RRPV BoNT-NMJ

Request for Information (RFI)

This RFI is issued by the Rapid Response Partnership Vehicle (RRPV) on behalf of the Biomedical Advanced Research and Development Authority (BARDA) to assess the current landscape of human-relevant neuromuscular junction (NMJ) micro-physiological systems (MPS). The goal is to understand their potential application for botulinum neurotoxin (BoNT) detection, potency measurement, and evaluation of medical countermeasures (MCMs). Advanced Technology International (ATI) is conducting this market research to identify organizations developing or operating NMJ platforms that could be adapted for use with BoNT serotypes A to G. This RFI is for information and planning purposes only and does not constitute a solicitation or commitment to procure services or products.

Currently, BoNT characterization and neutralization by MCMs rely on mouse-based bioassays. There is a growing interest in transitioning to human-relevant in vitro systems to reduce reliance on animal testing and provide mechanistic insight. NMJ micro-physiological systems are being explored as a potentially biologically relevant platform for measuring BoNT potency and evaluating MCM efficacy, with a focus on systems that can demonstrate recovery of neuronal signaling.

Respondents are invited to provide concise information on the following:

• Platform Description: Type of NMJ platform, components, development stage, maturity, throughput, scalability, ability to generate dose-response data, and system durability.

• Biological System: Cell sources, evidence of functional motor neuron-muscle fiber connectivity and NMJ formation, reproducibility, sensitivity, stability, and system recovery capabilities.

• Functional Readouts: Assays used, available readouts (e.g., muscle contraction, electrophysiology, calcium imaging), data recording frequency, and quantitative readout capability.

• BoNT Experience: Prior work with BoNT (A-G), including potency measurements or validation data, sensitivity, and assay dynamic range. Readiness to adapt platforms for BoNT testing if no prior experience exists.

• Regulatory Considerations: Validation/qualification strategy and experience with FDA engagement or regulatory qualification programs.

• Commercial/Manufacturing Considerations: Intellectual property limitations, commercial strategy, scalability, and platform material/manufacturing.

• Operational Considerations and Challenges: Potential challenges, access to Select Agent-accredited labs, potential partnerships, scalability/throughput for potency determination, and barriers to regulatory qualification.

• Current US Government Funding: Previous or existing US Government funding in this area and any identified funding gaps.

• Responses should be concise and no more than five (5) pages, excluding references.

• Proprietary information should be clearly marked; no classified information should be submitted.

• Responses must include organization name and contact information, a brief description of the company's area(s) of interest/capabilities/experience, and a description of the NMJ platform or technology.

• Submit responses electronically in PDF or Microsoft Word formats to rrpv@ati.org no later than 1pm ET on May 11, 2026.

• The subject line should be: "RFI Response: NMJ MPS Platforms for BoNT Potency Assay."

This RFI is for information and planning purposes only and does not constitute a solicitation or obligation. Responses will not be reimbursed and will be used solely for market research and planning purposes.