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

HIV和其他候选药物的临床前和转化疫苗开发（PTVDS）：该计划将为NIAID提供广泛而灵活的能力，这些能力是HIV和其他候选药物有前途的疫苗和相关产品的临床前和转化开发支持所需的。该计划下的合同将为工艺和产品开发、小规模生产、临床前试验和文件的所有阶段提供所需的支持和服务，从而为I、II和III期临床试验提交研究性新药（IND）。这些能力将使NIAID能够快速有效地解决开发和生产方面的差距。本合同将在任务领域E工艺开发、cGMP生产和稳定性下提供支持。

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.