Inactive

The purpose of this acquisition is to establish an appropriate current Good Manufacturing Practice (cGMP) Contract Manufacturing Organization (CMO) to support rapid vaccine development by manufacturin... The purpose of this acquisition is to establish an appropriate current Good Manufacturing Practice (cGMP) Contract Manufacturing Organization (CMO) to support rapid vaccine development by manufacturing vaccine Clinical Trial Materials (CTM) for trials of live-attenuated virus or inactivated virus vaccine candidates. Vaccine ancillaries or other biologics required to advance to clinical trials, such as virus challenge stocks, diluents, cell lines for use in the production of the vaccines, test materials, etc., are also within scope. Mandatory Qualification Criteria include: CMO with fully developed cGMP compliance systems. All CTM manufacturing activities are required to comply with cGMP. Required offeror capabilities: Capability for producing live virus drug substance in cultured mammalian cells. Capability for producing live virus drug substance in specific-pathogen-free (SPF) eggs. Evaluation Criteria shall include suitability of technical approach, principal technical staff, and facilities for capability and capacity to meet the SOW requirements.