ESTABLISHMENT OF A NATIONAL GENE VECTOR LABORATORY

国家基因载体实验室的建立

• 批准号: 7408248
• 负责人: LARRY A COUTURE
• 金额: $ 5.83万
• 依托单位: BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-30 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7408248
• 关键词: ESTABLISHMENT; NATIONAL; GENE; VECTOR; LABORATORY

This application proposes the establishment of a dual-purpose NGVL "vector production facility" at the Beckman Research Instituteof the City of Hope (COH). The facility will serve as the primary site for production of plasmid DNA- based vectors and, without additionalNGVL 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 additionalplasmid products in production. The staff has significant experience and expertise in the production of cGMP-compliant biologies 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/I1 biologies 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. The CBG is a purpose-built, two-story 20,000 sq. ft. building on the COH campus with approximately 9,000 sq. ft. of classified manufacturing space. The remaining space includes the departmental offices. QC labs and facility systems. The CBG staff completely manages and operates this $12-milHon facility. The NGVL support requested here will provide the resources to produce up to 15 clinical grade plasmid products and associated master cell banks per year plus a capacity of up to 3-4 adenoviral vector products per year. The COH is currently funding the establishment of 293 master and working cell banks that will be made available for NGVL production activities. All activitieswithin the CBG are monitored and documented through a thorough Quality System according to cGMP. The CBG supports the translation of academic-based technologies into the clinical setting and has made a significant commitment to the facility to support the development and production of recombinant proteins, viral and non-viral vectors, vaccines and ex-vivo manipulated cell products for phase I/II clinical studies.

本申请建议在Beckman建立一个两用NGVL“载体生产设施”， 希望之城研究所（COH）。该设施将作为生产质粒DNA的主要场所- 在没有额外NGVL资源的情况下，提供后备生产能力， 腺病毒载体。该设施已经生产了FDA审查的质粒材料，已用于人类 临床研究，目前有三个额外的质粒产品在生产中。工作人员经验丰富 以及生产符合cGMP的人类临床用生物制剂的专业知识。主任，副主任 和质量保证官具有生物技术行业的背景，在法规事务、产品和流程方面具有专业知识 开发、生产、质量体系和分子生物学、病毒学、血液学、细胞生物学和流程 细胞仪目前正在卫生组织办公室的资助下扩大现有进程。该设施在 根据cGMP生产I/I1期生物制剂，各种设施系统均应符合 已实施和正在进行的主确认计划。COH的生物医学和遗传学中心（CBG）， 拟议的NGVL将位于，目前生产重组单克隆抗体，质粒DNA，病毒载体和 离体操作的细胞产物。CBG是一个专门建造的两层20，000平方英尺的建筑。英尺COH校园内的建筑 约9,000平方米。英尺机密制造空间其余空间包括部门 合署QC实验室和设施系统。CBG的工作人员完全管理和经营这个1200万美元的设施。的 此处要求的NGVL支持将提供生产多达15种临床级质粒产品的资源， 相关的主细胞库加上每年高达3-4个腺病毒载体产物的能力。COH是 目前正在资助建立293个将用于NGVL的主细胞库和工作细胞库 生产活动。CBG内的所有活动均通过全面的质量体系进行监控和记录 根据cGMP。CBG支持将学术技术转化为临床环境，并已 作出了重大承诺，该设施，以支持开发和生产重组蛋白，病毒 以及用于I/II期临床研究的非病毒载体、疫苗和离体操作的细胞产物。