cGMP Manufacture, Fill-Finish, Release, Analytical and Stability Testing and Stability Program of a Nanoparticle Based HIV Envelope Vaccine

该合同项目将为NIAID提供广泛而灵活的能力，为有前景的HIV疫苗和相关产品及其他候选制剂的临床前和转化开发提供支持。该合同将为过程和产品开发的所有阶段、小规模生产、临床前测试和文件编制提供所需的支持和服务，从而导致新药研究（IND）提交I、II和III期临床测试。这些能力将使NIAID能够快速有效地解决开发和生产差距。

This contract program will provide NIAID with a broad and flexible range of capabilities that are required for preclinical and translational development support for promising vaccines and related products for HIV and other candidate agents. This contract will provide the support and services needed for all stages of process and product development, small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submissions for Phase I, II, and III clinical testing. These capabilities will allow NIAID to rapidly and efficiently address development and production gaps.