VACCINE TECHNOLOGIES TO ADVANCE NEXT GENERATION ANTHRAX VACCINES

推进下一代炭疽疫苗的疫苗技术

• 批准号: 9539145
• 负责人: HOWARD TRANTER
• 金额: $ 641.24万
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-27 至 2017-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9539145
• 关键词: Anthrax Vaccines; Biological Assay; Clinical Research; Cyclic GMP; Development; Formulation; Investigational Drugs; Process; Reagent; Support Contracts; Technology; Toxicology; Vaccines; Validation; next generation; product development; stability testing

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.

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。