细胞和基因治疗产品原材料的质量控制

1Pharmaceuticals and Medical Devices AgencyDisclaimer: The contents of this presentation represent the view of this presenter only, and do not represent the views and/or policies of the PMDA.Quality Control of the Raw Materials for Cell and Gene Therapy ProductsAtsushi NISHIKAWAPrincipal Reviewer, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), JAPAN2Pharmaceuticals and Medical Devices AgencyOutline1.Overview of CAR-T Products2.Quality control of raw materials for each type of modality –regulatory situation in Japan•Control of starting materials•Control of raw materials (FBS, trypsin, etc.)•Control of transgenic reagents•Risk management of adventitious agents3.Regulatory differences between regions3Pharmaceuticals and Medical Devices AgencyCAR-T Therapyhttps://www.cancer.gov/publications/dictionaries/cancer-terms/def/car-t-cell-therapyCAR:Chimeric Antigen ReceptorExtracellular receptorExtracellular hinge domainTransmembrane domainIntrace