A Platform analytical method for intact polysorbates in protein-containing biopharmaceutical products via HPLC-CAD

IF 1 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS

Journal of Liquid Chromatography & Related Technologies Pub Date : 2022-12-14 DOI:10.1080/10826076.2023.2207024

Katie A. Carnes, Lee D. Oliver, T. A. Brown, Roberto F. Delgadillo, Michelle S. Ward, Sina Mortazavi, Michael J. Morris, Justin W. Shearer, J. Fuller

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引用次数: 0

Abstract

Abstract Polysorbate (also known as “Tween”) 80 (PS80) is the most common surfactant in biopharmaceuticals. Here, we report a sensitive, and specific platform analytical method using reversed-phase high performance liquid chromatography employing a charged aerosol detector (HPLC-CAD), that offers the ability to quantitate intact PS80 and can distinguish between low recovery of PS80 and degraded PS80 by also monitoring several PS80 degradants which offers multiple improvements over various previously reported polysorbate analytical methods. The method employs protein/monoclonal antibody precipitation and is designed to be a quality control (QC) lab-friendly method. The method is distinguishable from other published methods because the quantification of the PS80 mono-esters is free from interference from known PS80 degradants. The method has demonstrated acceptable accuracy, precision, specificity, and sensitivity through qualification studies. The specificity afforded by the method allows for employment in forced degradation studies to discern kinetic information. Lastly, the method also has promising applications with other polysorbates (PS60, PS40, and all-laurate PS20) and shows acceptable performance with several types of biopharmaceutical proteins. Graphical Abstract

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HPLC-CAD平台分析含蛋白质生物制药产品中完整聚山梨醇酯的方法

摘要聚山梨醇酯（也称为“吐温”）80（PS80）是生物制药中最常见的表面活性剂。在这里，我们报道了一种使用带电气溶胶检测器（HPLC-CAD）的反相高效液相色谱的灵敏和特异性平台分析方法，其提供了定量完整PS80的能力，并且可以通过监测几种PS80降解物来区分PS80的低回收率和降解的PS80。该方法采用蛋白质/单克隆抗体沉淀，是一种质量控制（QC）实验室友好的方法。该方法与其他已发表的方法不同，因为PS80单酯的定量不受已知PS80降解物的干扰。该方法已通过鉴定研究证明了可接受的准确性、精密度、特异性和敏感性。该方法提供的特异性允许在强迫降解研究中使用，以辨别动力学信息。最后，该方法在其他聚山梨醇酯（PS60、PS40和全月桂酸酯PS20）中也有很好的应用前景，并且在几种类型的生物制药蛋白质中显示出可接受的性能。图形摘要

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来源期刊

Journal of Liquid Chromatography & Related Technologies 化学-分析化学

CiteScore

2.80

自引率

0.00%

发文量

审稿时长

4.9 months

期刊介绍： The Journal of Liquid Chromatography & Related Technologies is an internationally acclaimed forum for fast publication of critical, peer reviewed manuscripts dealing with analytical, preparative and process scale liquid chromatography and all of its related technologies, including TLC, capillary electrophoresis, capillary electrochromatography, supercritical fluid chromatography and extraction, field-flow technologies, affinity, and much more. New separation methodologies are added when they are developed. Papers dealing with research and development results, as well as critical reviews of important technologies, are published in the Journal.