The versatility of heart-cutting and comprehensive two-dimensional liquid chromatography in monoclonal antibody clone selection

被引：61

作者：

Sandra, Koen ^{[1
,2
]}

Steenbeke, Mieke ^{[1
]}

Vandenheede, Isabel ^{[1
]}

Vanhoenacker, Gerd ^{[1
]}

Sandra, Pat ^{[1
,2
]}

机构：

[1] RIC, President Kennedypk 26, B-8500 Kortrijk, Belgium

[2] AnaRIC Biol, Noorwegenstr 4, B-9940 Ghent, Belgium

来源：

JOURNAL OF CHROMATOGRAPHY A | 2017年 / 1523卷

关键词：

Monoclonal antibody; Biosimilar; Clone selection; Protein A; Two-dimensional liquid chromatography; THERAPEUTIC ANTIBODIES; MASS-SPECTROMETRY; RESOLUTION; IDENTIFICATION; STABILITY; VARIANTS; ASSAY;

D O I：

10.1016/j.chroma.2017.06.052

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

In recent years, two-dimensional liquid chromatography (2D-LC) has seen an enormous evolution and one of the fields where it is being widely adopted is in the analysis of therapeutic monoclonal antibodies (mAbs). We here further add to the many flavours of this powerful technology. Workflows based on heart cutting (LC-LC) and comprehensive (LC x LC) 2D-LC are described that allow to guide the clone selection process in mAb and biosimilar development. Combining Protein A affinity chromatography in the first dimension with size exclusion (SEC), cation exchange (CEX) or reversed-phase liquid chromatography mass spectrometry (RPLC-MS) in the second dimension simultaneously allows to assess mAb titer and critical structural aspects such as aggregation, fragmentation, charge heterogeneity, molecular weight (MW), amino acid sequence and glycosylation. Complementing the LC-LC measurements at intact protein level with LC x LC based peptide mapping provides the necessary information to make clear decisions on which clones to take further into development. (C) 2017 Elsevier B.V. All rights reserved.

引用

页码：283 / 292

页数：10

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