A phase-appropriate process development ensures comparable product quality and safety along the course of development and commercial manufacturing.
The drug product manufacturing process involves a number of unit operations, such as freezing/thawing, pooling, compounding, homogenization/mixing, pumping, filtration, lyophilisation, capping and visual inspection. These unit operations can have a significant impact on the drug product quality, and if not carefully chosen based on sound rationale, can lead to batch rejection and significant amount of rejects during inspection. Accordingly, the instruments and the material of contact should be evaluated for their suitability/compatibility, and the critical process parameters need to be identified and adequately controlled within certain ranges.
Our Drug Product Services (Lonza DPS) team’s experts and engineers can provide invaluable support in designing manufacturing process unit operations and parameters. Our process development experts can evaluate and characterize various unit operations, and support choice of the best materials/parameters to ensure successful drug product manufacturing.
The Drug Products Services team works closely with Drug Substance sites across the our network enabling an integrated and high quality One-Stop-Shop from a single service provider.
All services are available as standalone services.