CELL PROCESSING

这个项目的重点是使用转基因T细胞治疗癌症。其中三个 在研究过程中，四个项目将进行临床试验。这取决于是否有可用的 GMP生产设施，用于细胞治疗产品的制备。食品和药物管理局的设施 细胞和基因治疗中心已经运行了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 此应用程序中的项目将需要。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建立的细胞治疗加工设施 程序。它由6000多平方英尺的高效空气过滤器组成，10000级空间，分为8个单元 准备实验室、低温储存区、千类细胞分选分析实验室、 一个大的设备区和一个中央供应设施。该设施装备齐全，可在GMP下运行 条件，具有广泛的文件系统、条形码、环境监测和质量 保证、控制和改进计划。核心的其他组件是质量控制 实验室，对蜂窝产品和病媒进行内部测试，并负责日常工作 监督良好的制造规范；以及确保遵守的质量保证小组 GMP，并提供制造和发布的所有方面的独立概述。GMP工作人员还 有广泛的监管经验，并将与项目和核心A联系，以促进 对可行的临床试验进行实验室研究。总之，信元处理核心是 将提供对临床研究实施至关重要的服务的计划项目 在项目1、3和4中。

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.