CNS Organoid Neuropharmacological Analysis

The Food and Drug Administration Office of Acquisition and Grant Services seeks CNS organoid neuropharmacological analysis services, with proposals due July 6, 2026. This is a sole-source procurement intended for award to 28Bio under FAR Part 12 commercial item authority.

Place of performance is the United States. The work requires functional examination of neuromodulatory effects of a marketed small molecule drug in human CNS 3D brain organoids using the contractor's specialized human iPSC-derived 3D cortical organoid model to maintain comparability with existing FDA research data. The procurement is NAICS 541380, Testing Laboratories and Services.

The statement of work specifies testing 10 treatment groups with 32 organoids per group (n=32/group), with Ca2 flux measured using FLIPR Tetra analysis at multiple timepoints, viability assessed via LDH assay, and transcriptomic analysis performed via RNA sequencing. Primary objectives include characterizing acute and chronic neuromodulatory effects including spontaneous Ca2+ bursting; characterizing the role of the 5-HT5A receptor using co-treatment with inhibitor SB-699551; and evaluating transcriptional changes from chronic drug exposure. The period of performance runs August 1, 2026 through April 30, 2027, with final study design due two weeks after award, acute and chronic neuromodulatory effects data due January 31, 2027, and transcriptomic data due March 31, 2027. The contract is firm-fixed-price, net 30 days after government acceptance, with prices held firm through September 30, 2026. Contractor personnel must execute a Contractor's Commitment to Protect Non-Public Information Agreement (FDA Form 3398) establishing binding confidentiality obligations under 21 U.S.C. § 331(j), 21 U.S.C. § 360(j), 18 U.S.C. § 1905, and applicable statutes. Evaluation weights non-price factors (technical capability/risk including national security considerations for genomic data processing and past performance within three years) as significantly more important than price.