Task V33: Manufacturing of Master Cell Bank Production and Formulation Development for Antibacterial resistance

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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 antibacterial resistant pathogens. This contract also provides for manufacture of vaccines, vaccine components including adjuvants, vaccine delivery systems, other biologics, and challenge material.