生物仿制药开发中免疫原性评估的必要变化。

IF 1.8 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2025-03-01 Epub Date: 2025-02-03 DOI:10.1080/17576180.2025.2461373

Johann Poetzl

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引用次数: 0

摘要

免疫原性知识和表征分子的分析能力在过去十年中得到了发展。这为生物类似药的开发创造了机会，通过应用新的策略来证明拟议的生物类似药与其参考药之间的相似性。在生物类似药的免疫原性风险评估中，正在评估计算机和体外免疫原性评估工具在生物类似药开发中的实用性。建议在许可申请档案中对生物仿制药进行包括免疫原性风险评估在内的ISI，以促进卫生当局的审查，并结合分析和临床数据解释免疫原性。还应考虑操作方面的问题，以改进生物仿制药的免疫原性测试，例如S/N比和单酸样品分析。

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The changes necessary in the assessment of immunogenicity for the development of Biosimilars.

Immunogenicity knowledge and the analytical capabilities to characterize molecules have evolved within the last decade. This creates opportunities in Biosimilar development by applying new strategies to demonstrate similarity between a proposed Biosimilar to its Reference.Within Immunogenicity Risk Assessment for Biosimilars, in silico and in vitro immunogenicity assessment tools are being evaluated for their utility in Biosimilar development. An ISI including an Immunogenicity Risk Assessment is recommended for Biosimilars within the dossier of licensing applications to facilitate the review by Health Authorities and to explain the immunogenicity in conjunction with analytical and clinical data. Operational aspects should also be considered to refine immunogenicity testing of Biosimilars, e.g. S/N ratio and singlicate sample analysis.

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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.