cGMP Manufacture, Fill-Finish, Release, Analytical and Stability Testing and Stability Program of mRNA, Lipid Nanoparticle Based HIV Immunogens

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Preclinical and Translational Vaccine Development for HIV and Other Candidate Agents (PTVDS): This 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. Contracts under this program 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. This contract will provide support under Task Area E, Process Development, cGMP Manufacturing and Stability.