Organized by the ISCT Legal and Regulatory Affairs
Chair: William Janssen, Director, Cell
Therapy Facility, H. Lee Moffitt Cancer Center
Scott Burger, Principal, Advanced Cell and Gene
Christopher 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 comparability studies.
- Review US FDA and EMA regulatory requirements and guidance documents for
potency testing of cell-based products
- Discuss potency assay development and qualification, and use in lot release
- Effective use of functional assays in comparability studies
This product is a downloadable PDF containing a link to the mp4 video recording of this presentation featuring the Power Point slides and audio recording.