CELL PROCESSING

该计划的重点是使用转基因T细胞治疗癌症。三 四个项目将在研究期间进行临床试验。这些都依赖于一个可用的 用于制备细胞治疗产品的GMP生产设施。GMP设施 细胞和基因治疗中心已经运作了6年多。的细胞处理 该工厂在制备各种细胞产品方面具有相当丰富的经验， 将需要在此应用程序中的项目。它已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细胞治疗处理设施 程序.它包括超过6,000平方英尺的HEPA过滤，10,000级空间，分为8个单元 制备实验室，低温储存区，1,000级细胞分选和分析实验室， 一个大型设备区和一个中央供应设施。该设施设备齐全，可在GMP下运行 条件，广泛的文件系统，条形码，环境监测和质量 保证、控制和改进方案。核心的其他组成部分是质量控制 实验室，对细胞产品和载体进行内部检测，并负责常规 监测良好生产规范;质量保证小组，确保符合 GMP并提供生产和放行所有方面的独立概述。GMP工作人员还 具有丰富的监管经验，并将与项目和核心A保持联系，以促进 实验室研究转化为可行的临床试验。总之，细胞处理核心是一个重要组成部分， 将提供实施临床研究所必需的服务的计划项目 项目1、3、4。

This program projects focuses on the treatment of cancer using genetically modified T cells. Three of the four projects will undertake clinical trials during the course of the studies. These rely on the availability of a GMP manufacturing facility for the preparation of the 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 required for the projects in this application. 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. It consists of more than 6,000 square feet of HEPA filtered, Class 10,000 space, divided into 8 cell preparation laboratories, a low temperature storage area, a Class 1,000 cell sorting and analysis laboratory, a large equipment area and a central supply facility. The Facility is well equipped to operate under GMP conditions, with extensive documentation systems, barcoding, environmental monitoring and quality assurance, control and improvement programs. Additional 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 and will liaise with the projects and Core A to facilitate translation of laboratory studies into feasible clinical trials. In summary, the Cell Processing Core is a vital component of the Program Project that will provide services that are essential to the implementation of the clinical studies in Projects 1, 3 and 4.