Cell Processing and Vector Production

细胞处理和载体生产

• 批准号: 10025010
• 负责人: ADRIAN Philip GEE
• 金额: $ 9.31万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10025010
• 关键词: Adenovirus Vector; Basic Science; Cancer Center; Cancer Center Support Grant; Cell Therapy; Cells; Certification; Chemistry; Clinical; Clinical Research; Clinical Trials; Contracts; Data; Development; Disease; Documentation; Environment; Environmental Monitoring; Equipment; Flow Cytometry; Genes; Infrastructure; Investigational New Drug Application; Laboratories; Maintenance; Medicine; Microbiology; National Heart, Lung, and Blood Institute; Phase I/II Clinical Trial; Preparation; Procedures; Production; Protocols documentation; Quality Control; Quality Indicator; Regulation; Research Personnel; Resource Sharing; Resources; Retroviral Vector; Somatic Cell; Standard Preparations; System; Testing; Therapeutic; Training; Translations; United States Food and Drug Administration; Validation; Viral Vector; Work; cancer therapy; cell bank; college; cost; early phase clinical trial; experience; follow-up; gene therapy; good laboratory practice; neoplastic; pre-clinical; preclinical study; programs; quality assurance; research study; stability testing; tissue repair; vector

PROJECT SUMMARY: Cell Processing and Vector Production (CPVP) Shared Resource The Cell Processing and Vector Production (CPVP) Shared Resource provides manufacturing of therapeutic grade cellular therapy products and viral vector for use in early phase clinical trials. These must be prepared according to current Good Manufacturing Practices (GMP) as mandated by the Food and Drug Administration. This Shared Resource provides the infrastructure and environment to prepare, test, and release these products for use. It consists of a state-of-the-art facility with 22 manufacturing clean rooms and support facilities (quality control and flow cytometry laboratories, material management facilities etc.), and highly experienced manufacturing and quality control and assurance staff. This DLDCCC Resource will work with investigators to develop clinical scale manufacturing procedures, and release test specifications, testing procedures, quality assurance oversight, and regulatory assistance to assist in IND submissions. The resource has, therefore, facilitated the transition of cellular and gene therapy products from the basic science laboratories in the DLDCCC into early-phase clinical trials. The CPVP currently supports more than 50 clinical trials (21 actively accruing, 18 in follow-up, and 11 in stages of translation to investigational new drug applications [INDs]) held by DLDCCC investigators and does so at a much-reduced cost compared to commercial manufacturing and testing entities.

项目摘要：细胞处理和矢量生成(CPVP)共享资源 细胞加工和载体生产(CPVP)共享资源提供治疗性制造 用于早期临床试验的分级细胞治疗产品和病毒载体。这些都必须准备好 根据食品和药物管理局规定的现行良好制造规范(GMP)。 此共享资源提供基础架构和环境来准备、测试和发布 供使用的产品。它由一个最先进的设施组成，拥有22个生产洁净室和支持 设施(质量控制和流式细胞仪实验室、材料管理设施等)，以及高度 经验丰富的制造、质量控制和保证人员。此DLDCCC资源将与 研究人员制定临床标尺制作程序，并发布测试规范、测试 程序、质量保证监督和监管协助，以协助IND提交。该资源 因此，促进了细胞和基因治疗产品从基础科学的过渡 DLDCCC的实验室进入了早期临床试验阶段。CPVP目前支持50多个临床 试验(21项正在积极积累，18项在后续，11项处于转化为研究新药的阶段 申请[INDS])由DLDCCC调查人员持有，这样做的成本比 商业制造和测试实体。