Protein aggregation and bioprocessing

被引：620

作者：

Cromwell, Mary E. M.

Hilario, Eric

Jacobson, Fred

机构：

[1] Genentech Inc, Early Stage Pharmaceut Dev, San Francisco, CA 94080 USA

[2] Genentech Inc, Early Stage Analyt Dev, San Francisco, CA 94080 USA

来源：

AAPS JOURNAL | 2006年 / 8卷 / 03期

关键词：

aggregation; self-association; cell culture; purification; filling; manufacture;

D O I：

10.1208/aapsj080366

中图分类号：

R9 [药学];

学科分类号：

1007 [药学];

摘要：

Protein aggregation is a common issue encountered during manufacture of biotherapeutics. It is possible to influence the amount of aggregate produced during the cell culture and purification process by carefully controlling the environment (eg, media components) and implementing appropriate strategies to minimize the extent of aggregation. Steps to remove aggregates have been successfully used at a manufacturing scale. Care should be taken when developing a process to monitor the compatibility of the equipment and process with the protein to ensure that potential aggregation is minimized.

引用

页码：E572 / E579

页数：8

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