Cell &Vector Core

项目摘要 该申请的四个项目最终涉及使用免疫细胞治疗淋巴瘤。 美国食品和药物管理局（FDA）法规要求治疗性细胞群必须是 根据现行药品生产质量管理规范（cGMP）生产。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。细胞中心的cGMP设施 基因治疗由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。近20年来，工作人员已经制造了7,000多个细胞治疗最终 产品（和无数的中间体），以及超过60种临床级病毒载体和主细胞和工作细胞 支持60多项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国家体细胞加工实验室 NHLBI细胞治疗生产援助（PACT）计划合同下的设施。 制造服务由专门的专业流式细胞术实验室提供支持，该实验室执行 每年超过13，000次测试，质量控制（QC）实验室进行内部测试和环境测试 监测（> 25，000次测试/年），以及独立的质量保证（QA）小组，负责监督 合规性，并为NHLBI心血管细胞治疗研究提供合同QA服务 网络（CCTRN）。该计划是由基金会认可的细胞疗法 （FACT）、美国病理学家学会（CAP）和临床实验室改进 修正案（CLIA）。细胞和载体生产设施已在FDA和美国注册 农业部。除了生产责任外，核心员工在以下方面经验丰富： 将研究过程转变为符合GMP的程序，并提供监管建议。这 经验将是必不可少的，在支持这个淋巴瘤孢子应用程序的临床组成部分。

PROJECT SUMMARY The four projects comprising this application ultimately involve the use of immune 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. For nearly 20 years the staff have manufactured more than 7,000 cellular therapy final products (and countless intermediates), and >60 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 test annually, a quality control (QC) laboratory performing in-house testing and environmental monitoring (>25,000 tests/year), and an independent quality assurance (QA) group, which oversees compliance and provides contract QA services to the NHLBI Cardiovascular Cell Therapy Research Network (CCTRN). The program is accredited by the Foundation for the Accreditation of Cellular Therapy (FACT), the College of American Pathologists (CAP), and under the Clinical Laboratory Improvements Amendments (CLIA). The Cell and Vector Production facility is registered with the FDA and the US Department of Agriculture. 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.