Manufacturing for Clinical and Commercial Supply
Polpharma Biologics provides flexible development and manufacturing solutions to provide material for your biosimilar clinical trials and commercial supply. The way we have designed our facilities provides maximum flexibility, scalability and efficiency.
Mammalian Manufacturing Capabilities
- Physically separated mammalian production suite operated by dedicated staff
- cGMP fermentation scale of 2 x 2,000 L (nominal volume) for clinical and commercial supply
- Upstream and downstream process in single-use technology for fast changeover and zero cross-contamination risk
- Supply for preclinical, clinical and commercial supply
- Fully supported by our drug product and fill finish capabilities
- Gdansk, Poland: 2 x 50 L, 1 x 250 L, 1 x 1000 L
- Duchnice, Warsaw, Poland: 4 x 2000 L with a further 8 x 2000 L planned
Drug Product and Fill Finish
Polpharma Biologics provides drug product development and cGMP manufacturing of sterile biologicals in liquid and lyophilized forms at lab and large-scale. See our full range of drug product services here.
Manufacturing with us
Our extensive capacity means we can transfer in external processes or continue with projects we have performed process development for. Either way we understand that we are delivering material for pre-clinical and clinical trials and we always endeavor to get your product to patients.