SAM #SSN-BARDA-04202026

RFI: In Vitro Platforms for Botulinum Neurotoxin Potency and Countermeasure Evaluation

The Department of Health and Human Services (HHS), through the Office of the Assistant Secretary for Preparedness and Response (ASPR) and the Biomedical Advanced Research and Development Authority (BARDA), is seeking information on advanced in vitro platforms for botulinum neurotoxin (BoNT) testing. - Government Buyer: - Department of Health and Human Services (HHS) - Office of the Assistant Secretary for Preparedness and Response (ASPR) - Biomedical Advanced Research and Development Authority (BARDA) - Products/Services Requested: - Neuromuscular junction (NMJ)-based in vitro platforms for BoNT/A–G characterization - Systems must measure BoNT potency and evaluate efficacy of medical countermeasures - Platforms should reduce or replace mouse-based bioassays (e.g., Mouse Potency Assay, Mouse Neutralization Assay) - No specific part numbers or quantities provided (Request for Information only) - Unique/Notable Requirements: - Systems must provide mechanistic insight into BoNT activity - Ability to demonstrate recovery of neuronal signaling - Support for development of validated potency and neutralization assays - Focus on reducing animal testing in BoNT evaluation - No specific OEMs or vendors are mentioned in the notice - No product or service line items specified (information-gathering stage)

Description

Botulinum neurotoxins (BoNT/A–G) inhibit acetylcholine release at the neuromuscular junction through cleavage of SNARE proteins (e.g., SNAP-25, VAMP, syntaxin). Currently, BoNT characterization, including toxin potency and neutralization by medical countermeasures, is measured using mouse-based bioassays, primarily the Mouse Potency Assay (MPA) and Mouse Neutralization Assay (MNA), respectively.

There is increasing scientific, ethical, and regulatory interest in transitioning to human-relevant in vitro systems that can provide mechanistic insight while reducing reliance on animal testing. NMJ micro-physiological systems may provide a biologically relevant platform capable of measuring BoNT potency and evaluating countermeasure efficacy.

BARDA is interested in understanding whether NMJ-based in vitro platforms could support future development of validated assays capable of reducing and potentially replacing reliance on mouse bioassays for BoNT potency and neutralization measurements, with specific interest in systems that can show recovery of neuronal signaling and thereby be appropriate for medical countermeasures evaluation.

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