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

机译:使用过程数据评估生产规模的蛋白质纯化柱中的色谱性能

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Transition analysis was performed on production-scale chromatography data in order to monitor colunm performance.Analysis of over 300 transitions from several different chromatography operations demonstrated the utility of the techniques presented Several of the transitions analy6zed occurred on columns with known integrity preaches.The techniques proved sensitive for detection of these breaches.Seven transition calculations are pressented which was combined to produced a single overall integrity value fro each column In addition principal componenta anaylsis (PCA) was used to detect shifts in the transition pattern including those attributed to integrity breaches.Besides detection of integraity breaches,transition analysis proved useful in monitoring colunm efficiency over multiple column uses.
机译:为了监控色谱柱性能,对生产规模的色谱数据进行了过渡分析。对来自数种不同色谱操作的300多种过渡进行分析,证明了所提技术的效用。所分析的几种过渡发生在已知完整性讲究的色谱柱上。紧迫地进行了七个转换计算,这些转换计算相结合产生了每个列的单个整体完整性值。此外,主成分分析(PCA)用于检测转换模式中的变化,包括归因于完整性破坏的变化。检测集成违规,转换分析在监视多列使用中的柱效方面非常有用。

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