Task X4: Generation of a Shigella Vaccine Master Cell Bank

传染病疫苗和其他生物制品的制造和表征服务(MCS)合同提供各种产品开发服务，包括产品开发规划和可行性评估；I/II期临床研究的产品开发和符合cGMP标准的制造；毒理学研究；技术和设施审计；以及适用于提交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入新的疫苗和生物制品，以应对生物恐怖主义、抗药性病原体以及新出现和重新出现的传染病的潜在病原体。该合同还规定了挑战材料的制造。

The Manufacture and Characterization Services (MCS) for Vaccines and Other Biologics for Infectious Diseases contract provides a variety of 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.