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
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
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 2021. (*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