A Comprehensive N-Glycan Profiling Analysis of Bevacizumab Biosimilar by UHPLC with Fluorescence Detection and Q-TOF Mass

Gobal biopharmaceutical market is entering a new era of biosimilars - generic copies of commercialized monoclonal antibodies (mAbs), with the aim of providing less-expensive medication options. Thus far, more than 50 biosimilar products have been approved by USFDA and EMA. Despite this, biosimilar industry faces some significant hurdles. One of the major challenges is to produce biosimilars with the same/closest N-glycosylations as the reference mAb, as they play a crucial role in stability, bioactivity and immunogenicity of the product. That’s why an appropriate characterization of biosimilar product is essential. In this work, we established a robust, sensitive and reproducible analytical system on the basis of a Nexera Bio UHPLC coupled with Fluorescence detection and Q-TOF Mass Spectrometry for N-glycan profiling analysis of a bevacizumab biosimilar sample