Development of 3D Human Blood Brain Barrier Formation Assay
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Food and Drug Administration (FDA) 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 Assay. This notice serves to inform the public of the FDA's intent, with a response deadline for capability statements by June 12, 2026, at 3:00 PM EST.
Purpose
The objective is to develop an in vitro blood-brain barrier (BBB) formation and integrity new approach method (NAM). This NAM will be used for the evaluation of potential developmental neurotoxicity (DNT) hazards associated with foods and dietary supplements, ultimately enabling better prediction of chemical-induced developmental neurotoxicity.
Scope of Work
The contractor will be responsible for optimizing human-derived brain microvascular endothelial cells, neurons, and astrocytes for a multi-chip microfluidic plate format assay, requiring a minimum of 40 chips per plate. This includes selecting appropriate in-plate assay control chemicals for various assay endpoints and evaluating four performance compounds with expected activity.
Tasks & Deliverables
Key tasks involve obtaining three applicable human-derived cell types and optimizing them for the microfluidic plate format. The assay will evaluate barrier formation and integrity using phase contrast images, transendothelial electrical resistance (TEER), FITC-dextran permeability, and cell viability. Developmental neurotoxicity (DNT) will be assessed via quantitative immunofluorescence of neuronal and astrocyte markers, and cell viability. The contractor must evaluate at least two in-plate assay control chemicals at three concentrations and four performance compounds at eight concentrations. A primary deliverable is raw experimental data (electronic file, .csv or .RData preferred) for all chemicals and controls, to be provided within 60 days after experiment completion, along with all experimental protocols and deviations.
Contract & Timeline
- Type: Firm Fixed Price Purchase Order (Sole Source Intent)
- Intended Awardee: MIMETAS B.V.
- Set-Aside: None (Sole Source)
- Product/Service Code: AJ12 - General Science And Technology R&D Services; Applied Research
- Response Due: June 12, 2026, 3:00 PM EST
- Published: May 21, 2026
- Place of Performance: Contractor's facilities
Additional Notes
This is a special notice indicating the FDA's intent to award a sole source contract to MIMETAS B.V. in accordance with FAR Part 6.302-1 (a)(2)(ii), citing "Only one responsible source and no other supplies or services will satisfy agency requirement." While not a request for competitive proposals, any party believing they can meet the requirement may submit a written capability statement demonstrating their ability. Submissions will be reviewed, but the government retains sole discretion to compete the proposed contract. An award to MIMETAS B.V. is anticipated within approximately ten days after the response date unless other capable organizations are identified. Responses should be emailed to Hilda Aryeh at hilda.aryeh@fda.hhs.gov.