Intact protein analysis in the biopharmaceutical field

被引：154

作者：

Staub, Aline ^{[1
,2
]}

Guillarme, Davy ^{[1
,2
]}

Schappler, Julie ^{[1
,2
]}

Veuthey, Jean-Luc ^{[1
,2
]}

Rudaz, Serge ^{[1
,2
]}

机构：

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

[2] Univ Geneva, CMU, SCAHT, CH-1211 Geneva 4, Switzerland

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2011年 / 55卷 / 04期

关键词：

Intact protein; Biopharmaceutical analysis; Analytical methods; Liquid chromatography; Capillary electrophoresis; PERFORMANCE LIQUID-CHROMATOGRAPHY; CAPILLARY GEL-ELECTROPHORESIS; BILAYER-COATED CAPILLARIES; HUMAN GROWTH-HORMONE; FLIGHT MASS-SPECTROMETRY; GLYCEROL-WATER MEDIA; TOP-DOWN; ZONE-ELECTROPHORESIS; PROTEOMIC ANALYSIS; ESI-MS;

D O I：

10.1016/j.jpba.2011.01.031

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

In recent years, a growing number of biopharmaceutical proteins have been produced and are already available, or will be soon available, in the market. These molecules are more complex to analyze than conventional low molecular weight drugs, and thus need powerful analytical approaches for the entire development and delivery process. This review summarizes the analytical techniques available for intact protein determination and the main development steps in which they are applicable. A strong emphasis has been put on separation techniques, liquid chromatography and electrophoretic techniques, but mass spectrometry and spectroscopic approaches are also mentioned. Overall, we highlight how several analytical strategies are necessary to obtain global information. (C) 2011 Elsevier B.V. All rights reserved.

引用

页码：810 / 822

页数：13

共 136 条

[1] Practical comparison of 2.7 μm fused-core silica particles and porous sub-2 μm particles for fast separations in pharmaceutical process development [J].