ManufacturingofCellularGeneTherapiesEnsuringProduct.pptVIP

Manufacturing of Cellular Gene Therapies: Ensuring Product Safety and Quality Dan Takefman, Ph.D. Chief, Gene Therapy Branch Division of Cellular and Gene Therapies Center for Biologics Evaluation and Research FDA Before You Begin Manufacturing… Guidance for Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) Human Somatic Cell Therapy Investigational New Drug Applications (INDs) /cber/genadmin/octgtprocess.htm For phase I submission, product safety is the focus of the CM