BIOLOGICS in Europe
24kL Cell culture and purification - Exclusive production line
About the plant
Large Scale Manufacturing of therapeutic proteins — Exclusively for Your Biologics Program
Unlock the power of a trusted, fully automated max 24 kL working volume mammalian cell culture and purification facility — available exclusively for commercial production of your therapeutic protein (2 – 24kL).
For over two decades (2004–2025), our state of the art facility has reliably supplied monoclonal antibodies to global markets including the US, EU, and China. Operating at full capacity in the last three years, we consistently delivered more than 300 kg of drug substance each year (assuming 1 g/L productivity).
Located within our company active biotech and pharmaceutical manufacturing site, our facility is embedded in a mature ecosystem of quality, compliance, and operational excellence.
Exclusive Access. Uncompromising Quality.
When you partner with us, you gain:
- Exclusive use of the manufacturing facility for your product
- Maximum scheduling flexibility for seamless supply
- Manufacturing aligned with our high-quality standards and backed by an excellent regulatory inspection track record
- The option for tailored engineering modifications to suit your specific process needs
Integrated Analytical & Process Development Support
Your manufacturing program is fully supported by our in house laboratories, providing deep technical expertise.
Analytical Services
- Release testing
- Formal stability studies
- Method development & validation
- Management of biological critical reagents
- Comprehensive characterization of therapeutic proteins
Process Development Capabilities
- Process development and characterization studies
- Small scale troubleshooting
- Viral clearance studies
- Resin end of lifetime evaluations
- Additional tailored small scale process support
Your Biologic. Our Expertise. Shared Success.
Whether you’re launching a commercial program or scaling a late stage asset, our proven facility, expert teams, and exclusive access model give you the reliability and flexibility you need to meet global demand—today and tomorrow.
Compliance
- ICH
- EMA (EU GMP)
- FDA (cGMP)
- Health Canada (Canada GMP)
- World Health Organization (GMP / HACCP)
- NMPA (China GMP)
- TGA (Australia GMP)
- ANVISA (Brazil B-GMP)
- MFDS/KFDA (Republic of Korea GMP)
- PMDA/MHLW (Japan GMP)
- MHRA (UK GMP)
- TITCK (Turkish Health Authorities)
Activity
- Abs (Antibodies), Peptide, protein, hormone & enzyme, BIOLOGICS manufacturing
Features
- Uses: Commercial (Phase IV), Human
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
- Controlled substance: N/A
- BSL: 1, 2
- Therapeutic areas: N/A
- Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), ANVISA (Brazil), Turkish Health Authorities
Batch Size / Reactor
- Large, Batch, Fed-batch, > 5000 L
Services
- Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Downstream, Fill&Finish, Cell banking, Sterile product manufacturing, Upstream
