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Europea n Biotechnolog y

Science & Industry

Guide

Europea n Biotechnolog y Science &

Industry

Guide

© BIOCOM AG, Berlin 2025

European Biotechnology Science & Industry Guide 2025 (Vol. 15)

Published by:

BIOCOM Interrelations GmbH

Jacobsenweg 61 13509 Berlin, Germany

Tel. +49-30-264921-0

Fax +49-30-264921-11 service@biocom.de www.biocom.de

In cooperation with the European Biotechnology Network www.european-biotechnology.net

Editor: Andreas Mietzsch

Executive Producer: Andreas Macht

Production: Martina Willnow

Graphic Design: Michaela Reblin

Printed at: Druckhaus Sportflieger 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: 978-3-928383-95-0

Biotechnology is the magic key

An editorial in a European company guide with a look at the global political situation? That’s very unusual. But we live in strange times. On the one hand, we enjoy freedom, peace and historically unrivalled prosperity. On the other hand, we feel threatened. Not so much in the short term and in our personal environment, but noticeably. Democracy is suddenly perceived as exhausting. In addition, there is the impression that it is mostly only crazy dictators and simplifiers or rather trivial things that cause a splash, while the real problems are not being tackled. What about the threat to our biosphere from too much CO2 in the air? We are facing a natural disaster of almost biblical proportions and what do we do? Half the world is forced to invest its scarce resources in armaments to defend itself from an atavistic would-be tsar. And the USA is now governed by a man who can be described as ‘erratic’, which is already a sign of great self-restraint.

Is the risk aversion and fear of loss of the ageing population in many European countries behind the omnipresent suppression of the necessary? Or is it the dumbing down – ahem – blinding of the younger generation by the Unsocial Media? Or both? I recently read in a letter to the editor on the political situation: ‘No hope, nowhere!’ However, I would like to strongly disagree with this. Mankind already has all the means at its disposal to turn the tide. The only question is whether everything has to get much worse before the shackles of the past can be cast off enough for us to turn our attention to the future. And that brings me to the crux of the matter: the future can only consist of the masses of people adapting to the conditions of our planet again! Economising in cycles and consuming only as much as our ‘spaceship Earth’ can provide. The key to this is biotechnology – something that has unfortunately been largely forgotten. It has already established itself as the central technology in the pharmaceutical sector, but CRISPR/Cas and the New Genomic Techniques (NGT) are not being let off the leash, especially in the EU. One day in the not-too-distant-future, however, this will/must happen, and then we will have climate protection, growth, a unique selling point and a future all in one.

Biotechnologists are incorrigible optimists – otherwise we would be doing something different, faster and more profitable. And although the general conditions in Europe are not always the best (see above), the biotechnology sector in Europe is very successful and is growing in many places even against the trend. In this book, dear readers, you will find many optimistic messages. Companies large and small are focussing on biotechnology and life sciences. However, biotechnological research and later the transfer of the results to consumers require freedom, peace and a lot of money. But what will happen if the transatlantic community of values crumbles? What will be left of the free markets? As optimists, however, we continue undeterred because we are convinced that we are doing the right job.

With this in mind, I hope you all enjoy reading this 15th European Biotechnology Guide published with enthusiasm by BIOCOM®

european-biotechnology.net

Let’s save the planet!

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

Biotechnology: From green opportunity to wallflower

In politics, priorities can shift rapidly - much to the chagrin of the economy, which depends on longterm strategic planning. A notable example occurred in 2010, when the Renewable Energy Directive set the target of achieving 10% biofuel usage by 2020. However, support for biodiesel and bioethanol was swiftly abandoned in favour of emobility, culminating in the decision to ban new registrations of cars with combustion engines –including those using climate-neutral fuels – after 2035. A similar policy reversal is now unfolding under European Commission President Ursula von der Leyen (EPP). Her first legislative period (20192024) was characterised by the Green Deal, which emphasised regulatory measures to curb greenhouse gas emissions – particularly CO 2 – and a shift from fossil fuels to renewable resources as part of a bio(mass)-based bioeconomy. But in light of geopolitical tensions, particularly Russia’s aggression against Ukraine, von der Leyen has pivoted toward policies aimed at making Europe more competitive, more self-sufficient in raw materials as well as energy and more resilient to crises – at the expense of the Green Deal. This shift could have a negative impact on biotechnology, a key cross-sectoral and enabling technology.

in Europe and hinted at a future EU biotech law. The strategic paper outlines how to solve the challenges that the biotech and biomanufacturing sector in the EU faces. These include accelerating technology transfer to market, reducing regulatory complexity, improving access to financing, attracting skilled workers, eliminating value chain obstacles, enhancing IP protection, boosting public acceptance of new technologies, and strengthening economic security. Vestager’s EU initiative for biotechnology and bioproduction proposes several measures “to address these challenges in a timely manner”.

Leveraging research and boosting innovation: To help identify drivers and bottlenecks of innovation and technology adoption, the Commission ordered a study to investigate the EU’s position compared to other global leaders in industrial biotechnology. On top, the Commission is looking at how to speed up the development and use of biobased innovations within the Industrial Biotechnology Innovation and Synthetic Biology Accelerator (EU IBISBA) as a digital hub and service network for the sector.

European lip service

Credible studies indicate that the 2015 Paris Agreement target of permanently limiting global warming to 2°C (or better yet 1.5°C) above the 1850-1900 preindustrial average temperature was exceeded for the first time in 2024, reaching 1.67°C. Current forecasts project 2.5°C and above for the year 2100.

In March 2024, the previous EU Commission, represented by Executive Vice-President Margrethe Vestager, stated that biotechnology could help counteract both climate change and the increasing shortage of raw materials. As part of an ‘EU Biotech and Biomanufacturing Initiative’, she then presented eight measures designed to speed up technology transfer

Stimulating market demand: For bio-based products to gain a competitive edge, they want to assess their environmental impact compared to fossil-based alternatives. To ensure fair assessment, the European Commission will review the evaluation criteria for both fossil- and bio-based products, incorporating methods for carbon storage in construction materials. To accelerate the substitution of fossil feedstock and to stimulate the demand and market uptake of bio-manufactured products, the Commission will conduct an in-depth impact assessment on the feasibility of biobased content requirements for specific product categories and in public procurement, while also eliminating subsidies making the fossil-based industry more cost-effective. Furthermore, the Commission said it will explore how bio-manufactured non-food products can enhance their market positioning through improved labeling.

Streamlining regulatory pathways: The Commission has committed to assessing how EU legislation and its implementation can be streamlined to shorten the time-to-market for biotech innovations. A separate

EuropaBio

study is set to lay the foundations for a potential EU Biotech Act. To further support the sector, the Commission plans to establishing an EU Biotech Hub, designed to help biotech companies navigate regulatory complexities and access resources to scale up. Furthermore, so-called regulatory sandboxes are being considered. These controlled environments would allow novel solutions to be tested under the supervision of regulators for a limited amount of time, facilitating faster market entry.

Fostering public and private investments: The EU names several existing financing instruments to support biotechnology and biomanufacturing such as Horizon Europe; the Innovation Fund; and STEP. To foster the development and scale-up of innovations with the potential to create new markets, a key policy objective is to address specific challenges for biotech and biomanufacturing in the European Innovation Council (EIC) Accelerator Work Programme 2025. Further- Source:

more, the Commission has initiated a study to identify barriers and propose measures to support the consolidation of investment funds, stock exchanges and post-trading infrastructure. This effort aims to enable the development of the necessary scale, enhance the knowledge base, create deeper pools of liquidity and help lower the cost of financing for high-growth companies.

Strengthening biotech-related skills: According to the initiative presented by Vestager, large-scale and regional skills partnerships could play a key role in providing upskilling and reskilling opportunities in biotech and biomanufacturing. The Commission will explore the creation of a dedicated large-scale partnership for industry players in these fields, with potential co-financing through the Blueprint Alliances initiative under the Erasmus+ programme.

Updating standards: The Commission has stated that it will promote the elaboration and revision of Euro -

Fig. 1: EuropaBio’s vision of a pro-biotech EU policy approach.

Name ›

Boehringer Ingelheim Biopharmaceuticals GmbH

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

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

Areas of Activity › Net Sales › Relevant R&D Budget › Request for › Further Collaborations

Binger Strasse 173 55216 Ingelheim Germany

Rebekka Wuester

+49-6132-77-0 +49-6132-72-0 bioxcellence@boehringer-ingelheim.com www.bioxcellence.com around 53,000 in 2023 1885 in Ingelheim, Germany S1

Focus on human pharmaceuticals, animal health and biopharmaceutical contract manufacturing

25.6 billion in 2023 5.8 billion in 2023

Boehringer Ingelheim BioXcellence™ is a dedicated partner for biopharma companies, providing comprehensive development and GMP manufacturing services. Renowned for its reliability, the company supports clients throughout the lifecycle of their products, thus transforming biologic innovations into commercial realities.

Company profile

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow.

BioXcellence Manufacturing – Tailored Capacities. Reliable Supply. Your Success, Our Commitment. Boehringer Ingelheim BioXcellence™ is a leading biopharmaceutical contract manufacturer – a reliable partner that accompanies customers throughout the life cycle of their products. We provide E2E biopharmaceutical manufacturing based on mammalian cell culture and microbial fermentation.

We have extensive experience with a variety of different host cells, producing a broad range of molecules in accordance with cGMP manufacturing guidelines and covering all stages of development, including aseptic filling. Our focus is on creating value for our customers through robust processes, effective preparation for launch, and global clinical and commercial supplies of high-quality biopharmaceuticals.

We are committed to maintaining high-quality standards in all operations, with robust systems designed to meet stringent regulatory requirements, and strong quality control capabilities that ensure product quality at every manufacturing stage. Our team’s extensive regulatory experience and impressive inspection track record demonstrate our ability to navigate complex regulations and integrate in-depth technological knowledge into our operations.

World-Class Expertise

With over 40 years of biotechnology experience and a team of dedicated and highly trained employees, we have helped our customers bring more than 45 biopharmaceutical medicines to the market, serving patients all

over the world. Our expertise spans across various host cells, enabling us to produce a wide array of molecules. Our commercial portfolio comprises monoclonal antibodies, recombinant proteins, antibody fragments, and recombinant vaccines, and is complemented by intensive experience in bi- and multispecific antibodies, Fc fusion proteins, scaffolds, peptide hormones, and pDNA.

World-class Facilities

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. With more than 440 kL for mammalian cell culture and 12 kL for microbial fermentation in fully licensed multiproduct facilities we are your right partner for high-quality global supplies of biopharmaceuticals to patients. This is evidenced by our regulatory excellence. Our operations are based on fully licensed multi-product facilities for all major markets. One-quality, one-compliance, and oneregulatory form the foundation of our global network.

Your World-class Production Partner

For many of our customers, we are the preferred partner for reliable supplies. Seven of the top 10 pharmaceutical companies already trust us due to our extensive commercialisation experience. At Boehringer Ingelheim, we are deeply invested in the success of your product. Our shared passion is reflected in our commitment to providing the highest quality services and solutions to ensure your product reaches its full potential. Aside from our extensive experience and technical expertise, which complements yours, there are several other compelling reasons to choose us as your trusted contract manufacturing partner. At Boehringer Ingelheim, we have learned over the generations that the challenging path towards health innovation requires long-term commitment, resilience, and transformative action.

Let’s build a future together based on our history. We have capabilities to complement your expertise and are committed to turning your biologic innovation into commercial reality.

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