Cell and Vector Production

这个孢子专注于使用免疫治疗方法治疗淋巴瘤。五个中的四个 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制造设施。GMP设施位于 细胞和基因治疗中心已经运作了6年多。细胞加工 设施在制备各种蜂窝产品方面拥有相当丰富的经验，包括所有 会为孢子项目做好准备。它被指定为三个国家体细胞之一 NHLBI根据其细胞治疗生产援助合同提供的治疗处理设施 程序。向量生产设施，也将是核心的一部分，已经生产了超过 20个临床级别的腺载体，用于本地、国家和国际研究，是国家基因载体 腺病毒载体实验室。在制造临床级产品方面也有相当的经验。 逆转录病毒载体。核心的最后组成部分是质量控制实验室，该实验室在以下方面开展工作： 对蜂窝产品和病媒进行内部测试，并负责对产品的日常监测 和质量保证小组，确保符合GMP并提供 独立概述制造和发布的方方面面。GMP工作人员还拥有广泛的 有助于将实验室研究转化为临床试验的监管经验。总而言之， 细胞处理和载体生产核心是孢子的重要组成部分，将提供服务 这对临床研究的实施是必不可少的。

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.