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Cell Processing and Vector Production

细胞处理和载体生产

基本信息

批准号：
10239120
负责人：
ADRIAN Philip GEE
金额：
$ 9.67万
依托单位：
BAYLOR COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-07-01 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10239120
关键词：
Adenovirus Vector Basic Science Cancer Center Cancer Center Support Grant Cell Therapy Cells Certification Chemistry Clinical Clinical Research Clinical Trials Contracts Data Development Disease Documentation Environment Environmental Monitoring Equipment Flow Cytometry Genes Infrastructure Investigational New Drug Application Laboratories Maintenance Medicine Microbiology National Heart, Lung, and Blood Institute Phase I/II Clinical Trial Preparation Procedures Production Protocols documentation Quality Control Quality Indicator Regulation Research Personnel Resource Sharing Resources Retroviral Vector Somatic Cell Standard Preparations System Testing Therapeutic Training Translations United States Food and Drug Administration Validation Viral Vector Work cancer therapy cell bank college cost early phase clinical trial experience follow-up gene therapy good laboratory practice neoplastic pre-clinical preclinical study programs quality assurance research study stability testing tissue repair vector

项目摘要

PROJECT SUMMARY: Cell Processing and Vector Production (CPVP) Shared Resource The Cell Processing and Vector Production (CPVP) Shared Resource provides manufacturing of therapeutic grade cellular therapy products and viral vector for use in early phase clinical trials. These must be prepared according to current Good Manufacturing Practices (GMP) as mandated by the Food and Drug Administration. This Shared Resource provides the infrastructure and environment to prepare, test, and release these products for use. It consists of a state-of-the-art facility with 22 manufacturing clean rooms and support facilities (quality control and flow cytometry laboratories, material management facilities etc.), and highly experienced manufacturing and quality control and assurance staff. This DLDCCC Resource will work with investigators to develop clinical scale manufacturing procedures, and release test specifications, testing procedures, quality assurance oversight, and regulatory assistance to assist in IND submissions. The resource has, therefore, facilitated the transition of cellular and gene therapy products from the basic science laboratories in the DLDCCC into early-phase clinical trials. The CPVP currently supports more than 50 clinical trials (21 actively accruing, 18 in follow-up, and 11 in stages of translation to investigational new drug applications [INDs]) held by DLDCCC investigators and does so at a much-reduced cost compared to commercial manufacturing and testing entities.

项目概述：细胞处理和载体生产（CPVP）共享资源