CELL PROCESSING AND VECTOR PRODUCTION

细胞处理和载体生产

基本信息

批准号：
8180974
负责人：
ADRIAN GEE
金额：
$ 7.74万
依托单位：
BAYLOR COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-17 至 2015-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8180974
关键词：
Adenovirus Vector Adenoviruses Allogenic Antigens Arts Autologous Basic Science Blood Cells Bone Marrow Cancer Center Cancer Vaccines Cardiac Cardiovascular system Cell Line Cell Therapy Cell physiology Cells Chemistry Clinical Clinical Protocols Clinical Research Clinical Trials Contracts Country Cyclic GMP Cytomegalovirus Cytotoxic T-Lymphocytes Dendritic Cells Development Documentation Ensure Erythrocytes Flow Cytometry Gene-Modified Genes Goals Guanosine Triphosphate Herpesviridae Housing Human Cell Line Human Herpesvirus 4 Investigational Drugs Islet Cell Islets of Langerhans Laboratories Leukocytes Maintenance Manufacturer Name Medicine Mission Monitor Mononuclear National Heart, Lung, and Blood Institute Neurologic Pharmacologic Substance Phase Plasma Preparation Procedures Process Production Protocols documentation Quality Control Recording of previous events Regulation Reporting Research Infrastructure Research Personnel Resource Sharing Resources Retroviral Vector Running Sampling Services Site Somatic Cell Specificity Staging Stem cells Structure System T-Lymphocyte Testing Therapeutic Therapeutic Studies Tissues Umbilical Cord Blood United States Food and Drug Administration Viral Antigens Viral Vector Virus Work base cell bank cell type clinical practice college cost density experience gene therapy interest lymphoblastoid cell line manufacturing facility operation peripheral blood programs quality assurance repaired sound tissue culture 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. These services are provided at Baylor through the Cell Processing and Vector Production shared resource. This facility currently supports more than 20 IND cell and gene therapy studies, and is the only facility in the country to be designated as both a National Gene Vector Laboratory and a National Somatic Cell Therapy Laboratory. It produces nearly 1000 cellular therapy products and intermediates, and approximately 20 clinical grade vectors and cell banks annually. The associated Quality Control Laboratory tests and processes more than 12,000 samples annually. The Shared Resource has developed systems to ensure GMP/GTP compliance on an ongoing basis and has been successfully audited on multiple occasions by the FDA and accrediting organizations. 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. In 2009 the shared resource will move to a new state of the art facility comprising 23 clean room suites with all of the associated quality control, quality assurance, flow cytometry and materials management infrastructure. This will provide investigators with unparalleled resources. We believe that a shared resource 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，导致为 1 期和 2 期临床研究准备产品的需求增加。美国食品和药物管理局规定，这些材料必须根据现行的良好组织规范 [GTP] 或良好生产规范 [GMP] 法规进行生产。此外，这些产品在放行使用之前还需经过严格的质量控制测试。这种制造和测试基础设施的开发和维护既昂贵又费力。这些服务由贝勒通过细胞处理和载体生产提供共享资源。该设施目前支持 20 多项 IND 细胞和基因治疗研究，是该国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的设施。它每年生产近1000种细胞治疗产品和中间体，以及约20个临床级载体和细胞库。相关的质量控制实验室每年测试和处理超过 12,000 个样品。共享资源开发了系统，以确保持续符合 GMP/GTP 要求，并已多次成功通过 FDA 和认证组织的审核。据估计，该设施可以提供制造和测试服务，其成本是使用商业合同组织的四分之一到十分之一。 2009 年，共享资源将转移到一个新的最先进的设施，其中包括 23 个洁净室套房，并配备所有相关的质量控制、质量保证、流式细胞术和材料管理基础设施。这将为调查人员提供无与伦比的资源。我们相信这种类型的共享资源是现代癌症中心的重要组成部分。