美国FDA生物制品评估与研究中心CBER举措的最新情况

2024 CMC Strategy Forum JapanTokyo Marriott Hotel, JapanDecember 9-10, 2024Update on the initiatives at the Center for Biologics Evaluation and Research (CBER), U.S. FDAIngrid Markovic, Ph.D.Senior Science Advisor for CMCFDA/CBERCBER ICH Quality Lead & Regulatory Chair for ICH Q6 EWG12CBER Products•Gene therapies•Human tissues and cellular products•Xenotransplantation products•Allergenics•Live biotherapeutic products•Vaccines (preventative and therapeutic)•Whole blood, plasma, and blood products•Devices related to biologicswww.fda.gov3Presentation Outline •Lifecycle Management Tools – CP/PACMP •Application of platform technology provision•Efforts to facilitate CMC Readiness Pilot (CDRP) Program•Exploring concurrent submission and product review with other regulatory authorities for Cell & Gene Therapieswww.fda.govLifecycle Management Tools - CP/PACMP -Past, Present & Future5Some examples include:•Scale-up/scale-out, new manufacturing site, new analytical assay•Reacting to manufacturing