利用过程数据评估生产规模蛋白质纯化柱的色谱性能。

Use of process data to assess chromatographic performance in production-scale protein purification columns.

作者信息

Larson Tina M, Davis Jeff, Lam Harry, Cacia Jerry

机构信息

Manufacturing Science and Technology, Genentech, Inc., 1 DNA Way, MS 75B, South San Francisco, California 94080, USA.

出版信息

Biotechnol Prog. 2003 Mar-Apr;19(2):485-92. doi: 10.1021/bp025639g.

DOI:10.1021/bp025639g

PMID:12675591

Abstract

Transition analysis was performed on production-scale chromatography data in order to monitor column performance. Analysis of over 300 transitions from several different chromatography operations demonstrated the utility of the techniques presented. Several of the transitions analyzed occurred on columns with known integrity breaches. The techniques proved sensitive for detection of these breaches. Seven transition calculations are presented, which were combined to produce a single overall integrity value for each column. In addition, principal components analysis (PCA) was used to detect shifts in the transition pattern, including those attributed to integrity breaches. Besides detection of integrity breaches, transition analysis proved useful in monitoring column efficiency over multiple column uses.

摘要

为监测色谱柱性能，对生产规模的色谱数据进行了转换分析。对来自几种不同色谱操作的300多次转换进行分析，证明了所提出技术的实用性。所分析的几次转换发生在已知完整性遭到破坏的色谱柱上。这些技术被证明对检测这些破坏很敏感。给出了七种转换计算方法，将其结合可为每根色谱柱生成一个单一的整体完整性值。此外，主成分分析（PCA）用于检测转换模式的变化，包括那些由完整性破坏引起的变化。除了检测完整性破坏外，转换分析在监测多批次使用的色谱柱效率方面也被证明是有用的。