IGF::OT::IGF NIAID PRECLINICAL DEVELOPMENT SUPPORT - PRODUCTION OF CGMP NATIVE FLEXIBLY LINKED HIV-1 ENVELOPE PROTEIN

IGF::OT::IGF NIAID 临床前开发支持 - CGMP 天然柔性连接 HIV-1 包膜蛋白的生产

• 批准号: 9361947
• 负责人: THOMAS VANCOTT
• 金额: $ 611.04万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-12 至 2021-08-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9361947
• 关键词: AIDS prevention; Contracts; Data; Development; Documentation; Guidelines; HIV vaccine; HIV-1; Investigational Drugs; Investigational New Drug Application; Investigator-Initiated Research; Link; Modality; National Institute of Allergy and Infectious Disease; Pamphlets; Phase; Preclinical Testing; Process; Production; Protocols documentation; Research Personnel; Safety; Testing; authority; cGMP production; env Gene Products; flexibility; immunogenicity; microbicide; pre-clinical; research clinical testing; research study

This contract will provide NIAID with a broad and flexible range of nontraditional, proactive and developmentally-oriented capabilities to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies. These capabilities will allow NIAID to more rapidly and efficiently close development and production gaps. Activities include but are not limited to small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing. In particular this project is for the production of cGMP HIV-1 envelope protein.

该合同将为 NIAID 提供广泛且灵活的非传统、主动和以开发为导向的能力，以便在研究者发起的研究中出现此类产品时，为有前途的产品提供临床前开发支持。这些能力将使 NIAID 能够更快速、更有效地缩小开发和生产差距。活动包括但不限于小规模生产、临床前测试和文件记录，从而提交研究性新药 (IND) 以进行 I、II 和 III 期临床测试。 特别是，该项目用于生产 cGMP HIV-1 包膜蛋白。