Drug Product


Polpharma Biologics provides drug product development and cGMP manufacturing of sterile biologicals in liquid and lyophilized forms at lab and large-scale.

Our deep understanding of the nature of large molecules derived from our drug substance development activities serves as the basis for an efficient formulation and fill & finish process development. This synergistic approach enables us to provide targeted and rapid drug product development.

Biologics presentations are manifold – our flexible lines support various formats, ranging from 0.1ml pre-filled syringes to 50ml vials, be it liquid or lyophilized.

Drug Product Development Capabilities at a Glance

  • High-throughput instrumentation for DLS, MFI, DSC, nephelometry and mVROC measurements
  • Unit 445 stic light scattering and intrinsic fluorescence for excipient screening
  • Freeslate Protegé 300 for visible particles, color and turbidity measurements
  • Semi-automatic Flexicon filling station in isolator with stoppering and capping equipment
  • Container closure integrity testing system

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Drug Product Manufacturing Capabilities at a Glance

  • Liquid fill & finish combi-line for vials, syringes and cartridges
  • Throughput of up to 3,000 units per hour
  • Lyophillizer 5 sqm
  • RABS to secure aseptic filling conditions

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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).

  • Liquid fill & finish line with a throughput of up to 12,000 units per hour
  • Two lyophillizers with up to 20 sqm each

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.


Drug Product Process Development

Polpharma Biologics supports the entire biopharmaceutical product lifecycle, starting with process and formulation development.


Drug Product Manufacturing

We provide a full range of contract biomanufacturing services for both biosimilars and innovative molecules.

‘Smart Growth’ Operational Programme

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