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  6.  » Webinar – Process Optimization for Monoclonal Antibody (mAb) Commercial Manufacturing

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.

Click here to view the webinar