Cell Processing & Vector Production Resource

细胞处理

基本信息

批准号：
7514633
负责人：
ADRIAN Philip GEE
金额：
$ 8.07万
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 2010-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7514633
关键词：
Adenovirus Vector Basic Science Cancer Center Cell physiology Cells Chemistry Clinical Clinical Protocols Clinical Research Clinical Trials Contracts Cyclic GMP Development Documentation Economics Ensure Genes Goals Guanosine Monophosphate Guanosine Triphosphate Housing Laboratories Maintenance Manufacturer Name Medicine Mission Monitor Numbers Operative Surgical Procedures Pharmacologic Substance Phase Preparation Procedures Production Protocols documentation Purpose Quality Control Recording of previous events Regulation Reporting Research Infrastructure Research Personnel Resources Retroviral Vector Running Services Site Somatic Cell Staging Structure System Testing Therapeutic Tissues United States Food and Drug Administration Viral Vector base college cost experience gene therapy interest manufacturing facility quality assurance vector

项目摘要

Renewed interest in cellular and gene therapies has resulted in an increased demand to prepare products for Phase 1 and 2 clinical studies. The Food and Drug Administration has ruled that these materials must be manufactured under current Good Tissue Practice [GTP] or Good Manufacturing Practice [GMP] regulations. In addition, these products are subject to rigorous quality control testing prior to release for use. The development and maintenance of such a manufacturing and testing infrastructure is both expensive and labor intensive. As a result, the provision of these services through a core laboratory makes sense from both an economic and an organizational perspective. The proposed Cell Processing and Vector Production Resource, consisting of two GMP facilities and a Quality Control Laboratory, has the capability to manufacture a wide variety of cellular therapy products, as well as adenoviral and retroviral vectors. Led by Dr. Adrian Gee with an experienced staff, this Resource currently supports more than 20 IND studies, and is the only facility to be designated as both a National Gene Vector Laboratory and a National Somatic Cell Therapy Laboratory. The Resource has developed systems to ensure GMP/GTP compliance on an ongoing basis and has been successfully audited on multiple occasions by the FDA. It is estimated that this facility can offer both manufacturing and testing services at one-quarter to one-tenth the cost of using commercial contract organizations. We believe that a core of this type is an essential component of a modern Cancer Center.

人们对细胞和基因疗法重新产生兴趣，导致制备产品的需求增加用于 1 期和 2 期临床研究。美国食品药品监督管理局规定这些材料必须根据现行良好组织规范 [GTP] 或良好生产规范 [GMP] 法规制造。此外，这些产品在发布使用之前都经过严格的质量控制测试。这这种制造和测试基础设施的开发和维护既昂贵又劳动密集型。因此，通过核心实验室提供这些服务对双方来说都是有意义的。经济和组织的角度。拟议的细胞处理和载体生产资源，包括两个 GMP 设施和一个质量控制实验室，有能力生产各种细胞治疗产品，例如以及腺病毒和逆转录病毒载体。该资源由 Adrian Gee 博士和经验丰富的员工领导目前支持 20 多项 IND 研究，并且是唯一被指定为国家基因载体实验室和国家体细胞治疗实验室。资源已开发系统，以确保持续符合 GMP/GTP 要求，并已成功通过审核多次被 FDA 批准。估计该设施可以提供制造和测试服务成本仅为使用商业合同组织的四分之一到十分之一。我们相信，一个这种类型的核心是现代癌症中心的重要组成部分。