Manufacturer of Assayed Human Serum Controls

The contract requires the manufacture of liquid human serum-based, level 3 assayed controls containing over 50 analytes for use in clinical chemistry testing, with strict adherence to FDA compliance standards and certified assay accuracy to ensure reliable diagnostic performance. The controls must meet rigorous quality benchmarks to support clinical laboratories in maintaining precision and traceability across a broad spectrum of biochemical parameters. The solicitation is issued under the Department of Defense’s Medical Supply Chain MD Surg FSF as a subcontract, with a response deadline of August 3, 2026, and a place of performance designated as APO 09227-0000. The North American Industry Classification System code 325414 identifies the work as falling under pharmaceutical and medicinal chemical manufacturing, emphasizing the need for specialized expertise in biological product formulation. All deliverables must be fully compliant with regulatory requirements, and the manufacturer is expected to demonstrate proven capability in producing high-integrity analytical controls under controlled conditions.