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

HIV和其他候选制剂的临床前和转化性疫苗开发(PTVDS)：该计划将为NIAID提供广泛和灵活的能力，以支持针对艾滋病毒和其他候选制剂的有前景的疫苗和相关产品的临床前和转化性开发。根据这项计划，合同将为工艺和产品开发、小规模生产、临床前测试和文件编制的所有阶段提供所需的支持和服务，从而为第一阶段、第二阶段和第三阶段的临床测试提交研究新药(IND)。这些能力将使NIAID能够迅速有效地解决发展和生产差距。该合同将在任务区E、流程开发、cGMP制造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.