Launching the New Biotech and Biomanufacturing Hub

Landkarte *** Europa | Image credit: ©beugdesign - Stock.adobe.com

On 30 Jan. 2025, the European Commission (EC) launched a new Biotech and Biomanufacturing Hub to help European Union (EU) businesses, particularly small and medium enterprises (SMEs), to access support, expand, and grow (1).

The Hub offers access to EU funding for research and development (R&D), business development tools to market products on a global scale, regulatory guidance on product approval, and compliance and support for intellectual property rights to protect innovative products (1).

The Hub is accessible on the EC’s Your Europe portal to EU nationals, nationals of European Arenas Association (EAA) countries, family members of EU/EEA nationals, non-EU nationals that enjoy EU rights, and businesses with headquarters in a EU country (2). A task force of advisors will guide the continuous development of the portal (3).

STEP regulation

In June 2023, the EC proposed a regulation to establish a new platform for Strategic Technologies for Europe Platform (STEP) (4). STEP aims to support the development and manufacturing of critical technologies and to address any shortage of labour and skills. Several proposals were outlined in STEP to boost biotechnology and biomanufacturing in the EU, these are summarized in Figure 1 (5).

Figure 1. Proposals outlined in the European Commission’s Strategy to boost biotechnology and biomanufacturing in the EU. Figure courtesy of the author

On 1 March 2024, the STEP Regulation (Regulation (EU) 2024/795) came into force (6). The STEP platform has access to €160 billion in funds to invest in strategic projects that develop or manufacture critical technologies namely:

• biotechnologies—molecular biotechnology, pharmaceuticals, crop biotechnology.
• clean and resource-efficient technologies—capture and storage technologies, and heat pumps.
• digital technologies and deep technology innovation—artificial intelligence (AI), advanced connectivity, and quantum technologies (4).

STEP stakeholders include governments, regulatory bodies, industry leaders, research institutions, and the public. The STEP Task Force coordinates and cooperates with stakeholders to address funding challenges and identify new opportunities.

The EU aims to bolster its industrial competitiveness, enhance its strategic autonomy and resilience, and boost its economic security through investment in biotech and biomanufacturing, and the Hub is a key element of the EC’s strategy (7).

STEP has invested in 11 EU programmes including:

• Digital Europe Programme (DEP): Provides funding for projects including advanced digital skills AI, cybersecurity, supercomputing, and ensuring the wide use of digital technologies across the economy and society (8).
• European Defence Fund (EDF): This supports collaborative research and development (R&D) of defence capabilities with the EU budget (9).
• EU4Health: Established in response to COVID-19’s impact on medical and healthcare staff, patients, and health systems in Europe. It aims to improve and foster health in the EU (10).
• Horizon Europe (HE): Aims to tackle climate change and helps to achieve the United Nations’ (UN’s) Sustainable Development Goals and boosts the EU’s competitiveness and growth (11).
• Innovative Fund (IF): One of the world’s largest funding programmes for the demonstration of innovative low-carbon technologies (12).

Additional funding has been provided by STEP to the European Regional Development Fund (ERDF), Cohesion Fund, European Social Fund+ (ESF+), InvestEU, Just Transition Fund (JTF), and Recovery and Resilience Facility (13).

Future implications

The EC continues to strengthen the competitiveness and resilience of the European economy through investment in transformational technologies. The investment in the Biotech and Biomanufacturing Hub will not only support innovative European biotechs but also sends a clear message to the rest of the world that Europe means business (14).

References

1. EC. New Biotech Hub to Support Companies. ec.europa.eu. 20 Jan 2025.
2. Stur, B. New Biotech and Biomanufacturing Hub Will Support Innovative European Companies. European Interest. 2 Feb 2025
3. EC. Your Europe–Advice. ec.europa.eu (accessed 14 Feb. 2025).
4. EP. Strategic Technologies for Europe Platform (STEP). Think Tank. 15 Feb 2024.
5. Eteris, E. Biotechnology and Biomanufacturing in the EU: Perspective Strategy - Analytics, EU Law & Governance. Analytics, EU Law & Governance, Integrin Dk. EG in Europe. 15 May 2024
6. EC. Regulation (EU) 2024/795 of the European Parliament and of the Council of 29 February 2024 Establishing the Strategic Technologies for Europe Platform (STEP) and Amending Directive 2003/87/EC and Regulations (EU) 2021/1058, (EU) 2021/1056, (EU) 2021/1057, (EU) No 1303/2013, (EU) No 223/2014, (EU) 2021/1060, (EU) 2021/523, (EU) 2021/695, (EU) 2021/697 and (EU) 2021/241. ec.europa.eu. 29 Feb. 2024.
7. EC. Building the Future with Nature: Boosting Biotechnology and Biomanufacturing in the EU. EC.europa.eu. 20 Mar 2024.
8. EC. Digital Europe Programme. ec.europa.eu (accessed 14 Feb. 2025).
9. EC. European Defence Fund. ec.europa.eu (accessed 14 Feb. 2025).
10. EC. EU4Health. ec.europa.eu (accessed 14 Feb. 2025).
11. EC. Horizon Europe is the EU’s Funding Programme for Research and Innovation. ec.europa.eu (accessed 14 Feb. 2025).
12. EC. Innovation Fund. ec.europa.eu (accessed 14 Feb. 2025).
13. EC. STEP Strategic Technologies For Europe Platform. June 2024.
14. Yadav, R. European Commission Launches Biotech and Biomanufacturing Hub. The Bioeconomy. 31 Jan. 2025.

About the author

Cheryl Barton is founder and director of PharmaVision, Pharmavision.co.uk.

Article details

Pharmaceutical Technology® Europe
Vol. 37, No. 2
March 2025

®Citation

When referring to this article, please cite it as Barton, C. Launching the New Biotech and Biomanufacturing Hub. Pharmaceutical Technology Europe 2025 37 (2).