Potency Assays for ATMPs - Conception, Development, Validation, Matrixed Approaches and Assay Lifecycle

Advanced therapy medicinal products or ATMPs, are among the fastest growing areas of biotherapeutics, encompassing gene therapies, viral therapies, vaccines and cell therapies. The control strategies are very different from more traditional biologics, with quantitation of potency posing one of the greatest challenges. In this webinar, representative case studies will demonstrate considerations in the conception, development and validation of potency assays - mostly cell-based - for representative ATMPs. The use of different analytical technologies and complex assay schema will be provided along with consideration of timing, phase-appropriate validation (qualification) considerations and assay lifecycle guidance as the product moves through the clinical development phases. Topics for discussion will include data and statistical considerations and how data may be processed to extract relevant insights and monitor attributes such as relative potency. The implications of global regulatory guidance and precedence will also be discussed.

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