NIAID Preclinical Development Support - Production of Research Cell Lines

该合同将为NIAID提供广泛而灵活的非传统，主动和以开发为导向的能力，为有前途的产品提供临床前开发支持，当这些产品从制药商发起的研究中出现时。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、临床前试验和文件编制，以提交研究性新药（IND）进行I、II和III期临床试验。特别是，该项目将开发、生产、扩大规模、表征、配制、装瓶和释放临床级（cGMP）HIV-1 M组保守元件DNA，用于人体I期临床试验。

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 will develop, produce, scale-up, characterize, formulate, vial and release Clinical Grade (cGMP) HIV-1 M Group Conserved Element DNAs for human Phase I clinical trials.