cGMP Manufacturing

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

Capacities

  • 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.

Biosimilars

Cell Line Development

We take a different approach to other companies when developing biosimilar cell lines, we focus on delivering high titer cell lines and then tailoring modulation to match the given quality target product profile.

Biosimilars

Biosimilar Cell Lines

Ready to go, high expressing manufacturing biosimilar cell lines ready for development. Includes fusion proteins, enzymes and monoclonal antibodies which are available for out-licensing.

Biosimilars

Analytics & Bioassays

We have the most extensive bioanalytical and bioassay toolbox to ensure and test biosimilarity with originator therapeutics.

Biosimilars

Process Development

Our biosimilar process development focuses on quality and reducing cost. We know that it is critical to reduce overall cost of goods and the way we design our processes increases titer without increasing media and feed requirements.