VACCINE TECHNOLOGIES TO ADVANCE NEXT GENERATION ANTHRAX VACCINES

该合同支持产品开发活动，这些活动可能涵盖生产和制剂工艺开发到临床研究，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，研究性新药（IND）-使毒理学研究成为可能;以及支持产品开发所需的所有检测试剂和试剂的开发、认证和（必要时）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.