Pharmaceutical Development and Clinical Validation

This subcontract, titled Pharmaceutical Development and Clinical Validation, focuses on transitioning DC Recruiter technology from Technology Readiness Level 3 into a commercial medical product for prime contractors on Los Alamos National Laboratory projects. The scope of work includes formulating the spray, performing stability testing, and managing the entire FDA regulatory pathway, which encompasses pre-clinical animal studies and Phase I, II, and III human clinical trials. The project requires the use of bioreactors and clean-room facilities and must strictly adhere to Good Manufacturing Practice and Good Clinical Practice standards to deliver an FDA-approved pharmaceutical product. Managed by Triad under the Department of Energy, the performance will take place in Los Alamos, New Mexico, with a response deadline of December 16, 2026.