信噪比评估阿达木单抗生物仿制药免疫反应的大小、动力学和药代动力学影响。

IF 1.9 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2024-01-01 Epub Date: 2023-11-30 DOI:10.4155/bio-2023-0152

Davide Guerrieri, Matej Horvat, Jamie Fan, Jessie Wang, Lena Lemke, Oliver von Richter, Johann Poetzl

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引用次数: 0

摘要

背景:探讨抗药抗体(ADA)信噪比(S/N)作为一种新的免疫原性指标，用于评估健康受试者对单剂量GP2017(阿达木单抗生物类似药)的免疫反应。方法/结果:对用于ADA S/N比和ADA滴度分析的生物分析方法进行了灵敏度、精密度和药物干扰验证。ADA的信噪比与ADA滴度密切相关。ADA曲线下面积与ADAmax和药代动力学(PK)之间的相关性与ADA S/N比强于ADA滴度。结论:ADA S/N比值可以更灵敏地评估免疫反应的大小和动力学，与阿达木单抗PK有更好的相关性，在评估免疫反应对PK的影响方面优于ADA滴度。

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Signal-to-noise ratio to assess magnitude, kinetics and impact on pharmacokinetics of the immune response to an adalimumab biosimilar.

Background: The antidrug antibody (ADA) signal-to-noise (S/N) ratio was explored as a novel immunogenicity measure to evaluate the immune response of healthy subjects to a single dose of GP2017, an adalimumab biosimilar. Methodology/results: Bioanalytical methods used for the analysis of ADA S/N ratios and ADA titers were validated for sensitivity, precision and drug interference. ADA S/N ratios strongly correlated with ADA titers. Correlations between ADA area under the curve and ADA_max and pharmacokinetics (PK) were stronger for ADA S/N ratio than for ADA titers. Conclusion: ADA S/N ratio allowed for a more sensitive evaluation of the magnitude and kinetics of the immune response, was better correlated with adalimumab PK and was superior to ADA titers in assessing the impact of the immune response on PK.

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来源期刊

Bioanalysis BIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL

CiteScore

3.30

自引率

16.70%

发文量

审稿时长

2 months

期刊介绍： Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing. The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality. Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing. The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques. Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.