分子医学中的N-聚糖分析:创新者和生物相似蛋白疗法

Title:N-glycan Analysis in Molecular Medicine: Innovator and Biosimilar Protein Therapeutics

Volume: 20 Issue: 10

关键词: 生物相似学，生物相似学，生物治疗学，糖基化，抗体，分析，毛细管电泳，高效液相色谱

摘要: 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.

Cite this article as:

N-glycan Analysis in Molecular Medicine: Innovator and Biosimilar Protein Therapeutics, Current Molecular Medicine 2020; 20 (10) . https://dx.doi.org/10.2174/1566524020999201203212352