Scale-up of monoclonal antibody purification processes

被引：68

作者：

Aldington, Suzanne ^{[1
]}

Bonnerjea, Julian ^{[1
]}

机构：

[1] Lonza Biol, Purificat Dev, 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：

monoclonal antibodies; antibody purification; scale-up; GMP antibody production;

D O I：

10.1016/j.jchromb.2006.11.032

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

Mammalian cell culture technology has improved so rapidly over the last few years that it is now commonplace to produce multi-kilogram quantities of therapeutic monoclonal antibodies in a single batch. Purification processes need to be scaled-up to match the improved upstream productivity. In this chapter key practical issues and approaches to the scale-up of monoclonal antibody purification processes are discussed. Specific purification operations are addressed including buffer preparation, chromatography column sizing, aggregate removal, filtration and volume handling with examples given. (c) 2006 Elsevier B.V. All rights reserved.

引用

页码：64 / 78

页数：15

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