Phacilitate Leaders Forum

Phacilitate Leaders Europe Agenda 2018

Loading

Panel discussion: potency assays for comparability, characterisation and release

11-Sep-2018
Getting technical - Cell & Gene Therapy Europe
  • What type of release assays are adequate for a regulator to approve the product in both cell and gene therapies?
     
  • How do regulators define quality in release assays and how can the industry use this as a guide for regulatory approval?
     
  • How do regulators validate assays? What kind of assays can actually be validated?
     
  • Viral vectors and gene modified cell products: are these release assays really necessary? Do you need one for your starting material and one for your end product?
     
  • Advice on extractables and leachables - what is the regulatory guidance on determining the purity of the final product? Which tests have worked well for products that have made it to market?
     
  • Different regulations for EU and US- can we harmonise on the quality aspect of release testing?
     
  • How do you predict if a batch will be successful at a clinical level?
     
  • Consistency: How do you define your critical quality attributes and assays so you know each batch is the same?

 

Have your say: panel discussion to be opened up to the audience for input after each discussion point

Speakers
Derek Hei, Senior VP, Manufacturing, Quality & Regulatory - BlueRock Therapeutics
Janet Glassford, Senior Quality Assessor - Medicines and Healthcare Products Regulatory Agency (MHRA)
Sharon Longhurst, Head of CMC - Immunicum AB
Testimonials
  • Real thinking forward combining experts in the field from manufacturing, regulatory and value vision” – “great network with strong experience and sharing risks & opportunities
    Jean-Philippe Combal
    GenSight Biologics
  • The conference consistently proves to be a great forum for networking with industry leaders in the development of cellular and gene therapies as well as vendors for important technologies and services.
    Michael Covington
    Juno Therapeutics, Inc
  • It was a very interesting event as all participants, including speakers were ready to exchange, even on the most challenging subjects such as reimbursement, GMP guidance
    Bertrand Alexandre
    Celyad
  • Phacilitate EU delivered it's promise and more, the topics discussed were highly relevant, with very good and professional speakers and panelists. You will see me next year in Berlin.
    Dr Ohad Karnieli
    Karnieli Ltd