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.

Agency
National Institute of Health (NIH)
Type
Research and Development Contracts (N01)
Project #
272201200034C-4-0-1
Application #
8919543
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Center for Expermental Software Engr MD
Department
Type
DUNS #
City
College Park
State
MD
Country
United States
Zip Code
20740