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人源化单克隆抗体的命名:早期概念、当前挑战及未来展望

Nomenclature of humanized mAbs: Early concepts, current challenges and future perspectives.

作者信息

Mayrhofer Patrick, Kunert Renate

出版信息

Hum Antibodies. 2019;27(1):37-51. doi: 10.3233/HAB-180347.

DOI:10.3233/HAB-180347
PMID:30103312
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6294595/
Abstract

Nomenclature of monoclonal antibodies traditionally followed a strict scheme indicating target and species information. Because of the rapid advances in this field, emphasized by approval of four humanized and six human antibodies in 2017, the International Nonproprietary Name of new antibodies was updated profoundly by removing the species substem completely. In this review we give an overview about what developments led to the preference of the scientific community towards human-like antibodies. We summarize the major updates in naming schemes that tried to classify antibodies according to their humanization technique or to the final primary sequence and how this led to the erroneous perception to indicate expected immunogenicity. Following the new 2017 nomenclature update, there will not be any information available about the species origin in the names of new antibodies, which emphasizes the need for providing additional supplemental information to the scientific community and develop tools to accurately estimate and control the safety of new monoclonal antibody molecules.

摘要

单克隆抗体的命名传统上遵循严格的方案,标明靶点和物种信息。由于该领域的迅速发展,2017年有四种人源化抗体和六种人抗体获批,这凸显了这一进展。新抗体的国际非专利名称进行了大幅更新,完全去除了物种词干。在本综述中,我们概述了导致科学界倾向于类人抗体的发展情况。我们总结了命名方案中的主要更新,这些方案试图根据抗体的人源化技术或最终的一级序列对抗体进行分类,以及这如何导致了关于预期免疫原性的错误认知。遵循2017年的新命名更新,新抗体名称中将不再有关于物种来源的任何信息,这强调了向科学界提供额外补充信息以及开发工具以准确评估和控制新单克隆抗体分子安全性的必要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50ac/6294595/fe88671854aa/hab-27-hab180347-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50ac/6294595/fe88671854aa/hab-27-hab180347-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50ac/6294595/fe88671854aa/hab-27-hab180347-g002.jpg

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