Product Brochure
Process optimization for mAb commercial manufacturing
Process characterization and validation is an important step in the product development journey and late-phase development, and it is required before transferring an existing manufacturing process.
This case study demonstrates advancement of a monoclonal antibody from clinical to commercial phase under a highly compressed timeline.
The 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.