BIOLOGICS in Europe
22kL Cell culture and purification - Exclusive production line
About the plant
We offer our 22kL cell culture and purification facility for exclusive commercial production of therapeutic proteins through mammalian cell culture. Our highly automated and digitized facility has been in operation from 2004 up to 2025 and has been producing monoclonal antibodies for major markets (a.o. US/EU/China). In the last 3 years the facility was running at full capacity, i.e. 15 batches per year (300 kg of therapeutic protein @ 1 g/L). The facility is part of an active biotech and pharmaceutical manufacturing site producing Organon´s propietary products.
We offer manufacturing against our high Quality standards and we have an excellent regulatory inspection track record. The contract manufacturing contract will be exclusive allowing maximal flexibility to make enginering changes to fit your process.
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
