Detalles del proyecto
Description
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.
| Estado | Finalizado |
|---|---|
| Fecha de inicio/Fecha fin | 10/1/11 → 9/30/15 |
Financiación
- National Institute of Allergy and Infectious Diseases: US$ 986.910,00
ASJC Scopus Subject Areas
- Immunology