Pögel Neé Steinicke Franziska, Oltmann-Norden Imke, Wätzig Hermann
Institut für Medizinische und Pharmazeutische Chemie, Beethovenstr. 55, D-38106 Braunschweig, Germany.
Institut für Medizinische und Pharmazeutische Chemie, Beethovenstr. 55, D-38106 Braunschweig, Germany.
Anal Biochem. 2018 Mar 1;544:108-113. doi: 10.1016/j.ab.2017.12.027. Epub 2017 Dec 25.
Surface Plasmon Resonance Biosensors (SPR) are one of the most powerful tools to characterize protein binding, e.g. for drug discovery, like target identification, ligand fishing, assay development, lead selection and manufacturing quality control. However, there is increasing concern about its reproducibility in the light of the reproducibility crisis. Therefore an appropriate analytical instrument qualification (AIQ) is required for quality assurance of SPR instruments. AIQ is a prerequisite for analytical method validation and it is consisting of four parts, Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). PQ regularly executed is supposed to continuously control the performance of the instrument under actual running conditions. In this work a performance qualification method was developed for the SPR instrument Biacore X100. This method is suitable for the routinely control of the instrument performance for antibody-antigen binding measurements. Control charts were designed to get a clearly representable and easy implementable tool to check the critical parameters. These control charts and a straightforward protocol now allow the design and application of an individual performance qualification procedure that can be used in the laboratory routine. They serve as reference for individual standard operation procedures (SOPs).
表面等离子体共振生物传感器（SPR）是表征蛋白质结合的最强大工具之一，例如用于药物研发，如靶点识别、配体筛选、分析方法开发、先导化合物选择和生产质量控制。然而，鉴于可重复性危机，人们对其可重复性的担忧日益增加。因此，为确保SPR仪器的质量，需要进行适当的分析仪器鉴定（AIQ）。AIQ是分析方法验证的前提条件，它由四个部分组成，即设计确认（DQ）、安装确认（IQ）、运行确认（OQ）和性能确认（PQ）。定期执行PQ旨在在实际运行条件下持续控制仪器的性能。在这项工作中，为SPR仪器Biacore X100开发了一种性能确认方法。该方法适用于抗体 - 抗原结合测量中仪器性能的常规控制。设计了控制图，以获得一个清晰可表示且易于实施的工具来检查关键参数。这些控制图和一个简单的方案现在允许设计和应用可用于实验室日常工作的个性化性能确认程序。它们可作为各个标准操作规程（SOP）的参考。
