Cell Processing & Vector Production Resource

细胞处理

• 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
• 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

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.

对细胞和基因疗法的重新关注导致对制备产品的需求增加 1期和2期临床研究。食品和药物管理局规定，这些材料必须 根据现行组织质量管理规范[GTP]或药品生产质量管理规范[GMP]法规生产。 此外，这些产品在放行使用前均经过严格的质量控制测试。的 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都有意义 从经济和组织的角度来看。 拟定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， 以及腺病毒和逆转录病毒载体。由Adrian Gee博士和经验丰富的工作人员领导，该资源 目前支持20多项IND研究，是唯一一家既被指定为国家 基因载体实验室和国家体细胞治疗实验室。资源开发 系统，以确保GMP/GTP合规性的持续基础上，并已成功地审计了 多次被FDA据估计，该设施可以提供制造和测试 服务的成本是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。