SAM #RFQ_CDR-2026-135968

FDA Solicits Human Hindbrain Organoid Functional Assay Services from OrganoTherapeutics SARL

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Division of Applied Regulatory Science (DARS), is seeking specialized Human Hindbrain Organoid Functional Assay Services from OrganoTherapeutics SARL. - Government Buyer: - U.S. Food and Drug Administration (FDA), CDER, DARS - Key contacts: Jun Zhao, Iris Johnson (Contracting Officer) - OEM Highlight: - OrganoTherapeutics SARL is the sole-source provider for both organoids and assay services - Products Requested: - Human iPSC-derived hindbrain organoids - First delivery: 96 organoids in 96-well plate format with culture materials - Subsequent deliveries: 48 organoids each (11 additional deliveries) - Total: 12 scheduled deliveries - Part number: 0001 (for full delivery lot) - Services Requested: - Functional characterization of organoids using 3D multi-electrode array (MEA) technology - Testing FDA-identified drug and reversal-agent combinations (e.g., fentanyl + naloxone, alprazolam + flumazenil) - Batch-to-batch reproducibility evaluation - Collection and return of exposed drug solutions for FDA verification - Data analysis, delivery of raw/analyzed data, analysis files, and study reports - Work performed in a laboratory licensed for controlled substances - Part number: 0002 (for full assay service lot) - Unique Requirements: - OrganoTherapeutics SARL is identified as the only source capable of providing both the organoids and the functional assay services - Organoids must express specific hindbrain markers and be suitable for in vitro research on drug-induced effects on respiratory neural circuits - All functional characterization and testing performed at the contractor's facility - Strict batch reproducibility and sample return protocols - Estimated Contract Value: - $252,742.50 (sole-source justification) - Period of Performance: - Eighteen (18) months from award, covering all deliveries and services

Description

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Division of Applied Regulatory Science (DARS), intends to award a sole-source, Firm-Fixed-Price purchase order to OrganoTherapeutics SARL for Human iPSC-Derived Hindbrain Organoid Functional Assay Services.

The requirement includes the provision of human induced pluripotent stem cell (iPSC)-derived hindbrain organoids and associated materials necessary to support in vitro research evaluating drug-induced effects on respiratory-relevant neural circuits. The contractor will also perform functional characterization of the organoids using three-dimensional multi-electrode array (3D MEA) technology to assess electrophysiological responses to drugs known to affect respiratory function.

The functional characterization includes testing FDA-identified drug and reversal-agent combinations, MEA measurements, evaluation of batch-to-batch reproducibility, collection of exposed drug solutions for FDA verification, data analysis, and delivery of raw data, analyzed data, analysis files, and study reports.

The requirement also includes twelve scheduled deliveries of human hindbrain organoids to the FDA White Oak Campus. The first delivery will consist of 96 organoids, with subsequent deliveries consisting of 48 organoids each. Functional characterization will be performed at the contractor's laboratory.

The anticipated period of performance is eighteen (18) months from the date of award.

This acquisition is being conducted as a commercial service acquisition under RFO FAR Part 12. The Government's decision to restrict competition is documented pursuant to RFO FAR 12.102(a). Market research identified OrganoTherapeutics SARL as the only source capable of satisfying the Government's complete requirement for both the required human hindbrain organoids and associated functional assay services.

This notice is not intended to restrict consideration of any responsible source capable of meeting the Government's complete requirement. All responsible sources may submit a quotation and supporting capability information by the response date identified in this notice. Any timely response demonstrating the capability to satisfy the Government's complete requirement will be considered by the Contracting Officer prior to award.

NAICS: 541714 PSC: B504 – Special Studies/Analysis – Chemical/Biological Place of Delivery: FDA White Oak Campus, Silver Spring, Maryland Place of Service Performance: Contractor's laboratory

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