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Development of 3D Human Blood Brain Barrier Formation Assay

ID: FDA_5212026 • Type: Special Notice • Match:  100%
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Description

The Food and Drug Administration (FDA) intends to award a Sole Source Firm Fixed Price Purchase order to MIMETAS B.V. 704 Quince Orchard RD, Suite 260 Gaithersburg, Maryland 20878-1752.

In accordance with FAR Part 6.302-1 (a) (2)(ii) which states Only one responsible source and no other supplies or services will satisfy agency requirement .

The purpose of this notice is to inform the public that the Food and Drug Administration (FDA) anticipates issuing a Firm Fixed Price Purchase Order.

MINIMUMREQUIREMENTS :

See Attached Statement of Work

This notice is not a request for competitive proposals. However, any party that believes it can meet this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement.

Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to MIMETAS B.V. within approximately ten (10) days after the date of this notice unless the Government determines that any other organization has the capability to meet this requirement.

Response Date: June 12, 2026, by 3.00PM EST. Please email responses to Hilda Aryeh hilda.aryeh@fda.hhs.gov.

Hilda Aryeh

Contract Specialist

Background
The Food and Drug Administration (FDA) intends to award a Sole Source Firm Fixed Price Purchase order to MIMETAS B.V. The mission of the Division of Toxicology (DT) in the Office of Chemistry and Toxicology (OCT), Office of Laboratory Operations and Applied Science (OLOAS) of the Human Foods Program (HFP) is to develop, evaluate, and integrate modern predictive toxicological new approach methods (NAMs) to support regulatory and public health decision making.

This acquisition aims to develop an in vitro blood-brain barrier formation and integrity model for evaluating potential developmental neurotoxicity hazards of foods and dietary supplements.

Work Details
The contractor shall develop an in vitro blood-brain barrier formation and integrity new approach method for evaluating potential developmental neurotoxicity hazards. The work includes:

1. Obtaining three applicable human-derived cell types: brain microvascular endothelial cells, neurons, and astrocytes, in consultation with the technical point of contact.
2. Optimizing these cell types for a multi-chip microfluidic plate format with a minimum of 40 microfluidic chips per plate.
3. Evaluating barrier formation and integrity through phase contrast images, transendothelial electrical resistance (TEER), fluorescein isothiocyanate-labeled (FITC) dextran permeability, and cell viability assessments.
4. Conducting quantitative immunofluorescence analysis of nuclear, neuronal, and astrocyte markers along with cell viability to assess developmental neurotoxicity.

Place of Performance
The contract will be performed at MIMETAS B.V., located at 704 Quince Orchard RD, Suite 260 Gaithersburg, Maryland 20878-1752.
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Overview

Agency
Food and Drug Administration (FDA) [HHS]
Response Deadline
June 12, 2026, 3:00 p.m. EDT Due in 19 Days
Posted
May 21, 2026, 11:44 a.m. EDT
Set Aside
None
NAICS
54171 - Research and Development in the Physical, Engineering, and Life Sciences
PSC
AJ12 - General Science And Technology R&D Services; General Science And Technology; Applied Research
Place of Performance
Silver Spring, MD United States
Source
Open
Pricing
Fixed Price
Est. Level of Competition
Sole Source
On 5/21/26 Food and Drug Administration issued Special Notice FDA_5212026 for Development of 3D Human Blood Brain Barrier Formation Assay due 6/12/26.
Primary Contact
Name
HILDA ARYEH   Profile
Email
hilda.aryeh@fda.hhs.gov
Phone
None

Documents

Posted documents for Special Notice FDA_5212026

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Additional Details

Source Agency Hierarchy
HEALTH AND HUMAN SERVICES, DEPARTMENT OF > FOOD AND DRUG ADMINISTRATION > FDA OFFICE OF ACQ GRANT SVCS
FPDS Organization Code
7524-00223
Source Organization Code
100188033
Last Updated
May 21, 2026
Last Updated By
hilda.aryeh@fda.hhs.gov
Archive Date
June 27, 2026