Botulinum Neurotoxin Serotype a Specific Cell-Based Potency Assay to Replace the Mouse Bioassay 英文参考文献.docVIP

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Botulinum Neurotoxin Serotype a Specific Cell-Based Potency Assay to Replace the Mouse Bioassay 英文参考文献.doc

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Botulinum Neurotoxin Serotype a Specific Cell-Based Potency Assay to Replace the Mouse Bioassay 英文参考文献

BotulinumNeurotoxinSerotypeaSpecificCell-Based PotencyAssaytoReplacetheMouseBioassay EsterFerna′ndez-Salas*,JoanneWang,YaniraMolina,JeremyB.Nelson,BirgitteP.S.Jacky,K.RogerAoki DepartmentofBiologicalSciences,AllerganInc.,Irvine,California,UnitedStatesofAmerica Abstract Botulinum neurotoxin serotype A (BoNT/A), a potent therapeutic used to treat various disorders, inhibits vesicular neurotransmitterexocytosisbycleavingSNAP25.Developmentofcell-basedpotencyassays(CBPAs)toassessthebiological function of BoNT/A have been challenging because of its potency. CBPAs can evaluate the key steps of BoNT action: receptor binding, internalization-translocation, and catalytic activity; and therefore could replace the current mouse bioassay.Primaryneuronspossessappropriatesensitivitytodeveloppotentialreplacementassaysbutthosepotencyassays aredifficulttoperformandvalidate.ThisreportdescribesaCBPAutilizingdifferentiatedhumanneuroblastomaSiMacells andasandwichELISAthatmeasuresBoNT/A-dependentintracellularincreaseofcleavedSNAP25.Assaysensitivityissimilar to the mouse bioassay and measures neurotoxin biological activity in bulk drug substance and BOTOXH product (onabotulinumtoxinA).ValidationofaversionofthisCBPAinaQualityControllaboratoryhasledtoFDA,HealthCanada, and European Union approval for potency testing of BOTOXH, BOTOXH Cosmetic, and VistabelH. Moreover, we also developedandoptimizedaBoNT/ACBPAscreeningassaythatcanbeusedforthediscoveryofnovelBoNT/Ainhibitorsto treathumandisease. Citation:Ferna′ndez-SalasE,WangJ,MolinaY,NelsonJB,JackyBPS,etal.(2012)BotulinumNeurotoxinSerotypeaSpecificCell-BasedPotencyAssaytoReplace theMouseBioassay.PLoSONE7(11):e49516.doi:10.1371/journal.pone.0049516 Editor:SaraSalinas,CNRS,France ReceivedMay14,2012;AcceptedOctober9,2012;PublishedNovember21,2012 Copyright:?2012Ferna′ndez-Salasetal.Thisisanopen-accessarticledistributedunderthetermsoftheCreativeCommonsAttributionLicense,whichpermits unrestricteduse,distribution,andreproductioninanymedium,provide