Technologies to Advance Next Generation Anthrax Vaccines

推进下一代炭疽疫苗的技术

• 批准号: 9554731
• 负责人: VIDADI YUSIBOV
• 金额: $ 270.47万
• 依托单位: CENTER FOR EXPERMENTAL SOFTWARE ENGR MD
• 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 2019-07-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9554731
• 关键词: Address; Anthrax Vaccines; Award; Biological Assay; Clinical Research; Cyclic GMP; Development; Dose; Formulation; Investigational Drugs; National Institute of Allergy and Infectious Disease; Pharmaceutical Preparations; Process; Reagent; Technology; Toxicology; Vaccines; Validation; next generation; product development; stability testing

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.

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。