Development of an in vitro assay as correlate of passive immune protection against botulinum neurotoxin to minimize use of whole animal testing

This Small Business Innovation Research Phase I project will develop a non-animal based in-vitro assay for determining the efficacy of Botulinum (BoNT) neutralizing therapeutics; the dual nanopore assay (DNPA). New technologies are currently needed in order to facilitate the development and approval of BoNT vaccines and therapies, and align with the NIH and FDA"s guidance for reducing/replacing the number of vertebrate animals used in medical testing. Currently, the mouse lethality neutralization (MLN) assay is the standard test for determining the efficacy of BoNT neutralizing therapeutics. However, the inherent variability in sensitivity of the MLN assay due to different mouse species, test conditions, and the need to utilize live animal testing severely limit its accuracy and utility. EBS"s DNPA will be capable of monitoring the complete mechanism of all seven BoNT isoforms, making rapid analysis of BoNT neutralizing therapeutics, including complex mixtures, possible.