ELISA中和人血清抗曲妥珠单抗检测方法的建立与验证

Q3 Pharmacology, Toxicology and Pharmaceutics
M. A. Kolganova, O. S. Sagimbaeva, Ju. S. Borisova, E. E. Beketov, I. E. Shokhin
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引用次数: 0

摘要

介绍。曲妥珠单抗是第一种已知的抗her2药物,它彻底改变了最常见的癌症类型之一——乳腺癌的治疗。尽管曲妥珠单抗很早就被批准,但由于新的生物仿制药的出现,相关分析方法的进一步改进仍然具有相关性。例如,免疫原性——通常与生物药物相关的不良反应,仍可能与曲妥珠单抗相关。抗药物抗体,包括中和抗体,由曲妥珠单抗治疗引起,可影响药物的有效性和安全性。的目标。本研究的目的是开发和验证测定人血清中中和抗曲妥珠单抗抗体的分析方法。材料和方法。中和性抗曲妥珠单抗抗体测定采用竞争性ELISA法,在光谱可见范围内采用分光光度法检测。结果和讨论。验证了该方法的切入点、选择性、灵敏度、特异性、精密度和稳定性(短期和长期)。为了减少非特异性结合血清成分的背景噪声,最低所需稀释值为0.5%血清。切点计算值为14.62%。该方法的敏感性估计为1985.2 ng/mL的中和抗曲妥珠单抗抗体。结论。本研究结果可用于生物等效性临床试验中曲妥珠单抗免疫原性评价中人血清中和性抗曲妥珠单抗抗体的测定。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and Validation of the ELISA Method for Neutralizing Anti-trastuzumab Antibodies Detection in Human Blood Serum
Introduction. Trastuzumab is the first known anti-HER2 agent, which revolutionized the treatment of one of the most common cancer types – breast cancer. Despite trastuzumab being approved long time ago, further improvement of related analytical methods remains relevant primarily due to the emergence of new biosimilars. For instance, immunogenicity – adverse reaction which is usually associated with biological drugs, can still be relevant for trastuzumab. Anti-drug antibodies, including neutralizing antibodies, caused by trastuzumab therapy, can affect drug effectiveness and safety profile. Aim. The aim of this study was to develop and validate the analytical method for neutralizing anti-trastuzumab antibodies determination in human blood serum. Materials and methods. The neutralizing anti-trastuzumab antibody determination was carried out by the competitive ELISA method, using spectrophotometric detection in the visible range of the spectrum. Results and discussion. The developed method was validated for cut-point, selectivity, sensitivity, specificity, precision and stability (short-term and long-term). To decrease the background noise from non-specific binding of sera components, the minimum required dilution value was determined at 0.5 % serum. The calculated value for cut-point was 14.62 %. The sensitivity of the developed method was estimated at 1985.2 ng/mL of neutralizing anti-trastuzumab antibodies. Conclusion. The obtained results allowed us to apply the developed ELISA method for the neutralizing anti-trastuzumab antibodies determination in human blood serum during trastuzumab immunogenicity assessment in bioequivalence clinical trials.
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来源期刊
Drug Development and Registration
Drug Development and Registration Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
1.20
自引率
0.00%
发文量
61
审稿时长
8 weeks
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