实现治疗性抗体生物传感面临的挑战。

Challenges in realizing therapeutic antibody biosensing.

作者信息

Nagata Madoka, Wilson Ellie D, Ikebukuro Kazunori, Sode Koji

机构信息

Lampe Joint Department of Biomedical Engineering, The University of North Carolina at Chapel Hill and North Carolina State University, Chapel Hill, NC 27599, USA.

Department of Biotechnology and Life Science, Graduate School of Engineering, Tokyo University of Agriculture and Technology, Koganei 184-8588, Japan.

出版信息

Trends Biotechnol. 2025 Jul 23. doi: 10.1016/j.tibtech.2025.07.003.

DOI:10.1016/j.tibtech.2025.07.003

PMID:40707337

Abstract

Therapeutic monoclonal antibodies (mAbs) exhibit significant interindividual pharmacokinetic (PK) variability, necessitating therapeutic drug monitoring (TDM). However, current monitoring methods require complex and time-consuming laboratory analysis, making rapid dose adjustments challenging. This review discusses emerging technologies for on-site mAb monitoring, with a focus on recent advances in recognition elements and detection strategies. Novel recognition elements, such as anti-idiotype molecules and meditopes, enable specific detection, whereas direct detection methods that eliminate washing steps facilitate rapid bedside testing. We examine the prospects for continuous mAb monitoring based on current technological advances and regulatory considerations. Although challenges regarding sensor regeneration and stability remain, the technologies discussed hold promise to enable real-time therapeutic monitoring at the bedside.

摘要

治疗性单克隆抗体（mAb）表现出显著的个体间药代动力学（PK）变异性，因此需要进行治疗药物监测（TDM）。然而，目前的监测方法需要复杂且耗时的实验室分析，这使得快速调整剂量具有挑战性。本综述讨论了用于现场单克隆抗体监测的新兴技术，重点关注识别元件和检测策略的最新进展。新型识别元件，如抗独特型分子和中介表位，能够实现特异性检测，而消除洗涤步骤的直接检测方法则有助于快速床边检测。我们基于当前的技术进步和监管考虑，研究了连续单克隆抗体监测的前景。尽管在传感器再生和稳定性方面仍存在挑战，但所讨论的技术有望实现床边实时治疗监测。