Task V07: Qualification of a Shigella Serum Bactericidal Assay

任务 V07：志贺氏菌血清杀菌测定的鉴定

• 批准号: 10269063
• 负责人: THOMAS RUDGE
• 金额: $ 69.25万
• 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: 2020-09-18 至 2021-09-17
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10269063
• 关键词: Antimicrobial Resistance; Area; Biological; Biological Assay; Bioterrorism; Clinical; Communicable Diseases; Contracts; Development; Educational workshop; Emerging Communicable Diseases; Feasibility Studies; Immunology procedure; Investigational New Drug Application; Licensing; Office of Administrative Management; Reporting; Safety; Sampling; Serum; Services; Shigella; Shigella Vaccines; Site Visit; Testing; Toxicology; Training; Vaccines; Validation; bactericide; efficacy testing; evaluation/testing; immunogenicity; 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. Task areas include: 1) administrative management and technical support including training and workshops, and quality oversight and management (site visits, critical stage audits, and final study report audits), 2) development, qualification and validation of immune assays, 3) immunogenicity and efficacy testing, 4) non-clinical and clinical sample testing, and 5) safety/toxicology studies. 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。任务领域包括：1）行政管理和技术支持，包括培训和讲习班，以及质量的监督和管理（现场访问，关键阶段审计以及最终研究报告报告），2）2）免疫测定的发展，发展和验证，3）免疫原性和功效测试，4）4）非临床和临床样本测试，以及5）安全/毒理学研究。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。