Core C: GMP Cell and Vector Production

核心 C：GMP 细胞和载体生产

基本信息

批准号：
10704663
负责人：
Natalia Lapteva
金额：
$ 28.01万
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：
2007-09-11 至 2027-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10704663
关键词：
Accreditation Address Adverse reactions American Antigen-Presenting Cells Area Australia Cell Therapy Cells Chemistry Clinical Clinical Laboratory Improvement Amendments Clinical Protocols Clinical Research Clinical Trials Contracts Dedications Development Documentation Effector Cell Environmental Monitoring Equipment Europe Far East Flow Cytometry Foundations Generations Genes Genetic Good Manufacturing Process 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 Qualifying Quality Control Quality Indicator Reagent Records Regulation Research Research Personnel Resource Sharing Services Somatic Cell Source System Testing Therapeutic Training Translations United States Food and Drug Administration Validation Viral Vector cell bank cell preparation college experience gene therapy manufacture pre-clinical programs quality assurance translational study vector

项目摘要

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.

项目摘要包括该应用的三个项目使用免疫效应细胞来治疗淋巴瘤。食物和药物管理（FDA）法规要求必须在当前的良好制造实践（CGMP）。核心C（单元和矢量生产）将提供满足此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，以制备细胞和基因治疗产品。超过在过去的23年中，我们的员工生产了7,000多个蜂窝疗法最终产品（无数中间体）和> 70个临床级病毒向量以及大师和工作细胞库，以支持超过 60个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NHLBI合同下的国家体细胞加工设施细胞疗法（PACT）计划的生产辅助计划。制造服务由专用的专业流式细胞仪实验室，每年进行13,000次测试；质量控制实验室进行内部测试和环境监测（> 25,000次测试）；和一个独立质量保证小组，监督合规性。该计划已由蜂窝疗法的认证基金会，美国病理学家学院以及临床实验室改进修订。单元和矢量生产设施已在 FDA。除制造责任外，核心人员还经验丰富处理符合GMP的程序并提供监管建议。这种经历将是必不可少的支持这种淋巴瘤孢子施用的临床成分。