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1、大分子药物仪器分析方法开发及应用2019年8月目录背景介绍分析方法原理及应用分析方法验证举例背景介绍背景介绍MonoclonalAntibodyBispecificAntibodyAntibodyDrugConjugates抗体类药物质量标准制定张峰,孟淑芳,2013,《治疗性单克隆抗体类制品质量控制标准的思考》抗体类药物质量标准制定张峰,孟淑芳,2013,《治疗性单克隆抗体类制品质量控制标准的思考》抗体类药物质量标准制定《中国药典》2015年版《人用重组单克隆抗体制品总论》抗体类药物特性鉴定研究ProductsAttributeTest/AssayMWo
2、fIntactProtein/HeavyChain/LightChain/deglycosylatedProtein/deglycosylatedHeavyChain,N/C-TerminalSequencing,PrimaryStructureSequenceCoverage,AminoAcidContent,DisulfideBond,Extinctioncoefficient,Isoelectricetc.mAbPuritySizeHeterogeneity,ChargeHeterogeneityetc.PTMsDeamidation,Oxidation,
3、N-Glycosylationetc.HigherOrderStructureSecondaryStructure,TertiaryStructure,ThermoStabilityetc.Antigen-BindingActivity,Fc-ReceptorBindingActivity,PotencyCytotoxicity,CellGrowthInhibitionActivityetc.PrimaryStructureConjugationSiteADCSpecificPurityDrugDistribution,DAR,UnconjugatedmAbPo
4、tencyCytotoxicity目录背景介绍分析方法原理及应用--高效液相色谱法--毛细管电泳法--液质联用法分析方法验证举例分析方法原理及应用MethodAttributeSEC-HPLCSizeHeterogeneityIEC-HPLCChargeHeterogeneityRP-HPLCIdentity,Drug-LoadDistributionHILIC-HPLCGlycanProfile,Drug-LoadDistributionHIC-HPLCChargeHeterogeneity,DARCE-SDSSizeHeterogeneity,Drug
5、-LoadDistributioncIEF/iCIEFIdentity,pIvalue,ChargeHeterogeneity,DARLC-MSPrimaryStructureIdentification,PTMIdentification高效液相色谱法分子排阻色谱法(SEC)离子交换色谱法(IEC)反相色谱法(RPC)疏水色谱法(HIC)亲和色谱法(AC)分子排阻色谱法分子排阻色谱法分子排阻色谱法分子排阻色谱法分子排阻色谱法分子排阻色谱法分子排阻色谱法离子交换色谱法SurfacechargedistributionsfortheElongationfactor
6、Tuproteins(upper-left)andN.equitans(upper-right)andtheCelldivisioncyclefamilyprotein(lower-left)andN.equitans(lower-right).Basicregionisindicatedbybluecolor,acidicregionisindicatedbyredcolorandneutralregionisindicatedbywhitecolor.离子交换色谱法离子交换色谱法离子交换色谱法离子交换色谱法离子交换色谱法离子交换色谱法离子交换色谱法反相色谱法
7、TimRice,Agilent反相色谱法ApplicationNote720002060en,Waters反相色谱法反相色谱法反相色谱法毛细管电泳法毛细管电泳法HighPerformanceCapillaryElectrophoresis,Agilent毛细管电泳法CapillaryElectrophoresisofProteins,BeckmanCoulter毛细管电泳法CapillaryElectrophoresisofProteins,BeckmanCoulter毛细管电泳法CapillaryElectrophoresisofProteins,Beckma
8、nCoulter毛细管电