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.
Dean Pettit, Amgen
Yuan Xu, Novartis
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