Translation to Operational Practice

Understanding how to apply QbD principles during the development and commercialization of protein therapeutics can be challenging and will be covered in this session. Examples of topics will include; how to customize investment in QbD from low demand to high demand products as well as during development & post-licensure, the appropriate mitigation efforts to reliably achieve known CQAs and how to integrate QbD into internal Quality Systems or management practices.

Session Co-Chairs:

• Dean Pettit, Amgen

• Yuan Xu, Novartis

Confirmed Speakers

• Gregg Flynn, Amgen: Assessing the Criticality of Product Quality Attributes

• Clinton Weber, CMC Biologics:  Quality by Design Execution from a CMO Perspective

• Shan Jiang, Seattle Genetics: Control Strategies for Antibody-Drug Conjugates Drug Product Manufacturing