Revolutionizing ELISA development: The transformative impact of automation on monoclonal antibody potency assays

IF 3.4 3区医学 Q2 CHEMISTRY, ANALYTICAL

Journal of pharmaceutical and biomedical analysis Pub Date : 2026-04-15 Epub Date: 2025-12-19 DOI:10.1016/j.jpba.2025.117319

Xiaoran Xin , Douglas Pung , Amy Hsu , Monisha Dey , Qian Wu , Bo Feng , Dengyun Sun , Kevin Gurney , Anka Ehrhardt

引用次数: 0

Abstract

Enzyme-linked immunosorbent assays (ELISA) are a fundamental technique for determining the potency of monoclonal antibodies (mAbs), yet the traditional ELISA development process is often time-consuming and labor-intensive. In this study, we explored how automation and miniaturization in a 384-well format can revolutionize ELISA development, significantly enhancing throughput and accuracy. By employing automated liquid dispensing technology, we streamlined the optimization of assay parameters, leading to faster and more reliable potency measurements. Our findings not only demonstrate the feasibility of this innovative approach but also highlight its potential to transform the landscape of analytical assays in biopharmaceutical development.

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革命性ELISA发展：自动化对单克隆抗体效价测定的变革性影响

酶联免疫吸附试验（ELISA）是测定单克隆抗体（mab）效价的基本技术，但传统的ELISA开发过程往往耗时费力。在这项研究中，我们探索了384孔格式的自动化和小型化如何彻底改变ELISA的发展，显著提高通量和准确性。通过采用自动化液体分配技术，我们简化了分析参数的优化，从而实现更快，更可靠的效价测量。我们的发现不仅证明了这种创新方法的可行性，而且还强调了它在改变生物制药开发中分析分析的前景方面的潜力。

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

Journal of pharmaceutical and biomedical analysis 医学-分析化学

CiteScore

6.70

自引率

5.90%

发文量

588

审稿时长

37 days

期刊介绍： This journal is an international medium directed towards the needs of academic, clinical, government and industrial analysis by publishing original research reports and critical reviews on pharmaceutical and biomedical analysis. It covers the interdisciplinary aspects of analysis in the pharmaceutical, biomedical and clinical sciences, including developments in analytical methodology, instrumentation, computation and interpretation. Submissions on novel applications focusing on drug purity and stability studies, pharmacokinetics, therapeutic monitoring, metabolic profiling; drug-related aspects of analytical biochemistry and forensic toxicology; quality assurance in the pharmaceutical industry are also welcome. Studies from areas of well established and poorly selective methods, such as UV-VIS spectrophotometry (including derivative and multi-wavelength measurements), basic electroanalytical (potentiometric, polarographic and voltammetric) methods, fluorimetry, flow-injection analysis, etc. are accepted for publication in exceptional cases only, if a unique and substantial advantage over presently known systems is demonstrated. The same applies to the assay of simple drug formulations by any kind of methods and the determination of drugs in biological samples based merely on spiked samples. Drug purity/stability studies should contain information on the structure elucidation of the impurities/degradants.