Current advances in separation chemistry for antibody purification and analysis.

IF 1.8 4区 化学 Q3 CHEMISTRY, ANALYTICAL
Suprit Deol, Yutaka Matsuda, Yuki Hiruta
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引用次数: 0

Abstract

Monoclonal antibodies (mAbs) have become essential in modern therapeutics, offering high specificity and efficacy in treating diseases such as cancer, autoimmune disorders, and infectious diseases. With the increasing demand for mAbs, robust analytical and purification technologies are critical to ensuring their safety, efficacy, and consistency. This review highlights recent advances in the application of HPLC for both mAb analysis and purification. In the analytical domain, techniques such as size exclusion chromatography (SEC), hydrophobic interaction chromatography (HIC), ion exchange chromatography (IEX), and reversed-phase chromatography (RPLC) are explored for their role in evaluating mAb structural attributes and post-translational modifications (PTMs). These methods are indispensable for ensuring stability and functionality while meeting stringent regulatory requirements. In the context of purification, Protein A affinity chromatography remains the gold standard for initial capture of mAb; however, challenges such as high cost and harsh elution conditions have prompted the development of alternative purification technologies. IEX, HIC, multimodal, and membrane chromatography are also critical in achieving high-purity mAb products through multistep workflows, including intermediate purification and polishing stages. This review emphasizes the central role of HPLC in addressing the complex challenges of mAb manufacturing and characterization. By integrating established and emerging chromatographic techniques, it provides insights into the future directions of therapeutic antibody development.

抗体纯化与分析的分离化学进展。
单克隆抗体(mab)在治疗癌症、自身免疫性疾病和传染病等疾病方面具有高特异性和高效性,在现代治疗中已成为必不可少的药物。随着对单克隆抗体需求的增加,强大的分析和纯化技术对于确保其安全性、有效性和一致性至关重要。本文综述了HPLC在单抗分析和纯化方面的最新进展。在分析领域,诸如尺寸排斥色谱(SEC)、疏水相互作用色谱(HIC)、离子交换色谱(IEX)和反相色谱(RPLC)等技术被用于评估单抗的结构属性和翻译后修饰(PTMs)。这些方法对于确保稳定性和功能性,同时满足严格的监管要求是必不可少的。在纯化的背景下,蛋白A亲和层析仍然是单抗初始捕获的金标准;然而,诸如高成本和苛刻的洗脱条件等挑战促使了替代净化技术的发展。IEX、HIC、多模态层析和膜层析也是通过多步骤工作流程(包括中间纯化和抛光阶段)获得高纯度mAb产品的关键。这篇综述强调了高效液相色谱在解决单克隆抗体制造和表征的复杂挑战中的核心作用。通过整合现有的和新兴的色谱技术,它为治疗性抗体开发的未来方向提供了见解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Analytical Sciences
Analytical Sciences 化学-分析化学
CiteScore
2.90
自引率
18.80%
发文量
232
审稿时长
1 months
期刊介绍: Analytical Sciences is an international journal published monthly by The Japan Society for Analytical Chemistry. The journal publishes papers on all aspects of the theory and practice of analytical sciences, including fundamental and applied, inorganic and organic, wet chemical and instrumental methods. This publication is supported in part by the Grant-in-Aid for Publication of Scientific Research Result of the Japanese Ministry of Education, Culture, Sports, Science and Technology.
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