Cell Processing and Vector Production

细胞处理和载体生产

基本信息

批准号：
10239120
负责人：
ADRIAN Philip GEE
金额：
$ 9.67万
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：
2007-07-01 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10239120
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

项目摘要

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：细胞处理和载体生产 (CPVP) 共享资源细胞处理和载体生产 (CPVP) 共享资源提供治疗药物的制造用于早期临床试验的等级细胞治疗产品和病毒载体。这些必须要准备根据美国食品和药物管理局规定的现行良好生产规范 (GMP)。此共享资源提供了准备、测试和发布这些内容的基础设施和环境使用的产品。它由最先进的设施组成，拥有 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），并且高度经验丰富的制造和质量控制和保证人员。此 DLDCCC 资源将与研究人员开发临床规模生产程序，并发布测试规范、测试程序、质量保证监督和监管援助，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的转变 DLDCCC 实验室进入早期临床试验。 CPVP 目前支持 50 多个临床试验（21 项正在积极累积，18 项正在进行后续试验，11 项正在转化为研究性新药阶段）申请 [IND]）由 DLDCCC 研究人员持有，与相比，这样做的成本大大降低商业制造和测试实体。