The aim of this study was to semi-automate process analytics for the quantification of common impurities in downstream processing such as host cell DNA, host cell proteins and endotoxins using a commercial liquid handling station. By semi-automation, the work load to fully analyze the elution peak of a purification run was reduced by at least 2.41 h. The relative standard deviation of results among different operators over a time span of up to 6 months was at the best reduced by half, e.g. from 13.7 to 7.1% in dsDNA analysis. Automation did not improve the reproducibility of results produced by one operator but released time for data evaluation and interpretation or planning of experiments. Overall, semi-automation of process analytics reduced operator-specific influence on test results. Such robust and reproducible analytics is fundamental to establish process analytical technology and get downstream processing ready for Quality by Design approaches.

这项研究的目的是使用商用液体处理站对流程分析进行半自动化的过程分析，以量化下游处理中的常见杂质，例如宿主细胞DNA，宿主细胞蛋白和内毒素。通过半自动化，可充分分析纯化运行洗脱峰的工作量至少减少了2.41小时。在长达6个月的时间内，不同操作者之间结果的相对标准偏差最大程度地减少了一半，例如在dsDNA分析中从13.7％降至7.1％。自动化并不能提高一个操作员产生的结果的可重复性，但是会为数据评估，解释或计划实验腾出时间。总体而言，过程分析的半自动化减少了特定于操作员的对测试结果的影响。