Due to the growing number of therapeutic uses for botulinum neurotoxin (BoNT) within the medical and cosmetic industries, new characterization techniques are currently needed to assess toxin activity (e.g. potency) for accurate dose administration. BoNT potency is currently assessed using a mouse intraperitoneal injection assay, also known as the mLD50 assay, which is based on the rate at which a population of mice is euthanized upon exposure to BoNT. Not only does this assay require the use of vertebrate animals, conflicting with current FDA and NIH guidelines, it is also lengthy and has high variability. The mLD50 assay takes 3 to 4 days and yields high error rates due to variations in mouse sensitivity and test conditions. Electronic BioSciences, Inc. (EBS), which specializes in combining biological systems with high performance electronics for sensing applications, proposes to develop an in-vitro alternative to the mLD50 assay. This proposed low cost assay will be highly sensitive and capable of quickly characterizing the complete BoNT mechanism, thus providing insight into the toxin mode of activity not currently possible.
The proposed system is being developed as a commercial alternative to the mouse intraperitoneal injection assay to enable complete potency characterization of botulinum neurotoxin Type A (BoNT/A) therapeutics during production. BoNT/A is used in numerous medical treatments today, with its use expanding each year, and the accurate characterization of its potency is critical to patient safety. The benefits of the proposed system include reducing assay costs and testing times, improving the accuracy of the assay, and aligning with NIH and FDA guidelines for reducing the use of vertebrate animals for assays of biological activity.
