Recent developments of imaged capillary isoelectric focusing technology for in-depth biopharmaceutical characterization

IF 12 1区化学 Q1 CHEMISTRY, ANALYTICAL Trends in Analytical Chemistry Pub Date : 2025-06-01 Epub Date: 2025-02-26 DOI:10.1016/j.trac.2025.118212

Tao Bo , Feng Yang , Bo Yan , David A. Michels , Tiemin Huang , Janusz Pawliszyn

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Abstract

Imaged capillary isoelectric focusing (icIEF) has made remarkable strides in recent years, presenting the biopharmaceutical industry with a range of innovative solutions to characterize protein charge heterogeneity and streamline the development and manufacturing of biologics. This review highlights the latest advancements in icIEF technology for comprehensive biopharmaceutical characterization. Key innovations, including the development of critical reagents and capillary coatings, advanced icIEF fractionation, cutting-edge icIEF-MS online coupling, and novel applications for protein bio-interactions, are redefining icIEF analytical methodologies and broadening their applicability. These breakthroughs significantly enhance the characterization of complex therapeutic proteins, aiding researchers in mitigating challenges and setbacks during drug development and manufacturing. In describing these advances, we delve into multidisciplinary concepts spanning biology, chemistry, instrument design, and workflow optimization, aiming to inspire further innovations and insights in this dynamic, rapidly evolving field. Furthermore, this review traces the origins and 30-year evolution of icIEF technology by illustrating its continuous progression and expanding impact over time.

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用于生物制药深度表征的成像毛细管等电聚焦技术的最新进展

近年来，成像毛细管等电聚焦技术（icIEF）取得了显著的进步，为生物制药行业提供了一系列创新的解决方案，以表征蛋白质电荷异质性，简化生物制剂的开发和制造。本文综述了icIEF技术在生物药物综合表征方面的最新进展。关键的创新，包括关键试剂和毛细管涂层的开发，先进的icIEF分离，尖端的icIEF- ms在线耦合，以及蛋白质生物相互作用的新应用，正在重新定义icIEF分析方法并扩大其适用性。这些突破显著增强了复杂治疗蛋白的表征，帮助研究人员减轻了药物开发和制造过程中的挑战和挫折。在描述这些进展时，我们深入研究了生物学，化学，仪器设计和工作流程优化等多学科概念，旨在激发这个动态，快速发展领域的进一步创新和见解。此外，本文回顾了icIEF技术的起源和30年的演变，说明了它随着时间的推移不断进步和扩大的影响。

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来源期刊

Trends in Analytical Chemistry 化学-分析化学

CiteScore

20.00

自引率

4.60%

发文量

257

审稿时长

3.4 months

期刊介绍： TrAC publishes succinct and critical overviews of recent advancements in analytical chemistry, designed to assist analytical chemists and other users of analytical techniques. These reviews offer excellent, up-to-date, and timely coverage of various topics within analytical chemistry. Encompassing areas such as analytical instrumentation, biomedical analysis, biomolecular analysis, biosensors, chemical analysis, chemometrics, clinical chemistry, drug discovery, environmental analysis and monitoring, food analysis, forensic science, laboratory automation, materials science, metabolomics, pesticide-residue analysis, pharmaceutical analysis, proteomics, surface science, and water analysis and monitoring, these critical reviews provide comprehensive insights for practitioners in the field.