FMDV Antibody ELISA Kit Manufacturing (DIVA-Compatible)

The contract entails the manufacturing of DIVA-compatible ELISA kits designed to detect antibodies against FMDV 3ABC, requiring production within a facility licensed by the Center for Veterinary Biologics and full compliance with USDA regulations outlined in 9 CFR Parts 101–123. The resulting kits are intended for stockpiling by the National Animal Vaccine and Biologics Center to support national animal health preparedness. All manufacturing processes must adhere to strict quality control standards to ensure reliability, consistency, and regulatory acceptance for federal use. The work is to be performed at a designated location in Ames, Iowa, with a zip code of 50010, and the production facility must maintain continuous compliance with federal biologics manufacturing requirements. This is a subcontract opportunity with a North American Industry Classification System code of 325414, indicating biologic product manufacturing. The solicitation was posted on May 14, 2026, with a strict deadline for responses set for May 15, 2026, at 7:00 PM Eastern Time. The contracting agency is the U.S. Department of Agriculture, operating under the office designation Mrpbs Minneapolis Mn. While no set-aside preferences or point of contact details are provided, the urgency of the response window and the regulatory specificity of the deliverables underscore the critical nature of the project for national veterinary biodefense. All submitted proposals must demonstrate technical capability, proven experience in diagnostic kit production, and complete facility licensure under USDA standards to be considered.