Use of Process Data To Assess Chromatographic Performance in Production‐Scale Protein Purification Columns
Use of Process Data To Assess Chromatographic Performance in Production‐Scale Protein Purification Columns
复制标题
使用过程数据评估生产规模蛋白质纯化柱的色谱性能
DOI：
10.1021/bp025639g
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发表时间：
2003
影响因子：
2.9
通讯作者：
J. Cacia
中科院分区：
文献类型：
--
作者：
Tina M. Larson;Jeff S. Davis;H. Lam;J. Cacia
为了监测色谱柱的性能，对生产规模的色谱数据进行了过渡分析。对几种不同层析操作的300多个转变的分析表明了所提出的技术的实用性。分析的几个转变发生在已知完整性破坏的柱上。事实证明，这些技术对检测这些违规行为很敏感。提供了七个过渡计算，这些计算组合在一起，为每一列产生一个单一的整体完整性值。此外，主成分分析(PCA)被用来检测转换模式中的变化，包括那些归因于诚信破坏的变化。除了检测完整性破坏外，过渡分析在监测多个柱使用时的柱效率方面被证明是有用的。
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.