VACCINE TECHNOLOGIES TO ADVANCE NEXT GENERATION ANTHRAX VACCINES

该合同支持产品开发活动，可能跨越生产和配方工艺开发，通过临床研究，包括：cGMP中试批材料的制造、表征和发布；疫苗稳定性试验；进行非临床研究，例如新药研究（IND）毒理学研究；以及支持产品开发所需的所有检测和试剂的开发、确认和必要时的验证。

This contract supports product development activities that may 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; and development, qualification and, where necessary, validation of all assays and reagents needed to support product development.