Core C: GMP Cell and Vector Production

项目总结 组成这一应用程序的三个项目使用免疫效应细胞治疗淋巴瘤。食品与药品 美国食品和药物管理局(FDA)的规定要求，治疗细胞群必须在 现行良好制造规范(CGMP)。核心C(细胞和载体生产)将提供 满足这一要求所需的基础设施。细胞和基因治疗中心的cGMP设施 由22个ISO 7洁净室组成，设备齐全，可用于制备细胞和基因治疗产品。完毕 在过去的23年里，我们的员工已经制造了超过7,000种细胞治疗最终产品(以及无数 中间体)，以及70个临床级病毒载体和主细胞库和工作细胞库，以支持超过 60项IND研究和国际临床方案。在此期间，该设施被指定为国家 基因载体实验室和作为与NHLBI签约的国家体细胞处理设施 细胞治疗生产援助(PACT)计划。制造业服务由 专门的专业流式细胞仪实验室，每年进行13,000次检测；质量控制 执行内部测试和环境监测的实验室(&gt；每年25,000次测试)；以及 独立的质量保证小组，负责监督合规性。该项目得到了美国 美国病理学家学会细胞疗法认可基金会，并在 临床实验室改进修订。细胞和载体生产设施已在 美国食品和药物管理局。除了制造职责，核心员工在过渡研究方面经验丰富 将流程转化为符合GMP的程序，并提供监管建议。这段经历将是必不可少的 支持这一淋巴瘤孢子应用的临床成分。

PROJECT SUMMARY The three projects comprising this application use immune effector cells to treat lymphoma. Food and Drug Administration (FDA) regulations require that therapeutic cell populations must be manufactured under current Good Manufacturing Practices (cGMP). Core C (Cell and Vector Production) will provide the infrastructure necessary to meet this requirement. The cGMP facility at the Center for Cell and Gene Therapy consists of 22 ISO 7 clean rooms fully equipped for the preparation of cell and gene therapy products. Over the last 23 years, our staff have manufactured more than 7,000 cellular therapy final products (and countless intermediates), and >70 clinical grade viral vectors and master and working cell banks in support of more than 60 IND studies and international clinical protocols. During this period, the facility was designated as a National Gene Vector Laboratory and as a National Somatic Cell Processing Facility under a contract from NHLBI Production Assistance for Cellular Therapy (PACT) program. Manufacturing services are supported by a dedicated specialized flow cytometry laboratory, which performs >13,000 tests annually; a quality control laboratory performing in-house testing and environmental monitoring (>25,000 tests/year); and an independent quality assurance group, which oversees compliance. The program is accredited by the Foundation for the Accreditation of Cellular Therapy, the College of American Pathologists, and under the Clinical Laboratory Improvements Amendments. The Cell and Vector Production facility is registered with the FDA. In addition to manufacturing responsibilities, the Core staff are experienced in transitioning research processes into GMP-compliant procedures and providing regulatory advice. This experience will be essential in supporting the clinical components of this Lymphoma SPORE application.