Hydrophobic interaction chromatography for the characterization of monoclonal antibodies and related products

被引：108

作者：

Fekete, Szabolcs ^{[1
]}

Veuthey, Jean-Luc ^{[1
]}

Beck, Alain ^{[2
]}

Guillarme, Davy ^{[1
]}

机构：

[1] Univ Geneva, Univ Lausanne, Sch Pharmaceut Sci, Blvd Yvoy 20, CH-1211 Geneva 4, Switzerland

[2] Ctr Immunol Pierre Fabre, 5 Ave Napoleon 3,BP 60497, F-74160 St Julien En Genevois, France

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2016年 / 130卷

基金：

瑞士国家科学基金会;

关键词：

Hydrophobic interaction chromatography; Antibody-drug-conjugate; Therapeutic antibody; Method development; Columns; PRACTICAL METHOD DEVELOPMENT; FAB-ARM EXCHANGE; LIQUID-CHROMATOGRAPHY; SOLVENT COMPONENTS; MASS-SPECTROMETRY; PHASE SYSTEM; SALTING-OUT; PROTEINS; PURIFICATION; SEPARATION;

D O I：

10.1016/j.jpba.2016.04.004

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

Hydrophobic interaction chromatography (HIC) is a historical strategy used for the analytical purification and characterization of proteins. Similarly to what can be done in reversed-phase liquid chromatography (RPLC), HIC is able to separate protein species based on their hydrophobicity, but using different conditions. Compared to RPLC, the main benefit of HIC is its ability to perform separations under non denaturing conditions (i.e. physiological pH conditions, ambient mobile phase temperature and no need for organic solvents) and so an orthogonal method. The goal of this review is to provide a general overview of theoretical and practical aspects of modern HIC applied for the characterization of therapeutic protein biopharmaceuticals including monoclonal antibodies (mAbs), antibody drug conjugates (ADCs) and bispecific antibodies (bsAbs). Therefore, method development approaches, state-of-the-art column technology, applications and future perspectives are described and critically discussed. (C) 2016 Elsevier B.V. All rights reserved.

引用

页码：3 / 18

页数：16

共 99 条

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