Human Hindbrain Organoid Functional Assay Services.

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...