Process analytics for purification of monoclonal antibodies

被引：59

作者：

Flatman, Stephen ^{[1
]}

Alam, Imtiaz ^{[1
]}

Gerard, Jeffery ^{[1
]}

Mussa, Nesredin ^{[1
]}

机构：

[1] Lonza Biol Plc, Slough SL1 4DX, Berks, England

来源：

JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES | 2007年 / 848卷 / 01期

关键词：

antibodies; purification; analytical methods; process analytical technology;

D O I：

10.1016/j.jchromb.2006.11.018

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

The application of appropriate analytical methods is an essential requirement for the purification of therapeutic antibodies. A range of analytical methods need to be employed to effectively determine the purity, identity, integrity and activity of these important class of pharmaceuticals. These include notably electrophoresis, high performance liquid chromatography and immunoassays. Regulatory and industry demands in recent years have brought the need for improvements and many have been successfully implemented. This article reviews the current analytical methods applied to support the purification of monoclonal antibodies. (c) 2006 Elsevier B.V. All rights reserved.

引用

页码：79 / 87

页数：9

共 26 条

[1] Validation of a peptide mapping method for a therapeutic monoclonal antibody: what could we possibly learn about a method we have run 100 times? [J].