Task V32: MANUFACTURE OF INFLUENZA VIRUS HUMAN CHALLENGE MATERIAL FOR PHASE 1 AND 2

任务 V32：1 期和 2 期流感病毒人类挑战材料的制造

• 批准号: 10938084
• 负责人: SUNEEL SINGH
• 金额: $ 261.71万
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-26 至 2024-09-25
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10938084
• 关键词: Adjuvant; Biological Products; Bioterrorism; Clinical Research; Communicable Diseases; Contracts; Cyclic GMP; Development; Development Plans; Emerging Communicable Diseases; Human; Phase; Services; System; United States Food and Drug Administration; Vaccines; influenzavirus; manufacture; novel vaccines; product development; universal influenza vaccine; vaccine delivery; vaccine development

The Manufacture and Characterization Services (MCS) for Vaccines and Other Biologics for Infectious Diseases contract provides a variety of services spanning product development planning and feasibility assessments; product optimization; product development and cGMP compliant manufacture for Phase I/II clinical studies; technical and facility audits; and regulatory support appropriate for submission to the U.S. Food and Drug Administration (FDA). These services will facilitate the development and introduction of new vaccines and biologics against potential agents of bioterrorism and emerging and re-emerging infectious diseases. This contract also provides for manufacture of vaccines, vaccine components including adjuvants, vaccine delivery systems, other biologics, and challenge material.

传染病疫苗和其他生物制品的生产和表征服务（MCS）合同提供了涵盖产品开发规划和可行性评估的各种服务；产品优化;I/II期临床研究的产品开发和符合cGMP的生产；技术和设施审核；以及适合提交给美国食品和药物管理局（FDA）的监管支持。这些服务将促进开发和引进新的疫苗和生物制剂，以防止潜在的生物恐怖主义病原体以及新出现和重新出现的传染病。该合同还规定了疫苗、疫苗成分（包括佐剂）、疫苗递送系统、其他生物制剂和挑战材料的生产。