Task V03: Product Development Plans

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针对各种传染病的新疫苗和生物制剂。该合同还规定了候选疫苗、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。

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.