cGMP Manufacturing

Manufacturing for Clinical and Commercial Supply

Polpharma Biologics provides flexible development and manufacturing solutions to fuel today’s biopharma pipeline. We provide maximum flexibility, scalability and efficiency to produce drug substance and drug product for pre-clinical, clinical and commercial supply.

Mammalian Manufacturing Capabilities 

  • Physically separated mammalian production suite operated by dedicated staff
  • cGMP fermentation scale of 2 – 1,000 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 biologs 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.

HOW CAN WE HELP?

Whether you are looking to advance a biosimilar program, work on innovative molecules or learn more about our capabilities, we look forward to hearing from you.

Solutions

Discovery & Optimization

Our early stage antibody discovery and humanization platforms are designed to get you a high affinity antibody with the desired binding properties that is ready for the next stage of your project.

Solutions

Cell Line Development

Polpharma Biologics have over 25 years of success in generating high-yield production cell lines for innovative proteins.

Solutions

Process Development

Polpharma Biologics provides full process development support, from early development of mAbs to process and analytical methods development.

Solutions

Analytical Development

We can establish and qualify all required physico-chemical and bioanalytical methods in-house to fully characterize relevant target protein quality attributes.