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Functional Characterization and Assay Laboratory Services

Active
Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

General Info

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant SvcsView Agency

NAICS

541380 - Testing Laboratories and ServicesView NAICS

Place of Performance

MD

Set-Aside

NONE

Documents

This scope was carved out of RFQ_CDR-2026-135968.

The full solicitation package (3 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Human Hindbrain Organoid Functional Assay Services.

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → FDA Office Of Acq Grant Svcs
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Office AddressN/A
ContactsNo contact information available

Full Description

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Performs functional characterization of human hindbrain organoids for prime contractors on FDA CDER projects. Conducts 3D Microelectrode Array (MEA) testing and drug-response studies to evaluate compound responses. Utilizes 3D MEA systems within a DEA-licensed controlled-substance laboratory. Delivers data analysis reports, study reports, and returned samples.

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NAICS: 541714
New
Federal
Human Hindbrain Organoid Functional Assay Services.
Solicitation # RFQ_CDR-2026-135968
The U.S. Food and Drug Administration's Center for Drug Evaluation and Research intends to award a sole-source, firm-fixed-price purchase order to OrganoTherapeutics SARL for human induced pluripotent stem cell (iPSC)-derived hindbrain organoid functional assay services. The project aims to support in vitro research evaluating drug-induced effects on respiratory-relevant neural circuits over an eighteen-month period of performance. The scope of work is divided into two primary components: the provision of human hindbrain organoids and associated culture materials through twelve scheduled deliveries to the FDA White Oak Campus, and the performance of functional characterization services at the contractor's laboratory. Functional characterization will utilize three-dimensional multi-electrode array (3D MEA) technology to assess electrophysiological responses to FDA-identified drug and reversal-agent combinations. Deliverables include the delivery of 96 organoids in the first shipment followed by 48 organoids in subsequent deliveries, as well as raw data, analyzed data, analysis files, and comprehensive study reports. This acquisition is conducted as a commercial service under FAR Part 12, with the government restricting competition based on market research identifying OrganoTherapeutics SARL as the only source capable of meeting the complete requirement for both the specific organoid products and the associated functional assay services.
Research and Development in Biotechnology (except Nanobiotechnology)

POSTED

about 7 hours ago

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in 6 days
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