Horvath Csaba Memorial Institute of Bioanalytical Research, Research Institute of Biomolecular and Chemical Engineering, University of Pannonia, Hungary.
Curr Mol Med. 2020;20(10):828-839. doi: 10.2174/1566524020999201203212352.
The market segment of new biological drugs (monoclonal antibodies, fusion proteins, antibody-drug conjugates, and new modality protein therapeutics) is rapidly growing, especially after the patent expiration of the original biologics, initiating the emergence of biosimilars. N-glycosylation of therapeutic proteins has high importance on their stability, safety, immunogenicity, efficacy, and serum half-life. Therefore, Nglycosylation is considered to be one of the critical quality attributes. Consequently, it should be rigorously monitored during the development, manufacturing, and release of glycoprotein biologicals. In this review, first, the regulatory considerations for biosimilars are shortly summarized, followed by conferring the analytical techniques needed for monitoring and characterization of the N-glycosylation of biological drugs. Particular respect is paid to liquid phase separation techniques with high sensitivity and highresolution detection methods, including laser-induced fluorescence and mass spectrometry.
新型生物药物（单克隆抗体、融合蛋白、抗体药物偶联物和新型模式蛋白治疗药物）的市场细分领域正在迅速发展，尤其是在原创生物药物专利到期后，生物类似药开始出现。治疗蛋白的 N-糖基化对其稳定性、安全性、免疫原性、疗效和血清半衰期具有重要意义。因此，N-糖基化被认为是关键质量属性之一。因此，在糖蛋白生物制品的开发、生产和放行过程中应严格监测 N-糖基化。在这篇综述中，首先简要总结了生物类似药的监管考虑因素，然后介绍了监测和表征生物药物 N-糖基化所需的分析技术。特别关注具有高灵敏度和高分辨率检测方法的液相分离技术，包括激光诱导荧光和质谱。
