Quantitative comparison of the N-glycosylation of protein therapeutics using the glycosimilarity index (iGlycoS)

Andras Guttman, AOK-MMKK, Horvath Csaba Memorial Institute of Bioanalytical Research, Debrecen, Hungary (a.guttman@neu.edu)

Glycosylation is one of the most important critical quality attributes (CQA) of glycoprotein biotherapeutics. Biosimilars are biologic medical products, which are similar but not identical copies of already authorized biotherapeutics. The carbohydrate moieties of most glycoprotein based biological drugs play essential roles in serum clearance and such major mechanisms of actions as antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC) and anti-inflammatory functions. In addition, alteration in glycosylation may influence the safety and efficacy of the product. Glycosylation, therefore, is considered as one of the critical product quality attributes (PQA) of glycoprotein biotherapeutics, and consequently for their biosimilar counterparts. In this presentation a rapid and efficient sample preparation workflow is introduced in conjunction with a high resolution capillary gel electrophoresis based separation process to compare and quantitatively assess the glycosylation aspect of biosimilarity (referred to as glycosimilarity) between the innovator and a biosimilar versions of several high profile biotherapeutics, based on their N-linked carbohydrate signatures. The term of glycosimilarity index is introduced, based on the averaged biosimilarity criterion.

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Abstract Reference & Short Personal Biography of Presenting Author

András Guttman leads the biopharma related separation-application efforts at SCIEX, also heading the Horváth Csaba Memorial Laboratory of Bioseparation Sciences in University of Debrecen, Hungary. His work is focused on capillary electrophoresis and CESI-MS based glycomics and glycoproteomics analysis of biopharmaceutical and biomedical interests, with special attention to biosimilars and new modalities in the industry. Dr Guttman has over 300 scientific publications, wrote 35 book chapters, edited 4 textbooks and holds 23 patents. He is an external member of the Hungarian Academy of Sciences, on the board of several international scientific organizations editor-in-chief of Current Molecular Medicine and serves as editorial board member for a dozen scientific journals. He has been recognized by numerous awards including the Analytical Chemistry Award of the Hungarian Chemical Society (2000), named as Fulbright Scholar (2012), received the CASSS CE Pharm Award (2013), the Arany Janos medal of the Hungarian Academy of Sciences, the Pro Scientia award of the University of Pannonia and the Dennis Gabor Award of the Novofer Foundation in 2014. Dr Guttman also received the Dal Nogare Award of the Delaware Valley Chromatography Forum (2017), the Grand prize of the Swedish Chamber of Commerce (2017) and the Molnar Award (2019).