Encapsulated Lipid Bilayer Based Assay for Assessing Botulinum Neurotoxin Potency

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DESCRIPTION (provided by applicant): Unknown or poorly understood differences in the potency of therapeutics containing the botulinum neurotoxin Type A (BoNT/A) could result in over or under dosing of patients. The potency of BoNT/A therapeutics is currently assessed using a mouse intraperitoneal injection assay. However, due to the fact that this assay relies on the use of animals, and has an inherently high error rate due to the variability in the sensitivityof different mouse species and test conditions, a new standardized assay is needed. Electronic BioSciences proposes to develop a BoNT/A potency assay based on electrophysiological planar lipid bilayer techniques. This assay will utilize a reader and associated lipid bilayer based disposable cartridge for examining the functionality of the toxin in a given sample, and determining that samples potency. The proposed system will be able to assess the potency of a BoNT/A therapeutic with high accuracy at a low cost. PUBLIC HEALTH RELEVANCE: The proposed system will be used for assessing the potency of a therapeutic containing botulinum neurotoxin Type A (BoNT/A). The system is proposed as a standardized, low-cost, higher-accuracy alternative to the mouse intraperitoneal injection assay currently being used by BoNT/A researchers and manufactures.