Session P1: A-Vax: A QbD Case Study and Study Guide

Five vaccine manufacturers formed a collaboration to prepare a case study to illustrate how QbD could be applied to vaccine development. This recording of the opening session gives an overview of the case study with an initial discussion of critical quality attributes and control strategy development on the use of QbD in vaccine development.

Mark Schenerman, PhD, Vice President, Analytical Biochemistry, MedImmune, LLC
Michael P. Schwartz, PhD, Associate Director, US Regulatory Affairs, GlaxoSmithKline Biologicals
Cecile Ponsar, PhD, Director, Product and Process Technical Support, GlaxoSmithKline Biologicals  

Session P2: Case Study for Post Approval Change for Drug Substance

While detailed and specific discussion around the approach for managing a defined change is best handled through direct dialogue with regulatory health authorities, this recording discusses examples of how scientific data supporting a process might be used to manage change throughout the product life cycle, including some examples that might be encountered during process development prior to commercial approval.

Roman Drews, Senior Regulatory Scientist, CBER, FDA
Michael Kosinski, PhD, Distinguished Senior Investigator, Merck & Co., Inc.
Annick Vandercammen, PhD, Senior Scientist, Downstream Process Technology, GlaxoSmithKline Biologicals

Session P3: Case Study in a Post Approval Change for Drug Product

The overall A-Vax case study includes a wide variety of examples for exploration of tools for the implementation of QbD principles in the development of vaccines.  This recording dissects a body of scientific data supporting a lyophilization process and how this might be used to support changes to the production process in a post approval environment.

Pierre Chouvenc, PhD, Deputy Director, Manufacturing Technology, Sanofi Pasteur
Joseph Schaller, Principal Development Engineer, Sterile and Liquids Commercialization, Merck & Co., Inc.
John Eltermann , Supervisory Consumer Safety, CBER, FDA

Session P4: Bringing It All Together and Next Steps

Important aspects of implementing QbD in the development of vaccines include a common understanding between industry and regulatory health authorities on how the scope of content in regulatory filings might incorporate QbD information and the driving forces to merit the added effort required in preparation of the submission beyond that of a traditional regulatory filing.  During this recording, presenters and panelists examine some of these factors and explore what next steps might look like as industry and regulatory health authorities move forward.

Christian Klock, Deputy Director, Regulatory Affairs CMC, Sanofi Pasteur
Robert Repetto, Research Fellow, Bio-Therapeutics Development, External Affairs, Pfizer, Inc.
Philip R. Krause, MD, Deputy Director, Division of Viral Products, FDA

Q&A/Panel Discussion

Roman Drews, Senior Regulatory Scientist, CBER, FDA
John Eltermann , Supervisory Consumer Safety, CBER, FDA
Christian Klock, Deputy Director, Regulatory Affairs CMC, Sanofi Pasteur
Philip R. Krause, MD, Deputy Director, Division of Viral Products, FDA
Robert Repetto, Research Fellow, Bio-Therapeutics Development, External Affairs, Pfizer, Inc.
Mark Schenerman, PhD, Vice President, Analytical Biochemistry, MedImmune, LLC  
Timothy Schofield, Managing Director, Arlenda, Inc.