Cell &Vector Core

细胞

基本信息

批准号：
10247735
负责人：
ADRIAN Philip GEE
金额：
$ 31.38万
依托单位：
BAYLOR COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-04-01 至 2022-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10247735
关键词：
Accreditation Address Adverse reactions Agriculture American Antigen-Presenting Cells Area Australia Cardiovascular system Cell Therapy Cells Certification Chemistry Clinical Clinical Laboratory Improvement Amendments Clinical Protocols Clinical Research Clinical Trials Contracts Development Documentation Ensure Environmental Monitoring Equipment Europe Far East Flow Cytometry Foundations Generations Genes Genetic Immune Individual Infrastructure International Investigational Drugs Investigational New Drug Application Knowledge Laboratories Lymphoma Medicine Modification National Heart, Lung, and Blood Institute Outcome Pathologist Phase Plants Population Preparation Procedures Process Production Quality Control Quality Indicator Reagent Records Regulation Research Resource Sharing Services Somatic Cell Source Structure of thyroid parafollicular cell System Testing Therapeutic Therapeutic Studies Training Translations United States Food and Drug Administration Validation Viral Vector cell bank cell preparation college experience gene therapy operation pre-clinical pre-clinical research programs quality assurance translational study vector

项目摘要

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.

项目概要该应用程序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) 法规要求治疗细胞群必须是根据现行良好生产规范 (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 设施基因治疗中心拥有 22 个 ISO 7 级洁净室，设备齐全，可用于细胞和基因的制备治疗产品。近 20 年来，工作人员已制造了 7,000 多种细胞治疗最终产品产品（和无数中间体），以及 >60 种临床级病毒载体以及主细胞和工作细胞银行支持 60 多项 IND 研究和国际临床方案。在此期间，设施被指定为国家基因载体实验室和国家体细胞加工中心该设施隶属于 NHLBI 细胞治疗生产援助 (PACT) 计划合同。制造服务由专门的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) 实验室执行内部测试和环境测试监控（>25,000 次测试/年），以及一个独立的质量保证 (QA) 小组，负责监督合规性并向 NHLBI 心血管细胞治疗研究提供合同 QA 服务网络（CCTRN）。该计划获得细胞治疗认证基金会的认证 (FACT)、美国病理学家学会 (CAP) 以及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。除了制造职责外，核心员工还拥有以下方面的经验：将研究流程转变为符合 GMP 的程序并提供监管建议。这经验对于支持淋巴瘤 SPORE 应用的临床部分至关重要。