TASK V15: DEVELOPMENT OF ASSAYS AND REAGENTS FOR VACCINES

任务 V15：疫苗检测方法和试剂的开发

• 批准号: 10873656
• 负责人: THOMAS RUDGE
• 金额: $ 48.43万
• 依托单位: BATTELLE CENTERS/PUB HLTH RES & EVALUATN
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10873656
• 关键词: Biological; Biological Products; Bioterrorism; Communicable Diseases; Contracts; Development; Emerging Communicable Diseases; Feasibility Studies; Investigational New Drug Application; Licensing; Monkeypox virus; Reagent; Services; Vaccines; assay development; evaluation/testing; novel vaccines; product development; testing services; vaccine candidate; vaccine development

The Evaluation and Testing Services (ETS) for Vaccines and Other Biologics for Infectious Diseases contract provides a variety of product development services from early feasibility studies through activities required for the submission of Biologic License Application (BLA) and/or Investigational New Drug (IND) applications. These services will facilitate the development and introduction of new vaccine candidates and biologics (regulated by CBER) against potential agents of bioterrorism and emerging and re-emerging infectious diseases.

传染病合同的疫苗和其他生物制剂的评估和测试服务（ETS）提供了各种产品开发服务，从早期可行性研究到提交生物许可应用（BLA）和/或研究新药（IND）应用所需的活动。这些服务将促进对生物恐怖主义以及新兴和重新出现的传染病的潜在药物的新疫苗候选和生物制剂的开发和引入。