“NCI OA Special Notice of Subcontract Opportunity at the Frederick National Laboratory for Cancer Research”

The National Cancer Institute (NCI) is seeking a Contract Development and Manufacturing Organization (CDMO) to provide nanofiltration, fill and finish, and release testing services for a recombinant protein vaccine candidate. The vaccine candidate is intended for use in a US-based Phase 1 clinical trial. The CDMO must be US-based and provide services in accordance with current Good Manufacturing Practices (cGMP) and all applicable US Pharmacopeia (USP) standards. • The CDMO will be responsible for nanofiltration processing, fill and finish, and release testing of the vaccine candidate. • The vaccine candidate is generated from the 1c-SApNP platform (CHO Expression System). • The CDMO must be able to conduct activities in accordance with cGMP and USP standards. • The project involves conducting activities to support customized gap-filling for the vaccine candidate, including completion of reports and documentation, and evaluation of the vaccine candidate in a phase 1 clinical trial.