Technologies to Advance Next Generation Anthrax Vaccines

推进下一代炭疽疫苗的技术

• 批准号: 8563820
• 负责人: HOWARD TRANRER
• 金额: $ 650.18万
• 依托单位: UK HEALTH SECURITY AGENCY
• 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 2014-09-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8563820
• 关键词: Address; Anthrax Vaccines; Award; Biological Assay; Clinical Research; Cyclic GMP; Development; Dose; Drug Formulations; 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制造和配方工艺开发，包括：生产、表征和发布试点批次的cGMP材料；疫苗稳定性测试；进行非临床研究，例如支持新药物(IND)的毒理学研究；开发、鉴定以及在必要时验证支持产品开发所需的所有化验和试剂；以及向NIAID交付2000剂cGMP原料药以及2000剂cGMP最终候选容器。