Defining The Root Cause Of Batch-To-Batch Variability

During this opening segment of Cell & Gene Live, How To Reduce Batch-to-Batch Variation In Cell Therapy Manufacturing, Omkar Kowlaker, Ph.D., Head of Manufacturing and Supply Chain at NextGen Therapies Consulting at Deloitte and Donna Rill, Chief Technology Officer at Triumvira Immunologics each provide detailed explanations about the root of variation. They explain why seed material, whole blood or leukapheresis, which due to the patients have various treatment backgrounds, different stages of hematological reconstitution depending on those treatments, the variability among each person’s cells, as well as manufacturing processes are root causes.