cGMP Manufacturing

Polpharma Biologics operates a state-of-the-art biopharmaceutical cGMP production plant in Europe. The facility is equipped with disposable technologies for mammalian manufacturing and run by highly qualified and experienced personnel. A seamless transition into cGMP production is supported by close alignment and anticipation of commercial-scale requirements during both incoming process transfers and in-house scale-up.

Today’s markets require reliable, on-time supply of quality products. With our flexible facilities, we consistently meet your demand.

Mammalian Manufacturing Capabilities at a Glance

Our mammalian suite in Gdańsk was commissioned in 2016 and has since operated under cGMP conditions.

  • Physically separate 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

Microbial Manufacturing Capabilities at a Glance

Our microbial suite in Gdańsk was commissioned in 2018 and has since operated under cGMP conditions.

  • 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

Continued Expansion

We are expanding our drug substance manufacturing capacity through the commissioning of a brand new commercial facility in Duchnice, just outside of Warsaw, planned to be fully operational in 2021.

At Polpharma Biologics, we are eager to support your next biopharmaceutical project with our integrated development and large-scale industrial production capabilities.

SEE OUR FACILITIES

Polpharma Biologics operates three integrated facilities across Central Europe. Learn more about our specific capabilities by location.

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Drug Substance Process Development

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