SC3: QUALITY CONSIDERATIONS FOR GENE THERAPY VIRAL VECTORS

MONDAY, AUGUST 12 | 8:30 - 11:00 AM

Waterfront 2

ABOUT THIS COURSE:

Gene therapy viral vectors are complex biological medicinal products which pose a number of challenges with respect to quality and overall adventitious agent safety. Firstly, they are large complex viral particles which must be designed to be replication incompetent. Secondly, as the product is a suspension of viral particles, application of traditional viral reduction and elimination steps is not possible, so control of materials and the process become more important. This course outlines the testing expected to address these fundamental features and ensure a safe product of suitable quality is released.

WHAT YOU WILL LEARN:

  • What is gene therapy
  • Types of gene therapy vector
  • Typical manufacturing approach
  • Minimal expectations for testing
  • Regulatory science discussion on the rationale for the testing identified
  • Additional product and process-specific testing
  • Difference between testing expectations during clinical development compared to approval.
  • Reference materials
  • Stability testing

INSTRUCTOR BIOGRAPHY:

Christopher_BraveryChristopher Bravery, Ph.D., Consulting Regulatory Scientist, Consulting on Advanced Biologicals Ltd.

Christopher founded Consulting on Advanced Biologicals Ltd at the end of 2009 in order to focus his activities within the Regenerative Medicine sector. CAB Ltd provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialisation of regenerative medicine. Christopher has spent most of his career working in regenerative medicine: starting with a PhD in xenotranplantation immunology he first moved into industry in 1998 when he joined Imutran Ltd (A Novartis Pharma AG Co.) developing novel transgenic pigs to treat human organ failure. Following the closure of Imutran, Christopher moved to Intercytex and subsequently made the transition to regulatory affairs by joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time Christopher was involved with National implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.


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