VECTOR PRODUCTION

该计划项目探索了通过利用基因来加强T细胞治疗癌症 临床前研究和临床试验中体外扩增T细胞的修饰。对于这些不同的需求，有两个 实验室、临床病媒生产设施(VPF)和病媒开发实验室(VDL)， 在贝勒医学院的细胞和基因治疗中心内，都将被雇用来提供 适当的向量。这些实验室密切合作，开发出能够 最终根据当前的良好制造规范(CGMP)生产，用于临床。向量 开发实验室在病毒载体的创建、生产和质量控制测试方面拥有专业知识 进行基础研究，并在良好实验室操作规范(GLP)下运作。该设施还提供实验室 对调查人员进行培训，他们将利用这些载体并提供标准报告载体用于 可行性测试。第二个实验室，临床病媒生产设施，也是 CORE，已经为本地、国内和国际研究生产了20多种临床级腺病毒载体 是腺病毒载体的国家基因载体实验室。它还在以下方面拥有相当丰富的经验 临床级逆转录病毒载体的研制。核心依赖于核心B的质量控制实验室， 对蜂窝产品和病媒进行内部测试，并负责对 良好制造规范；以及确保符合GMP和 提供制造和发布的所有方面的独立概述。GMP工作人员还拥有 丰富的监管经验，有助于将实验室研究转化为临床试验。在……里面 摘要：向量核心是计划项目的重要组成部分，该计划提供的服务包括 对临床前研究和临床研究的实施至关重要。

This program project explores the enhancement of T cell therapy of cancer by employing genetic modification of ex-vivo expanded T cells in preclinical studies and clinical trials. For these diverse needs, two laboratories, the Clinical Vector Production Facility (VPF) and the Vector Development Laboratory (VDL), both within the Center for Cell and Gene Therapy at Baylor College of Medicine, will be employed to provide the appropriate vectors. These laboratories work closely together to develop novel vectors that can ultimately be produced under current Good Manufacturing Practices (cGMP) for clinical usage. The Vector Development Laboratory has expertise in the creation, production, and quality control testing of viral vectors for basic studies and operates under Good Laboratory Practices (GLP). This facility also offers laboratory training to the investigators who will utilize these vectors and makes available standard reporter vectors for feasibility testing. The second laboratory, the Clinical Vector Production Facility, which is also a part of the Core, has produced more than 20 clinical grade adenovectors for local, national and international studies and is a National Gene Vector Laboratory for adenoviral vectors. It also has considerable experience in manufacturing clinical grade retroviral vectors. The Core relies on the Quality Control Laboratory in Core B, 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 that will facilitate the translational of laboratory studies into clinical trials. In summary, the Vector Core is a vital component of the Program Project that provides services that are essential to the implementation of both preclinical and clinical studies.