Development of a rapid RP-UHPLC-MS method for analysis of modifications in therapeutic monoclonal antibodies
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- 作者：Bing Zhang ; zhangb25@gene.com" class="auth_mail" title="E-mail the corresponding author ; Justin Jeong ; Braydon Burgess ; Mansour Jazayri ; Yun Tang ; Yonghua Taylor Zhang ; yonghuaz@gene.com" class="auth_mail" title="E-mail the corresponding author
- 关键词：Monoclonal antibodies ; MAbs ; IdeS ; UHPLC ; Mass spectrometry ; High resolution ; Fc oxidation ; CQAs ; Peptide mapping ; Process characterization and process validation (PC/PV) studies
- 刊名：Journal of Chromatography B, Analytical Technologies in the Biomedical and Life Sciences
- 出版年：2016
- 出版时间：1 October 2016
- 年：2016
- 卷：1032
- 期：Complete
- 页码：172-181
- 全文大小：1782 K
文摘
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A 15 min RP-UHPLC method following IdeS digestion was developed for analyzing antibody modifications including oxidation.
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CpB treatment prior to IdeS digestion eliminated the interference of C-terminal lysine with oxidation.
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Antibody variants separated by RP-UHPLC were characterized by on-line MS.
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Oxidation levels measured by RP-UHPLC are in good agreement with those acquired by peptide mapping.
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RP-UHPLC provided high resolution and high throughput separation for antibody variants at subdomain level.