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提供广泛而灵活的非传统、前瞻性和发展导向的能力，当这些产品从研究者发起的研究中出现时，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、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，临床前测试和导致新药研究（IND）提交I， II和III期临床测试的文件。本项目主要用于cGMP HIV-1包膜蛋白的生产。