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Potency Testing - Webinar Recording (Mar 2011)

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Description

Potency Testing

 

Organized by the ISCT Commercialization Committee

Chair and Speakers:

Scott Burger, Principal, Advanced Cell and Gene Therapy
Christopher Bravery, Director, Consulting on Advanced Biologicals Ltd.

Webinar Overview:

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.

Objectives:
• 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 zipped folder containing an mp3 audio recording of the presentation and a PDF copy (or copies) of the Power Point slides.

 

 

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