Technologies to Advance Next Generation Anthrax Vaccines

通过该奖项可能涉及的产品开发活动范围涵盖通过临床研究进行的生产和制剂工艺开发，包括：中试批次cGMP材料的生产、表征和放行;疫苗稳定性试验;非临床研究的开展，例如，试验性新药（IND）-毒理学研究;开发、确认和（必要时）验证支持产品开发所需的所有测定和试剂;向NIAID交付2000剂cGMP散装原料药以及2000剂cGMP最终容器候选物。

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.