Table of Contents
Introduction
Europe has become the leading region for contract manufacturing of biologics and cell therapies due to sophisticated regulatory frameworks, innovation hubs, and extensive industrial know-how. Startups and established pharma companies alike can greatly benefit from the right CMO or CDMO partner.
Europe’s Distinguished Position in Biologics and Cell Therapy Manufacturing
Degree of Stringency of Regulations: Risk of relatively high prospect consistency and faster approvals through EMA stringent quality guidelines.
Innovation Clusters: Presence of technically skilled human resource and capacities for innovation are greatest in Germany, UK, Spain and Nordic countries.
Cost-Quality Efficiency: Southern and Eastern Europe are attractive options for capabilities that optimize cost without compromising quality.
Top European CDMO/CMO Contract Manufacturers
1. Rentschler Biopharma (Germany)
Provides full biopharma CDMO services, such as cell-line and process development, manufacturing, analytics and regulatory support services.
2. Recipharm (Sweden & pan-Europa)
A multi-modal CDMO with biologics, sterile fill-finish and clinical materials, extensive European footprint (multiple sites across Sweden, Italy, Germany, Spain, Portugal, etc.)
3. SynCo Bio Partners (Netherlands)
GMP CMO handling microbial and mammalian biopharmaceuticals from process development through clinical/commercial stages. One of few with both clinical and commercial capacity.
4. WuXi Biologics (Ireland, Germany)
A large CDMO focused on biologics with drug substance and fill-finish in Leverkusen, Wuppertal (Germany) and a huge single-use facility in Dundalk, Ireland.
5. AGC Biologics (Italy)
Operates in Bresso and Milan, specializing in biologics CDMO services including cell therapy production.
6. Magle Biopharma (Sweden)
Stem-cell focused CDMO, offering dedicated cell therapy manufacturing services.
7. VIVEbiotech (Spain)
GMP‑certified CDMO dedicated to lentiviral vector production—critical for gene and cell therapy pipelines.
8. 53Biologics (Spain)
Offers end‑to‑end biologics development, from DNA to proteins, serving preclinical through GMP manufacturing needs.
9. Histocell (Spain)
Develops cell therapy from iPSC, MSCs, exosomes, secretomes, plus dermocosmetic lines and device integration.
10. Liof Pharma (Europe-wide)
Specialist in aseptic manufacturing and lyophilization for biologics and injectables.
11. Mabion (Europe)
Integrated CDMO for biotherapeutics, including monoclonal antibodies and recombinant proteins.
12. Cenexi (France)
Focused on injectable and non‑injectable sterile liquid products—aping safety and quality.
13. Aenova (Europe)
One of the largest European CDMOs, delivering across various dosage forms globally.
14. Grifols (Spain)
Leader in plasma-based biopharmaceuticals and biomanufacturing for life science R&D and clinical trials.
15. Hovione (Portugal, Ireland)
CDMO offering APIs, inhalation products, and formulation services with strong regulatory credentials.
16. Lonza (Switzerland)
A leading global CDMO with industry-reputable biologics and modular manufacturing platforms.
Honourable mention:
Fujifilm Diosynth Biotechnologies (Denmark)
large investments in Hillerød, the largest end-to-end CDMO in Europe.
Note: Cellares is working to automate the manufacturing of cell therapy products but is only establishing an EU presence, so it is not an established CDMO player yet.
Choosing the Right Partner: Key Criteria
Technical Proficiency: Have you reviewed their viral vectors? stem cells? mAbs? Is their expertise appropriate for your biologic or cell therapy platform?
Manufacturing Scale: Review their capacity for process development & GMP scale-up.
Regulatory Experience: Have they been through an EMA/FDA inspection and enjoyed success with compliance?
Geography & Speed: How closely located to your market or supply chain? This can help mitigate logistics time.
Cost: How much less might it be in southern/eastern Europe?
Innovation & Automation: Is automation on their agenda (e.g. robotic systems related to cell therapy)?
Sustainability & Certifications: Interested in environmentally responsible science, eco-friendly manufacturing, and quality management (ISO)?
As the landscape of European CDMO's evolves pertaining to Biologics & Cell therapies, trends appear to point to the following areas of focus:
- Robotic and automated manufacturing approaches: What about Cellares “cell shuttle”? Scalable, high-throughput, and lower risk of human error.
- Expansion in facility investment & capacity: Companies like Fujifilm appear to be increasing capacity rapidly in response to demand.
- Sustainability & digitalization: Green chemistry? Data connectivity? Smart facilities?
Conclusion
The European CDMO landscape for biologics and cell therapies is rich in potential and diversity. Within Europe you can find everything from plasma based behemoths to viral vector focused boutique company to culture & expand stem cells to suit your needs at any stage of your pipeline. If you are ready to evaluate potential contract partners, consider their expertise, manufacturing scale, regulatory track record and innovation capabilities with regards to automation in order to achieve successful therapeutic advances.
