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• W3046103816 abstract "The muscle-relaxing effects of the botulinum neurotoxin (BoNT) serotypes A and B are widely used in clinical and aesthetic medicine. The standard method for measuring the biological activity of pharmaceutical BoNT products is a mouse bioassay. In line with the European Directive 2010/63/EU, a replacement by an animal-free method would be desirable. Whereas the existing approved in vitro methods for BoNT activity measurements are product-specific and not freely available for all users, the binding and cleavage (BINACLE) assay could become a widely applicable alternative. This method quantifies active BoNT molecules based on their specific receptor-binding and proteolytic properties and can be applied to all BoNT products on the European market. Here we describe the results of a transferability study, in which identical BoNT samples were tested in the BINACLE assay in four laboratories. All participants successfully performed the method and observed clear dose-response relationships. Assay variability was within an acceptable range. These data indicate that the BoNT BINACLE assay is robust and can be straightforwardly transferred between laboratories. They thus provide an appropriate basis for future studies to further substantiate the suitability of the BINACLE assay for the potency determination of BoNT products." @default.
• W3046103816 created "2020-08-03" @default.
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• W3046103816 date "2020-09-01" @default.
• W3046103816 modified "2023-09-24" @default.
• W3046103816 title "Transferability study of the BINACLE (binding and cleavage) assay for in vitro determination of botulinum neurotoxin activity" @default.
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• W3046103816 doi "https://doi.org/10.1016/j.biologicals.2020.06.007" @default.
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