AM24-ST-21-O: Critical Role of an Assay Lifecycle in Analytical Development for Cell and Gene Therapy Products (Enduring)

CABP CE Eligible

Testing of blood and blood products has evolved over decades into a series of standardized highly regulated processes to ensure the production of safe, pure, and potent products. In comparison, the newly emerging Advanced Therapies space is in the early stages of developing and standardization of analytical testing processes. Testing is a critical function of development and production of advanced therapies whether as a part of donor screening, qualification of starting material, monitoring of manufacturing processes or qualification of the final product. Key considerations in assay development include defining the analytical target profile (ATP), understanding the intended use of the advanced therapy, and determining sample types that will be tested. Development and implementation of a well-defined assay life cycle is essential to ensure that testing is performed appropriately, scientifically sound, and accurate. This session will cover the three stages of an assay life cycle and will look at the differences between assay qualification versus assay validation. It will also cover the concept of performing phase appropriate validations. Topics covered will include the Impact of using an assay life cycle, Analytical Target Profile (ATP), Analytical Control Strategy (ACS), qualification of new sample types, post assay implementation of monitoring processes, factors to consider when determining phase appropriateness of validations and description of newly developed potency assay platforms for the testing of cell and gene therapy products.