VECTOR PRODUCTION

本项目旨在探索通过基因工程技术增强T细胞治疗癌症的方法。 在临床前研究和临床试验中修饰离体扩增的T细胞。为了满足这些不同的需求， 实验室、临床病媒生产设施（VPF）和病媒开发实验室（VDL）， 都在贝勒医学院细胞和基因治疗中心，将被雇用， 合适的载体。这些实验室密切合作，开发新的载体， 最终根据现行药品生产质量管理规范（cGMP）生产，用于临床使用。矢量 开发实验室在病毒载体的创建、生产和质量控制测试方面具有专业知识 用于基础研究，并在良好实验室规范（GLP）下运行。该设施还提供实验室 培训将利用这些载体的研究者，并提供标准报告载体， 可行性测试。第二个实验室是临床病媒生产设施，也是 核心，已生产了20多个临床级腺病毒载体的地方，国家和国际研究 并且是腺病毒载体的国家基因载体实验室。它还在以下方面具有相当丰富的经验： 制造临床级逆转录病毒载体核心依赖于核心B中的质量控制实验室， 进行细胞产品和载体的内部测试，并负责对 药品生产质量管理规范;质量保证小组，确保符合GMP， 提供生产和放行所有方面的独立概述。GMP工作人员也有 丰富的监管经验，有助于将实验室研究转化为临床试验。在 总之，矢量核心是计划项目的重要组成部分，它提供的服务 这对临床前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.