Task V7: Clinical and NHP Sample Testing for SARS-CoV-2 Biological Product Candidates

任务 V7：SARS-CoV-2 候选生物制品的临床和 NHP 样品检测

• 批准号: 10329730
• 负责人: THOMAS RUDGE
• 金额: $ 17.23万
• 依托单位: BATTELLE CENTERS/PUB HLTH RES & EVALUATN
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-27 至 2022-08-26
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10329730
• 关键词: 2019-nCoV; Biological; Biological Products; Bioterrorism; COVID-19; COVID-19 testing; COVID-19 therapeutics; Clinical; Communicable Diseases; Contracts; Development; Emerging Communicable Diseases; Feasibility Studies; Investigational New Drug Application; Licensing; Sampling; Services; Vaccines; evaluation/testing; product development; testing services; therapeutic 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 biologics (regulated by CBER) against potential agents of bioterrorism and emerging and re-emerging infectious diseases.

传染病疫苗和其他生物制品的评估和测试服务（ETS）合同提供了从早期可行性研究到提交生物许可申请（BLA）和/或研究性新药（IND）申请所需的活动的各种产品开发服务。这些服务将促进开发和引进新的生物制剂（由生物和生物研究中心管制），以对付生物恐怖主义的潜在制剂以及新出现和重新出现的传染病。