Drug Product

OVERVIEW

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
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.

CDMO | DP

Drug Product Process Development

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

CDMO | DP

Drug Product Manufacturing

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