GMP Cell Therapy and Vector Core

GMP 细胞疗法和载体核心

基本信息

批准号：
9340314
负责人：
ADRIAN Philip GEE
金额：
$ 28.88万
依托单位：
UNIVERSITY OF TX MD ANDERSON CAN CTR
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-22 至 2018-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9340314
关键词：
Adenovirus Vector Area Basic Science Blood Cells Blood Component Removal Bone Marrow Calibration Cancer Center Cardiovascular system Cell Separation Cell Therapy Cell physiology Cells Chemistry Clinical Clinical Research Clinical Trials Code Contracts Dendritic Cells Disadvantaged Documentation Dose Engraftment Ensure Environmental Monitoring Equipment Gene-Modified Generations Genes Goals Guanosine Triphosphate Hematopoietic Housing Immune Institution International Investigational Drugs Investigational New Drug Application Laboratories Laboratory Study Maintenance Medicine Monitor National Heart, Lung, and Blood Institute Patients Phase Physiologic pulse Preparation Procedures Process Production Program Research Project Grants Protocols documentation Quality Control Records Regulation Reporting Research Infrastructure Research Personnel Resource Sharing Retroviral Vector Services Somatic Cell Source Stem cells Structure System T-Lymphocyte Testing Therapeutic Therapeutic Studies Tissues Training Translations Transplantation Tumor-Infiltrating Lymphocytes Umbilical Cord Blood Umbilical Cord Blood Transplantation United States Food and Drug Administration Viral Tumor Antigens Viral Vector Virus Work cell preparation cold temperature college experience gene therapy high efficiency particulate air filter improved manufacturing facility nanoparticle operation preclinical study programs quality assurance reconstitution stem vector

项目摘要

This Program Project Grant (PO1) explores the enhancement of cord blood transplantation by employing ex-vivo expansion of cord blood stem/progenitor and T cells in preclinical studies and clinical trials. All four projects will undertake clinical trials during the course of the studies. These rely on the availability of a GMP manufacturing facility for the preparation of the cellular therapy products and associated viral vectors. Projects 1 and 4 will use on the Good Manufacturing Practice (GMP) Facility at MD Anderson Cancer Center (MDACC) and Projects 2 and 3 will rely on the GMP facility and the Clinical Vector Production Facility at the Center for Cell and Gene Therapy Baylor College of Medicine (BCM). The GMP Facilities at BCM and MDACC have been in operation for more than 10 years. The Cell Processing Facilities at both institutions have considerable experience in the preparation of a wide variety of cellular products, including all that would be required for the Projects in this application. Both facilities consist of HEPA filtered. Class 10,000 space divided into multiple cell preparation laboratories, low temperature storage areas, cell sorting and analysis laboratories, large equipment areas and central supply facilities. Both Facilities are well equipped to operate under GMP conditions, with extensive documentation systems, barcoding, environmental monitoring and quality assurance, control and improvement programs. Additional components of the Core are the Quality Control Laboratories at BCM and MDACC, which perform in-house testing of cellular products (and vectors), and are responsible for routine monitoring of Good Manufacturing Practices; and the Quality Assurance Group to ensure compliance with GMP and provides independent overview of all aspects of manufacturing and release. The Clinical Vector Production Facility at BCM, which is also a part of the Core, has produced more than 30 clinical grade adenovectors and retroviral vectors for local, national and international studies. The GMP staff at both institutions have extensive regulatory experience that will facilitate the translational of laboratory studies into clinical trials. In summary, the GMP Laboratory Core is a vital component of the P01 that will provide essential services to the implementation of the clinical studies in Projects 1, 2, 3 and 4.

该计划项目拨款 (PO1) 探索在临床前研究和临床试验中通过体外扩增脐带血干细胞/祖细胞和 T 细胞来增强脐带血移植。所有四个项目都将在研究过程中进行临床试验。这些依赖于 GMP 生产设施的可用性来制备细胞治疗产品和相关病毒载体。项目 1 和 4 将使用 MD 安德森癌症中心 (MDACC) 的良好生产规范 (GMP) 设施，项目 2 和 3 将依赖贝勒学院细胞和基因治疗中心的 GMP 设施和临床载体生产设施医学学士（BCM）。 BCM 和 MDACC 的 GMP 设施已运行 10 多年。两个机构的细胞处理设施在制备各种细胞产品方面拥有丰富的经验，包括本申请中的项目所需的所有产品。两个设施均经过 HEPA 过滤。万级空间划分为多个细胞制备实验室、低温储存区、细胞分选和分析实验室、大型设备区和中心供应设施。两个工厂均配备齐全，可在 GMP 条件下运行，并拥有广泛的文件系统、条形码、环境监测以及质量保证、控制和改进计划。核心的其他组成部分是 BCM 和 MDACC 的质量控制实验室，它们对细胞产品（和载体）进行内部测试，并负责良好生产规范的日常监控；和质量保证小组，以确保符合 GMP 并提供制造和放行各个方面的独立概览。 BCM 的临床载体生产设施也是核心的一部分，已生产了 30 多种临床级腺载体和逆转录病毒载体，用于本地、国家和国际研究。两家机构的 GMP 工作人员都拥有丰富的监管经验，这将有助于将实验室研究转化为临床试验。综上所述，GMP实验室核心是P01的重要组成部分，将为项目1、2、3、4的临床研究的实施提供必要的服务。