VECTOR PRODUCTION

矢量制作

基本信息

批准号：
8217345
负责人：
ADRIAN Philip GEE
金额：
$ 29.84万
依托单位：
BAYLOR COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2002
资助国家：
美国
起止时间：
2002-09-01 至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/8217345
关键词：
Address Adenovirus Vector Adenoviruses Adopted Air Amino Acid Sequence Animals Archives Area Attention Back Baculoviruses Basic Science Biological Biological Assay Carbon Dioxide Cell Therapy Cells Chromatography Client Clinical Clinical Research Clinical Trials Cloning Collaborations Color Computer software Computers Contract Services Contracts Data Databases Dependovirus Detection Development Documentation Education Electronic Mail Electronics Emergency Situation Employee Endotoxins Ensure Environment Design Equipment Equipment and supply inventories Gene Delivery Gene Expression Gene Transduction Agent Genes Genetic Hazardous Chemicals High Pressure Liquid Chromatography Housing Human Resources Imaging technology Incubators Individual Industry Institution International Internet Job Description Label Laboratories Laboratory Personnel Laboratory Study Lasers Life Link Location Mails Maintenance Malignant Neoplasms Manufacturer Name Maps Medicine Methods Modification Molecular Biology Monitor Names Peptide Sequence Determination Persons Plasmid Cloning Vector Plasmids Play Printing Procedures Production Protocols documentation Qualifying Quality Control Reading Recommendation Records Reporter Reporting Research Personnel Retrieval Retroviral Vector Retroviridae Safety Sampling Schedule Security Serotyping Serum Services Shipping Ships Site Staging Sterility Subfamily lentivirinae Supervision System T-Lymphocyte Test Result Testing Time Training Transgenes Translational Research Update Vial device Viral Vector Virus Water Word Processing Work Writing Zebra base clinical practice college computerized database structure design detector experience expiration fluorescence microscope foot gene therapy good laboratory practice laboratory facility manufacturing facility manufacturing scale-up meetings member novel operation plasmid DNA pre-clinical preclinical study programs quality assurance research facility response tissue culture user-friendly vector web site

项目摘要

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.

该项目探索利用遗传技术增强癌症 T 细胞疗法在临床前研究和临床试验中对体外扩增的 T 细胞进行修饰。针对这些不同的需求，两个实验室、临床载体生产设施（VPF）和载体开发实验室（VDL），贝勒医学院的细胞和基因治疗中心将受聘提供适当的向量。这些实验室密切合作开发新的载体最终根据现行良好生产规范 (cGMP) 进行生产以供临床使用。向量开发实验室拥有病毒载体的创建、生产和质量控制测试方面的专业知识用于基础研究并按照良好实验室规范 (GLP) 进行操作。该设施还提供实验室对将使用这些载体的研究人员进行培训，并为以下人员提供标准报告载体：可行性测试。第二个实验室是临床载体生产设施，也是该实验室的一部分 Core，已生产 20 多种临床级腺载体用于本地、国家和国际研究是腺病毒载体国家基因载体实验室。也拥有丰富的经验制造临床级逆转录病毒载体。核心依靠核心B的质量控制实验室，对细胞产品和载体进行内部测试，并负责日常监测良好生产规范；以及质量保证小组，确保符合 GMP 和提供制造和发布各个方面的独立概述。 GMP 工作人员还拥有丰富的监管经验将有助于将实验室研究转化为临床试验。在总之，Vector Core 是该计划项目的重要组成部分，它提供的服务对于临床前和临床研究的实施至关重要。