Task X11: Product Development Plans and Feasibility Assessments

任务 X11：产品开发计划和可行性评估

• 批准号: 9469395
• 负责人: JAMES RICHARDSON
• 金额: $ 43.19万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-11-06 至 2020-05-01
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9469395
• 关键词: APBA1 gene; Antimicrobial Resistance; Bioterrorism; Clinical Research; Communicable Diseases; Contracts; Cyclic GMP; Development; Development Plans; Drug resistance; Emerging Communicable Diseases; Lassa fever virus; Phase; Services; Staphylococcus aureus; Toxicology; United States Food and Drug Administration; Vaccines; Zika Virus; novel vaccines; pathogen; 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, drug-resistant pathogens, 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剂的生产和表征服务（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;产品开发和cGMP合规生产，用于I/II期临床研究;毒理学研究;技术和设施审计;以及适用于提交给美国食品药品监督管理局（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，以对付潜在的生物恐怖主义制剂、抗药性病原体以及新出现和重新出现的传染病。 该合同还规定生产挑战材料。