . . . . . . . . . . . .

. . . .

30

Rechtsanwaltsgesellschaft . . . . . . . . . . . . .

. . . . 104

Bank of New York Mellon . . . . . . . . . . . . . . . .

. . . .

32

Microsynth AG . . . . . . . . . . . . . . . . . . . . . . . .

. . . . 106 . . . . 108

BioCopy AG . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . .

34

Molzym GmbH & Co.KG . . . . . . . . . . . . . . . . .

Bioengineering AG . . . . . . . . . . . . . . . . . . . . .

. . . .

36

New England Biolabs GmbH . . . . . . . . . . . . .

. . . . 110

38

OLS OMNI Life Science GmbH & Co.KG . . . .

. . . . 112

OPIS s.r.l. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . 114

40

PlasmidFactory GmbH & Co. KG . . . . . . . . . .

. . . . 116

42

Phyton Biotech GmbH . . . . . . . . . . . . . . . . . .

. . . . 118 . . . . 120

Biotype GmbH. . . . . . . . . . . . . . . . . . . . . . . . .

. . . .

Boehringer Ingelheim Biopharmaceuticals GmbH. . . . . . . . . . . . .

CasZyme. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . .

Catalent . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . .

44

Premier Research . . . . . . . . . . . . . . . . . . . . . .

Campania Bioscience . . . . . . . . . . . . . . . . . . .

. . . .

46

ProBioGen AG . . . . . . . . . . . . . . . . . . . . . . . .

. . . . 122 . . . . 124

CO.DON AG . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . .

48

ProductLife Group / ProductLife France . . . . .

Coherent Inc. . . . . . . . . . . . . . . . . . . . . . . . . .

. . . .

50

ProJect Pharmaceutics GmbH . . . . . . . . . . . .

. . . . 126

52

Rentschler Biopharma SE . . . . . . . . . . . . . . .

. . . . 128 . . . . 130

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

. . . .

Cybertron GmbH . . . . . . . . . . . . . . . . . . . . . .

. . . .

54

Resolve BioSciences GmbH . . . . . . . . . . . . . .

CZ Vaccines . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . .

56

Richter-Helm BioLogics GmbH & Co. KG . . .

. . . . 132

58

Sartorius CellGenix GmbH . . . . . . . . . . . . . . .

. . . . 134 . . . . 136

Enzymaster . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . .

Enzymicals AG . . . . . . . . . . . . . . . . . . . . . . . .

. . . .

60

SOCOREX ISBA SA . . . . . . . . . . . . . . . . . . . .

ERBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . .

62

Swiss Biotech Association SBA . . . . . . . . . . .

. . . . 138 . . . . 140 . . . . 142

Eurasanté . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . .

64

SynapCon© GmbH . . . . . . . . . . . . . . . . . . . . .

EuroJobsites Ltd . . . . . . . . . . . . . . . . . . . . . . .

. . . .

66

Technologiepark Heidelberg . . . . . . . . . . . . . .

68

Tentamus Pharma & Med Deutschland GmbH .

. . . . . 144 . . . . 146

EuropaBio . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . .

Excelya Group SAS . . . . . . . . . . . . . . . . . . . .

. . . .

70

Tosoh Bioscience GmbH . . . . . . . . . . . . . . . .

FGK Clinical Research GmbH . . . . . . . . . . . .

. . . .

72

UGA Biopharma GmbH . . . . . . . . . . . . . . . . .

. . . . 148

74

VelaLabs GmbH . . . . . . . . . . . . . . . . . . . . . . .

. . . . 150 . . . . 152

Fördergesellschaft IZB . . . . . . . . . . . . . . . . . .

. . . .

Formycon AG . . . . . . . . . . . . . . . . . . . . . . . . .

. . . .

76

Vetter Pharma International GmbH . . . . . . . . .

FyoniBio GmbH . . . . . . . . . . . . . . . . . . . . . . .

. . . .

78

Viscofan BioEngineering . . . . . . . . . . . . . . . . .

. . . . 154 . . . . 156 . . . . 158

Galenica AB . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . .

80

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

HealthCapital Berlin-Brandenburg . . . . . . . . .

. . . .

82

Zymo Research Europe GmbH . . . . . . . . . . . .

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Introduction

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Post-COVID-19 perspective for the European diagnostics industry While diagnostics heavyweights such as Abbott, Roche, bioMérieux, Bio-Rad, Danaher Corp, Siemens, Quest, Sysmex, ThermoFisher or Qiagen have publicly predicted a decrease in profits from COVID-19 PCR and rapid antigen testing in their 2022 outlooks, analysts expect a long-lasting post-pandemic effect on the market for in-vitro diagnostics (IVD). Experts and studies cite changing attitudes of governments, health insurance companies and patients toward routine diagnostic screening as a reason for a predicted post-pandemic annual growth rate (CGAR) of 4.5% following a stagnating IVD market from 2013 until the pandemic. That means they believe that the pandemic got many more people used to self-testing and that this might translate into increased readiness for screening tests both for infectious and chronic diseases. Additionally, an improved testing infrastructure has been already established beyond the top-5 EU IVD markets in Germany, France, the United Kingdom, Italy and Spain. According to MedTech Europe, which is currently preparing the IVD market statistics for 2021, the high demands for SARS-CoV-2 testing in 2020 led to an unprecedented increase of +25,4% in revenues compared to 2019.

Market forecasts for COVID-19 tests have generally been highly volatile because no one knows how the pandemic and viral variants will develop. Just before the first COVID-19 vaccines were approved for diagnostic testing, market forecasts dropped, but rose again shortly thereafter. The situation was similar before the dramatic increase in test demand in winter 2022 due to the highly contagious Omicron variant. Meanwhile, EU member states such as Denmark, Norway and Iceland announced, they will shortly reduce PCR testing capacities and obligations as well as travel restrictions for vaccinated travellers as the Omicron variant has just peaked and the daily number of cases in Europe have more than halved, from some 1.7 million daily COVID-19 cases in late January to around 730,000 by the end of February.

Only recently, EU researchers reported that the CEmarked antigen tests from 182 COVID-19 diagnostics

companies included in the EU common list were less sensitive with the Omicron (B.1.1.529) than with the delta variant (B.1.617.2) of the coronavirus (Med Microbiol Immunol., doi: 10.1007/s00430-022-00730-z). The rates of true positive test results for Omicron samples in the highest virus load category (Ct values < 25) ranged between 31.4% and 77.8% (sensitivity of 90% or greater required), while they dropped to 0-8.3% for samples with intermediate Ct values (Ct values 25-30).

However, other publications did not reproduce these findings, which used conserved samples instead of swabs freshly taken from the patient’s nose or throat.

On the other hand, unexpected new scientific results may result in a short-term increase for IVD tests measuring the activity of T memory cells of the immune system because the T memory cell activity seems to significantly determine the efficacy of vaccines to protect from hospitalisation, which might open up new markets for diagnostics companies. In fact, diagnostics companies such as Roche, Euroimmue, Qiagen, Viramed, Synlab and Oxford Immunotec already offer Elispot analyses for IFN-gamma detection, a marker for T cell activity. Customer interest in Qiagen’s Quantiferon SARS-CoV-2 test, launched in December 2021 that helps determine immunity status after COVID-19 vaccination, for example, is „high,“ according to the company. However, most IVD companies expect lower revenues from COVID-19 diagnostics than in 2021.

Preparing for the post-COVID era Pandemic success stories such as Lifebrain AG, the fastest-growing European diagnostics company during the pandemic, which created 600 new jobs in Vienna to handle a daily throughput of 800,000 PCR gargle tests and which has expanded its sequencing capacity last summer to identify new virus variants, feel just prepared for the post-pandemic era. They want to transfer their testing technology into the growing area of personalised human genetics testing in the future.

Lifebrain partner Lead Horizon plans to focus on digital solutions in screening and early detection of diseases after the pandemic. “We support the trend of being able to fight potential diseases faster by monitoring one’s

% 30

16000 13,971

14000 12000

10,845

10,943

10,603

10,549

10,580

10,736

10,758

10,965

11,102

11,145

25 20

10000

15

8000 10

6000 4000 1.5%

2000 0

0.9%

-0.5%

0.3%

1.5%

1.9% 0.2%

1.2%

5 0.4%

0

-3.1%

2010

2011

2012

2013

2014

2015

2016

Revenues (million €)

2017

2018

2019

2020

-5

Growth Rate

Figures of the IVD market before an during the COVID-19 pandemic

health regularly and thus live healthier for longer”, a spokesman said.

Picture: Medtech Europe

Cheaper and more often?

A PCR gargle test from Lifebrain has costed the Austrian health system just €6-7 while conventional PCR tests costed €30 to €40 if reimbursed or €70 if paid individually. The impact of low- cost testing translated into the highest number of EU tests per person in Austria (17.5/individual), which assured adequate contact tracing to limit the spread through prompt isolation of infected people during the peak of Omicron infections in Vienna. This compares to just 10.6 tests per person in Denmark, Europe’s No. 2 in COVID-19 testing, 6 per person in countries such as the UK and Greece, and 1-4 tests/per person in all other EU countries.

Larger players such as Qiagen NV, which reported a sharp increase in revenue to €2.25bn in 2021, are already growing at double-digit rates with screening tests such as the tuberculosis QuantiFERON test (2021: + 40%).

While Qiagen expects COVID-19 testing demand to decline, it hopes the demand for other tests to increase.

According to CEO Roland Sackers, the company will invest €200m to produce 21 further tests for sympto-

matic virus testing Qiagen’s next-generation sequencing business has also seen double-digit growth. The company expects this to provide opportunities for the early detection of future virus variants and for research of pharmaceutical companies developing personalised cancer medicines. Actually, Qiagen, Roche, Thermo Fisher, Sysmex and Abbott have comprehensive cancer biomarkers in their product portfolio.

Further IVD companies bet that patients will now be willing to try home tests to distinguish between influenza, COVID-19 and a common cold. Others see the market expanding as tests are developed to screen for the viruses that cause chronic diseases such as hepatitis C and HPV-induced cervical cancer.

Focus on cancer In the midst of the COVID-19 pandemics, EU policymakers have prepared the ground for further growth of the IVD branch: In 2020, the European Parliament set up the Special Committee on Beating Cancer to review EU action against cancer and suggest improvements. In midFebruary 2022, the committee published its final report and the majority of MEPs adopted its recommendations.

The bad news is: Europe represents less than 10% of 12TH EUROPEAN BIOTECHNOLOGY GUIDE 2022

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the world’s population, but accounts for 25% of all cancer cases. The good is, cancer is not necessarily a death sentence. In the EU, 40% of cancer cases are preventable and there are an estimated 12 million cancer survivors. Differences in cancer survival rates across EU countries exceed 25% and progress in molecular biology and personalised mRNA vaccines promise to diagnose cancer in a much earlier stage and thus improve

overall survival in the longer term. In brief: it is the very next business opportunity for the developers of IVD diagnostics and sequence- or imaging-based tumour boards. As the COVID-19 pandemic has had a negative impact on cancer cases, diagnostics companies can expect a huge demand for screening and prognostic biomarker tests following the pandemic: An estimated 100 million screening tests were not performed in Eu-

Most common types of cancers within the EU population. Almost 75% of cancer deaths occur in people aged 60 or older.

rope during the pandemic and an estimated one million cancer cases remained undiagnosed.

About €4bn have been earmarked to support the four pillars of the EU’s Beating Cancer Plan launched in 2021, two of which include cancer diagnostics:

› Early detection of cancer by improving access, quality and diagnostics and support Member States ensuring that 90% of the EU population who qualify for breast, cervical and colorectal cancer screenings are offered screening by 2025. To support achieving this, a new EU-supported Cancer Screening Scheme will be put forward. › Diagnosis and treatment through actions to ensure better integrated and comprehensive cancer care and addressing unequal access to quality care and medicines. By 2030, 90% of eligible patients should have access to National Comprehensive Cancer Centres linked through a new EU Network. In addition, a new ‘Cancer Diagnostic and Treatment for All’ initiative will be launched by the end of 2021 to help improve access to innovative cancer diagnosis and treatments and a European Initiative to Understand Cancer (UNCAN.eu) will help identify individuals at high risk from common cancers.

Additionally, a European Cancer Imaging Initiative will be set up to support the development of new computeraided tools to improve personalised medicine and machine-learning-based pattern recognition tools. Without conclusive action, by 2035 cancer cases are estimated to increase by almost 25%, making it the leading cause of death in the EU with an economic impact exceeding €100bn annually.

The Beating Cancer plan foresees to boost access to diagnostic tests to detect cancer-causing mutations that may help to prevent or detect early-stage cancer and guide treatment choices within a personalised cancer approach. Additionally, the MEPs adopted the plan to boost molecular epidemiology research tools that can provide new insights into the gene-environment interactions in cancer.

Most common types of cancer deaths in the EU ­member states.

Cancer screening According to the EU cancer initiative, inequalities between member states in cancer screenning should be eliminated by sharing of skills and know-how and testing capacities. Currently, only 18 Member States have national or regional population-based screening programmes for breast, cervical and colorectal cancers. An EU-supported cancer screening initiative foresees Member States to ensure that 90% of the EU population who qualify for breast, cervical and colorectal cancer screenings are offered screening by 2025. On top, Member States are requested to establish research programmes for the development of effective, accurate, non-invasive and innovative early diagnosis methods, such as biomarkers, for different types of cancer.

Additionally, diagnostics makers could benefit from the EU’s plan to monitor patients with chronic inflammations and viral infections such as hepatitis B and C patients to prevent cancer development. The MEPs have also called on the European Commission to develop EU guidelines for fostering research efforts to assess the inclusion of new science-based cancer screening programmes including lung, prostate, stomach and ovarian cancers and the role of artificial intelligence in cancer diagnosis.

Thomas Gabrielczyk 12TH EUROPEAN BIOTECHNOLOGY GUIDE 2022

10 | 11

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n a r o f s n t o e i n t u a l l o p S d e r e g e nda n

INDUSTRIA

BIOTEC Industrial Biotech Day › 7 October 2022, Berlin

On October 7th 2022, Europe’s biotech industry will meet in Berlin and show what it can contribute to solving the most dire problems of our time: INDUSTRIA BIOTEC, the showcase for industrial biotechnology!

What can visitors expect?

Sessions BIOTEC : FOOD BIOTEC : CAPITAL BIOTEC : WASTE BIOTEC : ENERGY BIOTEC : CHEMISTRY

Save the date and stay informed: www.industria-biotec.com

Exhibition Partnering Start-up Village

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Profiles

12TH EUROPEAN BIOTECHNOLOGY GUIDE 2022

14 | 15

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

›

› › › › › › › ›

›

10x Genomics

Partnering to Accelerate Drug Discovery with 10x Genomics

LeCarrefour, Dellaertweg 9D 2316 WZ Leiden The Netherlands emeacommunication@10xgenomics.com www.10xgenomics.com

Pharmaceutical and biotech companies are harnessing the power of 10x Genomics’ suite of solutions to identify and sustain a pipeline of novel targets and accelerate key assets through the development pipeline. These cutting edge technologies play an integral role in biomarker discovery, resolve complex therapeutic mechanism(s) of action and further our understanding of how therapies can be deployed to minimize resistance and separate responders versus non-responders.

FL I  ~1,000 2012 | Single Cell Gene Expression | Spatial Transcriptomics | Epigenomics | CRISPR | Single Cell and Spatial Multiomics

Complementary to single cell approaches 10x Genomics Visium Spatial Solutions are enabling clinical researchers to map the whole transcriptome with morphological context to discover novel insights into normal development, disease pathology, and clinical translational research.

(as of 2021)

The Top twenty pharmaceutical companies have integrated single cell platforms into their drug discovery and development process to advance their promising assets with higher confidence. Incorporating these costeffective and innovative technologies will mean a faster path to identifying the right targets.

This is the Century of Biology. Breakthroughs in the coming decades will transform the world. We accelerate this progress by powering fundamental research across the life sciences, including oncology, immunology, and neuroscience.

Reaching new levels of biological insight with single cell and spatial multiomics

Member of

European Biotechnology Net work

The vast complexities of biology require approaches to build a complete understanding, from single cells to tissues and beyond. 10x Genomics Chromium Single Cell products enable molecular profiling with multiomic capabilities in tens of thousands of single cells, and our Visium Spatial products provide a comprehensive understanding of the relationships between cellular function, phenotype, and location in intact tissue sections. Join us to learn how you can uncover molecular insights, dissect cell-type differences, detect novel cell

10X GENOMICS

subtypes and biomarkers, define gene regulatory interactions, and decipher spatiotemporal gene expression patterns. Resolve highly complex biological systems, while bringing into focus the details that matter most.

Targeted Gene Expression Combine the crucial insights enabled by high-throughput single cell and spatial gene expression analysis with the efficiency and scalability of pre-designed or custom panels.

Single Cell Gene Expression Increase your confidence in assigned sample reads, compatible with both whole transcriptome and targeted single cell gene expression.

Single Cell Immune Profiling Uncover the full diversity of the immune system with enhanced multiomic immune profiling. Leverage sensitivity improvements and higher immune receptor pairing rates to discover novel and rare cell populations and better characterize clonal diversity and expansion.

Single Cell Multiome ATAC + Gene Expression Simultaneously profile gene expression and open chromatin from the same cell, across thousands of cells, to enhance characterization of cell types and states, and reveal gene regulatory programs.

Visium with Immunofluorescence Simultaneously map and measure whole transcriptome spatial gene expression with protein across the entire tissue section to obtain a more complete picture of tissue biology.

12TH EUROPEAN BIOTECHNOLOGY GUIDE 2022

16 | 17

Name

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

Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Website Social Media Number of Employees Areas of Activity

›

› › ›

› › ›

3P Biopharmaceuticals Headquarters Polígono Mocholi, Plaza Cein, 1 31110 Noáin Spain Manufacturing site Polígono Mocholi, C/Mocholi, 2 31110 Noáin Spain

Company profile 3P Biopharmaceuticals is a Contract Development and Manufacturing Organisation (CDMO) specialised in process development and GMP manufacturing of biologics and cell therapy products using microbial and mammalian-based expression technologies.

3P is a robust manufacturing partner with a successful global track record and a highly qualified team that accompanies clients through the full life cycle of their products from cell line development through to clinical and commercial manufacturing.

In its state-of-the-art biomanufacturing facilities, the company also offers a comprehensive range of in-house analytical and development services as well as continuous regulatory support that improves the value of its client’s drug candidates.

›

Elena Erroba (Business Development Director) +34-948-34-64-80 withinus@3pbio.com www.3pbio.com

›

LI

GMP certified

›

300+

3P Biopharmaceuticals offers GMP manufacturing services for biologics.

›

› ›

›

| Biotechnology | Biomedicine | CDMO | End to hand | Biologics | GMP | Recombinant Proteins | Cell Therapy

GMP certified & FDA approved for: › API manufacturing (clinical trials & commercial production) › QC and release of API and final products for clinical trials and commercial supply

Highest Quality Standards 3P ensures the highest level of quality excellence and compliance with regulatory requirements.

Summary services › Cell line development and GMP cell banking › Process development and optimization › Analytical methods development, qualification & validation › Scale-up and cGMP manufacturing › DS & DP release › Process characterisation & validation › Commercial manufacturing › Tech transfer › Comparability studies › Formulation development

3P BIOPHARMACEUTICALS

Advanced therapies › Cell therapy products › Tissue-engineered products › Biomaterials (scaffolds or membranes)

Biologics facilities & equipment Process development capacities for mammalian: › Ambr 250® › Ambr 15® › BIOSTAT® Qplus 6 fold (6x1 L) › BIOSTAT® B-DCU II 2fold 5 L (2 x5 L) › BIOSTAT® B twin 5 L (2x5 L) Process development capacities for microbial: › BIOSTAT® B twin 2 L (2x2 L) › BIOSTAT® B twin 2 L (2x2 L) › BIOSTAT® B-DCU II 3fold (2x2 L + 1 x 10 L) › BIOSTAT® Cplus 10 L (Stainless steel biorreactor) GMP Manufacturing capacities for mammalian: › Single use bioreactors: 50 L, 200 L, 400 L, 2000 L GMP Manufacturing capacities for microbial: › Stainless steel bioreactors: 2x10 L, 3x100 L, 1000 L

Track record 3P is involved in GMP manufacturing projects starting from gene design up to commercial manufacturing bringing its clients on board at all stages of development. 3P works with various microbial and mammalian expression systems and has extensive experience in process development and GMP manufacturing of New Biological Entities (NBEs) including fusion proteins, vaccines, monoclonal antibodies, antibody fragments and other recombinant proteins as well as being specialised in biosimilar development and production. The company has a proven approach for the execution scale-down model validation and process characterisation to facilitate successful process validation and market supply.

3P delivers a profound knowledge of biologics manufacturing and its goal is to exceed clients’ expectations while providing tailored and effective solutions ensuring project success.

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

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Weismuellerstr. 50 60314 Frankfurt am Main Germany Dr Eckhard Guenther +49-069-42602-0 +49-069-42602-3444 info@aezsinc.com www.zentaris.com

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ILF

› › › › › › ›

› ›

Areas of Activity

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Biological Patents

›

External Collaborations

Request for Further Collaborations

Aeterna Zentaris GmbH

›

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16 2001 Endocrinology, autoimmune and CNS diseases, vaccines, COVID-19, Chlamydia trachomatis, rare and orphan diseases, growth hormone deficiency Several patents and patent applications covering our products and projects filed or licensed in Big and medium-sized pharmaceutical companies together with academic institutions We are interested in in-licensing late stage preclinical or clinical opportunities in our areas of activity and are potentially seeking development partners for our projects.

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

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

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

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

Our commercial and development partner for Macrilen™ for the US and Canada is Novo Nordisk, a global leader in endocrinology. In 2020 we entered into commercial agreements with Megapharm Ltd. to commercialise macimorelin in Israel and Palestine, and with Consilient Health Ltd., to commercialise macimorelin in Europe.

Recently we entered into commercial agreements with Er-Kim Pharmaceuticals for Turkey and NK-Meditech Ltd. for Korea.

Our business development efforts are ongoing to secure commercialisation partners for macimorelin in Asia and ROW.

AETERNA ZENTARIS

We are leveraging the clinical success of macimorelin to develop it also for the diagnosis of childhood-onset growth hormone deficiency (CGHD) to expand the existing indication. We have started a multinational pivotal Phase 3 efficacy study in Q4 2021 jointly with Novo Nordisk.

Our Expertise AEZS has strong scientific R&D expertise in endocrinology, CNS, and cancer, with a focus on small molecules, natural products, phospholipids, peptides, and proteins.

Pipeline Expansion Opportunities We are seeking growth opportunities as part of our efforts to re-establish a diversified, yet focused, development pipeline to leverage our expertise and experience.

We have recently signed licensing, and R&D agreements with the University of Würzburg, The University of ­Sheffield, and The University of Queensland.

CEO, Dr Klaus Paulini: “Aeterna Zentaris was established with strong expertise in research and development, which I believe is an incredible asset to the Company and one that we plan to leverage moving forward. Apart from investigating opportunities for new therapeutic applications of macimorelin, we are pursuing newly in-licensed projects with high unmet medical need and very interesting commercial potential. With our capabilities and specific know-how, we believe we are well-positioned to rapidly move promising projects into clinical development.”

Management Dr Klaus Paulini Dr Eckhard Guenther Giuliano La Fratta Dr Nicola Ammer Dr Michael Teifel

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Name Address/P.O. Box Postal Code/City Country Additional office Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity External Collaborations

Affimed

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

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Im Neuenheimer Feld 582 68120 Heidelberg Germany New York City, US Dr Angela Sickmann +49-6221-6743672 +49-6221-6743649 a.sickmann@affimed.com www.affimed.com

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LI

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150 2000

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Immuno-Oncology

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| Artiva | GHSG (Deutsche Hodgkin Studiengruppe) | Genentech | Leukemia and Lymphoma Society | MSD (Merck & Co.) | NKGen Biotech | Roche | Roivant | The University of Texas, MD Anderson Cancer Center

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

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

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

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

AFFIMED

Targeted tumour cell killing via innate immune cell engagement

innate cell

Tumour

Engager Therapy

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

In addition, AFM13 is investigated in a phase 1 combination study with adoptive NK cells.

AFM24 Innate cell target: CD16A Tumour target: EGFR

Release of Perforins and Granzymes

AFM24 binds to the EGFR, which is constitutively active in many solid tumors. AFM24 has demonstrated the killing of tumour cells independent of their mutational status (e.g. Ras) and is currently investigated in a Phase 1 study. Phase 1 clinical studies with the combination of AFM24 and adoptive NK cells as well as with Roche’s atezolizumab have been initiated.’

AFM28 Innate cell target: CD16A Tumour target: CD123 AFM28 is in development for acute myeloid leukemia and myelodysplastic syndrome.

Preclinical data show promising lysis of CD123-positive leukemic blasts and leukemic stem cells. A phase 1 study with AFM28 is in preparation.

Tumour Cell Lysis

AFM32 AFM32 is in preclinical development and the tumour target has not yet been disclosed. The program is partnered.

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Name

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Address/P.O. Box

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Postal Code/City Country Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity

AGC Biologics

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Seattle 21511 23rd Dr. SE 98021 Bothell, WA USA Nick McDonald +1-425-485-1900 +1-425-486-0300 contactus@agcbio.com https://www.agcbio.com/

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I FL

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2,400 2018 | Contract Manufacturing of Biopharmaceuticals | Process Development (Cell Line, Upstream, Downstream | Analytical Development (Bioassay, Formulation, cGMP Stability) | Quality and Regulatory | Process Validation | Microbial Fermentation and Mammalian Cell Culture | Plasmid DNA Production (pDNA services) | Messenger RNA Production (mRNA services) | Microbial Cell Banking | Bioanalytical Services | Viral Vector | Cell Therapy

AGC Biologics is a leading global Contract Development and Manufacturing Organisation (CDMO), with a strong commitment to delivering the highest standard of service to our clients and partners. The company currently employs more than 2,400 employees worldwide. Our extensive network spans three continents, with cGMP-compliant facilities in Seattle, WA; Boulder and Longmont, CO; Heidelberg, Germany; Milan, Italy; Copenhagen, Denmark; and Chiba, Japan.

AGC Biologics offers deep industry expertise and unique customised services for the scale-up and cGMP manufacture of biologics (with both mammalian and microbial platforms) and cell and gene therapies: from preclinical to commercial production.

Our integrated service offerings include cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage, protein expression – including our proprietary CHEF1TM Expression System for mammalian production – viral vector manufacturing, and cell engineering.

Cell & Gene Therapy Facility Capabilities AGC Biologics brings technical expertise to develop and optimise every aspect of cell & gene therapy development and manufacturing. Our services include messenger RNA (mRNA) and plasmid DNA (pDNA), viral vectors of different types (RVV, LVV, and AAV) in adhesion and suspension processes, and cell engineering (such as CD34+ hematopoietic stem cells, autologous and allogenic T-cells, and NK cells).

For viral vectors, our ready-to-use platform capabilities are built on cell factories (up to 48L) and bioreactors (from 200L up to 2,000L) using adherent and suspension processes, designed entirely in-house.

Our cell therapy capabilities cover numerous technologies, ranging from closed to open systems at different scales depending on client needs. Our quality system, cGMP manufacturing scale, facility layout, as well as regulatory qualifications, allow us to meet both clinical and commercial demand. As we perform more than 160 analytical tests in-house, AGC Biologics reduces turnaround time. With experience in manufacturing four

AGC BIOLOGICS

commercial products, we are the only C&GT CDMO with scientists that have experience bringing a product to market (Zalmoxis).

Microbial Facility Capabilities Microbial cell banking and storage › Master cell banks and working cell banks › Production, characterisation, and storage Process development › Upstream development › Downstream development › Analytical development Microbial manufacturing capabilities › Production of therapeutic proteins and plasmid DNA (pDNA) › Stainless steel fermenters with working volumes of 10L, 100L, 1,000L, 1,500L, and 3,000L › Continuous centrifugation harvest › Experience with E. coli, P. pastoris, and other microbial expression systems › Quality control release and stability testing

Mammalian Facility Capabilities Mammalian cell banking and storage › Master cell banks and working cell banks › Production, characterisation, and storage Process development › Upstream development › Downstream development › Analytical development Mammalian manufacturing capabilities › Production of therapeutic proteins, monoclonal ­antibodies, fragments, and other biologics › Single-use bioreactors with working volumes of 100L, 500L, 2,000L, and up to 6x2,000L (6-PackTM) › Stainless steel capacity in Boulder, CO, USA of 2x20,000L › Experience with several mammalian expression ­systems; facility approved commercially by EMA, FDA, HCA, PMDA › Quality control release and stability testing

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

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What We Do

Altasciences 575 Armand-Frappier Blvd. Laval, QC H7V 4B3 Canada Sophie Dubois +1-450-973-6077 contact@altasciences.com https://www.altasciences.com/

I +1,800 1992 Full-service CRO/CDMO offering comprehensive range of preclinical, clinical, bioanalytical, and CDMO services.

Areas of Activity

›

Preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, drug formulation and manufacturing, programme management, medical writing, biostatistics, and data management.

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions to offer pharmaceutical and biotechnology companies a proven, integrated approach to preclinical and clinical pharmacology studies, including bioanalysis, formulation, manufacturing, and analytical services. Our comprehensive, full-service solutions are customisable to specific sponsor requirements. With eight locations across North America, Altasciences helps sponsors get better drugs to the people who need them, faster.

Who We Are For over 25 years, our Altascientists have been partnering with drug sponsors to design the most efficient preclinical, clinical, bioanalytical, or manufacturing programmes that meet all regulatory requirements. We are committed to ensuring timely information capture, proactive communication, and smooth transitions between phases and studies.

Integrated Drug Development Solutions At Altasciences, early phase drug development is approached as a single continuum, rather than a series of separate steps. We can support your entire programme end to end, or you can partner with us for just one element — we offer complete flexibility. Our outsourcing platform enables you to work with a single, integrated partner from lead candidate selection to clinical proof of concept, and beyond. By centralising communication and scheduling using proprietary platforms as well as applying robust insights at each development stage, we help sponsors make more educated, faster, and more complete early phase drug development decisions. Our programme managers are the single point of contact for a comprehensive, full-service package designed to minimise hand-offs, resulting in shorter timelines and reduced costs. We call this Proactive Drug Development.

Member of

European Biotechnology Net work

8

LOCATIONS

ALTASCIENCES

IN NORTH AMERICA

Our Drug Development Solutions: Whether for one study or multiple programmes, we offer you a customised and synchronised approach to CRO and CDMO services for your regulatory submissions.

Preclinical Services: 3 facilities for a total of 550K sq. ft.

700+ safety studies conducted annually 500+ team members Full range of in vivo non-GLP and GLP safety evalation studies, for large and small molecules › Experience with both rodent and non-rodent species › Multiple routes of administration › › › ›

Clinical Services: › › › › › › ›

3 facilities in the United States and Canada 500+ beds 285+ clinical trials completed annually 400K+ participants in our database First-in-human to end of Phase II Specialty trials Healthy normal volunteers (HNVs), patients, and ­special populations

Bioanalytical Services: › › › › › ›

From discovery to preclinical to Phase IV 200+ highly trained regulatory bioanalysis specialists Capacity for 60,000+ study samples per month 25+ research and development scientists Small and large molecules Mass spectrometry, ligand binding, or hybrid assays

Manufacturing and Analytical Services: › › › ›

Small molecules Formulation development Phase I through commercial manufacturing ICH stability testing

Research Support Services:

A DIFFERENT KIND OF CRO/CDMO

› Centralised project and programme management › Scientific, regulatory, and strategic guidance for your IND/CTA submissions › Clinical protocol development › Data management › Biostatistics › Medical writing › Clinical reporting › CDISC › Archiving 12TH EUROPEAN BIOTECHNOLOGY GUIDE 2022

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

External Collaborations Request for Further Collaborations

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ASKA Biotech GmbH

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Veltener Str. 12 16761 Hennigsdorf Germany Anke Holzinger +49-3302-4941-430 info@aska-biotech.de https://www.aska-biotech.de

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FL I Q

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12 2018 S1; ISO 9001:2015

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

Our mission

| Contract manufacturing | E xpression and development of recombinant antibodies and proteins | Development and production of monoclonal antibodies | Cell line development and storage | Sample analysis of human sera and plasmas | Custom-production of ImmunoassayKits

We support our customers in their success. Our goal is to provide reliable services at competitive prices, to fulfill the specific requirements of our customers.

With over 20 years of experience in cell culture, hybridoma development, downstream processing and immunoassay production, we are able to provide an excellent service in constant quality. All employees are specialists in their field, which enables ASKA Biotech to answer every inquiry in a short time with customized solutions.

For this, we do not stop at the actual order, but think further and also advise our customers for the further process. Thus, every customer, regardless of the size of the company, benefits from our expertise.

| R&D units | IVD-, pharma and biotech-companies

Services

Cooperations and partnerships for long-term business relationships.

As an ISO 9001:2015 certified company, quality is from the beginning in ASKA’s focus as well as the supply of constant high-quality services and the customers’ satisfaction.

Our services include, but are not limited to, the following areas: ASKA’s rePro-Services: Within our rePro-Services ASKA expresses recombinant proteins and antibodies in mammalian cells. This can be realized transiently in HEK cells within weeks or via stable cell line development in CHO cells.

Thanks to transient gene expression, we can perform several small-scale productions in parallel or produce up to several grams of recombinant antibodies in a few weeks.

ASK A BIOTECH

ASKA’s monA-Services: Starting from mouse hybridoma development, ASKA Biotech develops the right antibody against the requested specific antigen. With further screening steps we are able to avoid cross reactivity or detect antibody-pairs.

Starting from an already existing hybridoma clone ASKA Biotech produces monoclonal antibodies in small and large scale under serum-free conditions.

We offer the option to dedicate the development and production of each antibody to our well-trained team with many years of experience. Alternatively, there is also the possibility to comply with customers protocol and specific needs for purification strategy, buffer, concentration, etc.

ASKA’s Immuno-Services: Our protein services are complemented by our sample analysis of human sera and plasmas and Immunoassaykit production services. ASKA Biotech offers you the entire range of services for development and production of immunoassays.

Additional Services: In addition, we offer several supplementary services such as cell line storage, aliquotation, protein polishing, diverse analytic methods, activity testing, lyophilization, and many more.

Methods, which are not in our portfolio yet, can be ­established upon request.

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

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B Medical Systems 17 Op Der Hei 9809 Hosingen Luxembourg Julian Precht +352-92-0731-1 julian.precht@bmedicalsystems.com www.bmedicalsystems.com

FL I  200-500 1979 | Vaccine Cold Chain | Medical Refrigeration | Blood Management Solutions

Who is B Medical Systems B Medical Systems is a global manufacturer and distributor of medical cold chain solutions. Based in Hosingen, Luxembourg, B Medical Systems is the global market leader in the vaccine cold chain and is a recognised innovator in the medical refrigeration industry. The company manufactures and distributes medical refrigeration solutions such as vaccine refrigerators, laboratory/pharmacy/blood refrigerators, lab/plasma freezers, contact shock freezers, ultra-low freezers, and transport boxes for medical grade storage and transport purposes across the world. All products are Class I or Class II(a) certified medical devices as per EU MDR regulations.

A wide range of medical refrigeration solutions Alongside its product lines for the Vaccine Cold Chain and the Blood Management solutions, B Medical Systems develops medical refrigeration solutions for research laboratories, universities, biobanks, pharmacies, and hospitals. The Pharmacy and Laboratory Refrigerators are designed to store vaccines, medicines, and samples at a temperature range of 2°C to 8°C, while the Laboratory Freezers can ensure a reliable storage at temperatures ranging from -41°C to -20°C. For ultracold temperature needs, B Medical Systems’ Ultra-Low Freezers can easily reach temperatures ranging from -86°C to -20°C. All these products have integrated remote monitoring and alarm systems allowing the safe storage of the specimens. Moreover, the high-quality materials used ensure better longevity and easy hygiene control, while the excellent storage capacity and modularity of the units allow the customers to make the best use of all the space available.

B MEDICAL SYSTEMS

Reliable transport solutions B Medical Systems also provides transport solutions for the safe transport of vaccines and biological specimens.

The model ranges include five passive transport boxes with different storage volumes and one active transport refrigerator working with a compressor. These models are ideal for intensive use with many transport applications across various temperature ranges (-80°Cto +8°C), even under difficult ambient conditions.

The COVID-19 emergency Since the beginning of the COVID -19 pandemic, B Medical Systems has been hard at work with various governments and organisations to prepare a cold chain infrastructure to support their immunisation campaigns, whatever the temperature requirements of the vaccines used may be. The company’s highly reliable Ultra-Low Freezers have been in high demand as they are able to cover a broad range of temperature prerequisites varying from -86°C to -20°C, while B Medical Systems’ Laboratory Refrigerators can be used for the more common specifications ranging from 2°C to 8°C.

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Name Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Website Areas of Activity Request for Further Collaborations

BNY Mellon

US Offerings Using Depositary Receipts (DRs)

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240 Greenwich Street New York, NY 10286 USA David Stueber +44 207 163 5220 david.stueber@bnymellon.com www.bnymellon.com

›

Depositary Receipts

More than 251 non-US biotechnology & healthcare companies have their equity securities traded on US markets in the form of DRs. The unique investor base, combined with the quality and depth of research coverage in the US is an important driver of this activity.

Given the sector’s importance, BNY Mellon has developed specialised expertise to meet the needs of companies. For investor relations support, management reporting and transactions, and corporate action servicing, BNY Mellon is the leading depositary bank.

›

› › › › › ›

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Assisting issuers with accessing US capital markets

Specific benefits of utilising DRs for a US listing A US-listed DR is the primary capital markets tool used by many non-US companies to list and/or raise equity capital in the US These exchange-listed, capital-raising DRs obtain maximum visibility and liquidity.

In connection with a potential US listing, while listing an ordinary share in the US may be possible, the benefits of the simplicity, flexibility, and lower cost provided by the DR structure offer numerous advantages. These advantages are the reason why a DR programme is a valued alternative for non-US companies listing in the US, even in the case of a single market listing. DRs are an accepted, proven, and economic way for non-US companies to access US capital markets.

The establishment of a DR programme (verses the US listing of ordinary shares) does not require any changes or require any reconciliation with current local administrative, governance, and registration procedures. US regulatory requirements are the same for an ordinary share or DR, but the administrative burden for a foreign ordinary share listed in the US is higher than that of a DR. A DR programme is simpler.

Accessing US markets using Depositary Receipts (DRs)

BNY MELLON

DR biotechnology & healthcare highlights Both 2020 and 2021 were extraordinary years for the biotechnology & healthcare sector. During the COVID-19 pandemic, the sector was innovative and resilient, therefore developing greater investor attention.

This momentum continued throughout 2021, with issuers continuing to raise capital via Initial Public ­Offerings outside their domestic markets.

From a regional perspective, DR issuers from the United Kingdom, Israel, France, and the Nordics were the most active and were responsible for over 61% of the volume of transactions.1 From an indication perspective, DR issuers whose therapies include oncology and immunology were ­responsible for 61% of the value of transactions.1 The average DR amount raised per transaction in 2021 was $141 million, 25% higher than the $113 million raised per transaction in 2020.1

A section of our recent biotechnology & healthcare DR programme establishments2: › › › › › › ›

Achilles Therapeutics (UK) BioNTech (Germany) Biophytis (France) Evaxion Biotech (Denmark) Genenta (Italy) Olink Holding AB (Sweden) Vaccitech (UK)

For more information, please visit the BNY Mellon website.

¹ Derived from public sources as of 31st December 2021.

2

These are selected examples solely for the purpose of this document. BNY Mellon provides no advice nor recommendation or endorsement with respect to any company or securities. Nothing herein shall be deemed to constitute investment advice or an offer to sell or a solicitation of an offer to buy securities.

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BioCopy AG

Copying Biomolecules – B-cell and T-cell Immunotherapies

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c/o Switzerland Innovation Park Basel Area AG Gewerbestrasse 24 4123 Allschwil Switzerland Dr Günter Roth +49-174-78-67-919 guenter.roth@biocopy.de www.biocpy.ch

›

IL

BioCopy has developed a globally unique method to copy biomolecules. This patented method is broadly applicable and enables rapid development of both, Bcell and T-cell immunotherapies and diagnostics. The target molecules can derive from a pathogen (for vaccines) or from a tumor (for cancer therapies). BioCopy is thus one of few companies worldwide that addresses two booming billion-dollar markets with its innovative technology platform: ultra-fast target identification for vaccines in the field of infectious diseases and T-cell therapy screenings in the field of oncology.

Name

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Address/P.O. Box

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Postal Code/City Country Contact Person Telephone Email Website Social Media Number of Employees Founded (year) Type of Laboratory

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Areas of Activity

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Biological Patents

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Request for Further Collaborations

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26 2016 Biochemistry l Biomolecular interaction studies l High-throughput kinetics l Vaccine development l Immuno-oncology Predominantly granted patent portfolio with currently 16 patent families that broadly secure our innovative technology and its applications worldwide We are interested in collaborations with companies in the field of vaccine development and T-cell therapies.

Copying Technology The basis of the BioCopy innovation is a biomolecule copier, which, in analogy to a photocopier, copies DNA, RNA or proteins from a DNA matrix. The genetic information, e.g. of a pathogen, is transferred to a special cavity chip so that each cavity contains a different fragment or mutation of the pathogen genome. Each cavity corresponds to an individual reaction chamber during the copying process. After adding a transcription/translation mixture and sealing the cavity chip with a specially coated glass slide, an individual copy of the contained fragment or mutation is generated in each cavity (“pixel”/ spot) as DNA, RNA or protein. This copy product binds to the slide surface, creating a corresponding array.

The resulting microarrays consist of thousands of spots which can be analyzed simultaneously with BioCopy’s SCORE-detection system.

Detection Technology Single color reflectometry (SCORE) enables label-free, real-time, high-throughput screening by analysis of biomolecular interactions and reliable determination of kinetic binding parameters. The SCORE system detects these interactions by measuring the change in layer thickness on the array surface that causes a color change. The SCORE system converts this color change into a binding signal. The graph can then be visualized immediately as an image or video.

BIOCOPY

Custom microarrays with over 1,000 different DNA, RNA or protein species on the surface can be analyzed within an hour using less than 10 μg of the target molecule.

Compared to state-of-the-art, this innovative technology enables measurements with a sample throughput that is 100 fold higher and a sample and material consumption that is 10 fold lower.

Development of innovative Vaccines and Immune Therapeutics Vaccinations are the best way to curtail epidemics.

Pathogens change their structure frequently and rapidly. Current methods of vaccine development can not keep up with these high mutation rates. With BioCopy’s technology, molecular changes in new or mutated pathogens can be identified within days, so that adapted, optimized vaccine precursors can be ­rapidly provided to protect against future pandemics. BioCopy’s technology can identifiy vaccine precursors for classical antibody-inducing B-cell vaccines as well as precursor identification of specific T-cell vaccines. Such a T-cell vaccine becomes vital when either the pathogen does not present good B-cell epitopes, or a classic B-cell response vaccine could cause dangerous side effects.

T-cell response characterization is also needed in the field of immuno-oncology, where T-cells are used to specifically eliminate tumor cells. BioCopy’s ultrahigh-throughput approach significantly accelerates the identification or development of selective, highly specific candidates for cancer therapeutics (e.g. for T-cell based cancer therapies) and facilitates extensive preclinical safety screening.

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

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› › › › › › › › ›

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Bioengineering AG Sagenrainstrasse 7 8636 Wald Switzerland Marc Bachmann +41-55-256-81-11 info@bioengineering.ch www.bioengineering.ch 140 1972 l Engineering & design l Service l Plants l Bioprocess control l Lab & pilot l Components

Company profile The visionary idea to provide the biotechnological industry and research community with equipment for excellence led to the foundation of Bioengineering in 1972. This idea has been put into practice by designing and constructing fermentation systems, including all components for large and small scales. By expansion of our product portfolio, based on the latest advancements in biotechnology, we are carrying this founding concepts into the 21st century.

Our company has been independent and autonomous since it was established. This approach has little in common with current corporate mind sets and the vast array of management models, which allegedly have answers for everything. It gives us the liberty for result-orientated commitment to the process specifications. Our research and design teams know how to set customers’ ideas on the road to implementation and turn them into practical reality, based on optimised organisational structures and – not least – sound financial planning.

Product portfolio Engineering & Design We build plants for our customers that meet their specific requirements. We do this at Bioengineering by having a team of dedicated engineers and designers working on every stage of a project. From the idea to the finished plant, there is a strong culture of innovation.

Our many years of experience in project management enable us to implement fast-track projects efficiently.

Service The support we offer goes beyond the planning, construction, and commissioning of plants. We provide expert knowledge, servicing, inspection, and documentation to assist with the operation of your plants. We perform two roles in one: that of an expert and a reliable partner.

Plants We design and build complete bioreactor and fermenter systems for well-known pharmaceutical and food companies. These systems are used in laboratories

BIOENGINEERING

and ­p roduction facilities to manufacture vaccines, biosimilars, starter cultures, and other products. It is no accident that our plants serve as a reference for an entire industry. With more than 45 years of experience in building plants, we have the experience, the knowledge, and the innovative capacity to realise even the most complex of plants.

Bioprocess Control We develop complex automation solutions with software and hardware for the plants and are thus in a position to offer a wide range of architectures and designs. This helps our customers to manage and monitor their plants perfectly and reliably.

Lab & Pilot We develop and build fermenters and bioreactors for laboratories and production facilities across the world.

These range from small expandable modular bench-top devices for research and development departments to scalable big plants for the manufacturing industry.

Components We develop and build components for our customers’ plants which perform very specific tasks depending on the application and the requirements. For example, components which ensure that cleaning is carried out in compliance with strict hygiene regulations and which have been reliably carried out in our plants for many years.

Every customer enjoys the advantages of our modular design approach: cost-effective transport, rapid installation, and streamlined testing and quality control. Our quality-assurance manual is the control system that ensures unified monitoring and documentation of the entire production sequence, with precise specifications, instructions, and prescribed procedures.

But the commitment to our customer does not end, once the system is installed and qualified. For us quality assurance also means providing our customers with aftersales services and replacement parts for many years to come. We have honoured that commitment for every facility built by Bioengineering since 1972.

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Biotype GmbH Moritzburger Weg 67 01109 Dresden Germany Dr Kathleen Clauß +49-351-8838-400 +49-351-8838-403 info@biotype.de www.biotype.de www.modaplex.biotype.de www.custom-solutions.biotype.de

Company Profile Biotype is a German biotechnology company that develops, manufactures, and distributes molecular in-vitro diagnostic kits for the detection and quantification of DNA- and RNA-based biomarkers. With over 20 years extensive expertise in the field of diagnostics, Biotype also provides contract development and manufacturing services. The company’s goal is to provide its customers, such as labs, pharma, and diagnostic companies with quality diagnostic tools & services.

LI Q

Assays for Molecular Diagnostics

85 1999 S1, BSL-2 ISO 13485 & ISO 9001 certified

Biotype’s portfolio of molecular diagnostic kits is used in routine laboratories supporting diagnosis and therapy in various molecular applications, such as oncology, hematology, pathogen detection, forensics, and ­veterinary.

| Molecular diagnostics | In-vitro diagnostics | Contract development | Contract manufacturing Strong network with numerous industry and academic partners Member of the Molecular Diagnostics Group (MDG); contributing solutions for healthcare, personalized medicine & digitalization

Proprietary Modaplex Platform Biotype offers a unique PCR benchtop system that simplifies the complexity of molecular diagnostics.

With little hands-on time and a simple workflow, the Modaplex platform can › Detect, differentiate, and quantify up to 50 DNA & RNA targets per 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.

BIOT YPE

Contract Development and Manufacturing Services The following points characterize Biotype’s Custom Solutions for molecular & immuno-based diagnostic tests: Assay Development & Performance Evaluation › Extensive experience in the field of molecular ­diagnostics and in-vitro diagnostics › Modular development process following Design Control Guidelines: From your idea to a marketable CE-IVD product › Bioinformatic analyses using state-of-the-art tools including machine learning and artificial intelligence for various types of biomarkers › Flexibility in biomarkers and platform technologies › Analytical and clinical performance studies Assay Manufacturing › Customized and cost-effective manufacturing processes (manual or high throughput automation) › Flexible batch sizes and formats to meet your needs › Production under clean room conditions › Supply chain management › Whole-process quality control › Customized packaging and kit assembly Regulatory Affairs & Registration Services › Assay validation on multiple platforms › IVDR support › Establishment and writing of all required documents › Application and CE registration Biotype will meet your outsourcing needs with › Rapid implementation › Flexibility › Transparency › High commitment

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Boehringer Ingelheim Biopharmaceuticals GmbH Binger Strasse 173 55216 Ingelheim Germany Matthias Reinig +49-6132-77-0 +49-6132-72-0 bioxcellence@boehringer-ingelheim.com www.bioxcellence.com around 52,000 in 2020 1885 in Ingelheim, Germany S1 Focus on human pharmaceuticals, animal health and biopharmaceutical contract manufacturing € 19.6 billion in 2020 € 3.7 billion in 2020 Boehringer Ingelheim BioXcellence™ seeks companies in need of biopharma development and GMP manufacturing services and helps customers to get their products to market on time.

Company profile Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Headquartered in Ingelheim, Germany, it operates globally with 176 affiliates and around 52,000 employees.

In 2020, Boehringer Ingelheim achieved net sales of about 19.6 billion euros.

Boehringer Ingelheim BioXcellence™ is a leading biopharmaceutical contract manufacturer — a preferred partner providing the entire production chain from DNA to Fill & Finish. With over 35 years of biotechnology experience, more than 5,000 dedicated and highly trained employees, and a global network we have helped our customers to bring 40 biologics to the market. We have also transferred and optimised more than 150 development and manufacturing projects at all stages from our customers to our facilities, as well as within our network.

We work with 70% of the world’s Top 20 pharma and many innovative biotech companies in getting the right treatments and therapies to patients.

Wherever you are, we are by your side.

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

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

BOEHRINGER INGELHEIM

We deliver progress. And it’s our pleasure.

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

We treat your products as if they were our own.

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

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

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CasZyme

About CasZyme CasZyme is a biotech company based in Vilnius, Lithuania. CasZyme aims to develop new discoveries, innovative applications, and top-quality research in the field of CRISPR-based molecular tools. The company seeks to create outstanding value for researchers and companies practising gene-editing worldwide.

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Sauletekio av. 7C LT10257, Vilnius Lithuania Monika Paule, CEO +37-060-611-496 monika@caszyme.com www.caszyme.com

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12 2017 Biotechnology

The founding team consists of Professor Virginijus Šikšnys, Chief Scientific Officer Dr Giedrius Gasiūnas, and Chief Executive Officer Dr Monika Paulė. The CasZyme founders were the first to demonstrate that CRISPR-Cas9 can be used to generate precise doublestrand breaks in DNA, thereby enabling a new era of gene editing.

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CRISPR, Molecular Tools, Gene Editing, Genomics, Genetic Engineering

Products Caszyme offers a platform of different CRISPR-based Cas proteins. Different industries and applications require proteins with different characteristics. CasZyme identifies, characterises, and develops these proteins and offers them to company clients for applications in human therapeutics, diagnostics, agriculture, research tools, and industrial biotech. CasZyme enables its clients and partners with company R&D services to apply CRISPR Cas proteins for various commercial solutions, such as new diagnostic tools, human treatment methods, new plant species, or reagents for science labs.

Partnerships CasZyme clients come from the US, Asia, and Europe.

The company is collaborating with different clients, from corporations to fast growing start ups, SMEs, academia, hospitals, etc. CasZyme has a long-term collaboration with agriculture company Corteva Agrisciences and research tools company New England Biolabs, as well as companies from the fields of human therapeutics and diagnostics.

CASZYME

Facilities CasZyme is based in Vilnius, Lithuania, where it has facilities and laboratories equipped with new infrastructure for research and development and a team of experienced employees, who are co-authors of top-level publications and patents related to CRISPR-Cas.

CasZyme activities: › Exploring new Cas proteins for various applications › Providing research services for CRISPR applications › Developing and characterising new CRISPR-based molecular tools.

CasZyme offers a variety of services for the needs of our clients: › Cas protein characterisation pipeline › Adaptation of gene editing tools according to clients’ needs › Gene editing workflow optimisation › Cell line and microbial engineering.

CasZyme offers services & solutions designed specifically for different industries: › › › › ›

Human therapeutics Diagnostics Industrial biotechnology Agriculture Research tools.

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

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Catalent Cell & Gene Therapy

Contract Manufacturing Services for Advanced Therapeutics

37, Rue Auguste Piccard 6041, Gosselies Belgium Hristina Kostic 00800-8855-6178 solutions@catalent.com biologics.catalent.com/ cell-gene-therapy

Catalent Cell & Gene Therapy is an industry-leading technology, development, and manufacturing partner for advanced therapeutics. Its comprehensive cell therapy portfolio includes a wide range of expertise across a variety of cell types, including CAR-T, TCR, TILs, NKs, iPSCs, and MSCs. With deep expertise in viral vector development, scale-up, and manufacturing for gene therapies and viral vaccines, Catalent is a fullservice partner for plasmid DNA, adeno-associated viral (AAV), lentiviral, and other viral vectors, and oncolytic viruses. An experienced and innovative partner, it has a global network of dedicated, small- and large-scale clinical and commercial manufacturing facilities, including an EMA- and FDA-licensed viral vector facility, and fill/finish capabilities located in the US and Europe. With integrated solutions for plasmid DNA, viral vectors, and autologous and allogeneic cell therapies through to clinical trial packaging and logistics, Catalent can provide full supply chain control, helping innovators get their advanced therapies to patients, faster.

ILF  18,000+ 2007 Cell Therapy, iPSC, Viral Vectors, Plasmid DNA, mRNA, Vaccines

Plasmid DNA Capabilities Plasmid DNA is a critical raw material for advanced therapeutics, including mRNA and viral vector-based cell and gene therapies and vaccines. Catalent offers plasmid DNA solutions, from supporting early activities such as lead identification to facilitating the transition to GMP manufacturing for clinical and commercial supply.

Our plasmid DNA services include: › CGMP cell banking › R&D and CGMP grade manufacturing › mg to 10+ g scale › Linearised plasmid for mRNA production With global development and manufacturing facilities, our experienced team is ready to help define and deliver an integrated programme from plasmid DNA to fill and finish for your advanced therapies.

CATALENT

iPSC Services Our end-to-end value chain offering tackles critical unmet needs in industrialising iPSC workflow. Catalent’s iPSC GMP cell banks utilise specialised reprogramming technology to transform commercial-use donor consented, clinically approved, cord blood collections into HLA-homozygous lines that are immune-compatible with a wide population.

Our dedicated iPSC expert team is comprised of the right blend of iPSC scientists and manufacturing experts working together to develop the next-generation scalable platforms to manufacture iPSC-based therapies.

Our complete toolkit offers the building blocks to industrialise iPSC-based cell therapies: › GMP lines and non-GMP equivalents, including human leukocyte antigen (HLA)-matched cell banks › iPSC reprogramming and differentiation services › Characterisation, manipulation, and release testing of iPSC banks › Cryopreservation and bank storage › Process development, manufacturing, and analytical method development for iPSC therapies

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Distretto Campania Bioscience Via L. De Crecchio, 7 80138 Naples Italy Amleto D’Agostino, Roberta Lauro +39-081-5667677 direttore@campaniabioscience.it r.lauro@campaniabioscience.it www.campaniabioscience.it 12 2013 | Industrial Biotechnologies | Innovative Technologies for the Biomedical Industry | Oncology | New Therapies | Genetics and Genomics | Cosmeceuticals, Nutraceuticals, and Functional Foods | ALISEI – National cluster on life sciences | CEBR – Council of European bioregions | EBN – European Biotechnology Network | Boosting collaboration with other EU clusters | EU projects collaboration | E xchanging best practices

Campania Bioscience operates as a regional institutional cluster, gathering together competences and facilities in the fields of health, biotech and agri-food with the commitment to valorising life sciences regional ecosystem.

Our mission is to generate a positive impact within our national community by sharing innovative products and services and strenghtening regional investment attractiveness and competitiveness, also by contributing to the training of highly qualified professionals in the field of life sciences.

The cluster is composed of 7 research entities, 47 companies and 1 technology transfer agency.

Campania Bioscience key competences: › Pharmacogenomics › Bioinformatics › Industrial Biotechnologies › Oncology › Gene expression and proteomics › Nutraceuticals, cosmeceuticals › Bioremediation and biodegradation › Molecular diagnostics › Gene therapy We firmly believe that our initiatives play a crucial role in terms of social impact, and for this reason we foster a seamless debate with local and national institutions and stakeholders on how to tackle contemporary challenges with our know-how, innovation, and passion.

Technological trajectories and projects Campania Bioscience is responsible for the management and implementation of R&D projects, with an overall value of €70 million; a few examples are given below:

(as of 2021)

Supporting new emerging industries in personalised health Member of

European Biotechnology Net work

INNOLABS project, together with seven other European clusters, aims to foster collaboration, transfer of knowledge, and opportunities among SMEs belonging

CAMPANIA BIOSCIENCE

to the fields of ICT, health, bio and medicine from different countries in order to develop, improve, and deliver disruptive technologies mainly related to mHealth, personalised healthcare and ageing populations. INNOLABS will select more than 100 innovative project ideas to accelerate and further support financially and with innovation services.

Creating genetic and genomic meta-cluster With the GEN.ERA project five EU life sciences clusters and agency partners join and share their international competences and know-how to improve the scale-up of European companies (start-ups and SMEs) involved in the genomics value chain applied to healthcare, by providing a facilitated and successful collective access to a targeted global market.

Developing innovative therapeutic approaches for drug-resistant cancer diseases The project SATIN focuses on the development of a technology platform for the pre-clinical and clinical trial of innovative therapeutic approaches for the treatment of drug- resistant tumours.

The project has an innovative scope by fostering technology transfer activities focused on both immuno-oncology and target tools to selectively attack cancer cells.

Innovative devices for SHAping the Risk of Diabetes The project IDF-SHARID focuses on the development of diagnostic tools for risk identification and early diagno‘‘sis of diabetes and aims to make molecular prediction of type 2 diabetes and the response or diagnosis of diabetes possible. IDF SHARID will exploit epigenetic and genetic information already available in the literature aiming at create, design, implement and test a prototype genomic LOC capable to identify specific epigenetic and genetic variants associated to individual risk of diabetes.

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CO.DON AG Warthestr. 21 (Headquarters) 14513 Teltow Germany

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Subsidiary: Deutscher Platz 5d 04103 Leipzig Germany Matthias Meißner, M.A. (Director Corporate Communications / IR / PR) +49-341-99190-330 +49-341-99190-309 info@codon.de www.codon.de 150 (2021) 1993 GMP/Integrated Isolator Technology (IIT)

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Tissue Engineering

Biological Patents

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For cell-based human tissue engineering therapeutics Various ongoing projects with several well-renowned hospitals, universities, and university hospitals in Europe in the field of product distribution, product development, clinical evaluation, and research CO.DON AG is seeking national and international corporate partners who have substantial resources in the field of tissue engineering and regeneration for distribution and marketing of the company’s products (international) as well as for the development of product lines.

The Company CO.DON AG develops, produces and markets autologous cell therapies for the minimally invasive repair of knee cartilage defects following trauma or degeneration. The medicinal product is a cell therapy product that uses only the patient’s own cartilage cells (“autologous chondrocytes”). CO.DON’s method is currently used in over 200 clinics in Germany and more than 17,000 patients have already been treated. In July 2017 CO.DON received EU-wide marketing authorisation for its product, with approval for Switzerland following in March 2019. The shares in CO.DON AG are listed on the Frankfurt Stock Exchange (ISIN: ISIN DE000A3E5C08).

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

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

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

CO.DON AG is certified in accordance with European Guidelines for Good Manufacturing Practice (EU-GMP) since 1997. In 1997 CO.DON AG was the first bio­ pharmaceutical 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

Innovation in Manufacturing In January 2020 CO.DON awarded a manufacturing licence for its newly built production plant in Leipzig.

This means that the Leipzig site is certified as GMPcompliant at the same time. GMP stands for Good Manufacturing Practice, a binding international standard to ensure the highest safety and quality in pharmaceu­ tical production processes.

The production site is one of the largest and most modern plants for the industrial-scale production of human cells. Routine production started in August 2021 to ensure that our cell therapy products of the highest quality are supplied to our users in Germany and other European countries.

The principle behind the Integrated Isolator Techno­ logy originally invented and developed for Teltow has been refined. Its modular construction means the plant is extremely flexible and can be expanded at any time.

Currently it consists of 3 isolators and 144 decentralised, mobile incubators, which have a capacity of 4,500 transplants a year. All resource planning and monitoring of the processes required to produce the cell therapy products is computerised.

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

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Name Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Website Founded (year) Areas of Activity

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Coherent Inc

Biosciences – The lasers you want with the performance you need.

5100 Patrick Henry Drive Santa Clara, CA 95054 USA Petra Wallenta (for EU) +49-6071-968-0 (for EU) tech.sales@coherent.com www.coherent.com 1966

Founded in 1966, Coherent is one of the world’s leading providers of lasers and laser-based technology for industrial, commercial, and scientific customers. With headquarters in the heart of Silicon Valley, California, and offices spanning the globe, Coherent offers a comprehensive product portfolio for applications across the life sciences and bioinstrumentation markets. These products range from simple laser diode modules to sophisticated multi-wavelength light engines. They are widely used in research, clinical, and analytical applications.

l Laser l Biotechnology l Laser-based solutions l DNA sequencing l Microscopy l Spectroscopy l Flow cytometry

No matter whether you’re an end user or an OEM, if you need a laser-based solution in life sciences Coherent has a standard or custom product that perfectly matches your life sciences needs and your budget. Just some of the applications we support include: Flow cytometry – Coherent supports the latest trends in multi-parameter analysers for research and clinical applications in COVID-19, as well as sorting applications such as sex selection now widely used for animal husbandry. This includes plug & play lasers at new ultraviolet wavelengths and multi-wavelength light engines that lower the cost and accelerate time to market. The superior performance of these lasers delivers data with the lowest coefficient of variation (CV).

Confocal microscopy – From the legacy 488 nm wavelength to our yellow (e.g., 561 nm) and near-IR (980 nm) wavelengths, Coherent has the perfect wavelength and power to match any dye or genetically expressed fluorescent protein. These lasers offer the ideal combination of a round, clean (M2 ≤ 1.1) beam and low output noise.

Member of

European Biotechnology Net work

COHERENT

DNA sequencing – Our unique wavelength and power scalable technology gives you the ideal laser wavelength to match any fluorescent nucleotide, as well as the power range needed to support high-throughput applications.

Super-resolution microscopy – Coherent provides lasers with the adjustable power needed for both stochastic photoswitching techniques like STORM and PALM, as well as deterministic techniques like STED and RESOLFT. The high beam quality and low noise of these lasers enable images with the highest possible resolution.

Spectroscopy – The unmatched breadth of the Coherent laser portfolio means that our lasers can be found in every laser-based spectroscopy method used in the life sciences. This includes narrow-line lasers for Raman, laser-spectrometer modules for the latest THz-Raman, and pulsed lasers optimised for both Maldi-TOF and LA-ICP-MS. Plus our one-box ultrafast lasers simplify even complex techniques like CARS and SRS. Multi-Photon Excitation (MPE) Microscopy – Coherent is a recognised leader in MPE imaging with a complete range of turnkey lasers delivering brighter images, deeper imaging, faster imaging, label-free imaging, and more. These range from widely tunable lasers to a new family of economic fixed-wavelength femtosecond lasers for both OEM and research applications, including label-free translational studies.

Coherent laser wavelengths range from the deep ultraviolet through the near-IR, with custom OEM wavelengths also available. Output powers span from milliwatts through multiple watts. And pulse widths cover everything from CW to a few femtoseconds.

For product updates, visit the company’s website at http://www.coherent.com.

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Name 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

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Coriolis Pharma Research GmbH

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

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150+ 2008 Contract research and development Formulation excellence for biopharmaceuticals, incl.: | Liquid and lyophilised formulations | Lyophilisation process development | Analytical services for biologics | Aggregate & particle analysis | Particle identification | Higher-order structure analysis | Forced-degradation studies | Long-term and in-use stability | Pre-formulation screening | Developability assessment | Supply of TOX-material | Level: R&D, GMP, S1 (BSL1), S2 (BSL2) Experience with 750+ different molecules gained in 1,500+ projects Worldwide clients in all stages of product development (early R&D to and beyond market approval). We collaborate with small virtual biotech firms, mid-size pharma-biotech, as well as TOP20 pharma-biotech companies.

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

Your partner with scientific excellence Coriolis is a globally operating service provider and one of the world leaders in formulation research and development of (bio)pharmaceutical drugs including proteins, vaccines, gene- and cell therapy products, viral vectors, nucleic acids, antibodies and related products, peptides, drug delivery systems, and small molecules.

More than 700 customers – from start-ups to Big Pharma – trust the expertise of Coriolis. We develop liquid and lyophilised formulations entirely in-house. For each individual project, our highly skilled scientists develop tailor-made study designs that align with our customers’ drug development strategies. Our formulation services support all phases of drug development from early R&D to and beyond market approval.

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

CORIOLIS PHARMA RESEARCH

Formulating innovation By following our mission of “Formulating Innovation”, we combine technologies, knowledge, and experience to add substantial financial value to our customers’ projects by generating IP for your pharmaceutical compound and supporting patent life cycle management in later phases.

Impressive analytical portfolio Coriolis can draw from a unique portfolio of more than 100 different analytical techniques – performed entirely in-house – to obtain orthogonal and meaningful data.

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

Your benefits Our high-quality services are driven by the scientific passion of our experts. You will also benefit from our scientific advisory board that includes some of the most renowned specialists in biopharmaceutical formulation development and particle characterisation: Prof. G. Winter, Prof. W. Friess, Prof. E. Wagner, Prof. G. Kersten, Prof. C. Schöneich, Prof. O. Merkel, Prof. S. Uchiyama, Prof. P. Arosio, and Prof. H. Svilenov. They are actively involved throughout each customer project – if desired – and contribute with independent advice to a successful outcome.

The scientific expertise of our project teams is also driven by our internal research unit – composed of post-docs, PhD candidates, and students – who continuously publish exciting articles in high-impact journals.

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Cybertron GmbH

Cybertron

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

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

| Development of laboratory equipment | Laboratory automation | Liquid handling | K inematic systems

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

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

The dispensing heads can be equipped with Teflon/ steel dispensing needles (1μl, 10μl, 100μl), disposable tips suitable for automation (20μl, 50μl, 200μl, 1000μl) or dosing systems for the sub-microlitre range (>100 nl). For sample preparation of comminuted/powdered

CYBERTRON

solids we also provide individually developed powder dosing heads. Depending on the application, the working deck or MDP tray can be individually configured with the desired number of 96/384/1536 MTP slots (SBS) and with various holders and adapters for deep well blocks, tubes (5–50 ml), and microtubes (0.5, 1, 2 ml). For the automation process in sample preparation we offer the following options: washing stations, external pump systems, cooling/heating adapter, temp. MTP orbital shaker, Magnetic Bead Station, SPE vacuum station, etc. Optional integration of UV-VIS-, FL- detection units (bottom read), biosensor technology, microfluidics, and other analytical measuring techniques.

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

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

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

Relevant R&D Budget

CZ VACCINES

Full-service biologics CDMO EU GMP certification CZ VACCINES is a full service provider. We cover the entire value chain from contract development through clinical phases I to III to commercial production of vaccines and biological products.

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La Relva s/n Torneiros 36410 O Porriño Spain Mercedes Rodriguez +34-986-330400 Mercedes.rodriguez@czvaccines.com https://czvaccines.com

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500+ (Zendal Group) 1993 | Biotechnology | CDMO | Development | Manufacturing | Vaccines | Virus, bacteria, cell cultivation | Aerobes and anaerobes, yeast | Covid-19 vaccines | Tuberculosis vaccines | One-Stop Shop | Biomedicine | Aseptic filling | Lyophilisation | GMP upstream & downstream processes

11% revenue

CZ VACCINES is also collaborating on the urgent development of solutions against COVID-19 through our research and manufacturing capabilities in the following projects: › NVX-CoV2373 (NOVAVAX) › Vaccine DNA PPAL-COVID19 [Spanish National Research Council (CSIC)] › Vaccine MVA-COVID-19(S) [Spanish National ­Research Council (CSIC)] › Coalition for Epidemic Preparedness Innovations (CEPI) › Others projects

Scientific Excellence CZ Vaccines has extensive scientific experience in developing new and ambitious projects that include different categories and vaccine platforms: › Human vaccines and animal vaccines › Against viral, bacterial, and parasite diseases › Conventional vaccines › Genetic engineering of live attenuated vaccines › Subunit vaccines (recombinant protein) › Latest generation DNA vaccines

CZ VACCINES

End-to-End CDMO Live & inactivated bacteria & viral vaccines up to BSL-2 Roller bottles, cell factory, & wave bioreactor Single-use & stainless steel bioreactors Sterile processing systems Centrifugation, ultrafiltration, diafiltration Chromatography (ÄKTA ready) Aseptic filling into vials Lyophilisation (clinical trial material and large scale) Process development / optimisation Quality control testing – microbiological: sterile/nonsterile, chemical-physical, and biological › Storage: (+2-8ºC), (-30ºC), (-80ºC) › › › › › › › › › ›

Manufacturing capabilities: CZ VACCINES has large manufacturing capacity located in several biotech plants in Spain and Portugal

cGMP Production capabilities: › › › › ›

Single-use bioreactors: 50L + 2x250L + 2x2000L Stainless steel bioreactors: 50L + 250L+ 2x2000L Single-use blending mixers: 2x 3000L Stainless steel vessels: 4x6000L State-of-the-art purification processes: chromatography (ÄKTA ready), centrifugation, ultrafiltration, diafiltration

cGMP fill & finish capabilities: › Liquid and lyophilised products up to BSL-2 › 4 filling machines: 6000 vials/hour - 2x12,000 vials/ hour – 24,000 vials/hour › 2 freeze dryers: up to 24,000 vials per run, and up to 180,000-200,000 vials per run › Component size: 2R-10R-20R › Manual & automatic visual inspection

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

Biological Patents

External Collaborations

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Enzymaster Deutschland GmbH

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Neusser Straße 39 40219 Düsseldorf Germany Dr Thomas Daussmann +49-211-158-216-10 +49-211-158-216-12 info@enzymaster.de https://enzymaster.de/

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206 2013 | Biocatalysis Research | Enzyme Panel Screening | Enzyme Engineering: Computer-Aided Directed Evolution of Enzymes | General and Customised Enzyme Screening Kits | Immobilisation of Enzymes | Reaction Process and DSP Development | Fermentative Enzyme Preparation and Formulation | Biocatalytic Manufacturing of Fine Chemicals, Intermediates, APIs, and other Compounds (Lab to Industrial Scale) Comprehensive international patent portfolio mainly in the field of novel engineered enzymes | JingJing Pharmaceutical Co., Ltd. | Haig Barrett, Inc.

Background Enzymaster Enzymaster provides a one-stop solution for the development and commercialisation of innovative and sustainable enzyme catalysis technologies. With our proprietary BioEngine ® and BioNavigator ® platforms as well as our long-term experience, we offer R&D services combined with the establishment of complete technology transfer packages and manufacturing collaborations to fine chemical, pharmaceutical, and other industries. Our portfolio includes enzyme identification, enzyme panel screening, smart enzyme engineering, process development, enzyme preparation by fermentation, and biocatalytic manufacturing. Enzymaster Deutschland GmbH, a subsidiar y of Enzymaster (Ningbo) Bio-Engineering Co. Ltd., is your reliable partner in the international market for enzyme applications and products manufactured by biocatalytic processes.

Enzymaster strives to contribute to a greener environment and improve manufacturing processes by helping organisations leverage the benefits of biocatalysts, decreasing dependence on toxic and often inefficient, purely chemical syntheses. Flexible fee-for-service models moving in lockstep with R&D programmes, high success rates, commitment to confidentiality, and the avoidance of one-size-fits-all IP policies allow Enzymaster to advance biocatalysis innovation rather than impede it, ultimately fuelling the future of manufacturing.

Green Magic Happens Here!

ENZYMASTER

BioEngine® Enzymaster has developed BioEngine ®, a proprietary ­directed evolution platform with integrated computational enzyme engineering. The implementation of computational hot spot identification, in silico enzyme library screening, and in silico recombination into the directed evolution cycle allows us to shift most of the screening efforts from the laboratory into the computer and cover a large sequence space of the target enzyme, all while accounting for the real chemical process conditions.

Based on the computational results, we construct smart, focused, and small libraries of enzyme variants, which can conveniently be screened via HPLC or GC to characterise a comprehensive range of desired properties for these variants. This enables us to reach the desired biocatalytic process target in typically only 3-6 rounds of combined in silico and experimental directed evolution. Therefore, BioEngine® can significantly speed up the process of bringing your idea to the market.

BioNavigator ® The BioNavigator ® platform is part of BioEngine ® and has been developed by Enzymaster as a proprietary in-house computational toolbox for sequence- and structure-guided combinatorial library design and enhanced diversity generation. BioNavigator ® is a set of state‑of‑the‑art methods for computational enzyme identification, in silico activity and selectivity prediction, and stability calculation under process conditions. This includes bioinformatics-driven hot spot identification, focused combinatorial library design, and in silico loop design. Artificial intelligence (AI) and structure‑based recombination algorithms are applied to in silico prescreening to enhance the combinatorial sequence diversity coverage beyond traditional random and sitesaturation mutagenesis approaches, thereby increasing the sequence space coverage and identifying all important sequence areas for fast and efficient enzyme engineering.

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

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Walther-Rathenau-Str. 49a 17489 Greifswald Germany Dr Rainer Wardenga +49-3834-515470 info@enzymicals.com www.enzymicals.com

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Enzymicals AG

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Enzymicals AG Industrial biocatalysis from gram to tonne We are people who truly believe in the benefits of in-vitro biosynthesis. With technologies, products, and offerings for the industrial implementation of biocatalysis, we support the global industry to enable the upcoming change to biologically inspired production concepts.

| Development and scale-up of chemoenzymatic processes incl. DSP | Customer-specific solutions in enzyme technology and biotransformation | Development and production of enzymes | Tailor-made fine chemicals, intermediates, and APIs

Enzymicals is your experienced partner for industrial biocatalysis from gram to tonne-scale, with more than a decade of experience. An interdisciplinary team of 20 scientists and technicians work on biological and chemical topics and represent the necessary know-how in analytics, molecular biology, fermentation, biocatalysis, and process chemistry to provide integrated solutions for industrial biocatalysis. The focus of the independent SME is the development and use of enzymatic processes for complex chemical synthesis, from initial catalyst lead-finding to process optimisation and scale-up, to realise tailor-made solutions for custom development and manufacturing. Our continuous activities in academic partnering and industrial collaborations result in the delivery of state-of-the-art concepts that are applicable at commercial scale. As a result, we add value and enable greener and safer manufacturing procedures.

IP protected by international patent applications and granted patents

Products & Services

20 2009 | S1 Biotech | Chemistry & Analytics | Process Engineering | K ilo Lab & Small-Scale Manufacturing

| Broad international academic R&D collaborations | Stakeholder networks | 4-chiral Network | Aminoverse B.V. | ChiralVision B.V. | Candidum GmbH | CMO and CDMO network | EU upPE-T | EU Macbeth

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 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, including 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

ENZYMICALS

well as for commercial production. Our enzyme portfolio contains a continuously 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 as 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. Within our network we provide processes in up to 85 cbm fermenters or for chemical processes in multi-kilogram to tonne scale equipment.

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 services 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. Our core working principles are high-quality R&D, professionalism, and customer satisfaction.

Let’s create value together.

Management Dr Erik de Vries, CEO Dr Sebastian Schätzle, CBO Dr David Liese, COO Dr Rainer Wardenga, BD 12TH EUROPEAN BIOTECHNOLOGY GUIDE 2022

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External Collaborations

Request for Further Collaborations

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ERBC (European Research Biology Center)

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Headquarters: Chemin de Montifault 18800 Baugy France Frank Visser (Chief Commercial Officer) +39-06-91095263 +39-06-9122233 fvisser@erbc-group.com www.erbc-group.com

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270 1972 Translational research, safety pharmacology, toxicology, from routine analysis to highly complex and customized studies | New Chemical Entity | Oligonucleotide | Protein | Peptide | Monoclonal antibody | Vaccine | Cellular therapy | Gene therapy | Excipient | Chemicals | Biocide | Plant protection products | Food & Feed Collaborations with pharmaceutical, biotech, chemical companies and CROs, from preclinical proof of concept to market Our business development team is happy to discuss your project and find tailor-made solutions for you challenges. Please do not hesitate to contact us at info@erbc-group.com

ERBC – the non-clinical engine Born on 1st November 2019, when CERB (France) acquired the toxicology activities from RTC (Italy). By merging the complementary portfolios of pharmacology and toxicology, a new full service provider was created and renamed to ERBC. ERBC is now a European leader in non-clinical studies to de-risk innovation and improve R&D productivity, offering all services from non-clinical proof-of-concept to market of any type of drug-candidate or chemical compound: › Comprehensive suite of experimental capabilities, preclinical models, regulatory pre-IND package and consultancy services › Multidisciplinary team of experts (>200 FTE), including leaders in safety cardiology, DART, electrophysiology and pathophysiology › >16,000 sqm facilities, with more than half dedicated to laboratories and animal housing › Deeply engaged in animal ethics and welfare Every year, study reports from our two Centres are successfully used in support of market authorization and new product approval submissions around the world, including the European (EMA, ECHA), US (FDA and EPA) and Japanese (MHLW and MAFF) regulatory authorities.

Investment in outstanding scientific and technical manpower, high-tech equipment and facilities are crucial cornerstones of our growth. The quality and reliability of our performance is reflected by the many ongoing and long-lasting collaborations we maintain with leading international pharmaceutical and chemical companies.

We innovate with 5 to 10 new models or methodological procedures every year.

Translational research With over 200 validated methods and models, a ­facilitated access to patient samples and a world class academic and industrial network, ERBC is uniquely positioned to establish the preclinical proof-of-concept of any therapies.

All animal models

ERBC

Safety pharmacology Over the past 40 years, ERBC has become a leader in safety pharmacology, conducting annually more than 400 non GLP or GLP-compliant safety pharmacology studies.

Core battery › Effect of the drug on vital functions in rodent and non-rodent species

All routes of administration

Follow-up studies › Cardiovascular System › Respiratory System › Central Nervous System › Autonomic Nervous System › Renal/Urinary System › Gastrointestinal System › Other Systems (immune, endocrine and hepatic functions)

Toxicology

Conventional • Oral • Intranasal • Intravenous bolus Advanced • Subcutaneous • Intratracheal • Dermal • Continuous intravenous • Intradermal infusion • Intramuscular • Intra-duodenal • Intraperitoneal • Intra-hepatic • Intravaginal • Intra-urethral • Intrarectal • Ocular (subretinal • Intravascular and intravitreal) • Ocular instillation • Cerebral (stereotaxia) • Intratechal (cisterna magna) • Intra-articular

ERBC offers a full range of services covering from exploratory programs to fully GLP-compliant toxicology studies. The latter range from acute to chronic toxicity, with different species and multiple routes of administration, to specialty toxicology. › General Toxicology › Developmental & reproductive toxicology (DART) › Neonatal and juvenile toxicology › Endocrine toxicology › Genetic toxicology › Carcinogenicity › In vitro toxicology › Cardiotoxicity › Local tolerance › Immunotoxicology

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Eurasanté

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Parc Eurasanté Ouest – 310, avenue Eugène Avinée 59120, Loos France Caroline Auberger +33-3-28-55-90-60 cauberger@eurasante.com https://lille.eurasante.com/

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111 1994 | Innovation | Technology transfer | Business development | Life sciences | Health | Nutrition

Eurasanté, one of the best innovative hubs for biotech in Europe Eurasanté is a technology transfer tool, an incubator, an accelerator, and a cluster manager in the Life Sciences sector in Northern France. Eurasanté assists French and foreign companies, entrepreneurs, scientists, and clinicians in their innovation and development projects in the Northern France region.

The region includes over 1,100 healthcare companies with 32,000 employees in this sector. Their strengths are in neurodegenerative diseases, medical chemistry, and nutrition. Eurasanté also promotes and develops the Eurasanté Bio-business Park, which hosts 8 hospitals, 4 universities, 7 specialised schools, 200 companies, and 50 laboratories within a European-wide scientific and medical site.

Eurasanté fosters technology transfer and collaborative projects and supports the emergence of start-ups and spin-offs. Two programmes have been created to stimulate the creation of start-ups in the biotechnology sector: the Eurasanté Bio Incubator and Bio-Accelerator.

They provide a range of services and expertise to help international start-ups wishing to penetrate the European healthcare market and to join an ecosystem among the most fertile in Europe. The Eurasanté Bio Incubator is ranked among the top 25 best European incubators fostering biotech start-up development (Labiotech.eu 2021). Since its creation in 2000, it has accompanied 260 projects, helped the creation of 140 start-ups that generated 1,300 jobs, and raised €670 million in equity.

Eurasanté facilitates the relocation of companies, whether they plan to expand or begin new activities in France, and gives access to investment funds dedicated to innovative start-ups: CAPTECH SANTE NUTRITION and French Tech Seed. These investment funds strengthen co-investment. For biotech start-ups wishing to start clinical trials, the funding needs can be supported through new fundraising, closed thanks to the public and private investors involved in the investment funds.

EURASANTÉ

BioFIT — the leading leading European partnering event for early-stage deals and investment rounds in the field of life sciences Eurasanté also organises four international healthcarerelated partnering events that aim to increase and improve interaction between academia and industry: BioFIT, as well as MedFIT (MedTech, Diagnostic, Digital Health), NutrEvent (Food, Feed, Nutrition, Health), and AgeingFit (Healthy Ageing).

As one of the top three European business conventions thanks to its record figures, BioFIT is the leading partnering event in Europe for technology transfer, academia-industry collaborations, and early-stage innovation deals in the field of Life Sciences. BioFIT is also the European marketplace for pre-seed, seed, and series A investment in Life Sciences.

During its previous edition (10th), which was held online, BioFIT delivered on its promise by bringing together more than 1,000 international key players from 35 countries, such as Big Pharma, emerging and small biotech companies, diagnostic companies, pre-seed / seed / series A investors, as well as professionals from tech transfer, academia, and research institutions.

BioFIT provides the ideal environment for academia and industry actors to build partnerships, to source innovative and competitive early-stage R&D projects, to facilitate the emergence of collaborative projects, to increase licensing opportunities, to obtain funding, and to facilitate market access.

The 11th edition of BioFIT will be held on 29 and 30 November, 2022 in Strasbourg, France.

More information and registration: www.biofit-event.com

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EuroJobsites Ltd.

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Unit 8, Kingsmill Business Park, Chapel Mill Rd. KT1 3GZ United Kingdom Lars Peter Svane +44-20-3608-8800 +32-2-790-32-00 info@eurojobsites.com EuroJobsites.com

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20 2003 Research Scientist and Pharma Expert Jobsites

EuroScienceJobs Since 2007, EuroScienceJobs has been advertising thousands 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 24,000 subscribers. Over 13,000 job alerts subscribers receive over 40,000 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 nine years ago. With over 3,500 LinkedIN followers, over 5,000 Facebook followers and over 1,500 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 4,000 research scientists are registered in the EuroScienceJobs CV database, plus thousands of other STEM candidates.

EUROSCIENCEJOBS EUROPHARMAJOBS

EuroPharmaJobs EuroPharmaJobs is focused on Regulatory Affairs, Pre-Clinical Research, 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 and biotech industries and research institutions. Candidates have degrees in areas like biochemistry, biotechnology, molecular biology and many other scientific and commercial disciplines.

Advertisers include pharmaceutical and biotech companies such as Lundbeck, Boehringer Ingelheim, Almirall, West Pharma, Astra Zeneca, 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 around 10,000 users every month, over 6,000 weekly newsletter subscribers, and every week around 15,000 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 EuroPharmaJobs CV database.

EuroScienceJobs – Areas of interest Biology Chemistry Biotechnology Molecular Biology Engineering Medicine Biochemistry Environment Pharmaceutical Nano-Technology Physics Microbiology Earth Science 0%

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EuropaBio aisbl

EuropaBio: Biotechnology for people and planet

Avenue des Arts 53 1000, Brussels Belgium Dovile Sandaraite d.sandaraite@europabio.org www.europabio.org

EuropaBio was founded in 1996, representing innovation, investment, and excellence from biotechnology within industry as the leading association in Europe.

FL I  I 13 1996 | Advocacy | Biotechnology representation | Policy and regulatory support

EuropaBio works with members to: › promote an innovative, coherent, and dynamic sector core for Europe’s industrial strategy › advocate free and open markets and the removal of barriers to competitiveness › champion socially responsible use of biotechnology to enable its full benefit for people and planet Members span the full range of industrial activity, from start-ups and SMEs through to multi-national companies, plus the National Associations that make up the ecosystem for biotechnology in Europe.

Healthcare Biotechnology Council The EuropaBio Healthcare Council champions the impact of innovative biotechnology advances for European citizens, supporting health and effectively treating disease, as well as harnessing the power of research for unmet clinical needs. It addresses the principles that underpin a successful and sustainable European sector, including the regulatory and legislative frameworks that translate innovation into effective and accessible treatments.

The Council highlights the critical role of a rich and diverse innovation pipeline for Europe, from research to SMEs to large-scale patient delivery, and includes the Patient BioForum, where people at the centre of healthcare help guide priorities across industry, research, healthcare, and policy.

Industrial Biotechnology Council Industrial biotechnology uses enzymes and microorganisms to make biobased products from renewable raw materials in sectors such as chemicals, food and feed, detergents, paper and pulp, textiles, and bioenergy.

The Business of Biotechnology Growing for Europe’s Tomorrow Biotechnology serves people, planet and economy, delivering the innovations and industries of the future for a sustainable and competitive Europe.

Industrial Gross Value Added (GVA) per year of €78.7bn, 1.5% of total GVA.

Over 900,000 people employed within the biotech industries.

4.1% average annual growth rate, one of the fastest growing sectors in Europe (average growth 1.9%).

EUROPABIO

EuropaBio’s Industrial Biotechnology Council develops sector-specific strategy, formal advocacy, and biotech positioning within teams of companies, national association representatives, and sector experts. These drive EuropaBio messaging and actions in the area of industrial biotechnology. The EU Green Deal is a primary focus, increasing political and public recognition of the relevance and value of industrial biotechnology. Activities centre around circular bioeconomy, food and feed, and our flagship event, the annual European Forum for Industrial Biotechnology and the Bioeconomy (EFIB).

EFIB 2022 The next edition of EFIB, Europe’s leading event on Industrial Biotechnology and the Bioeconomy, under the title “Next generation economies: Industrial biotechnology for a sustainable society”, will take place 26-27 October 2022 in Vilnius, Lithuania. The Forum will be co-hosted by the Lithuanian Biotechnology Association (LBTA) together with Go Vilnius – the city’s official business and tourism development agency.

More information can be found at www.efibforum.com.

National Associations Council (NAC)

€22 bn trade surplus in high value goods.

From: Measuring the Economic Footprint of the Biotechnology Industry in Europe (2021), an economic impact study conducted in 28 European countries, by the WifOR Institute for EuropaBio.

EuropaBio was founded through the shared ambition of countries across Europe and the NAC works to represent many of the key national priorities, while also supporting alignment and collaboration. Our National Associations bring the infrastructure, skills development, and other critical components to the biotechnology ecosystem.

Every year National Associations, biotech companies, policy makers, and others gather at the National Associations Council Summit, which serves as a platform to discuss the ongoing policy developments on the national level and the policy priorities and vision of the Presidency of the Council of the EU. The NAC Summit outcomes serve as key policy and initiative recommendations for the successful societal and economic performance of biotechnology across sectors.

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Excelya

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738 rue Yves Kermen 92100 Boulogne Billancourt France Alan Morgan +33-1-46-20-74-50 contact@excelya.com www.excelya.com

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900+ 2014 CRO Clinical Operations, Data Management, eTMF, Medical Writing & Publishing, Medical Affairs & Monitoring, Pharmacovigilance & Safety, Quality Assurance, Regulatory Affairs, Statistics & Programming, Strategic Development & Governance, Vendor Management & Oversight

Excelya is a premium independent CRO headquartered in Europe, providing support to clients around the globe in the pharmaceutical, medical device, and biotechnology industries. With a strong desire to add value and to deliver expertise to both clients and employees alike, Excelya strives to become an integrated part of sponsor teams and projects. By delivering long-term career development to staff, we are able to provide clients with contractors who are dedicated and are rich in expertise and experience.

With 900+ staff, decades of therapeutic experience, and global capabilities across 25+ countries, we are bringing a fresh approach to clinical trials. Full service.

FSP. Consulting.

To meet your needs, we leverage 30 years of local, therapeutic, and service experience. Our focus is on your project, for which we utilise our expertise, experience, and technology.

Our aim is to expertly recruit the right personnel and implement the right processes to help our clients meet their objectives. Not only do we have an impressive existing network of employees across Europe, India, and beyond, but we regularly attract and onboard highquality candidates. We believe that our people are our greatest assets, and have an internal team dedicated to sourcing, recruiting, and nurturing our best-in-class team members.

Not only does Excelya supply quality people to execute your clinical trials and R&D operations, we also have a uniquely scalable model where clients receive a tailored SLA that will deliver the results needed, in a way that satisfies a plethora of budgets, geographies, trial phases, therapeutic areas, and more.

EXCELYA

Talent management and project management are our core products, which we are able to deliver expertly across an array of different therapeutic areas. We operate in either a Full Service, Functional Service Provider, or Consulting framework, reflecting multiple operational capabilities.

Our tripartite solution model allows us to offer clients a highly customised level of service and experience.

We do not offer fixed packages, and no two Excelya projects look the same. They are always tailored and are as unique as the drug and medical device development companies we partner with. We are able to scale our influence and involvement in any clinical trial, according to client requirements.

Excelya has also been awarded a silver EcoVadis sustainability rating, in 2021, meaning that we have demonstrated consistent high standards and good practices in the areas of the environment, labor & human rights, ethics, and sustainable procurement, with ambitions to improve even further in the near future.

Excelya is proud to be the highest quality European CRO, with the most comprehensive service coverage throughout Europe. With a superb, highly qualified, experienced, and dedicated team who pride themselves on offering a high value service to our clients, we are confident that a partnership with Excelya will ensure that your R&D clinical trials run smoothly.

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

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FGK Clinical Research GmbH Heimeranstr. 35 80339 Munich Germany Martin Krauss, Dr Edgar Fenzl +49-89-893-119-0 martin.krauss@fgk-cro.com edgar.fenzl@fgk-cro.com www.fgk-cro.com www.fgk-pv.com www.fgk-rs.com 190 2002 Full service CRO (contract research organisation) offering a complete range of clinical development and consulting services: | Regulatory Affairs | Project Management and Monitoring | Medical Safety | Data Management / Biostatistics | Medical Writing | eSolutions for Clinical Trials | 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.

Member of

European Biotechnology Net work

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 190 employees – most of them located in our headquarters in Munich, Germany. Covering all phases and areas of clinical development, our focus is on phase II and III trials. We have experience in all important medical indications, including in particular in oncology, cardiology, neurology, dermatology, and gastroenterology.

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

Locations We directly supervise international projects and operate Europe-wide, with staff located in our headquarters in Munich, in our branch office in Berlin, and in our subsidiaries in the Czech Republic, Hungary, and Poland.

Our in-house CRAs monitor many European study sites themselves. For additional countries and sites in the US/Canada, we have suitable long-term partners.

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

FGK CLINICAL RESEARCH

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

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Fördergesellschaft IZB – Innovations- und Gründerzentrum Biotechnologie mbH 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 36 1995 S2 labs l Biotechnology l Life Sciences over 50 start-ups l Collaborations with the scientific faculties on the Campus Martinsried l Munich Life Science Pitch Day with the High-Tech Gründerfonds Management GmbH l IZBrunch - Science meets Sciencs l Law Lab - law for biotech businesses l Biotech Press Lounge

Hotspots for life science start-ups The IZB, founded in 1995, is the operating company for the Innovation- and Start-up Centers for Biotechnology located in Planegg-Martinsried and Freising-Weihenstephan, and has developed into one of the top ten biotechnology centers in the world. Currently, in an area totaling 26,000 m2, over 50 biotech companies with over 700 employees are located. An essential criterion for the success of the IZB is its close proximity to outstanding research at the Ludwig Maximilians-University (LMU) and renowned biotechnology research establishments on the Campus Martinsried, such as the Max Planck-Institutes für Biochemistry and Neurobiology.

Magnet for biotech start-ups Since 1995, the Planegg-Martinsried location, now covering 23,000 m 2, has accommodated Start-ups focusing on medical biotechnology. Since 2002, the IZB in Freising-Weihenstephan with 3,000 m2 of space offers optimal conditions for establishing companies in the sector of life sciences.

Here, young entrepreneurs and company founders come upon an optimal infrastructure for transforming their products or services into business propositions, within a competence cluster for life sciences that is one of the best in the world. S1 labs for fair rental prices, internal property management, close contact to the venture capital scene, as well as joint location marketing are also factors for our success, as is the flexibility to adapt space requirements to the development of our tenants.

Top research at the Campus Martinsried Today the scientific and business Campus Martinsried is one of the largest centres in Europe where teaching, basic scientific and clinical research, as well as technology innovation are combined on one campus. Located in the direct vicinity are other institutes such as the Max Planck-Institutes for Biochemistry and 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

IZB

(ZNP), the Gene Center and Institute for Biochemistry, the Biomedical Center, the BioSysM Bavarian Research Network for Molecular Biosystems Biosystems, the ­Institut of Chemical Epigenetics, Research Center ICON for Diseases of the Cardiovascular System of the LMU and the LMU Hospital (under construction) and the Surgery Center of the Clinical Center Grosshadern.

The close proximity of the scientific institutes around the Campus Martinsried confers a huge competitive advantage. Young scientists can profit from incorporating expertise in science and research into their own business enterprises; short distances promote interaction and cooperation between biotech companies – in terms of globalisation both factors are essential requirements for successfully entering world markets.

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

IZB – in brief › 26,000 m2 laboratory and office space for start-ups and growing companies › Home for over 50 start-ups › Business development support › In-house estate management › Center of an impressive research campus › Access to an international network › Flexible lab and office structures › Close contacts with investment partners › Joint location marketing › Attractive, modern conference rooms, also for external booking › IZB Residence CAMPUS AT HOME (42 Rooms) › Faculty Club G2B › Restaurants: SEVEN AND MORE and Café The Bowl › 2 day care centres (Bio Kids & Bio Kids2) 12TH EUROPEAN BIOTECHNOLOGY GUIDE 2022

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Name Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity External Collaborations

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Formycon AG

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Fraunhoferstr. 15 82152 Martinsried/Planegg Germany Sabrina Müller +49-89-864-667-100 +49-89-864-667-110 sabrina.mueller@formycon.com www.formycon.com

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~170 2012 Biosimilar Development, COVID-19 Drug Development FYB201, Formycon’s Biosimilar Candidate to Lucentis® (ranibizumab), licensed out to Bioeq AG, a joint venture between Strüngmann Group and Polpharma Biologics. Commercialisation of FYB201 by Coherus BioSciences, Inc. in the United States of America, Teva Pharmaceutical Industries Ltd. in Europe and other territories and MS Pharma in Middle East and North Africa.

FYB202, Formycon’s Biosimilar Candidate to Stelara® (ustekinumab), developed in a joint venture with Aristo Pharma GmbH, a company owned by the Strüngmann Group.

FYB203, Formycon’s Biosimilar Candidate to Eylea® (aflibercept), licensed out to Klinge Biopharma GmbH, a company owned by the Strüngmann Group.

FYB207, Formycon’s COVID-19 Drug in development with academic partners Prof. Dr Ulrike Protzer, Chair of Virology, and Prof. Dr Johannes Buchner, Chair of Biotechnology, Technical University of Munich. Licensed out to SCG Cell Therapy Pte Ltd for Asia-Pacific-Region (except Japan).

Who we are: Formycon is an expert company for the development of high-quality biopharmaceuticals, especially biosimilar medicines. The company’s pipeline contains three late-stage biosimilars, one preclinical biosimilar and an innovative COVID-19 drug.

Biosimilars – Medicines for the Future A biosimilar medicine is a biological medicine highly similar to another already approved biological medicine (the ‘reference medicine’). Biosimilars are approved according to the same standards of pharmaceutical quality, safety, and efficacy that apply to all biological medicines.

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

What we do: Formycon develops biosimilars for the rapidly growing disease areas of ophthalmology and immunology as well as for other key chronic diseases. Formycon covers all stages of biopharmaceutical development from analytics and cell line development to preclinical and clinical studies, all the way through to the preparation of regulatory submission documents.

We develop biosimilar medicines to meet the high standards of the world’s most regulated markets: European Union, United States, Canada, Japan, and Australia.

FORMYCON

Our Expertise: Our unique advantage lies in the vast expertise of our international scientists, our management, and our board members. Through their long and distinguished careers, these scientific and business professionals have already, in their past work, successfully brought the world’s first biosimilars to market and bring comprehensive experience and expertise spanning all stages of drug development – from market analysis and protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.

Innovative COVID-19 Drug Based on extensive experience in biopharmaceutical drug development, Formycon is also working on the development of a COVID-19 drug: with FYB207, ­Formycon is developing an efficient antiviral SARS-CoV-2 blocker based on a long-acting ACE2-immunoglobulin fusion protein.

SARS-CoV-2 and other corona viruses use the protein ACE2 on the surface of human cells as a portal of entry for respiratory infections. Formycon has therefore fused the human ACE2 protein with the constant part of human immunoglobulin to create an innovative COVID-19 drug (FYB207) that is protected against viral mutations, completely prevents cell infection in vitro, and can potentially be used against all coronaviruses that use ACE2 as a portal of entry for cell infection.

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

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FyoniBio GmbH Robert-Rössle-Str. 10 13125 Berlin Germany Dr Doreen Weigelt +49-30-9489-2500 contact@fyonibio.com www.fyonibio.com 20+ 2019 ISO 9001 certified and GCLP compliant S1 and Bio2 Service business with own technology platform in cell line development, USP/ DSP development, MS-based PTM & glycoanalytics, bioassays and clinical bioanalysis under GCLP

As spin-out from Glycotope we are a contract development organisation offering our 20 years of experience in developing biopharmaceuticals from cell line development to clinical bioanalysis and bioassays for our customers.

We are an ISO 9001 certified company located on the biotech campus Berlin Buch and operate in part under GCLP. We provide: › One-stop shop from clone development to RCB for CHO and GlycoExpress® cell lines › Process development ready to transfer to the GMP facility of your choice › Cutting edge know-how in glycobiology (analytics and cell biology) › Bioassay development for a wide range of proteins › Excellent know-how in PK, biomarker, and immunogenicity analysis of clinical samples under good clinical and laboratory practice (GCLP) › Excellent track record: Delivering high quality in ­service and products › Professional project management and customer care › Experienced team

Glycosylation and cell line development Gycosylation is dependent on the host cell line. FyoniBio provides cell line development services using its ­human GlycoExpress® (GEX®) cell lines as well as its CHO platform technology CHOnamite®.

Process development We offer upstream, downstream, formulation, and analytical development.

Our upstream process development is based on mammalian cell culture systems (GlycoExpress®, CHO-K1, CHO-DG44, and others) for fed-batch, perfusion, and intensified fed-batch processes.

FYONIBIO

Analysis of PTMs (incl. N- and O-glycosylation) We are skilled in state-of-the-art and advanced highresolution analytical UPLC-MS methods for various biomolecules.

Clinical bioanalysis Our core competencies are the evaluation of PK and PD characteristics of biotherapeutics as well as their immunogenic and neutralising potential. Assays are established and validated according to the current ICH, FDA, and EMA guidelines. Samples are analysed u ­ nder “Good Clinical Laboratory Practice” (GCLP).

Analysis of SNPs is another service of ours to select and stratify patients in clinical trials.

Bioactivity and cellular assays Adequate bioassays are needed during all stages of drug development.

We establish cell-based assays using different target and effector cells including human primary immune cells. Assay validation and application within clinical trials is our daily business.

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

Galenica AB

Galenica – The art of formulation Overview

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Medeon Science Park P A Hanssons väg 41 205 12 Malmö Sweden Lars Wannerberger +46-734-43-91-30 lars.wannerberger@galenica.se www.galenica.se

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80 1999 Pharmaceutical development Formulation development, manufacturing of clinical trial material SEK150m Interest in assisting partners in their development of non-sterile pharmaceutical products

Galenica is a Swedish privately owned pharmaceutical company, authorised by the Swedish Medical Product Agency.

Our business is divided into three separate units: › Drug product contract development (CRO) › Contract manufacturing (CMO) › Development and launching of own pharmaceutical dermal products (PHARMA) In the CRO unit Galenica supports and guides our partners in their pharmaceutical development programs.

We have expertise in pharmaceutical and analytical development as well as in production of clinical trial material up to phase III. In the CMO unit Galenica manufactures niched products for our customers to bring to market.

The PHARMA unit actively develops and launches ­Galenica’s own pharmaceutical products on the market, utilising our expertise in drug formulation, manufacturing, and quality control. Our first product on the market, Ovixan®, was an improved prescription-only mometasone cream formulation for the treatment of psoriasis and eczema. Our second product, Oviderm ®, was a moisturising cream for the treatment of dry skin.

Galenica also obtain the commercial rights in the Nordics for the product Ameluz, a product to treat mild to moderate actinic keratoses, skin growths caused by exposure to sunlight.

Galenica CRO – Experts in formulation development Galenica is a reliable contract development partner of pharmaceutical projects and has a proven track record when it comes to quality, knowledge, and flexibility, as well as keeping timelines.

Galenica performs high quality formulation service for our partners in the development of oral, dermal, nasal, rectal, and pulmonary products from small molecules to peptides. Galenica assists our partners in their pharmaceutical product development and our staff contribute with their long experience of almost all types of dosage

GALENICA

©Roger Nellsjö

©Josefin Widell Hultgren

forms. Our scientists formulate and manufacture clinical trial materials for all stages of our partner’s project. From simplified dosage forms in the earliest clinical stages to phase III batches of the final product.

Working to current GMP and ICH guidelines, and pharmacopoeias, Galenica provides pharmaceutical analytical services for a wide variety of development projects.

With an extensive range of fully qualified analytical equipment available, as well as stability study expertise, we work closely with our partners to assist every stage of the product development process. Our quality control analytical laboratories ensure compliance to current specifications, from raw materials to finished product.

Galenica has quality control systems with strict adherence to GMP regulations.

Our quality assurance staff continuously develop and maintain our quality system to ensure that we fulfil the requirements of the authorities. All activities at Galenica are project driven and each project is assigned a project manager, responsible for the evolving process. The ­project manager works closely with the customer, keeping direct communication lines open at all times. Galenica also provide regulatory services and we assist our partners through the regulatory hurdles associated with drug development, facilitating approval of submissions.

At our facilities in Medeon Science Park in the central of Malmö we have more than 4,700 m2 of lab, office, conference rooms and storage space. These state-of-the-art facilities will ensure that we can continue our successful growth journey during the coming years.

©Lars Strandberg

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

Telephone Email Website Social Media Areas of Activity

External Collaborations

The Berlin-Brandenburg BioRegion … … a Leading Hub for Life Sciences

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HealthCapital – Cluster Healthcare Industries Berlin-Brandenburg Fasanenstr. 85 10623 Berlin Germany Dr Kai Bindseil, Clustermanager HealthCapital Berlin-Brandenburg +49-30-46302-463 info@healthcapital.de www.healthcapital.de

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The region’s distinction is anchored in its unique research and clinical landscape, as well as its ability to closely link the key players in the life sciences and healthcare. Biotechnology, in particular, is a strong driving force within the Berlin-Brandenburg healthcare industries cluster – HealthCapital – generating innovation and growth there and beyond. Through networking the pharmaceutical, diagnostics and medical technology sectors completely new fields of business are created.

More than 250 biotechnology and around 30 pharmaceutical companies are located in the German Capital Region. They include market leaders like Bayer, Bausch & Lomb, B. Braun Melsungen, Berlin-Chemie, Pfizer, Sanofi and Takeda. Along with the sector’s many small and mid-sized companies, they benefit from close cooperation, both with science and with more than 140 hospitals – above all, one of Europe’s largest university hospitals: Charité – Universitätsmedizin Berlin. Customers from research and industry have access to patient cohorts of urban and rural populations of about 180 ethnicities, covering all medical indications. The many technology parks and networks in the various branches of modern biotechnology create the excellent infrastructure and technological support that characterize the BerlinBrandenburg life sciences area. Focus of biotech activity within the region are computational biology, biomedicine and diagnostics, therapeutics and regenerative medicine as well as industrial biotechnology.

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l Technology transfer between science and industry l Initiation and support of networks l Support for technology-oriented start-ups l Funding support for innovative project concepts l Providing and presenting regional life sciences information l Building and coordinating of scientific and interdisciplinary networks l Establishing contacts between experts from all disciplines l Organisation of events and seminars, Public Relations work for the life sciences region l Member of the Council of European Bioregions l ScanBalt l Member and contact point in Berlin for Enterprise Europe Network (EEN) l Collaborations with European Life Science clusters and SMEs in several Horizon 2020 projects and other activities l Go Cluster l Bio Deutschland l EIT Health l Global Health Hub

The Berlin-Brandenburg region is one of the leading, international locations for life sciences. The area concentrates on clinical research via a dense and compact healthcare network, and boasts a state-of-the-art IT infrastructure. It is no coincidence that the region is Germany’s ‘health capital’ as it is home to both the German government, as well as the centre for healthcare industries.

HEALTHCAPITAL

© Sliver - stock.adobe.com

… connected to the European Hotspots Active cooperation in the networks of Europe’s BioRegions has played a central role in the internationalisation efforts in the region. The region is a member of the Council of European Bioregions (CEBR), ScanBalt and EIT Health.

… offering Service and Support for Life Sciences in the Capital Region

© catalin - stock.adobe.com

The central contact and coordination office for all issues concerning life sciences in the German Capital Region is HealthCapital. At the interface of business, science and clinics, the HealthCapital cluster management drives networking and the technology transfer and supports companies interested in relocating to the region. Berlin Partner for Business and Technology and the Economic Development Agency Brandenburg (WFBB) are responsible for managing the cluster.

Meet us 2022 at

© Thomas Andreas - shutterstock.com

BIO Europe Spring | March 28-31 online DMEA | April 26-28 in Berlin, Germany BIO International Convention | June 13-18 in San Diego, USA BIO Japan | October 12-14 in Yokohama, Japan BIO Europe | October 24-26 in Leipzig, Germany MEDICA | November 14-17 in Düsseldorf, Germany

See you at BIONNALE 2022 | May, 11 and 12 in Berlin and online

© angellodeco - shutterstock.com EUROPEAN UNION European Regional Development Fund

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

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IBA Lifesciences GmbH

High performance research tools for cell and protein isolation

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

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

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l Strep-Tactin®XT l Twin-Strep-tag® l Streptamer® Numerous in- and out-licensing contracts

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

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

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

IBA

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

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

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

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

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

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

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Immunic Therapeutics

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Lochhamer Schlag 21 82166 Gräfelfing Germany Jessica Breu (Head of Investor Relations and Communications) +49-89-2080477-09 info@imux.com www.imux.com

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55 2016 | Immunology | Chronic inflammatory and autoimmune diseases | In November 2018, Japanese pharma company Daiichi Sankyo granted Immunic an exclusive global option to license IMU-856. Immunic exercised the option in January 2020. | In support of the InnoMuNiCH project, funded by the German Ministry of Education and Research, Immunic together with three partners – a Japanese pharma company, the University of Kyoto, and quattro research – initiated a three-year research project running from August 2019 to July 2022.

Immunic is a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases. The company’s development pipeline consists of three small molecule products: vidofludimus calcium (IMU-838) is a selective immune modulator that inhibits the intracellular metabolism of hyperactivated immune cells by blocking the enzyme DHODH; IMU-935 is a selective inverse agonist of the transcription factor RORγ/RORγt; and IMU-856 targets the restoration of the intestinal barrier function.

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

In the third quarter of 2020, Immunic reported excellent results from its phase II trial of vidofludimus calcium in relapsing-remitting multiple sclerosis (MS), achieving both primary and key secondary endpoints with high statistical significance. In the second half of 2021, Immunic enrolled the first patients in its phase III programme of vidofludimus calcium in relapsing MS and in its supportive phase II trial of vidofludimus calcium in progressive MS, which is designed to corroborate the drug’s neuroprotective potential. In addition, vidofludimus calcium is being tested in a phase II trial in ulcerative colitis. Top-line data is expected to be available in the second quarter of 2022.

IMMUNIC THERAPEUTICS

IMU-935: An oral IL-17 inhibitor in clinical phase I development IMU-935 is a highly potent and selective inverse agonist of the transcription factor RORγ/RORγt. The nuclear receptor RORγt is believed to be the main driver for the differentiation of Th17 cells and the expression of cytokines involved in various inflammatory and autoimmune diseases. In December 2021, Immunic reported positive safety, tolerability, and pharmacokinetic results from the single and multiple ascending dose portions of the phase I trial of IMU-935 in healthy volunteers.

Immunic extended this trial, as planned, to assess safety, tolerability, and exploratory disease endpoints in patients with psoriasis. In addition, Immunic is currently conducting an open-label phase I dose escalation trial of IMU-935 in progressive metastatic castration-resistant prostate cancer.

Immunic’s third programme, IMU-856, is an orally available, small molecule modulator that targets a yet undisclosed protein. Based on preclinical data, Immunic believes this compound appears to represent a novel and potentially paradigm-shifting treatment approach, as the mechanism of action targets the restoration of the intestinal barrier function. A phase I trial is currently ongoing. The single and multiple ascending dose studies in healthy volunteers are planned to be followed by a third one in patients with diseases involving bowel barrier dysfunction.

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

From inception through 2021, Immunic raised net cash of approximately USD 260 million from private and public offerings of preferred and common stock.

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

Biological Patents External Collaborations

Request for Further Collaborations

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Indivumed GmbH

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

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>250 2002 L2, S1 Service and partnering in the field of personalized cancer medicine; interna­ tional standardisation of tissue, blood and clinical data collection in >60 can­ cer clinics in Europe, North-America and Asia; Multi-omics analysis of cancer tissue combining WGS with proteomics, phosphoproteomics, whole transcrip­ tomics, and immuno­phenotyping; Data analysis using bioinformatics, artificial intelligence, and other tools. Various kinds of laboratory services for target and biomarker development.

Indivumed has been granted several patents relating to cancer biomarkers.

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

Indivumed intends to enter into ­strategic collaborations with industry partners for the joint development of cancer diagnostics and therapeutics.

Company overview Indivumed is a global oncology company and a unique resource for accelerating cancer research and advancing precision oncology.

Founded in 2002 as one of the first companies in the field of personalized cancer therapy focused on the phenoytypic characterization of cancer in individual patients with the mission to unveil the complex mechanisms of cancer.

Cancer cells change expression profiles such as RNA, proteins, and phosphoproteins within minutes when tissue is removed from the body. This major challenge for researchers was resolutely addressed with the development and implementation of >130 SOPs since 2002 in the established Indivumed Global Clinical ­Network, which contains more than 60 cancer clinics and practices in ­Europe, North- and South-Amercia, and Asia.

With identical collection and processing standards for tissue and comprehensive clinical data from all kinds of solid tumors from tens of thousands of patients annually, Indivumed offers biospecimens and comprehensive clinical information of unparalleled depth and quality.

Services & Partnering Based on this data, Indivumed offers specialized ­products and services, as well as development partnerships through two different business units.

IndivuServ At IndivuServ we provide a wide range of ISO-certified and GCP-compliant services based on our own biobank and state-of-the-art laboratories. These services include: › Access to biospecimens from our Indivumed Multiomics biobank, routine pathology biobank samples, and our Liquid biopsy biobank (longitudinal plasma) samples from cancer patients within our oncology practice network to perform for example nucleic acid testing (e.g. free circulating tumour DNA)

INDIVUMED

› Immunohistochemistry assay development including multiplex assays, in-house digital pathology, supporting target validation and companion diagnostics development › Further, research services of various kinds including immunophenotyping of tumours and drug testing in viable tissue cultures (e.g., immunooncology compound testin). We also offer the Spatial Transcriptomics technology to our customers IndivuType IndivuType is a world leading discovery solution for personalized oncology that helps identify and validate novel disease mechanisms, drug targets, and biomarkers.

Unlike conventional, genomics-only approaches, ­IndivuType is based on the integration of deep multiomics data (genomics, transcriptomics, proteo­mics, and phosphoproteomics) with clinical and digital pathology data — all based on the highest quality biospecimens. Combined with the analytical power of our proprietary AI platform nRavel® this creates a superior discovery solution to understand cancer mechanisms and tumor progression, and to drive more effective and personalized drugs to treat cancer patients.

IndivuType pursues independent drug development activities — we can act as a service provider in early oncology research or be a trusted partner for AI and data driven development of novel cancer treatments.

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

Financing Indivumed generates revenue through the commerciali­ sation of its products and services. To build IndivuType, the first multi-omics cancer database, it has received funds from private investors, the European Investment Bank, and the European Regional Development Fund.

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Name Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Website Social Media Number of Employees Type of Laboratory Areas of Activity

External Collaborations

Intravacc

Intravacc: the bridge between concept and late stage clinical studies Even the most promising vaccines do not always make it out of the laboratory into large-scale production. At Intravacc we are fully aware of the challenges on the long road to vaccine development. We substantially reduce the risks and costs involved with developing vaccines.

How? By bridging the gap between your concept and late stage clinical studies.

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Antonie van Leeuwenhoeklaan 9 3721 MA Bilthoven The Netherlands Michiel Stork (Vice-President Business Development) +31-30-7920300 bd@intravacc.nl www.intravacc.nl

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The Netherlands-based Intravacc, part of the Utrecht Science Park location Bilthoven, is one of the world’s leading organisations with many years of experience in translational vaccinology. As an established independent clinical development and manufacturing organisation (CDMO) in the vaccine industry, Intravacc offers a wide range of expertise and is the bridge between your discovery and the start of your phase I/II clinical trials in humans.

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150 ML-II, BSL-2 | Bacterial and viral vaccine development | Process, formulation, and assay development | (Pilot) Production, QC & QA | Clinical and regulatory affairs | Academia | Public health organisations (WHO, BMGF) | Biotech and pharmaceutical companies

Global Track Record Intravacc has transferred vaccine technologies all over the world; 30% of all the childhood vaccines worldwide are based on know-how and technology from Bilthoven.

Our track record includes: › Global technology transfer of oral polio, measles, DPT, Hib vaccines › In-house developed Hib vaccine concept is marketed by two partners. › Influenza technology has been transferred to 38 partners around the world. › Improved Sabin Inactivated Polio Vaccine (sIPV) production process transferred to five vaccine manufacturers in emerging economies. › Four COVID-19 vaccines in development

INTRAVACC

Our Certified Facilities As one of the leading CDMOs we serve academia, public health organisations (WHO, BMGF), biotech and pharmaceutical companies. With a state-of-the-art infrastructure and more than 2,000 sqm of ML-II, biosafety level (BSL) 2, equipped and certified laboratories, including QC laboratories and several GMP clean rooms for biomanufacturing, Intravacc is your ideal CDMO partner. Our integrated services range from bioassay, methods, upstream, downstream, and formulation development all the way to pilot GMP production, ready for you to start your (pre)clinical studies.

Our Vaccine Development Pathway (VDP) Service We design and develop vaccines, improve production processes for vaccines, and prepare drug substances to enable pre-clinical and clinical studies at cGMP-level under our VDP process. For new vaccine development processes, we use established blue prints and scalable platform production processes. These are designed according to regulatory requirements, using mathematical models, and are scalable from lab to high-volume production-scale bioreactors. Rationally designed processes are tested in our laboratory facilities using the latest ICH-guidelines and insights. We have longstanding, extensive experience and capabilities in vaccine development, which can be applied to different vaccine concepts. We provide tailored solutions and enable your high-potential candidate vaccine to become ready for market entry. The most critical part of your development programme is our commitment to establishing manufacturing-ready processes early, in order to enable the most streamlined transition of your programme from clinical to large-scale manufacturing. At Intravacc, we are focused on high quality, speed, simplicity, and reproducibility as we develop your candidate vaccine to allow you to enter the clinic as soon as possible.

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

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invIOs GmbH

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Campus-Vienna-Biocenter 5 1030 Vienna Austria Peter Llewellyn-Davies +43-1-8656577 invios@invios.com www.invios.com

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Immuno-Oncology

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invIOs stands for innovative immuno-oncology (IO) and is focused on the discovery and development of cancer immunotherapies. invIOs is a fully owned subsidiary of APEIRON Biologics AG. We are pioneers in the research & development of cell therapies targeting novel immune checkpoints and in immunomodulation.

Our Innovative Immuno-Oncology Pipeline Despite successes with current therapies such as immune checkpoint inhibitors, there are large numbers of non-responders and patients who relapse following treatment. Due to these limitations, there is a huge demand for novel tumour therapies. The invIOs pipeline currently comprises two autologous cell therapy projects based on a platform technology targeting the master checkpoint inhibitor Cbl-b, as well as one small molecule asset. › APN401 is an out-patient cell therapy with a very short needle-to-needle treatment time. Based on our platform technology, Cbl-b is silenced in white blood cells, thus leading to a highly specific activation of innate and adaptive immune responses. It is our lead project, currently being evaluated in a clinical Phase Ib trial in patients with advanced solid tumours. › APN441 is a tumor-specific cell therapy approach utilizing our platform technology and Cbl-b to activate local, tumor-associated tumor infiltrating lymphocytes (TILs). It is in an early development stage for patients with glioblastoma. › INV501 is a novel small molecule candidate intended to activate anti-tumour immune responses and addresses a novel, undisclosed IO target.

INVIOS

Our lead project APN401 – a siRNAbased cell therapy targeting Cbl-b The discovery of a new “master” regulator of immunecell activation has been proven to help override negative signals to activate immune cells. Cbl-b is an intracellular protein that can be silenced in immune cells, triggering their re-activation. It has been shown that the blockade of Cbl-b activates immune cells and enables them to destroy cancerous cells. We have developed a proprietary platform technology process targeting Cbl-b and potentially other checkpoints in human cells from patients.

The clinical programme APN401 is a first-in-class out-patient approach to strengthen immune reactivity through Cbl-b silencing. In a first-in-human study, the treatment was safe and well tolerated. Silencing Cbl-b could provide a revolutionary new treatment to awaken anti-tumour responses, providing new hope for patients with various tumours, as monotherapy but also in combination with other approaches.

APN401 is the first clinical candidate based on our cell therapy platform. It enables rapid treatment of patients using their own immune cells for reactivation in an outpatient setting. The novel concept allows access to and treatment for indications that had not previously been addressable by cell therapy.

Our Innovation Hub: dedicated to delivering lifesaving medicines in IO A crucial part of our business model for value growth is our Innovation Hub. The goal is to accelerate promising drug candidates to tangible value points. We are continuously scouting for promising innovative early-stage projects in the field of immuno-oncology and will advance them into next-generation therapies until clinical proof of concept. With full-range in-house development capabilities (preclinical and clinical) and a seasoned and dedicated team, invIOs accelerates projects with entrepreneurial excellence.

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

iOmx Therapeutics AG

First-in-class immuno-oncology drugs targeting novel cancer immune evasion mechanisms. iOmx Therapeutics AG was founded in 2016 and focuses on the development of first-in-class, next-generation cancer immuno-therapy drugs, which are designed to neutralise the inhibitory function of novel tumour or tumour-associated myeloid cell-expressed immunecheckpoint modulators.

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

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

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30 2016 | Next-generation cancer immunotherapies | Drug development | Immuno-oncology

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

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

To further extend the iOmx pipeline, an evolved version of the screening platform is currently being applied to identify and validate novel checkpoint targets in tumourassociated myeloid cells.

Overall, the iOTarg™ platform points the way to next-generation immunotherapy approaches that are designed to increase the clinical impact of immunecheckpoint therapies.

IOMX

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

Two highlights of the company’s pipeline are lead programme IMT-07 with OMX-0407, a small molecule sensitising tumour cells to the effect of immune-derived tumour necrosis factor (TNF) in the tumour microenvironment, and IMT-18 programme with a first-inclass IGSF11-targeting antibody, designed to eliminate tumour-induced immune suppression. For both programmes proprietary drug candidates with monotherapy potential have been identified and are currently in preclinical development. The company’s lead antibodies and kinase inhibitors have shown very promising single agent anti-tumour effects in multiple preclinical studies.

Outlook iOmx Therapeutics will rapidly advance its promising pipeline through IND-enabling activities to clinical proofof concept for selected drug candidates. Lead product candidate OMX-0407 will enter clinical development in late 2022. Furthermore, new screens will deliver I/Oactive leads targeting novel myeloid checkpoints.

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Name 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

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IRBM S.p.A

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Via Pontina Km 30,600 00071 Pomezia (Rome) Italy Heidi Kingdon Jones +39-06-91093-692 +39-06-91093-654 bd@irbm.com / h.kingdon@irbm.com https://www.irbm.com/

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200 2009 | Chemistry | Biology | NMR | Animal facility | Analytics | Prep lab (Kg-scale, non GMP) | BSL 1, 2, 2+ Integrated drug discovery | Display technologies | Antibody discovery | Peptide drug discovery | Small molecule drug discovery | Biomarker identification and development | Discovery and translational biology | High-content and high-throughput biology and screening | ADME/DMPK | In vivo pharmacology | Structural biology and virtual screening | Antios Therapeutics | MSD | MD Anderson Cancer Center | AstraZeneca (with IRBM’s Advent) | CHDI

European Biotechnology Net work

IRBM is a former MSD site operating as an innovative contract research organisation working across all aspects of drug discovery and early development for different modalities – small molecules, peptides and antibodies.

Excellent drug discovery track record Scientific excellence is in our DNA. Our team has invented and worked on 4 marketed drugs: ISENTRESS® (a first-in-class HIV integrase inhibitor), ZOLINZA® (the first HDAC inhibitor for non-small cell lung cancer), Grazoprevir (ZEPATIER® for HCV), and ZEJULA® (a PARP inhibitor for ovarian cancer). We have delivered over 25 preclinical candidates, and published an unprecedented number of papers.

Customised solutions for each project Based on our experience, IRBM offers tailored solutions to clients and contributes know-how as well as critical assessment of the results. As many of the studies are exploratory by nature, IRBM often uses its strong scientific foundation to develop completely novel methods and experimental set-ups. Through our scientific expertise, providing insights and the highest quality standards, we advance your project swiftly and cost-effectively without compromising on quality.

Target to candidate nomination We foster collaborations with organisations from the pharmaceutical, biotech, and academic sectors to accelerate drug discovery from target validation and hit identification to candidate nomination. Our 200-plus strong, multidisciplinary team works at a state-of-theart R&D facility near Rome where projects are carried out “under one roof” enabling rapid cycle times and close integration of the scientific teams.

IRBM

World-class integrated drug discovery More than a third of IRBM’s partnerships have been integrated projects for both small molecules and peptides, combining biology, chemistry, ADME, and in vivo studies, which profit enormously from the tightly knitted disciplines located in one facility. Staff turn over is low and many of the scientific team have worked together on drug discovery projects for more than 20 years.

A few key capabilities are highlighted below.

Assay development and screening We identify and expand high-quality hits and hit series ­using one or more hit-finding strategies through our wide range of biochemical/cell-based assay platforms. We carry out high-throughput screening campaigns using our diverse and highly curated small molecule collection and/or your libraries.

Phage display We interrogate a vast number of different molecules quickly and efficiently to identify the best and most promising binders for a particular target, with our inhouse collection of high-complexity, proprietary, fullyhumanised antibody and peptide libraries. We construct custom libraries, with design, selection and screening strategies suited to your needs, based on over 20 years’ experience.

Peptide drug discovery We discover and develop a variety of peptide drug candidates, including, but not limited to, macrocycles that incorporate multiple constraints or peptides conjugated to fatty acids, cholesterol, and polymers. IRBM is one of the leading experts in the field of peptide drug discovery - stemming from our heritage as MSD’s Peptide Research Centre of Excellence.

Biomarker identification and development We design and implement the most successful preclinical and clinical biomarker plan for your programme, based on our deep expertise in target engagement, pharmacodynamics, and responder identification biomarkers.

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Name 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

ITM Isotope Technologies Munich SE

Targeted cancer diagnostics and therapies

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Lichtenbergstrasse 1 85748 Garching / Munich Germany Julia Hofmann / Susanne Karlsson Corporate Communications +49-89-329-8986-6000 +49-89-329-8986-6061 communications@itm-radiopharma.com www.itm-radiopharma.com

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ITM, a radiopharmaceutical biotech company, is de­ dicated to providing the most precise cancer radio­ therapeutics and diagnostics to meet the needs of patients, clinicians and partners through excellence in development, production and global supply. With patient benefit as the driving principle, ITM is advancing a broad pipeline combining its medical radioisotopes with targeting molecules to develop precision oncology treatments. ITM is leveraging its leadership and nearly two decades of radiopharma expertise combined with its worldwide network to enable nuclear medicine to reach its full potential for helping patients live longer and better.

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370 2004 Radiopharmaceutical biotech company | Oncology | Precision Medicine | Targeted Radionuclide Therapy | Nuclear Medicine

Targeted Radionuclide Therapy or Peptide Receptor Radionuclide Therapy (PRRT) is an emerging class of cancer therapeutics, in which radiation is delivered ­directly to the tumor while minimizing radiation exposure to normal tissue. In contrast to conventional external radiotherapy, Targeted Radionuclide Therapy is defined by the intravenous infusion of a radiopharmaceutical.

Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, thereby destroying tumor tissue. The highly precise localization enables targeted treatment with minimal impact to healthy surrounding tissue.

Often, the targeting molecule can be used in a “theranostic” approach for both therapeutics and diagnostics.

For diagnosis, the targeting molecule is linked with a diagnostic radioisotope, for therapy with a therapeutic radioisotope. This allows tumors and metastases to be both precisely localized at an early stage, and subsequently treated following the same mechanism.

ITM

ITM is developing a proprietary portfolio and precision oncology pipeline of targeted treatments in various stages of clinical development, which address a range of cancers such as neuroendocrine tumors, glioblastoma, osteosarcoma and bone metastases, prostate cancer, as well as folate receptor α positive tumors like lung, ovarian or breast cancer. To validate the Targeted Radionuclide Therapy approach, efficacy and safety of the lead candidate n.c.a. 177Lu-Edotreotide are currently being compared to standard treatments for patients with neuroendocrine tumors of gastroenteric or p ­ ancreatic origin in two Phase III clinical trials, C ­ OMPETE & ­COMPOSE. The unique combination of ITM’s longstanding expertise, high-quality radioisotopes and global supply network enables ITM to develop new Targeted Radionuclide Therapy based treatment options for hard-to-treat cancer indications. ITM strives to positively impact the treatment algorithm currently in place for solid tumors and make a tangible impact in improving the lives and treatment outcomes of cancer patients.

For more information about ITM, please visit: www.itm-radiopharma.com

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Name Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Website Social Media Founded (year) Areas of Activity

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KML Vision GmbH

Empowering Life Sciences Research With Smart Image Data Analysis

Nikolaiplatz 4 8020 Graz Austria Dr Philipp Kainz (Co-Founder, CEO) +43-680-156-75-96 office@kmlvision.com www.kmlvision.com

KML Vision is an award-winning company providing high-end AI-driven applications for the efficient analysis of multidimensional microscopy images. The company’s unique software solutions reduce effort and increase throughput for their clients thanks to the automation and replicability of complex image analysis workflows with powerful deep learning technology.

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2016

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| Artificial intelligence solutions for bioimage analysis | Microscopy imaging software | Bioimage data management | Life sciences fields: pathology, histology, cytology, angiogenesis research, tissue regeneration research, neuroscience, microbiology, and many more

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| Medical University of Graz, Austria | Medical University of Vienna, Austria | Fresenius Kabi Austria GmbH, Austria | Fraunhofer Institute for Integrated Circuits (IIS), Germany | PreciPoint GmbH, Germany | SciNote, Slovenia | Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, Austria | Graz University of Applied Sciences, Austria | University of Applied Sciences Upper Austria, Austria | University of Bari, Italy | Amsterdam UMC, The Netherlands

KML Vision’s state-of-the-art bioimage analysis applications are offered on the intuitive cloud platform IKOSA, allowing smart data management and user collaboration.

The automated bioimage analysis applications within IKOSA cover a wide array of life sciences disciplines such as pathology, histology, angiogenesis research, regeneration research, neuroscience, and microbiology, to name a few.

KML Vision’s satisfied customers and cooperation partners come from all sorts of life sciences industry fields, including universities, academic research institutions, contract research institutions, and pharmaceutical and biotech companies.

KML Vision’s philosophy The main drivers behind KML Vision’s business philosophy are curiosity and the passion for innovation.

By bringing leading-edge software solutions into existence, the company paves the way for new scientific breakthroughs. KML Vision is committed to continuous dialogue with the life sciences industry and academic institutions for the realisation of new targeted software concepts.

KML VISION

AI technology that makes a difference in bioimage analysis Artificial intelligence automates entire bioimage analysis workflows, allowing IKOSA users to generate reproducible insights into complex biological processes with unprecedented speed and accuracy.

IKOSA users widely benefit from integrating AI-technology into image analysis workflows by: › Developing targeted image analysis algorithms › Increasing research throughput › Automating image analysis methodologies › Increasing image recognition accuracy › Saving time and resources

KML Vision’s products and services at a glance The IKOSA platform offers versatile software solutions, each covering specific research needs.

Image analysis solutions: › IKOSA AI: Deep learning algorithm development for bioimage analysis without any coding › IKOSA Prisma: A broad portfolio of ready-to-use deep learning bioimage analysis applications › IKOSA Prime: Custom software development s­ ervices tailored to specific research needs Image data management solutions: › IKOSA ISTIX: Advanced manual microscopy imaging software › IKOSA Portal: Comprehensive bioimage data ­management and smart user collaboration

Partner up with KML Vision KML Vision is your experienced partner for handling a broad spectrum of bioimage analysis research tasks.

New strategic collaborations and exciting imaging project ideas are always welcome.

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

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External Collaborations

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LIFE & BRAIN GmbH Venusberg Campus 1 53127 Bonn Germany Dr Per Hoffmann, Ira Herrmann +49-228-6885-100 +49-228-6885-101 info@lifeandbrain.com www.lifeandbrain.com 35 2002 S1, S2 High throughput generation and interpretation of omics data; stem cell-based customer-specific services for neurological disease modelling and compound development

Several international patents filed or granted covering in-house technologies Illumina Inc.

LIFE & BRAIN is a biomedical enterprise and commercial hub of the University of Bonn Medical Centre founded in 2002 located in Bonn, Germany.

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

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

LIFE & BRAIN

LIFE & BRAIN CELLOMICS provides stem cell-based cell culture systems and customer-specific services for neurological disease modelling and compound development. Our areas of competence encompass the generation of induced pluripotent stem cells (iPS cells), neural iPS cell differentiation and customer-specific cell production and assay development.

Proprietary technologies make it possible to generate pure, cryopreservable neural, neuronal and glial cells. from pure, cryopreservable populations. Through our close collaboration with the outstanding scientists at the Institute of Reconstructive Neurobiology and as part of a large number of national and EU-wide research projects, we systematically implement innovative stem cell-based technologies and optimize these technologies for biomedical applications on an industrial scale.

Our focus is on assay development: Using healthy and disease-specific iPS cell lines, we develop phenotypic assays together with our clients for use in disease research and drug discovery. Based on established differentiation protocols, we provide the adaptation and optimization of cell production and quality controls.

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

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Maiwald Patentanwalts- und Rechtsanwaltsgesellschaft mbH Elisenstraße 3, Elisenhof 80335 Munich Germany Dr Eva Dörner +49-89-747266-0 +49-89-776424 info@maiwald.eu www.maiwald.eu

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230 1995 Law Firm Sectors: | Pharma & Biotech | Organic Chemistry & Polymers | Inorganic & Construction Materials | Food & Agriculture | Electrical & Mechanical Engineering | Communication & Information Technology | Mobility & Energy | Displays & Light | Measuring & Process Technology | Medical Technology & Imaging | Artificial Intelligence & Digitalization Legal Areas: | Patents & Utility Models | Supplementary Protection Certificates | Trademarks & Designs | Copyright | Competition & Antitrust Law | Compliance | Contract Law | Employee Invention Law | Pharmaceutical Law | Data Protection | Plant Variety Protection Strategy: | IP Search | IP Consulting

As one of Germany’s largest and best-known firms in the field of intellectual property, Maiwald’s foremost aim is to achieve the best possible solution for each client in each particular case. Maiwald employs about 230 people working out of Munich and Düsseldorf. The interdisciplinary teams work closely with each other and with foreign associates, always with an eye to the client’s particular needs, whether start-up, medium-sized firm, or large corporation, across all industrial sectors.

Maiwald’s team does its utmost to ensure that all IP matters are handled with competence and care, irrespective of the client’s physical location, whether in Germany, Europe, or beyond.

Client-oriented solutions and personal consultation are at the heart of Maiwald’s professional approach.

About 80 highly qualified patent attorneys, attorneysat-law, and technical experts, an in-house patent search department, and numerous client-specific teams of paralegals put their extensive range of skills and experience at the clients’ disposal in order to arrive at the best possible customised IP solutions. Client satisfaction is evidenced by the long-standing business relationships with many prestigious corporations.

Main areas of practice Maiwald advises and represents domestic and international clients from all technical fields across the entire spectrum of intellectual property law. When appropriate, an interdisciplinary exchange of information and expertise can take place between various teams, ensuring that the optimal solution is achieved in each particular case.

Maiwald’s patent attorneys Maiwald’s team of patent attorneys combine their expertise across various technical fields and advise and represent clients across a wide range of industries.

Maiwald’s patent attorneys have extensive experience in the management of international patent portfolios.

Services include drafting and filing patent applications

MAIWALD

and coordinating worldwide prosecution as well as defending, enforcing, and contesting IP rights. Patent attorneys also prepare freedom-to-operate (FTO) opinions based on thorough research and analysis to establish whether existing IP rights of third parties could potentially stand in the way of a client’s particular product or manufacturing process. Clients also benefit from the exceptional expertise in opposition and appeal proceedings before the German and European Patent Office as well as in infringement and nullity proceedings before the national courts.

Maiwald’s attorneys-at-law Maiwald’s team of attorneys-at-law can boast many years of experience in trademark, design, copyright, and contract law as well as patent infringement litigation, particularly in the conduct and coordination of international litigation proceedings.

Close cooperation between patent attorneys and attorneys-at-law is especially important in patent infringement litigation, since this type of proceedings generally calls for a comprehensive overview of the various national regulations as well as a thorough grasp of the particular technology. The interdisciplinary teams provide a comprehensive package of services to guarantee the successful conduct of legal proceedings in an international arena, also in cases where speed is of the essence, such as in preliminary injunction proceedings or border seizure procedures.

However, Maiwald’s attorneys-at-law would be the first to acknowledge that litigation is not always the best solution. They are skilled advocates in arbitration and mediation proceedings and are trusted experts when it comes to negotiating licensing contracts

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Contract Research

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Microsynth AG Schützenstrasse 15 9436 Balgach Switzerland Dr Markus Schmid, Christof Wunderlin (Co-CEOs) Dr Christoph Grünig (Head of Contract Research) Johanna Brändli (Head of Quality Management) +41-71-722-83-33 info@microsynth.ch www.microsynth.com www.ecogenics.ch 1989 S1/S2, GMP/GLP | Oligonucleotide synthesis | Sanger sequencing | Next generation sequencing | DNA/RNA isolation | PCR, qPCR, digital PCR | Genotyping | Contract research/outsourcing | Contract manufacturing (e.g. ASOs, probes) | Assay Development | Assay Validation (ICH Guidelines) l GxP(-like) analysis of customer test items (Sanger, NGS, qPCR & dPCR) | Process outsourcing | Genomics research

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

Oligonucleotide Synthesis Microsynth is a pioneer and industry expert in oligonucleotide manufacturing. Customers can choose from a broad range of different backbones (DNA, RNA, 2’-MOE, 2’-OMe, LNA, PTO), modifications (MGB, GalNac, >250 in total), and purifications. From small-scale research primers to defined µmol ranges of probes for use in molecular diagnostics, up to ASOs, siRNAs, and aptamers for drug discovery applications, Microsynth can be your solution provider in the field of oligonucleotide synthesis.

DNA/RNA Analysis More than 25 years of experience in DNA Sanger sequencing has made Microsynth one of the leading sequencing suppliers in Europe. Having established Sanger sequencing labs in Switzerland, Germany, France, and Austria, the company is able to offer a Sanger sequencing service in those countries featuring unrivalled speed and an environmentally friendly pickup service. And it has set another industry standard through its Ecoli Nightseq ®. This is a new gamechanging service for sequencing plasmids from E. coli in a much faster and more cost-effective way.

Microsynth’s broad offering of high-quality nextgeneration sequencing services spans the full range of Illumina sequencing platforms – a comprehensive set of sequencing libraries including small RNA, total RNA, and DNA – enabling DNA and RNA sequencing of all organisms from viruses to humans, as well as plasmids

MICROSYNTH

and cosmids. Applications offered range from single loci to whole genome and transcriptome to metagenome analyses. Interpretation of results is supported by dedicated and state-of-the-art bioinformatics analysis pipelines tailored to each project type. From first-class consulting to in-house bioinformatics providing reliable and user-friendly results, all needs are met.

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

Contract Research/Outsourcing Microsynth has considerable experience running many different research projects for its customers, including the development of new protocols. Its successful projects in basic, preclinical, and clinical research range from one-month to multi-year projects. The solid track records in microbiology, genomics, molecular biology, and bioinformatics of Microsynth’s experienced researchers help its customers define the best strategy for addressing their research questions.

Microsynth offers a broad portfolio of validated techniques and protocols. Professional project management, high-throughput sample logistics, and close cooperation with customers ensure that every outsourced project is completed in a cost-efficient manner and on time. For typical applications covered by Microsynth, please see the graphic on the left.

Quality Management System Microsynth puts every effort into constantly improving the underlying production processes, and the majority of its branches are ISO 9001:2015 certified. The NGS and Sanger sequencing department, as well as the fragment length analysis of Microsynth AG, are also ISO/ IEC 17025:2017 accredited (STS 0429). Furthermore, Microsynth AG is authorised by Swissmedic to perform quality control of medicinal products using GMP Sanger sequencing. Finally, Microsynth AG is ISO 13485:2016 certified for the production and distribution of nucleic acids and components for IVD manufacturers and the provision of associated activities.

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

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Molzym GmbH & Co. KG

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Mary-Astell-Straße 10 28359 Bremen Germany Marina Linow +49-421-69-61-62-0 +49-421-69-61-62-11 info@molzym.com www.molzym.com

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35 2003 Manufacturer and supplier of products: | CE IVD kits for infection diagnosis | Microbial DNA extraction (manual and automated) | PCR assays and master mixes | DNA-free PCR reagents and polymerases | Customised master mixes Molzym is interested in collaborations that are directed to the development and manufacturing of individualised, pre-analytic, and analytic solutions, including automation.

Molzym was founded as a privately owned enterprise in Bremen, Germany, in 2003. Ever since, Molzym has been committed to the development of innovative solutions to serve biological research and diagnosis of infectious diseases. In December 2019, Molzym joined Gradian Diagnostics to accelerate growth of its molecular diagnostic solutions. Our developmental efforts are particularly focused on new processes enabling and facilitating the molecular diagnosis of infectious diseases caused by bacteria and fungi. Meanwhile, more than 50 high-quality products are available for molecular microbial analysis by PCR- and NGS-based methods in 30 countries worldwide.

Expertise Molzym manufactures ultra-clean and highly active amplification reagents and kits for microbial DNA extraction from a variety of clinical specimens. Reagents and consumables are supplied free of contaminating microbial DNA – guaranteed lot by lot. Our customers appreciate the ability to increase the number of amplification cycles and thus lower the limit of detection dramatically without false positive results arising from contaminating microbial DNA. Another core expertise is Molzym’s unique MolYsis™ technology for the depletion of host DNA from usually sterile human and animal samples, a well-known factor that negatively influences sensitive PCR and microbiome analysis at low microbial loads.

Products & automation MolYsis™ is Molzym’s proprietary technology of host DNA depletion, allowing targeted isolation of microbial DNA from a great variety of clinical samples. Ultra-pure, DNA-free PCR reagents and master mixes allow for the precise detection of microbes in humans and animal models. Complete assays for the broad-range amplification of selected regions of the 16S and 18S rRNA genes of bacteria and fungi are available. Basic and dye master mixes can be used with custom primers for PCR and real-time PCR analysis.

MOLZYM

The latest development is a walk-away robotic system, SelectNA™plus, for the fully automated host DNA depletion and extraction of microbial DNA from clinical and other material. SelectNA™plus brings the utmost technical advances to the demands for contamination-free and low-hands-on processing of samples.

With SepsiTest™-UMD and Micro-Dx™, Molzym offers two CE-marked in vitro diagnostic solutions for the culture-independent detection of pathogens that cause various diseases. Both kits include reagents for the depletion of human DNA and the targeted isolation of microbial DNA from a variety of clinical samples, e.g. whole blood, CSF, BAL, joint aspirates, tissue biopsies, abscesses, and other specimens. Manual DNA isolation can be accomplished with SepsiTest™-UMD, and with Micro-Dx™ the process is fully automated on the SelectNA™plus robot. Precise detection is performed with broad-range 16S/18S PCR and sequencing analysis to identify the pathogens down to the species level.

Both assays are especially applicable for samples that were negative after culturing, e.g. due to prior antibiotic treatment or fastidious growth requirements.

Service Molzym offers customised manufacturing of master mixes decontaminated of microbial DNA for improved assay performance at increased amplification cycles.

The Molzym team appreciates your interest and is at your disposal for further information about our products and developmental issues.

Please call at: +49-421-69-61-62-0 or send your inquiries to info@molzym.com.

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be INSPIRED

drive DISCOVERY

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stay GENUINE

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)

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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

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1981

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

New England Biolabs – putting science first Created “by scientists for scientists”, NEB is renowned for consistently providing exceptional product quality and unsurpassed technical support. For over four decades, NEB has been shaping the landscape of bioscience research by discovering, developing, and supporting superior research reagents. In addition to NEB’s commitment to scientific innovation and customer satisfaction, NEB notably ensures the environmental sustainability of the company’s business practices. Our passion is our promise. A supplier-of-choice for scientists across the globe, NEB offers the largest selection of recombinant and native enzymes for genomic research.

While restriction enzymes remain part of our core product portfolio, our ever-expanding offering also includes products related to PCR and qPCR, gene expression, sample preparation for next-generation sequencing, synthetic biology, and CRISPR/Cas9 gene editing, as well as glycobiology, epigenetics, and RNA analysis. A recognised leader in the field of enzymes and reagents, NEB has earned a world-wide reputation for setting the highest standards for quality and value.

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

NEW ENGL AND BIOL ABS

projects. With this dual focus on both basic and applied research, NEB’s culture is collaborative and academic.

Latest innovation in enzyme technology Our outstanding expertise in protein engineering and evolution has led to the creation of unrivaled enzymes and unique workflows in the library preparation and target enrichment for the NGS space. These products set the benchmarks for optimal performance and ease-of-use in modern molecular biology laboratories. Moreover, NEB’s specialised offerings for alternative DNA assembly, isothermal amplification as well as novel reagents for CRISPR/Cas9 based genome editing makes us a firstchoice supplier for today’s molecular biologists.

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

Customised Solutions/OEM/GMP NEB’s OEM business unit has been delivering customised manufacturing, tailor-made enzyme formulations, and packaging solutions to customers for over 25 years.

Relying on this extensive experience, we have recently completed building a new GMP-grade manufacturing facility to offer a select set of tailor-made products enabling OEM customers and partners to use NEB’s top-class products directly in their specific applications, or to bring them to regulated markets.

New England Biolabs GmbH The NEB subsidiary in Germany represents the service hub for Central Europe. From our location in Frankfurt, we serve scientists and industry customers in Germany, and Austria and support our network of distribution partners across Europe.

www.neb-online.de

For up-to-date information please visit our web site at www.neb-online.de.

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

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OLS OMNI Life Science

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Karl-Ferdinand-Braun-Straße 2 28359 Bremen Germany Dr Andreas Friese +49-421-27-61-69-0 info@ols-bio.com https://www.ols-bio.com

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50 2004 | Cell Counting | Cell Culture | Imaging | Flow Cytometry | Cell Analysis

OLS – Your Partner in Cell Research Focusing on people and innovations, OLS OMNI Life Science accelerates research in life sciences and biotechnology with smart, reliable, and user-friendly technologies. Our products are found in laboratories of both the public and private sector, as well as laboratories of the pharmaceutical and biotechnology industries.

The broad portfolio includes instruments, media, reagents, consumables, as well as services and consultation for cell counting, cell culture, imaging, flow cyto­ me­try, and cell analysis. This enables us to accompany you during the entire research process, from conception to conclusion.

Cell Counting Researchers need to know their cells and the most important factor is cell concentration and viability.

Our self-developed CASY Cell Counter & Analyzer is a highly reliable and user-friendly device to determine cell numbers exactly, no matter the cell type (iPSCs, PBMCs, bacteria, yeast, algae, etc.), even under consideration of aggregates. The results are reproducible, statistically robust, and GMP/GLP-compliant with rapid measuring speed.

Cell Culture Advances in disease modelling and increasing rejection of animal testing has led to the rise of organoid & spheroid research. The CERO 3D Incubator and Bioreactor – developed and manufactured in Bremen – allows for benchtop cultivation of these 3D cell structures.

Our advanced approach for cell suspension allows for high longevity and viability under precisely controlled conditions.

In order to cater to all the needs of your cell culture lab, we provide a comprehensive portfolio of HiMedia lab products. HiMedia is an internationally established and renowned vendor of certified lab supplies. Our vast catalogue encompasses cell culture media, sera, stains, bio reagents & chemicals in numerous variations, as well as lab consumables.

OLS OMNI LIFE SCIENCE

Imaging We provide a wide range of products for any imaging need, if you want to keep an eye on your cells.

The xCELLigence Real-time Analyzer eSight combines real-time cell impedance-based analysis with live cell imaging. It can be used in a wide range of applications, such as immuno-oncology, proliferation assays, cytotoxicity and apoptosis, or viral infections of cells.

The zenCELL owl incubator microscope is a compact way of visualising real-time data within your incubator.

Inside, 24 mini-microscopes enable a new simultaneous observation of your cell culture.

Your drug discovery efforts can also be substantiated by the Hermes WiScan Screening Workstation. It is a flexible, high-quality, and automated device, supports precise Z-stacking, and operates at high speeds of image acquisition.

Flow Cytometry When it comes to flow cytometry, OLS provides a large range of products. Our NovoCyte Flow Cytometers offer different properties, functionalities, and designs for every need, with 3-5 lasers.

The Proteintech antibody portfolio comes with conjugated and unconjugated primary antibodies validated for flow cytometry.

Using advanced microfluidics, the NamoCell Single Cell Dispenser sorts and dispenses single cells directly into multi-well plates.

Cell Analysis Both immune cells and tumour cells have many varying behaviours, requiring deep insight with high sensitivity.

The xCELLigence Real Time Cell Analyzer (RTCA) technology allows detection of these cellular changes, such as adhesion, cell number, morphology, cell contacts, or infections. It evaluates up to 4x384 well-plates noninvasively and simultaneously for your drug discovery and pre-clinical studies.

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

Annual Turnover External Collaborations Request for Further Collaborations

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OPIS s.r.l.

Via Matteotti 10 20832 Desio Italy Giovanni Trolese +39-0362-633-1 +39-0362-633-633 office@opiseurope.com www.opiseurope.com www.clinical.net

I ca. 240 1998 Premium support for clinical drug and device development

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| Pharma | Biotech | Medical device | Food supplements

Our organisation OPIS is a Global clinical CRO providing premium clinical trial management for multi-country trials. In addition to phase I-IV drug-related trials, OPIS also manages preand post-marketing clinical investigations for medical and diagnostic devices, as well as nutraceutical/food supplement studies.

Founded in 1998, OPIS is a premium Global CRO, with roughly 300 employees. The company operates from its Italian headquarters and twelve other offices located around the world ( Spain, France, Germany, UK, Belgium, Sweden, Poland, Switzerland, The Netherlands, United States, Taiwan, and Australia).

Our expertise In 23 years of combining medical, regulatory, statistical, and technological expertise, OPIS has assisted a huge number of 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 a solid 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 in compliance with laws and regulations, while achieving the objective at a quick paste. Our strength lies in the passion for what we do and in the quality with which we deliver. We believe that clinical studies, particularly those incorporating scientific and methodological innovation, can significantly contribute to medical progress and to better quality of life.

OPIS

Our core business OPIS provides clinical research services and drug development consultancy to pharma, biotech, and Medical device IBM. 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 therapeutic-specific attention. Operational staff that include medical writers, regulatory experts, project managers, and 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 randomization, safety reporting, and study drug handling.

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Early phase trials Phase I to IV Pre- and post-market studies Observational research Real World Evidence studies Investigator Initiated Trials Medical Device Clinical Investigations Nutraceutical studies

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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

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

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PlasmidFactory GmbH & Co. KG Meisenstr. 96 33607 Bielefeld Germany Dr Martin Schleef/Dr Marco Schmeer +49-521-2997-350 +49-521-2997-355 info@plasmidfactory.com www.plasmidfactory.com

I 32 2000 | Contract Manufacturing of plasmid and minicircle DNA in different quality grades for research up to clinical applications |H igh-Quallity-Grade plasmid and minicircle DNA as starting material for GMP productions, e.g. of mRNA or viral vectors, also in gram scales | In Stock Service for AAV Helper & Packaging Plasmids (pDG/pDP) and for further plasmids and minicircles (e.g. reporter genes) | Analysis of plasmid topology

Biological Patents

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Request for Further Collaborations

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PlasmidFactory owns any relevant know-how, patents and licensces for plasmid and minicircle manufacturing Fruitful long-term cooperations with renowned academic and industrial institutions in the fields of gene and cell therapy and vaccination PlasmidFactory is always interested in working in long-term and strategic collaborations with pharmaceutical and biotech companies that require plasmid or minicircle DNA for (pre-) clinical applications.

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

Customised plasmids and minicircles PlasmidFactory’s individual manufacturing service is frequently used by researchers from the fields of transfection and drug delivery, virus production, nanobiotechnology, gene therapy, cell or tumour therapy, and RNA or DNA vaccination. The company offers the production of plasmid and minicircle DNA in several quality grades: Research Grade and ccc Grade qualities for research purposes and pre-clinical applications, and High-Quality-Grade as starting material for e.g. GMP production of RNA, viral vectors and CAR-T cells.

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

Other services On request, plasmid DNA storage and logistics can be organised, supplementing the company’s service portfolio.

PlasmidFactory’s proprietary method for quantification of the structural diversity of plasmid DNA by means of capillary gel electrophoresis (CGE) is the only reliable method able to determine the stability of plasmid DNA during storage.

PL ASMIDFACTORY

High Quality Grade Plasmid and Minicircle DNA

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In LARGE s Starting material for GMP production of mRNA, viral vectors & CAR-T cells

Minicircle – a safe vector system Minicircles (MC) are circular DNA molecules that are generated e.g. by an intramolecular (cis-) recombination from a parental plasmid (PP). The difference between MC and standard plasmid vectors for gene therapy or nucleic acid vaccination is that the MC contains neither the bacterial origin of replication (needed only in bacteria for the amplification of plasmids in cell division) nor any antibiotic resistance markers or other selection systems to keep the plasmid in high amounts within the producer cell.

Hence, minicircles are the most promising tools to achieve both and increased efficacy and regulatory requirements for future clinical applications.

PlasmidFactory is the exclusive owner of all relevant patents and IP in this field and provides service production of these supercoiled monomeric constructs, according to clients’ requirements.

Starting material for mRNA vaccines in large quantities

grafeting gmbh stock.adobe.com

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

The better way to DNA!

PlasmidFactory has developed and established the process for the production of the corresponding plasmid DNA.

PlasmidFactory.com

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

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Phyton Biotech GmbH Alter Postweg 1 22926 Ahrensburg Germany Kai Schütte +49-4102-4906-64 +49-4102-4906-69 kai.schuette@phytonbiotech.com www.phytonbiotech.com 75 1993 Comprehensive services for the development and commercialisation of high-value compounds using our award-winning Plant Cell Fermentation (PCF®) Technology.

Established in 1993, Phyton Biotech offers comprehensive process development and commercial manufacturing services for fermentation-based products.

Best known for our award-winning and environmentally responsible Plant Cell Fermentation (PCF®) platform, we have expanded our profile into other cell systems, offering development and supply solutions for a wide array of products including phytochemicals, biopharmaceuticals, and other high-value compounds. This PCF® technology coupled with our extensive experience allows Phyton Biotech to serve a variety of global markets, including pharmaceutical, traditional medicines, agricultural, food ingredients, natural health, and cosmetics industries.

Our PCF® technology PCF ® promotes the natural processes of plant cell growth and biosynthetic pathway expression of plant material in a controlled and fully defined bioreactor environment. Starting material is sourced without any environmental impact and the optimal cell cultures are developed in-house. Selected cell lines are scaled up in stirred tank bioreactors without the sunlight requirement.

Finally, Phyton Biotech’s specialised product recovery and downstream technology allows for the preparation of extracts and purification of molecules.

Utilising this cutting-edge technology, Phyton Biotech offers a time, risk, and cost balanced path to commercially viable production processes, adding sustainability, reliability, quality, and scalability to the supply chain.

Our unique capabilities address the entire development chain. Phyton Biotech maintains one of the world’s largest plant cell culture collections, allowing for the unique selection and sourcing of plant material. Subsequent cell line development, process development, downstream development, chemical processing, scaleup, and commercial GMP production in up to 75,000L bioreactors guarantees Phyton Biotech’s position as the global leader in PCF®.

PHY TON BIOTECH

Specialty fermentation solutions Phyton Biotech’s unique state-of-the-art facilities and impressive history of expertise in development and production enable us to carry out other Specialty Fermentation solutions beyond PCF® hand-in-hand with our customers — from first cells to scale-up and through to product recovery. We offer comprehensive services for the development and commercialisation of manufacturing processes for high-value compounds including small molecules and biologicals.

Our API business Phyton Biotech operates two GMP-certified, FDA and EDQM inspected facilities in Germany and Canada with full in-house QA/RA and QC capabilities, and supplies substantial amounts of Paclitaxel and Docetaxel with full control over the entire upstream and downstream production process. By providing a safe, reliable, highquality supply of finished Active Pharmaceutical Ingredient (API) product that meets USP and EP standards, Phyton Biotech is the largest global commercial provider of Paclitaxel and Docetaxel API via PCF® to a customer base of pharmaceutical manufacturers around the world.

In summary Through our expertise and experience, Phyton Biotech continues to offer world-class development, supply, and commercial manufacturing solutions in an environmentally responsible and sustainable way through our PCF® and Specialty Fermentation platforms for a wide range of high-value fermentation-based compounds.

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

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Premier Research 3800 Paramount Parkway Suite 400, Morrisville, NC 27560 USA

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Premier Research (Germany) Europaplatz 5 64293 Darmstadt Germany Raphaela Schnurbus +49-6151-5201600 +49-6151-5201602 raphaela.schnurbus@ premier-research.com https://premier-research.com/

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2,400+ 1989 Biotech, Specialty Pharma, Rare Diseases, Cell & Gene Therapy, Oncology, Analgesia, Dermatology, Neuroscience, Pediatrics, Women’s Health, Medical Devices, Diagnostics, Real-World Science & Late Phase Research

Premier Research is a clinical research, product development, and consulting company dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments.

As a global company, Premier Research specialises in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.

Our Approach We are continually optimising our processes to deliver the right mix of agility and knowledge to support our most innovative biotech and specialty pharma sponsors.

What we do Your compound shows spectacular promise, but it seems there’s an obstacle at every turn – finding hardto-reach patients, defining relevant endpoints, navigating the regulatory maze, and ultimately obtaining clean, conclusive data.

Our Built for Biotech model is a compilation of the most successful techniques and capabilities observed across our experience, applied to provide a specialised customer experience.

Collaborative Approach We are committed to helping our customers answer the unmet needs of patients across a broad range of medical conditions.

Our specialised global task forces are dedicated to smart study optimisation and risk management throughout the trial to support drug development strategies.

Therapeutically focused teams of clinical professionals have the knowledge and experience necessary to effectively manage any situation that may arise in your trial. Our approach is firmly grounded in comprehensive project management principles and well-defined processes.

PREMIER RESEARCH

Amazing Science It’s amazing and often very complex science, and we’ve positioned ourselves right in the middle of the action, where pioneers are doing the most exciting work.

Whether you’re a single-compound start-up or more interested in pursuing science than in negotiating the arcane maze of protocol review and recruitment modeling, we can help with planning, design, execution, and conclusive results.

More than just clinical services, we offer unique perspectives, intelligent study designs, and a relentless focus on compliance and providing conclusive data.

Conclusive Data We are constantly investing in innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.

This allows us to continually improve on product development and study outcomes.

Consulting Premier Consulting is a strategic product development and global regulatory consulting partner dedicated to supporting the specialised needs of emerging biotech and specialty pharma companies. These small to midsize companies are the very heart of drug development.

Like them, we are dedicated to the patient journey and driven by the challenges of bringing new life-saving technologies to market.

Creative Solutions to Your Most Complex Product Development Challenges Wherever you are in the development life cycle, from raising funds and developing a regulatory strategy to patient recruitment and data analysis, we are positioned to help.

Our drug development and regulatory experts are relentlessly thorough, constantly asking why (and why not), taking nothing at face value, and being flexible enough to pivot and regroup when circumstances demand. We know biotech and understand the passion and commitment that drives our sponsors. It is what drives us, too.

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

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Herbert-Bayer-Str. 8 13086 Berlin Germany Dr Lutz Hilbrich (CEO) +49-30-322-935-100 +49-30-322-935-400 info@probiogen.de cmo@probiogen.de www.probiogen.de

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ProBioGen AG

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240 1994 S1, S2 l Biopharmaceutical development and GMP production facility l Biopharmaceutical contract development and manufacturing l Proprietary technologies for improving product characteristics and process efficiency ProBioGen holds numerous international patents on technologies to improve product quality/potency and enhance cellular productivity.

With many international companies and research organisations, e.g.

Boehringer Ingelheim, Bayer, CRISPR, Novartis, etc.

ProBioGen works with biotech and pharma companies that develop complex therapeutic glycoproteins or viral vaccines. Services include cell line and process development up to GMP manufacturing, using animal and human cell lines. In addition, proprietary product/process-improving technologies are out-licensed.

Intelligent biopharmaceutical solutions Internationally renowned specialist for developing and manufacturing complex biopharmaceutical active ingredients with the aid of state-of-the-art services and innovative technologies, with manufacturing authorisation for human biopharmaceuticals according to FDA/EMA standards.

Experience & client feedback For over 27 years we have been a successful development and manufacturing partner for leading biotechs and pharmas on novel products, biosimilars, e.g. mAbs, Fc-fusion proteins, clotting factors, and enzymes. Clients value our scientific expertise, excellent working relationships, and outstanding flexibility.

Unique services Quality development services We offer true “one-stop-shop” complete service packages from early lead optimization, rapid and integrated development of high-producer cell lines, processes, and analytical methods, up to full GMP manufacturing programmes. Our comprehensive analytics portfolio includes IPCs, release tests, and in vitro bioactivity assays. Innovative technology platforms to optimise yields, boost product potency, increase development speed, and cut manufacturing costs; all independently available for licensing.

Integrated cell line and process development Our pharmaceutical cell line development with CHO.RiGHT® platform includes proprietary, royalty- and license-free expression vector technology, DirectedLuck™ transposase, CHO host cells, and our own chemically defined media platform. The excellent reputation of our cell line development skills is based on fine-tuned, individually tailored clone selection procedures and early integration of upstream and downstream selection parameters. This allows the selection of the optimal expression strategy for each protein and enables rapid and economic upstream process development.

Reliable and flexible contract manufacturing We offer GMP production in fully state-of-the art disposable systems in fed-batch and continuous processes in up to 1000L bioreactors, including:

PROBIOGEN

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Your Biologics. ® Elevated.

USP & DSP Development Cell Banking (MCB/WCB) GMP Manufacturing Analytical Development

Cell-based activity assays A range of cell-based activity assays for potency and mode-of-action analyses is established or can be developed from scratch.

Innovative technologies GlymaxX® ADCC enhancement Our glyco-engineering technology prevents cellular fucose synthesis and thus antibody fucosylation, for maximised ADCC cell-killing activity against tumour and infected cells.

This works for novel and existing producer cell lines, your expression platform, and can be licensed independently.

Glyco-engineering Fucose, galactose, and sialic acid levels of glycoproteins can each be adjusted, e.g. in biosimilar projects.

DirectedLuckTM – Transposase for superior titers Our novel proprietary transposase for efficient gene delivery, homogenous clone pools, and high-titer clones (up to 8 g/L) cuts hands-on lab time and overall timelines; available for licensing.

Productivity-boosting pathway modulator An engineered Cdc42 enzyme for typically increased cellular productivity is applicable to existing cell lines and expression platforms; available for licensing.

AGE1.CR® viral vaccine manufacturing platform Duck cell line to replace CEFs 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.

Human artificial lymph node – immunofunction testing Our fully human, mini bioreactor-3D matrix system for longterm testing of drugs for immune as well as immunogenicity function bridges the gap between animal studies and human clinical trials.

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

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ProductLife Group 14 rue Gerty Archimède 75012, Paris France Adrien Decheix +33-787-603-325 adecheix@productlife-group.com https://www.productlifegroup.com/

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F I 650 1993 Consulting & outsourcing services

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compliance, market access, pharmacovigilance, and medical information

PLG at a glance ProductLife Group’s mission is to improve human health by delivering regulatory compliance services for the safe and effective use of medical solutions.

For almost 30 years, PLG has supported clients through the entire product life cycle, combining local expertise with a global reach spanning more than 140 countries, with HQ in France (Paris) and offices in UK (Cambridge), Germany (Haan, close to Düsseldorf), Belgium (Ninove), Italy (Milan), Switzerland (Basel), Czech Rep. (Prague), etc.

See https://www.productlifegroup.com/worldwidepresence/.

PLG provides consulting and outsourcing services in the areas of regulatory affairs, quality and compliance, market access (pricing & reimbursement), vigilance, and medical information, covering both established products and innovative therapeutics & diagnostics.

With the goal of continuously improving the value delivered to people and customers, PLG is committed to long-term partnership, innovation, flexibility, and cost efficiency.

PLG BIOTECH solutions Discovering and developing treatments that mean alleviating suffering, extending life, and improving its quality requires time, top professionals, significant resources, collaboration across sectors and borders, and complex and risky processes with no guarantee of success in the search for new breakthroughs.

PLG has set up a team of biopharmaceutical and medtech experts with extensive experience and a strong understanding of bio-pharmaceutical product development, registration, market access, health economics, and commercialisation.

PLG provides flexible and tailored pre-clinical, clinical, and market access solutions designed to help mid-size and small biopharmaceutical and medtech companies move forward in their effort to get treatments to patients

PRODUCTLIFE GROUP

– from helping to define the development plan, to implementation of all stages of product development, through to launch and commercialisation – in order to deliver compelling results to regulatory authorities, investors, and stakeholders.

PLG assists the companies with: 1. reaching product development milestones faster, and 2. effectively managing the development programme from pre-clinical to post-marketing and beyond.

PLG also assists biopharmaceutical companies PLG also offers specific support to biopharmaceutical start-ups through all phases of product development, market access, and post-marketing: Geography Expanding activities in the US, Europe, and Asia. The US is the leading player in the healthcare field. Northern Asia is making more rapid progress in advanced therapy R&D than the US and Europe.

Regulatory New regulatory pathways for emerging diseases and technologies (specialised medicines, curative medicines, combination therapies, personalised therapies, CAR-T, DC- vaccination…)

Clinical outcomes Defining the criteria of clinical outcomes with biopharmaceutical companies is a new need in order to balance with the HTA. HTA The HTA (Health Technology Assessment) needs to take into account the growing numbers of EU and US agencies.

Pricing Pricing payment models in line with the development of new and innovative technologies.

Digital health Digital health (AI) is integrated into new medicine development (time and cost savings).

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Name Address/P.O. Box Postal Code/City Country Telephone Fax Email Website Social Media Founded (year) Type of Laboratory

Areas of Activity

Biological Patents External Collaborations

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ProJect Pharmaceutics GmbH

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

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2010 Contract research and development; chemistry; cytotoxic; S1 (BSL-1); S2 (BSL-2) Analytical characterisation; preformulation screening; formulation development; freeze drying cycle development; lyophilisation process and scale-up; pre-clinical batch manufacturing; technology transfer Several patents in freeze drying and formulation Operating a network for seamless development from expert to expert, from pre-clinic to fill/finish. Competence network player as formulation specialist for DS and DP CMOs worldwide / process specialist for scalable drug products ensuring manufacturability.

Cross-country competence hub with business partners in Asia.

Credited laboratory for Wyatt Technology in Europe.

We partner with small biotechnology, mid-size pharma, as well as large top players in pharma/biotechnology – from DSP development to early and late drug product phases up to life cycle management. We offer customised solutions for challenges in formulation, analysis or process and particularly for unmet needs not yet supported by the industry.

ProJect Pharmaceutics is one of the leading European CRO service providers specialised in formulation and manufacturing process development for parenteral drug products including biologics (rec. proteins, antibodies, fusion proteins), peptides, ADCs, cytotoxics, small molecules, generics, viral therapeutics, GMOs, ATMPs, VLPs, and other nanoparticular drug delivery systems.

We pursue innovative, quality-by-design based, rational concepts of pharmaceutical development following ICHQ8 and other guidelines. We support our worldwide clients to develop a consistently high-quality pharmaceutical product, transferable, scalable, and manufacturable under GMP conditions. ProJect Pharmaceutics is led by experts with >25 years of experience in pharmaceutical industries. In about 850 m2 we operate dedicated labs for biologics, cytotoxics (OEL4), and a BSL-2 unit.

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

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

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

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

PROJECT PHARMACEUTICS

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

Freeze drying › Rational cycle development (robust, collapse-safe, cost and time efficient) › Bulk lyophilisation (solid or powder) › Freeze drying out of organic solvents › Annealing and controlled nucleation › Easy lyophilisate reconstitution › Aseptic freeze drying › Robustness testing (definition of design space) › Smooth technology transfer and process scale-up › Lyophilisation in vials, (dual chamber) systems and syringes, bulk trays, containers in nest&tub configuration › Scanning electron microscopy (SEM) › Time lapse video and IR thermal camera monitoring

ADCs and cytotoxics A deep understanding of the challenges when processing highly potent drugs, such as limited solubility in water and rapid degradation, paired with long experience and comprehensive know-how of lyophilisation from various organic solvents and solvent / water mixtures enables us to provide specific solutions for cytotoxics and ADCs.

Viral therapeutics and GCT products › › › › ›

Virus particle stabilisation (lyophilised formulation) Full factorial DoE formulation design Aggregation tendency screening Lyo cycle development Aseptic pilot batch manufacturing

Fill&finish As state-of-the-art development experts we are teamed up with state-of-the-art contract manufacturing experts to provide high-quality parenterals from pre-clinical to clinical and large commercial scale.

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Name 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

External Collaborations

Rentschler Biopharma SE

A world-class biopharmaceutical CDMO

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Erwin-Rentschler-Str. 21 88471 Laupheim Germany Dr Cora Kaiser (Senior Director Corporate Communication) +49-7392-701-0 +49-7392-701-300 communications@ rentschler-biopharma.com www.rentschler-biopharma.com

Rentschler Biopharma is a leading global contract development and manufacturing organisation (CDMO), focused exclusively on client projects. From its headquarters in Laupheim, Germany, and its site in Milford, MA, USA, Rentschler Biopharma offers process development and manufacturing of biopharmaceuticals. The company’s high quality is proven by its long-standing experience and excellence as a solution partner for its clients. Rentschler Biopharma is a familyowned company with about 1,100 employees. In Stevenage, UK, Rentschler Biopharma launched a company dedicated to cell and gene therapies, Rentschler ATMP Ltd.

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1,100 1927 S1 | Contract development and manufacturing organization (CDMO) for biopharmaceuticals | Cell and Gene Therapy Services with Rentschler ATMP Ltd Strategic alliance with Leukocare AG, located in Munich, Germany, for bestin-class formulations Strategic collaboration with Vetter, headquartered in Ravensburg, Germany, for high quality aseptic filling and secondary packaging

Request for Further Collaborations

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Rentschler Biopharma offers bioprocess development and cGMP manufacturing solutions from concept to market for pharma and biotech companies in long-term collaborations and strategic collaboration settings.

Your trusted partner from concept to market Rentschler Biopharma’s end-to-end offering includes biopharmaceutical process development and manufacturing as well as related consulting activities such as project management and regulator y suppor t.

Rentschler Biopharma is highly experienced in the development and cGMP manufacturing of monoclonal antibodies, designer proteins, and other therapeutic proteins in compliance with international standards (EMA/FDA). Since 2020, the company has expanded into the promising field of mRNA production.

Working collaboratively with its clients, Rentschler Biopharma provides customised solutions with optimised work packages for each development stage.

State-of-the-art cGMP facilities and cell culture processes are leveraged for manufacturing for both, clinical studies and commercial supply. Consistent monitoring of the international regulatory landscape and in-depth understanding of the necessary regulatory documentation (CMC), ensures that each project is properly documented in accordance with international regulatory requirements.

In order to offer value-adding solutions across the entire process chain, the company has entered into a strategic alliance with Leukocare for formulation development. Another strategic collaboration is with Vetter for aseptic manufacturing and packaging. The desired goal of the collaboration with Vetter is the alignment of manufacturing approaches that enable clients to bring their products to patients more easily and faster.

RENTSCHLER BIOPHARMA

Bioprocess development › Fast and efficient supply for multiple candidate screening › Robust and scalable CHO cell lines for cGMP manufacturing › Efficient cell culture and purification processes › Well-established analytical methods › Advanced formulation development exclusively by Leukocare AG

Best-in-class formulation development Rentschler Biopharma’s strategic alliance with Leukocare offers best-in-class formulation development considered at every step of the biopharmaceutical development and manufacturing process.

Operating at the interface of drug substance and drug product development, Leukocare combines sound knowledge of biopharmaceutical formulation development with bioinformatics and biostatistics. Thus, bioinformatics, biostatistics and design of experiment (DoE) are combined at Leukocare to explore a broader design space than conventional approaches in order to reach optimal formulations in less time at lower costs.

cGMP biomanufacturing › Multiple stainless steel bioreactor lines, including a twin system with 2x 3,000 L › Flexible single-use bioreactor lines up to 2,000 L › State-of-the-art purification processes › Guaranteed product quality and purity in accordance with cGMP guidelines › Four new 2,000 L single-use bioreactors will be added by late 2023 As a world-class solution provider, we ensure optimum time-to-clinic and time-to-market by accelerating timelines to create competitive advantage for our clients. For seamless market approval, we consult and assist clients with regulatory queries, develop optimised strategies, and generate complete documentation for approval of clinical studies and market launch.

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Resolve BioSciences GmbH

Creative Campus Monheim Gebäude A03 Alfred-Nobel-Straße 10 40789 Monheim am Rhein Germany Joanne Dimitrakopoulos +49-2173-2975-200 info@resolvebiosciences.com www.resolvebiosciences.com

IL  72 2021 spatial biology, transcriptomics, neuroscience, oncology, cardiovascular, immunology, computational biology, developmental biology, microscopy, gene expression, infectious diseases, toxicology, drug development, biomarkers, organoids, atlasing, agrigenomics

Resolve Biosciences is enabling scientists to apply the power of Molecular Cartography™ technology to gain new insights based on the highest-resolution view of spatial biology. We operate two service laboratories: in Monheim am Rhein, Germany, and San Jose, CA, USA. We also began deploying commercial instruments at customer sites early in 2022.

Groundbreaking Technology Under development since 2016, our pioneering platform and fully automated workflow feature proprietary, highly multiplexed, single-molecule fluorescence in situ hybridisation technology, which offers full spatial context at subcellular resolution in three dimensions.

Unlike other approaches, our Molecular Cartography platform provides the required sensitivity, specificity, and workflow convenience to elucidate the cell’s complex transcriptional landscape without destroying the tissue section or cell culture sample.

This innovative approach was designed for the multiplexing needs of most scientists for basic, translational, and clinical research. The underlying technology is modular and flexible enough to incorporate the interrogation of DNA, protein, and metabolomic data layers in the future.

Advantages › Subcellular resolution – diffraction-limited, single­ molecule detection with a resolution of 300 nm › Highly multiplexed – each sample can be analysed by up to 100 different probe sets › Superior sensitivity – enables visualisation of millions of individual transcripts per sample › Transcriptomic reach – suitable for short transcripts down to 612 base pairs › Sample integrity – allows further interrogation using immunohistochemistry or fluorescent dye labelling

RESOLVE BIOSCIENCES

Context Matters Applications › › › › › › ›

Cancer Neuroscience Developmental biology Cell atlasing Toxicology Infectious disease Agriculture

Research Highlights › SARS-CoV-2 Infection and Inflammatory Response — Medical University of Graz, Austria: Our Molecular Cartography platform is enabling scientists to gain a better understanding of subcellular gene regulation and how the infection affects neighbouring cells over time. › Human Brain Development — MRC Laboratory of Molecular Biology, Cambridge, UK: The team is ­applying the power of Molecular Cartography to brain organoids to unravel the spatial logic of neural tissue development. › Retina Gene Expression and Cell Type Evolution — University College London, UK: The team is using Molecular Cartography technology to better understand how a healthy retina develops and changes with advancing age. › Human and Mouse Liver Atlasing - VIB Ghent University, Belgium: Spatial proteogenomics revealed distinct and evolutionarily conserved hepatic macrophage niches. › Spatial organization of ependymal cells - Norwegian University of Science and Technology, Norway: The team is using Molecular Cartography for the validation of ependymal cell spatial organization in the zebrafish brain.

Visualization of gene expression gradients of 10 markers between portal and central veins in adult mouse liver.

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

Biological Patents

External Collaborations Request for Further Collaborations

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Richter-Helm BioLogics GmbH & Co. KG

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Suhrenkamp 59 22335 Hamburg Germany +49-40-55290-801 +49-40-55290-888 BusinessDevelopment@ richter-helm-biologics.eu www.richter-helm.eu

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~295 1987 Contract development and manufacturing of biopharmaceuticals derived from microbial systems Several patents on manufacture of recombinant proteins Richter-Helm is working with biotech and pharma companies worldwide Richter-Helm’s Business Development team will be pleased to learn more about your needs for development and GMP manufacturing services to bring your project one step further.

For more detailed information please contact us.

GMP-compliant microbial production of biopharmaceuticals – Flexibility makes the difference Richter-Helm is a successful and constantly growing Germany-based GMP-compliant contract manufacturer of biopharmaceuticals specialised in products derived from bacteria and yeasts.

Over the past 30 years Richter-Helm has gained substantial experience in the development and manufacture of a variety of product classes including therapeutic proteins and peptides, antibody formats (e.g. VHH), bacterial vaccines, and plasmid DNA (pDNA).

The company currently operates a development facility and two cGMP manufacturing facilities with bioreactor capacities of up to 1,500 litres. The addition of two highly flexible production trains with capacities of 300 and 1,500 litres and fully separated flows in a new facility building opens up capacity for new and further projects, enabling GMP manufacturing from phase I to III up to commercial supply.

With flexibility, commitment to good manufacturing practice, and total transparency our experienced, team offers highly specialised contract development and manufacturing services to support the global pharmaceutical and biotechnological industries.

With its solid experience and strong expertise in the field, Richter-Helm is the partner of choice for pDNA production and its supply in different grades and quantities, and for different applications. There is an established analytical platform specifically for pDNA products, including a generic and validated quality control testing approach.

Richter-Helm ensures the highest pharmaceutical quality standards, as verified by major regulatory bodies including EMA, FDA, PMDA, ANVISA, Health Canada, and MFDS as well as by numerous customer audits.

RICHTER-HELM

Products and services The highly motivated and experienced teams at RichterHelm have excellent expertise in development and GMPcompliant 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 are available to support strain selection. Small-scale models of existing processes provide helpful tools for trouble shooting, process characterisation, and validation. Furthermore, small-scale models also ensure a smooth scale-up to large-scale GMP-compliant manufacture.

The quality system at Richter-Helm meets the strictest standards of quality in biopharmaceutical production.

Our in-house quality control 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 phases 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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Name Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year)

Sartorius CellGenix GmbH

High-quality GMP reagents for cell and gene therapy manufacturing

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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

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IQ

Sartorius CellGenix is a leading global supplier of highquality raw materials for the expanding market of cell and gene therapy as well as regenerative medicine.

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

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80 1994 GMP Clean Room facilities A/B/C/D S1/S2 Ex vivo raw materials for Cell & Gene Therapy Regenerative Medicine Distribution in Europe for Saint Gobain FEP cell culture and cryopreservation bags l T cells l MSCs l iPSCs, ESCs l NK cells

Sartorius CellGenix is headquartered in Freiburg, Germany and operates a subsidiary near Boston in Portsmouth, NH, USA. In Juli 2021 the life science group Sartorius acquired a majority stake in CellGenix.

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

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

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

SARTORIUS CELLGENIX

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.

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

With many years of experience in the field of cell and gene therapy, Sartorius CellGenix has always taken active interest in supporting the advancement of the regulatory framework in this evolving environment.

We filed the first FDA DMF for a cytokine as ancillary reagent in 2002 and co-authored chapter <92> with the USP in 2010.

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

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

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Socorex Isba SA Chemin de Champ-Colomb 7a 1024 Ecublens Switzerland Yves Lachavanne (Marketing & Sales Support Manager) +41-21-651-6000 socorex@socorex.com www.socorex.com

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Liquid handling instruments

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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,

SOCOREX ISBA

soft-padded ejector button allows low-pressure activation. 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 Qualitix® ideally combines with the 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.

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 Address/P.O. Box Postal Code/City Country Telephone Email Website Number of Employees Founded (year) Areas of Activity

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Swiss Biotech Association

The central resource for the Swiss biotech industry

Stauffacherstrasse 16 8004 Zurich Switzerland +41-44-455-56-78 info@swissbiotech.org www.swissbiotech.org 3.5 (FTE) 1998

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™.

National cluster development powered by Swiss Biotech Association National and international stakeholders of the Swiss biotech industry

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

• Broaden your network, meet peers and investors • Increase your impact and visibility • Secure significant cost savings • Capture new business and attract talent • Unite with fellow members to strengthen the Swiss biotech hub Join the Swiss Biotech Association swissbiotech.org/welcome

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

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.

1 Nation 1 Biotech Cluster

Check-out the wide range of member benefits on www.swissbiotech.org/welcome and reach out to us (www.swissbiotech.org/team) if you have any questions or wish to discuss how we can best support your venture.

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

External Collaborations

Request for Further Collaborations

SynapCon GmbH

Best Clinical Research Software Distributor 2022

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Taunusanlage 8 c/o WeWork 60329 Frankfurt am Main Germany Sven Engel +49-0151-676-039-61 info@synapcon.com www.synapcon.com

Lauded as the “Best Clinical Research Software Distributor 2022” for the biotech industry, one of the many awards and accreditations it has earned, SynapCon has made a name for itself in both its innovations and globally focused attitude. In streamlining clinical management systems, the firm has achieved great success and customers from all disciplines.

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Member of

10 2021 Clinical Research Accelerator, Technology, Consultancy Innovations on, AWS, IP Ocean, Aifinity, Evaluation Software Development, Universities of Mainz, Manchester, and Leipzig, BlueCloud Biotech, CROs, Universities

European Biotechnology Net work

Developing software solutions that specifically focus on cost reduction for clients running clinical trials, SynapCon offers a range of services that enable digital transformation and the setting of rigorous standards.

This expedites its clients’ clinical product trials, allowing products like devices and drugs to be available to patients more quickly and easly. In this way, SynapCon seeks to reduce the burden on the healthcare system.

This goal has informed every aspect of its operation, and its solutions are therefore some of the most advanced technologies and business models available. Through the implementation of IT systems by its team of dedicated specialists, who work with a finger on the pulse of the dynamic biotech industry, it prides itself on working with its customers as well as for them. By collaborating with clients, market leaders, and stakeholders, it makes its vision of bettering the medical infrastructure worldwide a communal effort, and one every participant has an active voice in.

Its flagship product, the electronic Trial Master File (eTMF), is a specifically designed module for SynapCon’s clinical trial management system. With this product, the firm empowers its clients to work with a web-based and highly intuitive platform that allows them to prepare and complete audit-proof trial master files that are GCP compliant. It seeks to assemble data into a compliant template structure, enabling users to collaborate virtually on the same project, automatically storing history to prevent loss, and giving users an easy way to navigate when handling large data pools. This system is a method by which SynapCon provides value to customers along the entire value chain of clinical trials, making for better functionality and streamlined use of funding across

SYNAPCON

the board. In an industry that can face issues regarding budget cuts, this is an incredibly useful service, and thus SynapCon has made itself a linchpin. The eTMF’s benefit for the cost element of clinical trials starts with reducing the procedural bloatware needed in project management, allowing everything to be handled in one place. Its software is used by stakeholders across the industry. Such entities include pharma, biotech, and medtech, as well as clinical research organisations and medical universities.

Recently, SynapCon has been working hard towards the release of its new online networking platform. Slated for release during March, its unique and user-friendly design will allow stakeholders a new means of site selection that it hopes will further change the way the industry operates. The CEO, Sven Engel, is a biotechnician and expert in his field, and the expertise earned in over 20 years of clinical trial management is something the company benefits from. He knows first-hand the struggles and challenges faced by clinical trial management teams, and therefore knows what needs addressing to make things easier. In this way, SynapCon lets its clients focus more on the research and the data than the hours of trialling various logistical systems. Sven himself created his first clinical trial management solution in 1999, and from this humble starting point the updates and developments have been continuous and ongoing. Today, the system is up to date and more competitive than ever, improved to meet the needs of modern-day clinical trials.

Need more information. Visit us via info@synapcon. com on LinkedIn https://www.linkedin.com/company/ synapcon-group/ or at www.synapcon.com.

For a proposal please contact: sales@synapcon.com.

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Name 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

External Collaborations

Request for Further Collaborations

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Technologiepark Heidelberg GmbH

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.

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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

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Strong partners at your side

13 1984 S2 standard, GLP, and GMP labs

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

100,000 sqm across six locations. Tenants leverage the close proximity to Heidelberg University, German Cancer Research Center (DKFZ), European Molecular Biology Lab (EMBL), and twelve university hospitals with more than one million patients per year.

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| Biotechnology | Pharmaceuticals | Digital health | Medical technology | Bioinformatics | Organic electronics | Environmental technologies | IT / Artificial Intelligence / VR | Association of University Research Parks (AURP) | BIO Deutschland e.V. | Biotechnology Innovation Organisation (BIO) | BioRN Network e.V. | Bundesverband Deutscher Innovations-, Technologie- und Gründerzentren e.V. (BVIZ) | Heidelberg Startup Partners e.V. | International Association of Science Parks and Areas of Innovation (IASP) | K I Bundesverband | Biotechnology | Pharmaceuticals | Digital health | Medical technology | Bioinformatics | Organic electronics | Environmental technologies | IT

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

Accelerator programmes Three accelerator programmes at Heidelberg Technology Park offer a fast lane for life science, IT and AI startups.

The Life Science Accelerator Baden-Württemberg includes seminars, workshops and mentoring by seasoned entrepreneurs and market experts. The Up2B Accelerator for IT startups with a B2B focus includes programmes for business modelling, product development and funding.

The KI-Garage is a three-step programme helping to turn AI research results into products and services, and create startups with promising business models.

TECHNOLOGIEPARK HEIDELBERG

International network Heidelberg Technology Park has been the root of BioRN, the regional life science research and industry cluster.

Additional memberships include the Association of University Research Parks (AURP), BIO Deutschland e.V., Biotechnology Innovation Organisation (BIO), KI Bundesverband, Bundesverband Deutscher Innovations-, Technologie- und Gründerzentren e.V. (BVIZ), and the International Association of Science Parks and Areas of Innovation (IASP). Active participation ensures optimal representation of our tenants and members.

Space to grow Our Business Development Centre (BDC) of fers 7,000 sqm of wet lab, cleanroom, and office space.

The building is part of Heidelberg Innovation Park (HIP), Heidel­berg’s latest area of innovation. The BDC Heidelberg includes a dedicated conference centre as well as co-working and acceleration areas. BDC Heidelberg is home of the ­‘AI Lab Kurpfalz, a joint initiative of the Heidelberg Technology Park, the Baden-Württemberg Connected Network, as well as the UC Berkeley Data-X Lab. Its aim is to give small and medium-sized enterprises access to the future technology AI.

Park – in brief › Approx. 100,000 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, IT and AI startups › Access to a large network of investors › Business development support › Entrée to an international network › Central location › Flexible infrastructure › Kindergarten › Conference center › Bistro/canteen › Car and eBike sharing station › International Partner Port © Thilo Ross, Technologiepark

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Tentamus Pharma & Med Deutschland GmbH, site Bad Kissingen

Tentamus Pharma & Med Deutschland GmbH is your Contract Laboratory for Pharmaceutical and Medical Device Analytics

Columbiastraße 14 97688 Bad Kissingen Germany +49-971-785-580 +49-971-785-58-25

Together with our clients, we tailor the chosen testing methods precisely and efficiently to the relevant requirements and regulations and document the analyses reliably and in compliance with regulatory rules. If required, we also develop and validate individual testing methods.

Tentamus Pharma & Med Deutschland GmbH, site Karlsruhe Am Hubengut 3 76149 Karlsruhe Germany +49-721-957-919-500 +49-721-957-919-900

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Tentamus Pharma & Med Deutschland GmbH, site Oldenburg

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Würzburger Straße 3 26121 Oldenburg Germany +49-441- 3613-265-440 +49-441-3613-265-441 Dr Sven Asche / Dr Dominik Herzog info-tpmd@tentamus.com Tentamus-pharma.de

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100 2021 Contract Laboratory for Pharmaceutical and Medical Device Analytics Pharmaceuticals, Medical Devices, Bioanalytics, In vitro Analytics, Instrumental Analytics (ASS, ASA, AES, ICP-MS/-OES, GC, LC, IC, IR, TOC, TLC), Cell- and Immune Analytics, Micro- & Molecularbiology, GMP Laboratory

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GMP-certified Registered with the FDA Accredited in accordance with ISO 17025 Our microbiological laboratory is authorised to handle biosafety level 2 microorganisms (human and animal pathogens as defined by the German Infection Protection Act (Infektion-schutzgesetz) and the German Animal Health Act (Tiergesundheitsgesetz)) and biosafety level I GMOs. We have a licence from the Federal Opium Agency of the German Federal Institute for Drugs and Medical Devices (BfArM) to handle various narcotic drugs.

We offer batch certification and EU retests performed by qualified personnel.

We hold a manufacturing licence in accordance with Section 13 of the German Drugs Act (AMG), which enables our qualified personnel to monitor pharmaceuticals testing and release products.

We have a specially equipped cytostatic area in which we can safely process and analyse cyto­toxic raw mate­rials and pharmaceuticals.

TENTAMUS

We concentrate on in vitro analytics and offer the following testing platforms: › GMP laboratory for pharmaceutical analytics including physico-chemical and instrumental analytics › Microbiology for pharmaceutical and biopharma­ ceutical quality control › GMP laboratory for cell and immune analytics with high-end read out systems (flow cytometry/Meso­ scale MSD) › Laboratory specialised in bioanalytics and molecular biology › Platform for stability storage and stability testing › Narcotic drug analysis of medicinal analysis

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

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Tosoh Bioscience GmbH Im Leuschnerpark 4 64347 Griesheim Germany Regina Roemling +49-6155-7043700 +49-6155-8357900 Info.tbg@tosoh.com www.tosohbioscience.de >20 1989 Supplier of chromatography instruments, media, HPLC and UHPLC columns Application support in analysis and purification of biomolecules.

Tosoh Bioscience is an acknowledged global leader in the field of liquid chromatography with a focus on bioseparations. For more than 30 years, Tosoh Bioscience is providing cutting-edge solutions to meet the needs of customers developing and producing new biologics, biosimilars or biobetters, such as plasma products, monoclonal antibodies, recombinant proteins, vaccines and oligonucleotides.

Our product portfolio encompasses SEC instruments and a comprehensive line of media and prepacked process development, HPLC, and UHPLC columns. These products are popular in the biotech and biopharmaceutical industry and used in R&D, downstream processing, and quality control. Typical applications comprise the purification of therapeutic proteins in lab, pilot, and commercial scale, as well as their characterisation by HPLC or UHPLC. Latest developments comprise TOYOPEARL rProtein A and L for the capturing of antibody constructs, salt tolerant ion exchange and mixed-mode media, and a revolutionary HPLC column for the analysis of IgG glycoforms based on their affinity to the Fc receptor, TSKgel FcR-IIIA-NPR. Recently, the award winning LenS3® MALS detector for (U)HPLC and GPC - the most profound innovation in light scattering technology for decades – has been introduced in Europe.

Headquartered in Griesheim Germany, in the Frankfurt/ Rhine-Main Metropolitan Region, Tosoh Bioscience’s European operations offer extensive technical support like application development, on-site training and workshops. One of the services that stand out in the industry is the Tosoh Chromatography Workshop Series providing a comprehensive background to the chromatographic purification of biomolecules.

TOSOH BIOSCIENCE

Tosoh Bioscience is part of the Tosoh Group, a Japanese chemical and speciality products and materials group, founded in 1935, which comprises over 100 companies worldwide and a workforce of more than 13,500 people.

Our brands TOYOPEARL® and TSKgel® are renowned for their quality and reliability. The stationary phases cover all common modes of liquid chromatography, including ion exchange, hydrophobic interaction (HIC), mixedmode, reversed phase, hydrophilic interaction (HILIC), size exclusion (SEC) and affinity.

In 2021, our renowned HPLC column brand TSKgel celebrated its 50th birthday.

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

Request for Further Collaborations

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UGA Biopharma GmbH Neuendorfstr. 20a 16761 Hennigsdorf Germany Sylwia Naamane +49-3302-2024-900 +49-3302-2024-901 info@ugabiopharma.com www.ugabiopharma.com 40 2009 S1 | Cell Line Development Services | New Biological Drug Development | Biosimilar Development | Ready-to-Use Biosimilar Cell Lines | Cell Culture Media and Feeds UGA Biopharma is seeking | Strategic partnerships for upscaling and GMP manufacturing | Collaboration for development of NBEs or biosimilars | Cooperation partners for in-licensing our Ready-to-Use Biosimilar Cell Lines We would be happy to discuss your request.

UGA Biopharma is an expert in the area of developing mammalian cell lines for biopharmaceutical products.

We offer customised cell line development services for new biological entities (NBEs) and biosimilars. UGA’s mission is to deliver high-end contract services that satisfy and exceed customer expectations. With our dedication to constantly improving our operations, we see ourselves as a reputable and prosperous player known for quality and reliability.

Customised Cell Line Development Services UGA Biopharma is the right partner for industry and academia when it comes to the development of cell lines expressing biologics for clinical trials and market access. We guarantee consistently high quality and full traceability of Cell Line Development activities. Our proprietary approach for success is a combination of host cell line, optimised expression vector, and high performance First CHOice® medium and feeds. Unique and long lasting expertise in cell line development, bioprocess optimisation, downstream processing, and analytics complete our services.

Ready to Use Biosimilar Cell Lines* Biologics are one of the most cost-intensive treatments on the global market today, which implies the need for low-cost alternatives. UGA has gained its expert knowledge by developing biosimilar cell lines for twelve years now. UGA ensures high analytical biosimilarity by balancing clone choice, USP process, and DSP development carefully for each biosimilar. Besides developing a biosimilar cell line on request, we promote a broad spectrum of Ready to Use Biosimilar Cell Lines, including documentation, which are ready to out-license to a collaboration partner: › Adalimumab › Bevacizumab › Mepolizumab › Nivolumab › Omalizumab › Trastuzumab

UGA BIOPHARMA

High Performance First CHOice® Medium and Feeds First CHOice® Medium is a high performance cell culture medium optimised for mammalian cell lines. In combination with First CHOice® Feeds it has been optimised to boost the cell growth and productivity in batch, fed-batch, and perfusion processes. The completely chemically defined, animal component- and protein-free medium has been developed in close cooperation with customers using CHO-S, CHO-DG44, and CHO-K1 cell lines in order to minimise stress-related metabolites such as lactate and ammonia. In this way high product quality and cell viability is guaranteed during all cultivation phases.

*Disclaimer: Until the expiration of the patent and potential supplementary protection certificates related to the reference medicinal product the client must not (i) produce, offer or put on the market the respective medicinal product or possess the product for such purposes, or (ii) use the cell lines or products offered by UGA Biopharma except for experimental use or for studies and trials necessary to obtain a marketing authorization for medical products in accordance with Art. 11 No. 2 and 2b of the German Patent Act. The client undertakes to pay to the patent holder for each case of contravention against the undertaking set forth in the preceding sentence a penalty, the amount of which shall be determined by the patent holder at its reasonably exercised discretion and in case the PARTNER considers patent holder’s determination of the penalty to be not equitable judicially reviewed upon request of the PARTNER by the patent litigation chamber of the district court in Düsseldorf (Germany).

Brand names of reference medicinal products within this presentation are the trademarks of different pharmaceutical companies with whom UGA does not have any business or licensing relationship.

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

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VelaLabs GmbH A Tentamus Company

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Brunner Strasse 69/3 1230 Vienna Austria DI (FH) Markus Roucka +43-1-890-597911 +43-1-890-597910 office@vela-labs.at www.vela-labs.at

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84 2006 Analytical services, contract laboratory for pharma and biotech from drug development to product release (GLP, GCLP, GMP)

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> €7-8m

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NBS-C, Protagene, Eurofins-DiscovRx

External Collaborations

Protein characterisation, ligand binding assays, cell-based assays, microbiological / sterility analysis, non-clinical and clinical services, physico-chemical analysis

VelaLabs is a globally active GLP and GMP certified and GCLP-compliant contract laboratory that offers indepth analytical characterisation services for all types of pharmaceuticals, with a focus on biologics.

VelaLabs combines a focused, customer-orientated approach, a highly motivated team, and broad expertise in analytical development and quality control. VelaLabs supports pharma and biotech companies, starting from early drug development to non-clinical & clinical phases up to product commercialisation and market release in Europe.

VelaLabs – a Globally Active Analytical Services Laboratory Characterisation / Analytical Portfolio To support the product development of pharmaceuticals such as biopharmaceuticals, biosimilars, monoclonal antibodies, hormones, growth factors, and small molecules, VelaLabs offers methods in accordance with relevant ICH guidelines from development to method validation.

The analytical portfolio of VelaLabs includes: › Physico-chemical methods › Cell-based (customised) bioassays (potency, cytotoxicity, proliferation…) › Reporter gene bioassays (RGA) › Ligand binding studies (Biacore/SPR, ELISA) › Lectin microarrays / glycoprofiling › Bio-analytics for clinical testing · Pharmacokinetic (PK) · Pharmacodynamic (PD) · Immunogenicity testing (anti-drug antibodies (ADA)) › Bio-safety (BSL 2) testing capabilities

Biologics and biosimilars The analytical portfolio covers a wide range for proteins, with standard methods such as gel electrophoresis, Western blot, HPLC, and PhEU methods. For higher complex molecules like antibodies our extended portfolio covers the Fab part (e.g. target binding by ELISA,

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SPR, FACS) and the Fc related part (e.g. Fc gamma receptor binding by SPR, C1q binding by ELISA, and biological assays that are related to the mode of action of anti-proliferation, CDC, ADCC, apoptosis). For the analysis of glycosylation patterns of proteins, VelaLabs offers an exploratory method using lectin microarray technology.

YOU EXPERT FOR CONTRACT YOUR EXPERT PHARMCEUTICAL FOR CONTRACT TESTING

PHARMACEUTICAL TESTING

Microbiological Services

YOUR EXPERT FOR CONTRACT BIOLOGICALS PROTEINS BIOSIMILARS BIOPHARMACEUTICALS PHARMACEUTICAL TESTING ANTIBODIES HORMONES VACCINES ATMPS Analytical Development Method Qualification / Validation / Transfer Batch Release (EU) / Batch to Batch Comparison Cell Culture Based Assays Comparability Studies Clinical Assays (Bioequivalence) Bioanalytical Methods (PK/PD) Immunogenicity Testing

BIOLOGICALS PROTEINS BIOSIMILARS BIOPHARMACEUTICALS ANTIBODIES HORMONES VACCINES ATMPS Analytical Development www.vela-labs.at Method Qualification / Validation / Transfer Batch Release (EU) / Batch to Batch Comparison Cell Culture Based Assays Comparability Studies Clinical Assays (Bioequivalence) Bioanalytical Methods (PK/PD) Immunogenicity Testing

www.vela-labs.at

In addition, VelaLabs can also offer microbiological services, e.g., sterility testing in accordance with ISO EU pharmaceutical requirements as well as environmental control and germ identification using different approaches.

Endotoxin measurements with various methods including recombinant factor C (rFC) or Low Endotoxin Recovery (LER) testing is part of the portfolio, as well as Bioburden or TOC testing.

Storage and Stability Vela Labs can carry out stability studies in stability chambers (WEISS) and has qualified equipment for storage ranging from liquid nitrogen (LN2) and ultradeep freezers (-80°C) to walk-in cold storage rooms (-20°C/ +4°C).

Consultancy on GMP storage of test materials: VelaLabs offers consultancy on current Good Manufacturing Practice (cGMP) and current Good Clinical Laboratory Practice (cGCLP) with a main focus on analytics.

Location and Lab Space VelaLabs is located in Vienna and has a total area of 2,600 m² (laboratory and office spaces), of which approximately 1,200 m² are GxP laboratory spaces including a state-of-the-art bio-safety level 2 (BSL2) laboratory.

We are looking forward to supporting your analy­tical needs and will be happy to advise you personally: +43-189-059-7911 12TH EUROPEAN BIOTECHNOLOGY GUIDE 2022

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Vetter Pharma International GmbH

A strategic partner focused on your success

Eywiesenstrasse 5 88212 Ravensburg Germany Andrea Wesp +49-751-3700-0 EU and other international inquiries: info@vetter-pharma.com US inquiries: infoUS@vetter-pharma.com Asia Pacific inquiries: infoAsiaPacific@vetter-pharma.com www.vetter-pharma.com Approx. 5,700 1950

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-theart 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.

Development support, aseptic contract filling and packaging of compounds into syringes, vials, and cartridges

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.

Strategic collaboration with Rentschler Biopharma SE, headquartered in Laupheim, Germany, for bioprocess development and API production (since July 2020)

Resources for every stage of growth

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 40 years of expertise in high-quality,

VETTER PHARMA INTERNATIONAL

state-of-the-art aseptic filling – and experience-based solutions that add value and increase efficiency. Vetter Commercial Manufacturing provides: › Fill and finish › Analytical services › Regulatory support › Life cycle management Vetter Packaging Solutions Packaging matters Material compatibility. Patient convenience. Market differentiation. There are many factors to consider in the selection of your primary and secondary packaging materials.

Which ones matter most to your compound’s performance and long-term potential? Vetter’s packaging experts help you find the right solutions throughout your product’s life cycle. Vetter Packaging Solutions provides: › Customised packaging development › Systems & technologies › Serialisation services › Logistic services › Sterile water for injection

Fast facts: Vetter-at-a-glance › Headquarters in Ravensburg, Germany › Commercial production sites in Ravensburg and Langenargen, Germany › Additional clinical development facilities in Rankweil, Austria and Chicago, US › Branch offices for Asia Pacific in Singapore, Japan, South Korea and China › Approximately 5,700 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 12TH EUROPEAN BIOTECHNOLOGY GUIDE 2022

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Viscofan BioEngineering, a business unit of Naturin Viscofan GmbH

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Badeniastraße 13 69469 Weinheim Germany Dr Lluís Quintana +49-6201-86-358 +49-6201-86-226 contact@bio.viscofan.com www.viscofan-bioengineering.com

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14 2008 Development and manufacturing of collagen products for | regenerative medicine | biomedical R&D | nutraceuticals | University of Tübingen (Germany) | University of Navarra (Spain) | Fraunhofer Institut IGB (Stuttgart, Germany) | Hospital Gregorio Marañón (Madrid, Spain) | FC Barcelona (Spain) | CELLINK (Sweden) | FILK Institute (Freiberg, Germany) | TriAnkle EU Project (Horizon 2020) | ARDAT Project (Innovative Medicines Initiative IMI-2) | VASCage GmbH (Austria)

Your partner for collagen in regenerative medicine Viscofan BioEngineering is a business unit of Naturin Viscofan GmbH – the centre of excellence for collagen within the Viscofan group, a global leader in collagen production.

Building on 85 years of experience in industrial-scale bovine collagen production for the food market, we use this extensive know-how to develop advanced solutions for the biomedical sector. The goal of our collagen portfolio is to facilitate cell biology research and to ultimately enable the development of novel therapies in regenerative medicine.

Unique collagen scaffolds for a wide range of applications As an essential structural component of the extracellular matrix, collagen type I provides a scaffold to support cell attachment and function, as well as organ integrity.

What sets our collagen matrices apart is firstly the intense yet gentle purification of insoluble collagen type I fibres, which preserves their native and complex structure, resulting in high biocompatibility and mechanical strength. Secondly, we shape the collagen fibre mass into customisable scaffolds with unique properties that are ideal for applications in tissue engineering, regenerative medicine, and medical device technologies. › Collagen membranes as biodegradable cell support for tissue regeneration Extruded to flat membranes, the dense network of long collagen fibres provides strength and flexibility to create versatile, biodegradable supports for tissue regeneration. For customisation, we adjust thickness, tensile strength, elasticity, biodegradation time, and other properties to optimally serve diverse applications such as advanced wound healing and urethra or hernia repair.

Our Collagen Cell Carrier® (CCC) is a native matrix for adherent primary cells, cell lines, and stem cells for in vitro and in vivo use. The standardised thin (20 µm) and elastic, yet strong membrane is especially suited as a biological vehicle for cell implantation.

VISCOFAN

An i­nnovative tool for the development of ATMPs, its use as a stem cell-loaded cardiopatch for treatment of cardiomyopathy has justbeen evaluated in a phase I clinical trial. › Viscolma® collagen mass for coating medical ­devices As a smooth fibrous mass with concentrations of up to 15% collagen, Viscolma® can be used for individual research applications such as the development of 3D cell culture scaffolds. Moreover, the putty-like mass is especially suited for biocompatible coating of implantable medical devices. › Soluble collagen for cell & tissue culture research Our soluble collagen is used for thin coating of cell culture vessels and as a hydrogel for 3D cell and tissue cultures, promoting authentic cell performance.

Certified manufacturing – safe products We start our production with traceable bovine raw material from New Zealand, a country with negligible BSE risk. Our collagen membranes and Viscolma® are ­provided both in R&D and medical grade quality, the latter manufactured in our GMP-compliant production unit.

Viscofan BioEngineering is certified according to DIN EN ISO 9001 (Quality management systems) and DIN EN ISO 13485 (Medical devices – Quality management systems). This ensures the highest possible product safety for all medical products.

Enabling breakthroughs in regenerative medicine Provided both in research and medical grade quality, our collagen products permit easy and cost-efficient bench-to-bedside transfer. Moreover, together with our partners, Viscofan BioEngineering is also developing its own pipeline of products in regenerative medicine. With the combination of premium products, our all-round know-how in collagen manufacturing, and expert customer support, Viscofan BioEngineering promotes new breakthroughs in medical development and is open to collaborations.

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Name

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

Request for Further Collaborations

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YUMAB GmbH Science Campus Braunschweig-Süd

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Inhoffenstr. 7 38124 Braunschweig Germany Alexander Ehm +49-531-481170-0 info@yumab.com www.yumab.com

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IQ

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27 2012 S1, S2 | Fully human antibody discovery & lead development | Antibody Libraries | Engineering & Humanisation | Professional R&D services (CRO) | Optimised conditions for start-up, biotech & biopharma companies | Flexible entry & exit points at any project stage | Partnered innovation YUMAB seeks clients & partners in biopharma, biotech & diagnostic industry as well as partners with innovative research projects, who need a reliable partner in human antibody development

YUMAB is a contract developer of fully human antibodies for the global biotechnological and biopharmaceutical industry. Starting in 2012 with the goal to bridge the gap between innovative research and novel therapies, the company has become an important driver of the general trend in immunotherapy toward the use of fully human antibodies.

The versatile technology platform combined with a longstanding and proven expertise makes YUMAB the partner of choice for the development of novel antibodies for therapeutic applications, diagnostics, or vaccines tailored to the clients’ needs. R&D projects customised with flexible entry and exit points at any stage and for any immunotherapeutic strategy appeal to start-ups, biotech, or biopharma companies.

With the starting pandemic early 2020, YUMAB collaborated with the University Braunschweig and other partners to develop antibodies against SARS-CoV-2. The promising results ended in the YUMAB spin-out CORAT Therapeutics GmbH (see seperate company profile on page 68 ), founded in May 2020. The collaboration and its success were honored with the Innovation Award of the state of Lower Saxony at the end of September 2020. Currently, the antibody drug candidate COR-101 is in the clinical phase Ib/II, which is being conducted at five study centers in Germany. Here, COR-101 is being tested in hospitalized patients, in particular to assess safety, tolerability, and efficacy.

The YUMAB® platform: fast & reliable translation from innovation to drugs The YUMAB® R&D platform delivers fully human antibodies, the closest to natural germline among those on the market, using fast and reliable in vitro discovery technologies. The company’s highly diverse, human antibody libraries contain 1011 natural antibody sequences and specificities to all types of antigens. Unlike animalderived, chimeric, humanised, or synthetic antibodies, each YUMAB® antibody sequence has been shaped in the human body, which maximises epitope diversity and overcomes restriction by in vivo immune responses while minimising immunogenicity and potential adverse effects in clinical development.

YUMAB

Our advanced in vitro selection technology is also efficient for rare and difficult target antigens and allows pre-design of epitope specificity, interspecies X-reactivity, affinity, stability, and other properties early in the discovery and development process. First antibody candidates are identified swiftly within a few weeks and are highly developable into all types of antibody drug formats such as full-length IgGs, Fabs, scFvs, bispecifics, CARs, fusion proteins, and ADCs. YUMAB provides tailored service and partnering concepts to jump-start translation from research innovation to drug development with affordable entry costs, flexible licensing options, and no additional third-party obligations.

YUMAB at a glance Human antibody discovery platform › Natural fully human libraries for low immunogenicity › Optimised in vitro selection to address difficult targets › Rapid discovery within weeks Direct link to lead development › Advanced antibody lead development & optimisation › All antibody drug formats, all disease areas › Robust & fast process with high success rates

FULLY HUMAN ANTIBODY DISCOVERY PLATFORM

YUMAB® platform › Fully integrated discovery & development platform from target to optimised lead › Customised project plans with flexible entry & exit points › Smooth translation from bench to bedside Flexible services, collaborations & partnering › Contract R&D as fee-for-service & flexible licence options › No technology access fees › Partnered collaboration to translate research innovation into drug development

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

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Zymo Research Europe GmbH Mülhauser Str. 9 79110 Freiburg Germany +49-761-60068-71-0 +49-761-60068-71-20 info@zymoresearch.de www.zymoresearch.de > 20 1994 | Microbiomics | Epigenetics | Sample Collection

Vision and Mission From its birthplace in a small garage in Orange, California, to the industry leader it is today, Zymo Research has been led by the vision to have a positive impact in the biomedical field and to contribute to the greater good of humanity. That vision touches every aspect of Zymo Research and has guided the company’s growth, culture and creation of the most innovative and valuable biomedical tools and services since 1994.

Now, Zymo Research is a globally established biotechnology company and industry leader in the fields of epigenetics, microbiomics and the emerging NextGene Sequencing space. While the company provides some of the most technologically advanced and reliable products in the industry, everything is driven by the fundamental belief that “the beauty of science is to make things simple.”

Epigenetics As the industry leader in epigenetics, Zymo Research offers a complete product portfolio and analytic services for epigenetics research. Zymo Research’s suite of EZ DNA Methylation™ products are of highest quality, the most trusted, and most cited technologies for bisulfite conversion. Zymo Research is committed to enhance the epigenetic studies by providing researchers of every discipline with quality products needed to answer the big questions in molecular biology research today.

One of the special services of Zymo Research is the myDNAge™ test including the analytical service which is based on Next-Gene sequencing and is used to determine the biological age. The DNAge™ technology is based on the epigenetic aging clock (Horvath’s Clock) which analyzes DNA methylation patterns and provides information about the influence of lifestyle or disease on the aging process.

ZYMO RESEARCH

Microbiomics The field of microbiomics has been developing rapidly in recent years and still there is a lack of standardisation and reproducibility of data in different labs. To address the fundamental challenges, Zymo Research is leading the development of new microbiome-grade tools in this field. These include the first commercially available microbiome reference materials, the first DNA extraction kit designed to ensure non-biased cell lysis, and the first cold-free and unbiased method to preserve microbial samples.

Zymo Research’s goal is to eliminate bias across micro­ biomics workflows and provides a complete pipeline from collection to analysis. The standardized workflows improve the reproducibility of data across labs.

Sample Collection on Earth and in Space Zymo Research received recognition from NASA for their cooperation and dedication in the development of a unique sample collection tube to support human research aboard the International Space Station (ISS).

A custom solution was made for NASA’s research, with DNA/RNA Shield™ to preserve microbial metatranscriptomic profiles in space until missions are complete, and samples can be brought back to earth for analysis.

DNA/RNA Shield™ enables superior stabilization of nucleic acids and allows convenient and safe shipment of samples at room temperature worldwide and beyond.

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© Swiss Biotech Association

SWISS BIOTECH DAY

... ONE BIOTECH CLUSTER

OTECHNOLOGY” GROUP

sector is internationally visible. The project-specific participating companies (most of them young and internationally less savvy) find a comprehensive partner al companies are exploring the opwhich is helping to put them in the public window. have been opened up by modern bio- The participating Life Science Regions are important ecially in the field of “white” or indusinternal carriers of the dynamics in the Biotech secogy. And they are also applying these tor, thus enhancing the common understanding of the herever it makes sense. The SBA takes industry. This and more knowledge is brought into Sign on our website atEuropa www.swissbiotechday.ch seriously and has in formed a working Bio, the European Biotech Association, where staybiotechnology. updated aboutthe anySBA news. lly dedicatedand to white is an active member. strial Biocatalysis Consortium is an er in this effort. The group includes tional companies that support white as a pillar of Main economic growth. The sponsors: es are in agreement with OECD

with the Swiss Biotechnet (see pages develops training programmes and uses for the industry. It is of importance y specifies its training needs so that de can create tailor-made education.

Sponsors: nsures that the industry gets the right the right education. The SBA profits ing alliance “Swiss Biotech” (see box) orm. Thanks to Swiss Biotech, the

SWISS BIOTECH...

May 2-3, 2022

...is an alliance of four leading Biotech regions of Switzerland (Bio Alps, BioPolo Ticino, Basel Area and Greater Zurich Area). They have combined efforts to streamline interests of the national biotech sector. The SWX Swiss Exchange holds a leading position in terms of lifescience listings and offers companies from that industry – be they located in Switzerland or abroad – access to an internationally recognised financial marketplace. The initiative was co-founded by the SBA which also manages the executive Organized by: office of Swiss Biotech.

Congress Center Basel

@

Domenico Alexakis is Executive Director of the Swiss Biotech Association.

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For further information please visit www.swissbiotechassociation.ch www.swissbiotech.org

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VOLUME 12

2022

12th European Biotechnology Guide

European Biotechnology Guide Science & Industry

ISBN 978-3-928383-83-7

European Biotechnology Net work