The scope of product development activities that may be addressed through this award span manufacturing and formulation process development through clinical studies, including: manufacturing, characterization and release of pilot lot cGMP material;vaccine stability testing;conduct of non-clinical studies, e.g., Investigational New Drug (IND)-enabling toxicology studies;development, qualification and, where necessary, validation of all assays and reagents needed to support product development;and the delivery to the NIAID of 2000 doses of cGMP bulk drug substance as well as 2000 doses of cGMP final container candidate.
