A tool for increasing the lifetime of chromatography resins

被引：36

作者：

Gronberg, Anna ^{[1
]}

Eriksson, Malin ^{[1
]}

Ersoy, Maria ^{[1
]}

Johansson, Hans J. ^{[1
]}

机构：

[1] GE Healthcare Biosci AB, Dept Res & Dev, Uppsala, Sweden

来源：

MABS | 2011年 / 3卷 / 02期

关键词：

bioprocess; cleaning-in-place; chromatography; high-throughput; monoclonal antibody; process development; protein A; screening;

D O I：

10.4161/mabs.3.2.14874

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

There is a steadily increasing demand for speed, cost efficiency and process understanding within biopharmaceutical process development. To match this, a high-throughput method for screening of cleaning-in-place (CIP) conditions for chromatography resins has been developed. The methodology includes fouling of MabSelect SuRe chromatography resin in 96-well filter plates, cleaning of the fouled resin by incubation in different CIP agents, and finally, analysis of the residual impurities on the resin after cleaning. This article describes the improvements that transformed the method from low throughput and significant manual interference to a totally automated method with high throughput and good reproducibility.

引用

页码：192 / 202

页数：11