IGF::OT::IGF - Gene Therapy Resource Program (GTRP) Lentivirus Vector Production

IGF::OT::IGF - 基因治疗资源计划 (GTRP) 慢病毒载体生产

• 批准号: 8862323
• 负责人: KENNETH CORNETTA
• 金额: $ 6万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-01 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8862323
• 关键词: Animal Model; Clinical; Clinical Research; Contractor; Contracts; Dose; Funding; Gene Transfer; Laboratories; Lentivirus Vector; National Heart, Lung, and Blood Institute; Pharmacology and Toxicology; Production; Regulation; Research Personnel; Resources; Safety; Testing; United States Food and Drug Administration; gene therapy; programs; vector

The Lentiviral vector production core laboratory contract involves production of scalable clinical grade Lentiviral vectors, in accordance with Good Manufacturing Practices (GMP), as defined by the Food and Drug Administration (FDA), and applicable State and Federal regulations, for use by NHBLI funded investigators. It is expected that the contractor will produce an average of Twelve (12) vector batches per year for a minimum of three (3) batches for clinical studies or for safety and efficacy/dose/pharmacology/toxicology testing with large animal models.

慢病毒载体生产核心实验室合同涉及按照美国食品药品监督管理局（FDA）规定的药品生产质量管理规范（GMP）以及适用的州和联邦法规生产可扩展的临床级慢病毒载体，供NHBLI资助的研究者使用。预计承包商将平均每年生产12个载体批次，至少3个批次用于临床研究或大型动物模型的安全性和有效性/剂量/药理学/毒理学试验。