Hydrophilic Interaction Chromatography Hyphenated with Mass Spectrometry: A Powerful Analytical Tool for the Comparison of Originator and Biosimilar Therapeutic Monoclonal Antibodies at the Middle-up Level of Analysis

被引:82
作者
D'Atri, Valentina [1 ]
Fekete, Szabolcs [1 ]
Beck, Alain [2 ]
Lauber, Matthew [3 ]
Guillarme, Davy [1 ]
机构
[1] Univ Geneva, Sch Pharmaceut Sci, Geneva, Switzerland
[2] Ctr Immunol Pierre Fabre, 5 Ave Napoleon 3,BP 60497, St Julien En Genevois, France
[3] Waters Corp, 34 Maple St, Milford, MA 01757 USA
基金
瑞士国家科学基金会;
关键词
2-DIMENSIONAL LIQUID-CHROMATOGRAPHY; CRITICAL QUALITY ATTRIBUTES; STRUCTURAL-CHARACTERIZATION; EFFECTOR FUNCTIONS; SERUM CLEARANCE; N-GLYCANS; CETUXIMAB; FUTURE; IGG1; COMBINATION;
D O I
10.1021/acs.analchem.6b04726
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
The development and approval processes of biosimilar mAbs depend on their comparability to originators. Therefore, analytical comparisons are required to assess structural features and post translational modifications (PTM) and thereby minimize the risk of being clinically meaningful differences between biosimilar and originator drug products. The glycosylation pattern of mAbs is considered to be an important critical quality attribute (CQA), and several analytical approaches have been proposed that facilitate characterizing and monitoring a glycosylation profile, albeit mainly at a glycan and glycopeptide level of analysis. In this study, we demonstrate the utility of hydrophilic interaction chromatography (HILIC) hyphenated with mass spectrometry (MS) for the qualitative profiling of glycosylation patterns at the protein level, by comparing originator and biosimilars mAbs (Remicade/Remsina/Inflectra, Herceptin/Trastuzumab B, and Erbitux/Cetuximab B) using a middle-up approach. We demonstrate the ability of HILIC to resolve hydrophilic variants of protein biopharmaceuticals at the middle-up level of analysis, its complementarity to reversed phase liquid chromatography, and its hyphenation to MS. HILIC features combined to MS make a powerful analytical tool for the comparison of originator and biosimilar mAbs that could eventually be applied in routine analyses for quality control.
引用
收藏
页码:2086 / 2092
页数:7
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