CMC Considerations for Commercial-Ready ADC Manufacturing Processes to Enable Accelerated Timelines | CPhI North America

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CMC Considerations for Commercial-Ready ADC Manufacturing Processes to Enable Accelerated Timelines

Courtney Morget, Ph.D. (Senior Scientist, AbbVie)

Location: bioLIVE Theater

Date: Wednesday, May 1

Time: 11:00am - 11:20am

Track: The BPI Theater

Vault Recording: TBD

The pipeline for ADCs continues to grow, and many programs have accelerated timelines. Companies need to start with the end in mind, and there are key decisions that are necessary during the course of CMC development to enable these timelines and ensure the ADC manufacturing process is commercial-ready. This presentation will focus on the importance of establishing commercial analytical methods early, planning process characterization strategy and timing relative to PPQ, strategic manufacturing site selection to enable commercial manufacturing with minimal changes during development and defining the process validation and comparability strategy to support the validation lifecycle.