Conjugation site analysis of antibody-drug-conjugates (ADCs) by signature ion fingerprinting and normalized area quantitation approach using nano-liquid chromatography coupled to high resolution mass spectrometry

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• 作者：Hua Sang^a ; ^b ; ¹ ; Gaoyuan Lu^a ; ^b ; ¹ ; Yazhong Liu^a ; ^b ; Qiyue Hu^c ; Weifeng Xing^c ; Dongbing Cui^c ; Fang Zhou^a ; ^b ; Jingwei Zhang^a ; ^b ; Haiping Hao^a ; ^b ; Guangji Wang^a ; ^b ; ^{Guangjiwang@hotmail.com} ; Hui Ye^a ; ^b ; ^{cpuyehui@cpu.edu.cn}
• 关键词：ADC ; Conjugation site analysis ; T-DM1 ; Lysine conjugation ; Signature ion fingerprinting ; Normalized area quantitation
• 刊名：Analytica Chimica Acta
• 出版年：2017
• 出版时间：22 February 2017
• 年：2017
• 卷：955
• 期：Complete
• 页码：67-78
• 全文大小：1942 K
• 卷排序：955

文摘

An integrative approach was developed for conjugation distribution analysis of ADCs. The Signature Ion Fingerprinting method allows determining DM1-conjugation sites. The conjugation levels were obtained via the Normalized Area Quantitation method. The conjugation levels are correlated with the residues' microenvironment. The DM1-conjugation specificity of TDM1 is conserved across batches.