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

International Aids Vaccine Initiative, New York NY

Investigators

Abstract

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.