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.
|Effective start/end date||1/10/11 → 30/09/15|
- National Institute of Allergy and Infectious Diseases: $2,237,069,820.00
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