Task V06: Process development and manufacture of cGMP compliant parvovirus B19 vaccine drug product for use in Phase I/II clinical trials

Advanced Bioscience Laboratories, Inc., Kensington MD

Investigators

Abstract

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.