Validation of Flow Cytometry Methods in Cellular Therapies
Time: 12:00 pm
day: Day One
• Multi-parameter flow cytometry is a key analytical platform to measure identity, purity and strength of in-process drug substance and final drug product.
• Due to the complexity of the cellular drug product, lack of existing reference standards and appropriate calibration materials, limited regulatory guidelines, as well as the quasiquantitative nature of the output, producing reliable and reproducible data is especially challenging in the context of a cGMP environment
• Here, we describe how the Breyanzi™ program addressed these challenges and contributed to a successful licensure. Validation runs were executed based on customized experimental design, and statistical analyses were performed for individual validation parameters to address requirements and concerns by Regulatory Authorities