March 20, European Commission Q&A on Biotech and Biomanufacturing Exchange
What are the current industrial applications of biotechnology and biomanufacturing?
Biotechnology and biomanufacturing, the use of biotechnology and biological resources and their conversion into chemicals, products and energy, are transforming a wide range of industrial sectors, including chemicals, textiles, cosmetics and agri-foods, and bringing new sustainable consumer products to the market.
Biorefineries are facilities used to convert biomass into a range of bio-based materials and also to convert wood into innovative, high value-added products: biochemicals, insulation foams, biocomposites, engineered foams, and so on. A European company is developing batteries made from hard carbon powder (refined lignin) that have a scalable model for commercial production.
In the textile sector, biotechnology offers an environmentally sustainable alternative, especially in dyeing, printing and finishing processes. Enzymatic treatments reduce water and energy consumption and contribute to a lower environmental impact.
In the health field, mRNA therapeutics helped discover the new mRNA-based vaccine for Crown pneumonia, saving millions of lives.
In addition to vaccines against infectious diseases, RNA therapies are being developed to treat cancer as well as rare and cardiovascular diseases.
In the agri-food sector, biotechnology increases crop yields, enhances resistance to pests and diseases, reduces environmental impacts, and improves food quality and nutritional content.
What is the role of biotechnology in the EU economy?
Biotechnology is one of the fastest growing innovative industries in the EU with high labor productivity. Biotechnology directly contributes Euro31 billion to its overall GDP, creates 210,700 direct jobs in healthcare, industry and agriculture, and provides 625,700 jobs (indirect and induced employment) to the overall economy.
What are the advantages of products made from biomaterials or clothing made from recycled biofiber?
Products made from sustainable bio-based raw materials offer many economic, social and environmental benefits. This choice not only encourages businesses and consumers to adopt sustainable practices, but also promotes innovation.
For example, choosing children's toys made from bio-based materials or clothing made from recycled bio-based fibers can bring advantages in terms of environmental impact, biodegradability, resource conservation, energy efficiency, recycling and waste reduction. Bio-based materials come from renewable sources, reducing dependence on fossil fuels and potentially lowering carbon emissions. Similarly, garments made from recycled biofibers help reduce the environmental footprint of traditional textile production. The use of recycled materials in apparel conserves natural resources by reducing the need for virgin raw materials. This supports sustainable development by reducing the environmental impact of resource extraction and processing. In addition to their environmental benefits, bio-based products enhance the competitiveness and modernization of our economies. These products have a great potential for growth and high labor productivity, contributing to the economic growth of the EU and promoting job creation.
Biobased materials and products tend to be more expensive than fossil materials and products. Does the communication include any measures to address this issue?
In order to be successful in the marketplace, bio-based products need to demonstrate sustainability and reduce their environmental impact when compared to petrochemical products. Life Cycle Assessment (LCA) is a key methodology for assessing the environmental impact of products. While different LCA methodologies have been developed, the committee recommends the Product Environmental Footprint (PEF) methodology, which was last reviewed in 2021. In the next periodic revision (2025-2026), in the light of recent scientific developments, the Committee will review the assessment of fossil-based and biobased products to ensure equal treatment and incorporation of carbon storage methods in building materials.
In order to accelerate the substitution of fossil feedstocks and stimulate demand and market uptake of biomanufactured products, the European Commission will conduct an in-depth impact assessment of the feasibility of biocomponent requirements for specific product categories and public procurement. Such requirements could be established through an enabling act under a new eco-design regulation for sustainable products, in line with the EU's international commitments.
On the consumer side, the European Commission will explore how biomanufactured non-food products can better present themselves for bioproduct labeling by. This will inform consumers about the biological content of products, raise awareness and allow them to make informed choices. When consumer demand for biobased products increases, manufacturers may scale up production, thereby realizing economies of scale and potentially reducing production costs. A number of market pull measures could facilitate the commercialization of innovative biotechnology and biomanufacturing solutions.
The simplification of the regulatory framework and streamlining of the authorization process are intended to promote innovation, increase transparency and reduce costs for consumers, thereby accelerating the entry of products into the market.
Why are intellectual property rights important for the biotechnology and biomanufacturing sectors? What will the Commission do in this regard?
Intellectual property rights (IPRs) play a key role in biotechnology and biomanufacturing because they allow biotechnology innovators to protect the results of their research and thus recoup the large upfront capital investment required. It is also often an important asset that emerging biotechnology start-ups can offer to secure financing. Providing a stable, predictable and balanced IPR framework to protect and evaluate biotechnology innovations and facilitate access to them is therefore essential to ensure the viability of the EU biotechnology ecosystem.
The Commission will continue to encourage the remaining Member States to join the Unitary Patent System and will support the speedy finalization of negotiations on legislative reform proposals for Supplementary Protection Certificates (SPCs) in order to reduce costs and administrative burdens, while increasing the legal certainty and transparency of patents and SPCs in the biotechnology ecosystem.
How can the EU attract biotech and biomanufacturing investment?
In order to attract investment in Europe, the EU can utilize a wide range of financing instruments to support biotechnology and biomanufacturing (e.g. Horizon Europe also through the Biobased European Circulation Joint Undertaking (CBE JU); Innovation Fund; InvestEU). In addition, Hera Invest provides a financing mechanism to attract private investment targeting small and medium-sized enterprises (SMEs) for advanced R&D in medical countermeasures and related technologies. For high-growth European technology companies in later stages of growth, growth financing is available through the European Investment Bank's (EIB) European Technology Champions Initiative (ETCI).
In addition, biotechnology will benefit from the European Strategic Technology Platform (STEP), which aims to promote investment in key technologies in the digital, clean and biotechnology sectors using existing funding instruments such as the Horizon Europe program, the European Defense Fund, the InvestEU or Cohesion Policy Fund and the Recovery and Resilience Plan.
The European Commission will advocate for the inclusion of biotechnology and biomanufacturing in the European Innovation Council's (EIC) 2025 Accelerator Work Program to develop and scale up innovation.
Finally, the European Commission will launch a study to identify barriers and ways to support the integration of investment funds, stock exchanges and post-trade infrastructures in order to better finance the later stage growth of the EU's high-tech expansion, including biotech operations.
What are the links between the communication on biotechnology and biomanufacturing and the EU's policy framework for the bioeconomy?
Biotechnology and biomanufacturing are important technologies for achieving the objectives of the EU Bioeconomy Strategy. The forthcoming review of the EU Bioeconomy Strategy will consider how biotechnology and biomanufacturing can be supported and developed.
The bioeconomy covers all sectors and systems that depend on biological resources, their functions and principles. It encompasses terrestrial and marine ecosystems and the services they provide and links them to each other; all primary production sectors that use and produce biological resources and all economic and industrial sectors that use biological resources and processes to produce food, feed, bio-based products, energy and services. To be successful, the European bioeconomy needs to have sustainability and circularity at its core. This will promote the revival of our industries, the modernization of our major production systems, environmental protection and will enhance biodiversity.
How will the European Commission promote artificial intelligence (AI) in biotechnology?
The European Commission, through its Research, Innovation and Digital Technology funding program, invests in advances in all areas of science driven by artificial intelligence, including biotechnology.
Artificial intelligence in science is one of its most promising and exciting uses. In a policy brief released in December 2023, Artificial Intelligence in Science, the committee explored ways to use AI to advance and accelerate scientific discovery for the benefit of society. These include assessing the appropriateness of new base models for scientific and other AI research aids, specifically for scientific work. One of the most pioneering examples of artificial intelligence applications Biotechnology collaboration is the European Molecular Biology Laboratory There is also DeepMind's Alpha Folding to Mapping and Publishing More than 200 million protein structure predictions, including the entire human proteome.
To further promote such scientific breakthroughs, Horizon Europe, the world's largest multilateral research and innovation program, is investing in all areas of progressive science driven by artificial intelligence, including biotechnology.EU-invested company Amadeus uses artificial intelligence for colorectal cancer detectionDrug combPersonalized cancer therapy programAIDD drug research and development programAI4LIFE program "Enhancing life scientists' access to AI image analysis" demonstrates the EU's commitment to integrate AI into biotechnology research and development.
In addition, the Commission's "GenAI4EU" initiative aims to promote the adoption of Generative Artificial Intelligence across the European Union, with the Horizon Europe and Digital Europe programs investing €500 million by 2027; biotechnology is one of the priority sectors.
How can the Circular Biology Europe joint project and the Innovative Health Initiative (IHI) partnership contribute to innovative biotechnology and biomanufacturing in Europe?
The Circular Bio-based Joint Undertaking (CBE JU) is a strategic public-private partnership vehicle for the European biotechnology and biomanufacturing industry, aimed at scaling up the production capacity of innovative bio-based chemicals and materials to commercial scale.
Some of the programs administered by CBE JU include:
The PEFerence program is helping to address the impact of plastic waste on the environment and our health by bringing 100% bio-based polyester to market. Bio-based polyester is more environmentally sustainable than fossil-based polyester and is fully recyclable. The goal is to replace most fossil-based plastics with 100% bio-based polyesters based on FDCA for bottles, films and fibers. The innovative industrial-scale, cost-effective biorefinery in Delftsgill, the Netherlands, is producing the bio-based chemical furanodicarboxylic acid (FDCA). It will be inaugurated in September 2024 and fully operational.
AFTERBIOCHEM Saint-Avold's (France) flagship program harnesses what is traditionally considered waste to create high-value products and solutions through the use of advanced fermentation processes. The "first-of-its-kind" biorefinery is developing the first integrated chemical platform for converting by-products from the sugar beet industry into biologically sourced industrial chemicals that can be used in food preservatives, cosmetics and fertilizers. It is supporting local sugar beet farmers in the region by creating new business models, diversifying revenue streams and creating new highly skilled green jobs. The plant will be inaugurated in early 2025.
The Innovative Health Initiative (IHI) funds a number of research programs that incorporate biotechnology, a key technology in the development of therapeutic and preventive strategies for a wide range of diseases.The IHI initiates programs in areas of disease where the burden on patients and society is high, such as cancer or cardiovascular disease.
IHI-funded projects lay the foundation for the development of new, safe and effective innovations such as diagnostics and treatments. In doing so, IHI also helps the EU health sector to remain globally competitive.IHI is committed to the objectives of key EU policy initiatives such as the European Plan to Beat Cancer, the new European Industrial Strategy and the European Pharmaceutical Strategy. For example, the project Ardat will provide new knowledge, tools and standards needed to accelerate product development of advanced therapeutic drugs MMUCAN analyzed the tumor microenvironment of 3,000 patients to identify biomarkers that show which patients are most likely to respond well to immunotherapy. The program White Mahogany focuses on predicting the impact of monoclonal antibodies and vaccines on antibiotic resistance.
How does the Industrial Biotechnology Innovation and Synthetic Biology Accelerator (EU-IBISBA) contribute to biotechnology development in the EU?
This Industrial Biotechnology Innovation and Synthetic Biology Accelerator (EU-Ibisba) is a distributed research infrastructure designed to accelerate knowledge and early research results in the fields of biotechnology and synthetic biology towards maturity and further development by industrial research and innovation organizations.EU-Ibisba's expertise falls within the field of industrial biotechnology and focuses on the integrated development of biological processes that can be used for commercial.
EU-IBISBA supports industrial biotechnology research by providing first-class facilities for all industrial biotechnology professionals. One of its key strengths is the provision of one-stop integrated R&D services at all stages of bioprocess development. Other key strengths are the promotion of standardization, interoperability and best data practices (data is stored in the IBISBA Knowledge Center ensuring integrity, security and privacy).
EU - Ibisba also helps develop smart solutions for biomanufacturing by combining biotechnology with artificial intelligence, digital twins and cloud technologies.
What is European Horizons doing to increase public understanding and trust in biotechnology?
Public trust is key to the acceptance of biotechnology solutions in many application areas. Science-based communication provides an opportunity to ensure balanced public risk perception and acceptance.
Two excellent examples of European Horizon funded projects are.
The B-TRUST project brings together partners from member states to develop a transparent and inclusive governance model to enable the application of biotechnology in the bio-based and agri-food sectors. More specifically, to (1) inform and create transparency related to consumer and environmental safety, (2) leverage citizen and other stakeholder engagement, and (3) develop and exchange best practices.
The European Gene and Cell Therapy Exchange Consortium (EuroGCT) brings together 47 collaborating organizations and institutions in Europe with the aim of providing reliable and accessible information on the use of cells and genetic material in the treatment of disease.EuroGCT provides (1) patients, people affected by disease, healthcare professionals and citizens with accurate scientific, legal, ethical and social information related to cell and gene therapy, ( 2) a source of information for the research community on the practical steps required for the development of cell and gene therapies.
How does the European Innovation Council (EIC), part of Horizon Europe, contribute to supporting start-ups in biotechnology?
Through the Horizon Europe program, the EIC has provided around €350 million in support and investment in biotechnology and biomanufacturing, ranging from early-stage research to investment in individual start-ups and SMEs in areas such as industrial biotechnology, healthcare biotechnology and novel food products such as cellular agri-foods involving bacteria, yeast, algae and fungi.
The current EIC work program includes a targeted call focusing on "Precision Fermented Foods and Algae" (global market forecasts suggest a more than 20-fold increase in investment in precision fermented proteins by 2030) and another new area of activity, albeit with a greater focus on early-stage research, which offers opportunities for biotech-driven solar energy conversion into fuels and chemicals. Conversion to fuels and chemicals offers opportunities:Solar cell factories are single-celled microorganisms (cyanobacteria, microalgae) that convert sunlight, water, and carbon dioxide directly into fuels or chemicals, and may produce a wide range of products, from hydrogen to synthetic fuels or pharmaceuticals.
Examples of EIC-funded biotech companies are.
Infinite Roots Mushlabs is a biotech company from Hamburg, Germany that has developed a fermentation technology to produce edible mushroom roots called mycelium. The bioprocessing technology creates mushroom biomass rich in protein, dietary fiber and micronutrients with a delicious flavor from mycelium cultivated in a controlled and optimal environment.
Hoba Therapeutics, an early-stage biotechnology company headquartered in Denmark, has developed innovative therapies for the treatment of chronic neuropathic pain and sensorineural hearing loss through the discovery of a new family of endogenous human proteins: meteorin and cometin.
In addition, the European Commission will advocate for the inclusion of biotechnology and biomanufacturing in the European Innovation Council's (EIC) 2025 Accelerator Work Program to develop and scale up innovation.
How will the European Commission continue to support research and development in biotechnology and biomanufacturing for health?
European Horizon funds health biotechnology and biomanufacturing through R&I projects driven by scientific opportunities, such as the European Research Council (ERC) and Marie Sklodowska-Curie Action Program (MSCA), as well as R&I collaborations, networks, infrastructures, and partnerships, which provide added value for Europe or call for a global approach. As a result, biotechnology and biomanufacturing innovations are integrated into many health-related EU-funded actions, with almost 600 projects and EUR 1.5 billion funded by European Horizons to date.
The Communication proposes a series of concrete actions in an effort to create an enabling environment for R&I activities in the EU. The project aims to facilitate the transfer of research results to the fields of medicinal products, prevention and diagnostics by.
Explore the possibility of providing specific support to SMEs for the clinical development of biotechnology-based pharmaceutical products and promote "lab-to-factory" technology transfer.
Working to further improve and streamline the clinical trial process in the EU Accelerating Clinical Trials in Europe (EU Act) initiative
Launch a study on the implementation of the Clinical Trials Regulation (CTR) to assess its impact on clinical research in Europe and prepare a report on the functioning of the CTR.
Simplification of the regulatory framework and regulatory sandboxes to test new solutions, such as those proposed for breakthrough therapies under the reform of drug legislation.
Explore the possibility of piloting a regulatory sandbox for health products under the IHI framework, laying the groundwork to support the most innovative products to the market and end-users, including, most importantly, patients.
Initiate a study to assess the current situation and determine how best to utilize existing assets and infrastructure in health biotechnology, including those developed jointly, in order to increase biomanufacturing capacity within the EU.
