Cell Processing and Vector Production

项目总结：细胞处理和载体生产（CPVP）共享资源 细胞加工和载体生产（CPVP）共享资源提供治疗药物的生产 用于早期临床试验的细胞治疗产品和病毒载体。这些必须准备好 根据食品药品监督管理局规定的现行药品生产质量管理规范（GMP）。 此共享资源提供了准备、测试和发布这些 产品使用。它包括一个国家的最先进的设施，22个制造洁净室和支持 设施（质量控制和流式细胞术实验室、材料管理设施等），和高度 经验丰富的制造和质量控制和保证人员。此DLDCCC资源将与 研究者开发临床规模的生产程序，并发布检测质量标准，检测 程序、质量保证监督和监管协助，以协助IND提交。资源 因此，促进了细胞和基因治疗产品从基础科学 DLDCCC的实验室进入早期临床试验。CPVP目前支持50多个临床 试验（21项正在进行中，18项处于随访阶段，11项处于转化为研究性新药的阶段 申请[IND]），并且与 商业制造和测试实体。

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.