Development of 3D Human Blood Brain Barrier Formation Assay

The Food and Drug Administration intends to award a sole source firm fixed price purchase order to MIMETAS B.V. for the development of a 3D human blood-brain barrier formation and integrity model to assess developmental neurotoxicity of foods and dietary supplements. This action is justified under FAR Part 6.302-1(a)(2)(ii) due to the determination that MIMETAS B.V. is the only responsible source capable of meeting the agency’s specific requirements, as no other entity can provide the required technology or method. The scope involves optimizing human-derived brain microvascular endothelial cells, neurons, and astrocytes within a multi-chip microfluidic platform containing at least 40 chips per plate, establishing barrier integrity metrics including transendothelial electrical resistance, FITC-dextran permeability, and cell viability, and evaluating developmental neurotoxicity through quantitative immunofluorescence of nuclear, neuronal, and astrocyte markers. Four performance compounds and at least two in-plate control chemicals at three concentrations will be tested, with raw experimental data including all protocol deviations required in electronic format within 60 days of completion. All work must be performed at the contractor’s facilities, and deliverables will be submitted to the designated technical point of contact. The solicitation, identified as FDA_5212026 under NAICS code 54171, was posted on May 21, 2026, and responses in the form of capability statements must be received by June 12, 2026, at 3:00 PM EST via email to Hilda Aryeh. The Government retains full discretion to compete the requirement based on any responses received, though an award to MIMETAS B.V. is anticipated within ten days of the notice unless a viable alternative is identified.