Structure Characterization and Differentiation of Biosimilar and Reference Products Using Unique Combination of Complementary Fragmentation Mechanisms

A LC-MS/MS workflow was developed for differentiating minor difference of protein structure in biosimilar and reference products using an Orbitrap Fusion LC-MS/MS, and PepFinder 1.0 software. This new approach offers efficient, confident and comprehensive analysis, not only for biosimilar comparability study but also for lot-to-lot comparison of a same compound.