TASK V31: PROCESS DEVELOPMENT FOR PANFUNGAL VACCINES

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以及新出现和重新出现的传染病。

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.