RRPV BoNT-NMJ

The Biomedical Advanced Research and Development Authority (BARDA) is seeking information on human-relevant neuromuscular junction (NMJ) micro-physiological systems for botulinum neurotoxin (BoNT) detection, potency measurement, and evaluation of medical countermeasure neutralizing activity. The goal is to transition from mouse-based bioassays to in vitro systems that can provide mechanistic insight while reducing reliance on animal testing. Respondents should provide information on their NMJ platform, including its type, development stage, and ability to generate dose-response data. They should also describe their experience with BoNT, regulatory considerations, and commercial/ manufacturing considerations. • NMJ platform type and components • Current development stage and maturity level • Ability to generate dose-response data • Ability to differentiate between botulinum neurotoxin serotypes • Cell sources and evidence of functional motor neuron-muscle fibers connectivity • Reproducibility, sensitivity, and stability of the system • Capabilities for system recovery and reestablishment of signaling outputs after injury