Translation to Operational Practice

Wednesday, February 27, 2013, 8:00am-9:40am PST

 

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

Clinton Weber

Clinton Weber is currently the Associate Director of the BioProcess Sciences group at CMC Biologics, responsible for Process Transfer and Process Validation at CMC.  Clinton has 20 years of experience in Biotechnology Development and Manufacturing, having worked in virtually all facets of the biotech industry: Process Development, Manufacturing, Engineering and Quality.  Previous company experience includes Immunex, Amgen, Berlex, Bayer, and NNE Pharmaplan.  He has worked on over a dozen GMP Manufactured products.

Greg Flynn

Greg received his PhD in chemistry from the University of California at Santa Barbara and did postdoctoral work at Princeton University (James Rothman).  Prior to joining Amgen in 2003, he worked at Baxter Inc and was on the faculty at University of Oregon (Chemistry).  He is in the Process and Product Development department at Amgen, where his recent work has been focused on Quality by Design and understanding the criticality of product quality attributes.

Shan Jiang

Shan Jiang, received her Ph.D. degree in Industrial and Physical Pharmacy from Purdue University. She has over 15 years industry experience in protein formulation development, clinical and commercial manufacturing of biological drug products. She has worked in several pharmaceutical and biotechnology companies. Her current position is Director of Formulation and Fill/Finish Department in Seattle Genetics Inc, focusing on antibody-drug conjugates (ADC) development and manufacturing.

She is an active member in various scientific/technology communities, and has been invited to speak at...