ESTABLISHMENT OF A NATIONAL GENE VECTOR LABORATORY

国家基因载体实验室的建立

• 批准号: 7360454
• 负责人: LARRY A COUTURE
• 金额: $ 51.1万
• 依托单位: BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7360454
• 关键词: ESTABLISHMENT; NATIONAL; GENE; VECTOR; LABORATORY

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. DESCRIPTION (provided by applicant): This application proposes the establishment of a dual-purpose NGVL "vector production facility" at the BRICOH. The facility will serve as the primary site for production of plasmid DNA-based vectors and, without additional NGVL resources, provide back-up production capacity and capability for adenovirus based-vectors. The facility has produced FDA-reviewed plasmid material that has been used in human clinical studies and currently has three additional plasmid products in production. The staff has significant experience and expertise in the production of current Good Manufacturing Practices (cGMP)-compliant biologics for human clinical use. The Director, Associate Director and QA Officer have backgrounds in the biotechnology industry with expertise in regulatory affairs, product and process development, manufacturing, quality systems and molecular biology, virology, hematology, cell biology and flow cytometry. Scale-up of current processes is under way with funding from the COH. The facility is operated in accordance with cGMP for production of Phase I/II biologics and the various facility systems are subject to an implemented and ongoing Master Validation Plan. The COH's Center for Biomedicine and Genetics (CBG), where the proposed NGVL will be located, currently produces recombinant monoclonal antibodies, plasmid DNA, viral vectors and ex-vivo manipulated cell products.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，不一定是研究者的机构。描述（由申请人提供）：本申请提议在 BRICOH 建立一个双用途 NGVL“载体生产设施”。该设施将作为生产基于质粒 DNA 的载体的主要场所，并且在没有额外 NGVL 资源的情况下，为基于腺病毒的载体提供备用生产能力和能力。该工厂生产了经 FDA 审查的质粒材料，已用于人类临床研究，目前还有另外三种质粒产品正在生产中。员工在生产符合现行良好生产规范 (cGMP) 的人类临床生物制剂方面拥有丰富的经验和专业知识。董事、副董事和质量保证官员拥有生物技术行业背景，在监管事务、产品和工艺开发、制造、质量体系和分子生物学、病毒学、血液学、细胞生物学和流式细胞术方面拥有专业知识。在 COH 的资助下，目前工艺的规模正在扩大。该设施按照用于生产 I/II 期生物制剂的 cGMP 进行运营，并且各种设施系统均须遵守已实施且正在进行的主验证计划。 COH 的生物医学和遗传学中心 (CBG) 是拟议的 NGVL 所在地，目前生产重组单克隆抗体、质粒 DNA、病毒载体和离体操作细胞产品。