RRPV BoNT-NMJ

Closed Pre-Solicitation Posted

Solicitation number
SSN-BARDA-04202026
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Washington, District of Columbia, United States
Points of contact

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR), through the Biomedical Advanced Research and Development Authority (BARDA), is seeking information on neuromuscular junction (NMJ) micro-physiological systems capable of detecting and measuring botulinum neurotoxin (BoNT) potency across serotypes A through G, as well as evaluating the efficacy of medical countermeasures. This Request for Information (RFI) is issued through the Rapid Response Partnership Vehicle (RRPV) for market research and planning purposes to assess the current landscape of available NMJ platforms. Key requirements include systems utilizing human cells and tissue that can demonstrate recovery of neuronal signaling, with the ability to reduce or potentially replace reliance on traditional mouse-based bioassays (Mouse Potency Assay and Mouse Neutralization Assay). BARDA is specifically interested in supporting existing NMJ system development rather than new system creation, and respondents should only participate if they are actively developing or operating such platforms. Interested organizations must submit written responses not exceeding five pages (excluding references) to rrpv@ati.org by May 11, 2026, at 1:00 PM ET.

This is a pre-solicitation notice with no set-aside designation, and no incumbent contractors or specific award values are identified at this stage. The RFI responses will not be reimbursed, as this is an informational market research effort rather than a commitment to procure. Respondents must provide detailed information on platform description, biological system specifications, functional readouts, prior BoNT experience, regulatory considerations, commercial and manufacturing factors, and operational challenges. Organizations should include company description, contact information, and clearly mark any proprietary information in their submissions, which must be formatted as PDF or Microsoft Word documents. The specific timeline for subsequent solicitation and procurement activities has not been disclosed in this pre-solicitation notice.

Notice text

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.

Files

File Type Posted
RRPV_RFI_BoNT-NMJ RFI.pdf PDF

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