Microbial Fermentation Manufacturing

State of the art cGMP facilities for microbial fermentation

  • Physically separate microbial production suite operated by dedicated staff
  • cGMP fermentation scale of 500 L/batch (nominal volume) for clinical and commercial supply
  • Upstream process including primary recovery in stainless steel technology
  • Downstream process in single-use technology for fast changeover and zero cross-contamination risk

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

Fermentation Recovery & Purification Development

For both Upstream and Downstream process development we utilize a number of advanced techniques to quickly establish processes that will yield the optimal outcome at the highest level of efficiency.

Solutions

Analytical Development

All required physico-chemical and bioanalytical methods are established and qualified in-house to fully characterize relevant target protein quality attributes, including in-depth analysis of post-translational modifications.