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Unattended reaction monitoring using an automated microfluidic sampler and on-line liquid chromatography
Analytica Chimica Acta ( IF 6.2 ) Pub Date : 2018-04-01 , DOI: 10.1016/j.aca.2017.11.070
Darshan C. Patel , Yaqi "Fara" Lyu , Jorge Gandarilla , Steve Doherty

In-process sampling and analysis is an important aspect of monitoring kinetic profiles and impurity formation or rejection, both in development and during commercial manufacturing. In pharmaceutical process development, the technology of choice for a substantial portion of this analysis is high-performance liquid chromatography (HPLC). Traditionally, the sample extraction and preparation for reaction characterization have been performed manually. This can be time consuming, laborious, and impractical for long processes. Depending on the complexity of the sample preparation, there can be variability introduced by different analysts, and in some cases, the integrity of the sample can be compromised during handling. While there are commercial instruments available for on-line monitoring with HPLC, they lack capabilities in many key areas. Some do not provide integration of the sampling and analysis, while others afford limited flexibility in sample preparation. The current offerings provide a limited number of unit operations available for sample processing and no option for workflow customizability. This work describes development of a microfluidic automated program (MAP) which fully automates the sample extraction, manipulation, and on-line LC analysis. The flexible system is controlled using an intuitive Microsoft Excel based user interface. The autonomous system is capable of unattended reaction monitoring that allows flexible unit operations and workflow customization to enable complex operations and on-line sample preparation. The automated system is shown to offer advantages over manual approaches in key areas while providing consistent and reproducible in-process data.

中文翻译:

使用自动微流体进样器和在线液相色谱进行无人值守反应监测

在开发和商业制造过程中,过程中的采样和分析是监测动力学曲线和杂质形成或排除的一个重要方面。在制药工艺开发中,该分析的很大一部分选择的技术是高效液相色谱 (HPLC)。传统上,用于反应表征的样品提取和制备都是手动进行的。这对于长流程来说可能是耗时、费力且不切实际的。根据样品制备的复杂性,不同的分析人员可能会引入可变性,在某些情况下,样品的完整性可能会在处理过程中受到影响。虽然有可用于使用 HPLC 进行在线监测的商业仪器,但它们在许多关键领域都缺乏能力。有些不提供采样和分析的集成,而另一些则在样品制备方面提供有限的灵活性。当前产品提供有限数量的可用于样品处理的单元操作,并且没有工作流程可定制性选项。这项工作描述了微流体自动化程序 (MAP) 的开发,该程序使样品提取、操作和在线 LC 分析完全自动化。灵活的系统使用基于 Microsoft Excel 的直观用户界面进行控制。自主系统能够进行无人值守的反应监测,允许灵活的单元操作和工作流程定制,以实现复杂的操作和在线样品制备。自动化系统显示出在关键领域比手动方法具有优势,同时提供一致和可重复的过程数据。
更新日期:2018-04-01
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