Clinical Trial Materials for Virus Vaccines

This contract seeks to engage a Contract Manufacturing Organization (CMO) with fully developed current Good Manufacturing Practice (cGMP) compliance systems to support the rapid development of vaccines. The primary focus is on manufacturing Clinical Trial Materials (CTM) for trials involving live-attenuated or inactivated virus vaccines, as well as producing ancillary biologics necessary for advancing clinical trials, such as virus challenge stocks, diluents, cell lines, and test materials. The CMO must demonstrate the capability to produce live virus drug substances both in cultured mammalian cells and in specific-pathogen-free eggs, ensuring all manufacturing activities strictly adhere to cGMP standards. The procurement, issued by the National Institutes of Health (NIH) under the Department of Health and Human Services, is classified under NAICS code 541714 and the solicitation number RFP75N93020R00008. Evaluation of proposals will be based on the technical approach, qualifications of principal technical staff, and the adequacy of facilities in meeting the statement of work requirements. The contract aims to quickly support vaccine clinical trials by securing reliable and compliant manufacturing resources, with coordination managed through the NIH’s Office of Acquisitions in Bethesda, Maryland. Point of contact information is provided for potential offerors to facilitate communication.