Encapsulated Lipid Bilayer Based Assay for Assessing Botulinum Neurotoxin Potency

描述（由申请人提供）：含有A型肉毒杆菌神经毒素（BoNT/A）的治疗剂的效力差异未知或了解不多，可能导致患者给药过量或剂量不足。目前使用小鼠腹膜内注射测定来评估BoNT/A治疗剂的效力。然而，由于该测定依赖于动物的使用，并且由于不同小鼠物种和测试条件的灵敏度的可变性而具有固有的高错误率，因此需要新的标准化测定。Electronic BioSciences提出开发基于电生理平面脂质双层技术的BoNT/A效价测定。 该测定将利用读取器和相关的基于脂质双层的一次性盒来检查给定样品中毒素的功能性，并确定样品效力。所提出的系统将能够以低成本以高准确度评估BoNT/A治疗剂的效力。 公共卫生相关性：拟议的系统将用于评估含有A型肉毒杆菌神经毒素（BoNT/A）的治疗剂的效力。该系统被提出作为一个标准化的，低成本的，更高的精度替代目前正在使用的BoNT/A的研究人员和制造商的小鼠腹腔注射测定。

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.