Webinar – Process Optimization for Monoclonal Antibody (mAb) Commercial Manufacturing
Summary: Process characterization and validation is an important step in the product development journey and late-phase development. In some cases, process optimization is required for an existing manufacturing process before process characterization begins. Catalent will share a case study of a monoclonal antibody (mAb) from clinical to commercial phase under a highly compressed timeline. This presentation highlights the strategic plan Catalent executed to meet the needs of the program without sacrificing the thorough scientific evaluation of the process required for a successful validation campaign.
- Details on the optimization process for both upstream and downstream manufacturing processes.
- Catalent’s workflows for process characterization of the optimized process with examples.
- A case study of how to strategically decrease the timeline from process optimization to commercial manufacturing.