【药典】生物药-Orbitrap 高分辨质谱在抗体偶联药物质量分析中的应用

前言 

完整分子量测定 ...............................................................................................02 

肽图解析 ..........................................................................................................05 

糖型分析 ..........................................................................................................10 

终产品中游离小分子毒素药物的定量 ...............................................................12 

抗体偶联药物的生物分析 .................................................................................13 

抗体类药物高级结构解析 - 氢氘交换质谱 ........................................................13 

宿主细胞残留蛋白的鉴定 .................................................................................15 

绪论 

Antibody–Drug Conjugates: Perspectives and Characterization ........................17 

Solving the Analytical Challenges of ADC Characterization ...............................38 

Tackling Analytical Method Development for ADCs ...........................................43 

抗体非靶向共价偶联药物分析 

Complete characterization of a lysine-linked antibody drug conjugate by native  LC/MS intact mass analysis and peptide mapping ...........................................51 

ADC 单抗药物的分子质量、氨基酸序列、糖基化位点以及 ADC 药物结合位点鉴 定 .....................................................................................................................64 

Versatile data processing software leverages Orbitrap data for intact and sub-unit  mass analysis of protein biotherapeutics ...........................................................71 

Monoclonal Antibody and Related Product Characterization Under Native  Conditions Using a Benchtop Mass Spectrometer ............................................74 

Quick screening of intact antibody and antibodydrug conjugates with integrated  microfluidic capillary electrophoresis and mass spectrometry ...........................81 

IdeS-cleaved mAb subunit analysis with LC-HRAM-MS: a quick and accurate  comparison of biosimilar and originator biotherapeutics ....................................90 

半胱氨酸巯基偶联（重链间靠非共价键结合）

Complete Characterization of a Cysteinelinked Antibody-Drug Conjugate  Performed on a Hybrid Quadrupole-Orbitrap Mass Spectrometer with High Mass  Range ..............................................................................................................99 

Exactive Plus EMR 高分辨质谱仪实现非变性状态 ADCs 药物的分析 .............102 

Enabling Mass Spectrometric Analysis of Intact Proteins in Native Conditions on A  Hybrid Quadrupole-Orbitrap Mass Spectrometer ............................................106

生物分析 

Quantitative Analysis of an Antibody Drug Conjugate using MSIA D.A.R.T.‘S  Technology, an Integral Part of the Universal Ligand Binding Mass Spectrometric  Immunoassay (LB-MSIA) Workflow ...............................................................109 

抗体药物高级结构解析 -- 氢氘交换质谱 Characterization of Conformation of Therapeutic Antibody Aggregation with  Optimized Hydrogen/Deuterium Exchange Mass Spectrometer ....................118

Characterization of the Conformation of Therapeutic Antibody Oxidation Variants  with Optimized Hydrogen/Deuterium Exchange Mass Spectrometry .............121 

Evaluation of different Hydrogen/Deuterium Exchange data processing software  by looking at conformational changes induced by mAb aggregation .............124 

糖型分析 

A Complete Workflow Solution for Monoclonal Antibody Glycoform  Characterization Combining a Novel Glycan Column Technology and Bench-Top  Orbitrap LC-MS/MS ......................................................................................128 

宿主细胞残留蛋白分析 

基于 nanoLC-MS/MS 建立对重组蛋白药物中宿主细胞残留蛋白分析方法 ....134

• 赛默飞OrbitrapAstral高分辨质谱仪

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