Task X18: Process Development and Early Reagent Manufacturing for Vaccines and Other Biologics

任务 X18：疫苗和其他生物制剂的工艺开发和早期试剂制造

• 批准号: 9922694
• 负责人: JAMES RICHARDSON
• 金额: $ 14.38万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-26 至 2020-04-25
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9922694
• 关键词: Adjuvant; Biological; Clinical Research; Communicable Diseases; Contracts; Cyclic GMP; Development; Development Plans; Influenza; Phase; Process; Reagent; Services; System; United States Food and Drug Administration; Vaccines; influenza virus vaccine; novel vaccines; product development; vaccine candidate; vaccine delivery

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 a wide array of infectious diseases. This contract also provides for manufacture of candidate vaccines, vaccine components including adjuvants, vaccine delivery systems, other biologics, and challenge material.

疫苗和其他传染病生物制剂的制造和表征服务 (MCS) 合同提供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。 这些服务将促进针对多种传染病的新疫苗和生物制剂的开发和引进。 该合同还规定生产候选疫苗、疫苗成分（包括佐剂）、疫苗输送系统、其他生物制品和挑战材料。