Cell and Vector Production

细胞和载体生产

• 批准号: 7253735
• 负责人: ADRIAN Philip GEE
• 金额: $ 13.93万
• 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: 2007-04-01 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7253735
• 关键词: Adenovirus Vector; Cell Therapy; Cell physiology; Cells; Clinical; Clinical Research; Clinical Trials; Contracts; Ensure; Genes; Guanosine Monophosphate; Housing; Immunotherapeutic agent; International; Laboratories; Laboratory Study; Lymphoma; Monitor; Operative Surgical Procedures; Preparation; Process; Production; Quality Control; Reproduction spores; Retroviral Vector; Services; Somatic Cell; Testing; experience; gene therapy; manufacturing facility; programs; quality assurance; vector

This SPORE focuses on the treatment of lymphoma using immunotherapeutic approaches. Four of the five projects will initiate clinical trials during the course of the studies. This depends on the availability of aGMP manufacturing facility for the preparation of the vectors and cellular therapy products. The GMP Facilities at the Center for Cell and Gene Therapy have been in operation for more than 6 years. The Cell Processing Facility has considerable experience in the preparation of a wide variety of cellular products, including all that would be prepared for the SPORE projects. It has been designated one of three National Somatic Cell Therapy Processing Facilities by the NHLBI under its Production Assistance for Cell Therapy Contract Program. The Vector Production Facility, which would also be a part of the Core, has produced more than 20 clinical grade adenovectors for local, national and international studies and is a National Gene Vector Laboratory for adenoviral vectors. It also has considerable experience in manufacturing clinical grade retroviral vectors. The final components of the Core are the Quality Control Laboratory, which performs in- house testing of cellular products and vectors, and is responsible for routine monitoring of Good Manufacturing Practices; and the Quality Assurance Group that ensures compliance with GMP and provides independent overview of all aspects of manufacturing and release. The GMP staff also have extensive regulatory experience that will facilitate the translational of laboratory studies into clinical trials. In summary, the Cell Processing and Vector Production Core is a vital component of the SPORE that will provide services that are essential to the implementation of the clinical studies.

该 SPORE 重点关注使用免疫治疗方法治疗淋巴瘤。五中之四 项目将在研究过程中启动临床试验。这取决于 aGMP 的可用性 用于制备载体和细胞治疗产品的生产设施。 GMP 设施位于 细胞和基因治疗中心已运行超过 6 年。细胞处理 该工厂在制备各种细胞产品方面拥有丰富的经验，包括所有 将为 SPORE 项目做好准备。被指定为国家三大体细胞之一 NHLBI 根据其细胞治疗合同生产援助提供治疗加工设施 程序。矢量生产设施也将成为核心的一部分，已生产了超过 20 个用于本地、国家和国际研究的临床级腺载体，是国家基因载体 腺病毒载体实验室。在制造临床级方面也拥有丰富的经验 逆转录病毒载体。核心的最后组成部分是质量控制实验室，它执行以下操作： 细胞产品和载体的内部测试，并负责良好的日常监测 制造实践；质量保证小组确保符合 GMP 并提供 对制造和发布的各个方面进行独立概述。 GMP 工作人员还拥有广泛的 监管经验将促进实验室研究转化为临床试验。总之， 细胞处理和载体生产核心是 SPORE 的重要组成部分，将提供服务 这对于临床研究的实施至关重要。