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 verifi…

Excerpt as published. The complete description, attachments, and any amendments are on the official notice.