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首页> 外文期刊>Biotechnology Progress >Case Study and Application of Process Analytical Technology (PAT) towards Bioprocessing: Use of Tryptophan Fluorescence as At-line Tool for Making Pooling Decisions for Process Chromatography
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Case Study and Application of Process Analytical Technology (PAT) towards Bioprocessing: Use of Tryptophan Fluorescence as At-line Tool for Making Pooling Decisions for Process Chromatography

机译：案例研究和过程分析技术（PAT）在生物加工中的应用：色氨酸荧光作为在线工具来制定过程色谱的合并决策

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摘要

Process analytical technology (PAT) has been gaining momentum in the biopharmaceuti-cal community due to the potential for continuous real time quality assurance resulting in improved operational control and compliance. Two imperatives for implementing any PAT tool are that "variability is managed by the process" and "product quality attributes can be accurately and reliably predicted over the design space established for materials used, process parameters, manufacturing, environmental, and other conditions." Recently, we have been examining the feasibility of applying different analytical tools to bioprocessing unit operations. We have previously demonstarted that commercially available online-high performance liquid chromatography and ultra performance liquid chromatography systems can be used for analysis that can facilitate real-time decisions for column pooling based on product quality attributes (Rathore et al., 2008a,b). In this article, we review an at-line tool that can be used for pooling of process chromatography columns. We have demonstrated that our tryptophan fluorescence method offers a feasible approach and meets the requirements of a PAT application. It is significantly faster than the alternative of fractionation, offline analysis followed by pooling. Although the method as presented here is not an online method, this technique may offer better resolution for certain applications and may be a more optimal approach as it is very conducive to implementation in a manufacturing environment. This technique is also amenable to be used as an online tool via front face fluorescence measurements done concurrently with product concentration determination by UV.
机译：过程分析技术（PAT）在生物制药界获得了不断发展的动力，这是因为它可以持续实时地保证质量，从而改善了操作控制和合规性。实施任何PAT工具的两个必要条件是“通过过程管理可变性”和“可以在针对所用材料，过程参数，制造，环境和其他条件建立的设计空间中准确可靠地预测产品质量属性”。最近，我们一直在研究将不同的分析工具应用于生物处理单元操作的可行性。我们以前已经证明，可以使用市售的在线高效液相色谱和超高效液相色谱系统进行分析，这些分析可以基于产品质量属性促进色谱柱池的实时决策（Rathore等，2008a，b）。在本文中，我们回顾了一种在线工具，可用于合并过程色谱柱。我们已经证明，我们的色氨酸荧光方法提供了一种可行的方法并满足了PAT应用的要求。它比分离，脱机分析然后合并的替代方法快得多。尽管此处介绍的方法不是在线方法，但是此技术可能会为某些应用程序提供更好的分辨率，并且由于它非常有利于在制造环境中实施，因此可能是一种更理想的方法。该技术还适合通过正面荧光测量与紫外光确定产品浓度同时进行的在线工具。

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