An Assay for Immunogenic Detection of Anti‐PEG Antibody

Author:

Zhu Xiang12,Luo Weizhe12,Zhang Donghui13ORCID,Liu Runhui12ORCID

Affiliation:

1. State Key Laboratory of Bioreactor Engineering East China University of Science and Technology Shanghai 200237 China

2. Key Laboratory for Ultrafine Materials of Ministry of Education Frontiers Science Center for Materiobiology and Dynamic Chemistry Shanghai Frontiers Science Center of Optogenetic Techniques for Cell Metabolism Research Center for Biomedical Materials of Ministry of Education School of Materials Science and Engineering East China University of Science and Technology Shanghai 200237 China

3. School of Biotechnology East China University of Science and Technology Shanghai 200237 China

Abstract

AbstractWith the increasing use of polyethylene glycol (PEG) based proteins and drug delivery systems, anti‐PEG antibodies have commonly been detected among the population, causing the accelerated blood clearance and hypersensitivity reactions, poses potential risks to the clinical efficacy and safety of PEGylated drugs. Therefore, vigilant monitoring of anti‐PEG antibodies is crucial for both research and clinical guidance regarding PEGylated drugs. The enzyme‐linked immunosorbent assay (ELISA) is a common method for detecting anti‐PEG antibodies. However, diverse coating methods, blocking solutions and washing solutions have been employed across different studies, and unsuitable use of Tween 20 as the surfactant even caused biased results. In this study, we established the optimal substrate coating conditions, and investigated the influence of various surfactants and blocking solutions on the detection accuracy. The findings revealed that incorporating 1 % bovine serum albumin into the serum dilution in the absence of surfactants will result the credible outcomes of anti‐PEG antibody detection.

Funder

National Natural Science Foundation of China

Publisher

Wiley

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