Task X5: Master Cell Bank for Chlamydia Trachoma Vaccine

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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. This contract provides for regulatory activities for vaccines and other biologics under the NIAID Preclinical Services for Manufacturing and Characterization Services Program and may include development of a Manufacturing Report; Chemistry, Manufacturing and Controls (CMC) Information; a Master File; Pre-IND document, and other required regulatory documents.