Organized by the ISCT Commercialization
Chair and Speakers:
Principal, Advanced Cell and Gene Therapy
Bravery, Director, Consulting on Advanced Biologicals Ltd.
Potency testing is often the most
challenging aspect of cell therapy characterization, requiring understanding of
the product’s biological function, which may involve interactions with other
cell populations and other effects of the local microenvironment, and effective
in vitro measurement of this function in a scientifically valid,
controlled, timely manner. This webinar will review US and European regulatory
requirements and guidance on potency testing for cell therapy products,
including strategies for development and qualification of suitable functional
assays. A case study presentation will provide practical examples of potency
testing development, and will address the critical role of functional testing in
• Review US FDA
and EMA regulatory requirements and guidance documents for potency testing of
• Discuss potency assay development and qualification,
and use in lot release.
• Effective use of functional assays in comparability
This product is a downloadable zipped folder containing an mp3 audio recording of the presentation and a PDF copy (or copies) of the Power Point slides.