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

传染病疫苗和其他生物制品的制造和表征服务(MCS)合同提供各种服务，包括产品开发规划和可行性评估；产品优化；I/II期临床研究的产品开发和符合cGMP的生产；技术和设施审计；以及适用于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各种传染病的新疫苗和生物制品的开发和引入。该合同还规定了候选疫苗、包括佐剂在内的疫苗组件、疫苗输送系统、其他生物制品和挑战材料的制造。

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.