Cell &Vector Core

细胞

基本信息

批准号：
9354049
负责人：
ADRIAN Philip GEE
金额：
$ 32.69万
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
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/9354049
关键词：
Accreditation Address Adverse reactions Agriculture Amendment American Antigen-Presenting Cells Area Australia Cardiovascular system Cell Therapy Cells Certification Chemistry Clinical Clinical Protocols Clinical Research Clinical Trials Contracts Development Documentation Ensure Environmental Monitoring Equipment Europe Far East Flow Cytometry Foundations Generations Genes Genetic Immune Individual 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 Research Infrastructure 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.

项目摘要包括该应用的四个项目最终涉及使用免疫细胞治疗淋巴瘤。食品药品监督管理局（FDA）法规要求治疗细胞种群必须为根据当前良好的制造实践（CGMP）制造。核心C（细胞和矢量产生）将提供满足此要求所需的基础架构。细胞中心的CGMP设施基因疗法由22个ISO 7洁净室组成，以制备细胞和基因治疗产品。近20年来，员工制造了7,000多个蜂窝疗法最终产品（和无数中间体）和> 60个临床级病毒向量以及主和工作单元银行支持60多个IND研究和国际临床方案。在此期间，设施被指定为国家基因矢量实验室，并被指定为国家躯体细胞处理 NHLBI生产援助（PACT）计划的合同中的设施。制造服务由专门的专业流式细胞仪实验室支持，该实验室的执行 >每年13,000个测试，质量控制（QC）实验室进行内部测试和环境测试监视（> 25,000次测试）和一个独立的质量保证（QA）组，该小组监督合规性并为NHLBI心血管细胞疗法研究提供合同质量检查服务网络（CCTRN）。该计划获得了蜂窝疗法认证基金会的认可（事实），美国病理学家学院（CAP）以及临床实验室的改进修正案（CLIA）。单元和矢量生产设施已在FDA和美国注册农业部。除制造职责外，核心人员还经验丰富将研究过程转变为符合GMP的程序并提供法规建议。这经验对于支持这种淋巴瘤孢子应用的临床成分至关重要。