Drug Substance

OVERVIEW

Polpharma Biologics provides flexible development and manufacturing solutions to fuel today’s biopharma pipeline. We are one of only a few companies globally that operates dedicated manufacturing lines for both mammalian and microbial expression systems for maximum flexibility, scalability and efficiency.

Whether your product relies on mammalian or microbial technology, we are proud to offer both – on time, and to scale.

Drug Substance Process Development Capabilities at a Glance

  • ambr® high-throughput bioreactor systems
  • Bioreactors coupled with a Novaflex bioanalyzer
  • Biostat bioreactors for process transfer

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Mammalian Manufacturing Capabilities at a Glance

  • 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

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Microbial Manufacturing Capabilities at a Glance

  • Physically separated 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

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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.

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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.

CDMO | DS

Drug Substance Manufacturing

Once process development is complete, we can conduct a smooth and efficient tech transfer to continue on your journey to market.