Core C: GMP Cell and Vector Production

项目摘要 该申请的三个项目使用免疫效应细胞治疗淋巴瘤。食品药品 美国食品药品监督管理局（FDA）法规要求治疗性细胞群必须在FDA监管下制造。 现行药品生产质量管理规范（cGMP）。核心C（细胞和载体生产）将提供 为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，用于制备细胞和基因治疗产品。超过 在过去的23年里，我们的员工已经生产了7，000多个细胞治疗最终产品（以及无数 中间体）和超过70种临床级病毒载体以及主细胞库和工作细胞库， 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国家体细胞处理设施根据合同从NHLBI 细胞治疗生产援助（PACT）计划。制造业服务由一个 专门的流式细胞仪实验室，每年进行超过13，000次检测;质量控制 进行内部测试和环境监测的实验室（> 25，000次测试/年）;以及 独立的质量保证小组，负责监督合规情况。该计划是由 美国病理学家学会细胞治疗认证基金会， 临床实验室改进修正案。细胞和载体生产设施已在 FDA.除了生产责任外，核心员工在过渡研究方面经验丰富 将生产过程转化为符合GMP的程序，并提供监管建议。这种经验将是必不可少的 支持本淋巴瘤孢子应用程序的临床组成部分。

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.