Task V30: GMP Manufacturing of WNV Vaccine

任务 V30：西尼罗河病毒疫苗的 GMP 生产

• 批准号: 10794913
• 负责人: WANG HONG
• 金额: $ 143.08万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-15 至 2028-05-14
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10794913
• 关键词: Biological Products; Bioterrorism; Clinical Research; Communicable Diseases; Contracts; Cyclic GMP; Development; Development Plans; Emerging Communicable Diseases; Phase; Services; Toxicology; United States Food and Drug Administration; Vaccines; West Nile virus; manufacture; novel vaccines; product development; vaccine development

The Manufacture and Characterization Services (MCS) for Vaccines and Other Biologics for Infectious Diseases contract provides a variety of product development services spanning product development planning and feasibility assessments; product development and cGMP compliant manufacture for Phase I/II clinical studies; toxicology 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 challenge material.

传染病疫苗和其他生物制品的制造和表征服务(MCS)合同提供各种产品开发服务，包括产品开发规划和可行性评估；I/II期临床研究的产品开发和符合cGMP标准的制造；毒理学研究；技术和设施审计；以及适用于提交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入新的疫苗和生物制品，以应对生物恐怖主义和新出现和重新出现的传染病的潜在病原体。该合同还规定了挑战材料的制造。