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

To serve the growing global demand for biopharmaceuticals, we have included into our network the new Polpharma’s commercial-scale GMP production facility* for drug substance manufacturing and aseptic fill & finish. It is located in Duchnice, just outside of Warsaw, and is planned to be fully operational in 2020. (*Polpharma Biologics’ CMO partner)

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.

CDMO | DS

Drug Substance Process Development

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