Drug-to-antibody determination for an antibody-drug-conjugate utilizing cathepsin B digestion coupled with reversed-phase high-pressure liquid chromatography analysis

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• 作者：Michael Adamo^a ; ^{michael.adamo@bms.com} ; Guoyong Sun^a ; Difei Qiu^b ; Joseph Valente^b ; Wenkui Lan^b ; Hangtian Song^a ; Mark Bolgar^b ; Amit Katiyar^a ; Girija Krishnamurthy^a
• 关键词：Cathepsin B ; DAR ; Drug to antibody ratio ; ADC ; Antibody drug conjugate
• 刊名：Journal of Chromatography A
• 出版年：2017
• 出版时间：20 January 2017
• 年：2017
• 卷：1481
• 期：Complete
• 页码：44-52
• 全文大小：2265 K
• 卷排序：1481

文摘

A cathepsin B enzymatic method for cleaving the drug from ADC molecules is proposed. The method employs a cleavage/reduction of the mAb prior to cathepsin B treatment. Superior cathepsin B cleavage is obtained compared to currently published literature. The method is useful for determining DAR in ADCs with a cathepsin B cleavable linker.