Glycosylation of biosimilars: Recent advances in analytical characterization and clinical implications

Abstract

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SARS-CoV-2 Proteome Microarray for Mapping COVID-19 Antibody Interactions at Amino Acid Resolution

“… 15 However, specific glycosylation on peptides is challenging and thus was not considered in this study. 31 Third, 80 000 genomic sequences of SARS-CoV-2 have been submitted to the Global Initiative on Sharing All Influenza Data (GISAID) database ( ) since the preparation of our proteome microarray. These new strains could be included in the next version of the SARS-CoV-2 proteome microarrays.…”

Discovery of Highly Active Recombinant PNGase H+ Variants Through the Rational Exploration of Unstudied Acidobacterial Genomes

“…The study of protein N-glycosylation is an active area of biotechnological research, given that all antibodies, and many biotherapeutics as well as extracellular and cell surface proteins bear these post-translational modifications (Overington et al, 2006;Saldova et al, 2017). The detailed analysis of therapeutic glycoproteins is of great importance, as the quality and effectiveness of these drugs strongly depend on the consistency of their glycan moieties (Berkowitz et al, 2012;Duivelshof et al, 2019). Peptide-N 4 -(N-acetyl-β-glucosaminyl) asparagine amidases (PNGases) enzymatically release asparagine-linked glycan moieties from glycoproteins and have been described as valuable tools in the analysis of glycotherapeutics (Wang and Voglmeir, 2014).…”

A Simple Strategy to Eliminate Hexosylation Bias in the Relative Quantification of N‐Glycosylation in Biopharmaceuticals

“…[6] This is especially relevant in the context of regulatory issues if glycoform "fingerprinting" is to be considered as aC QA in the future. [7] Yet, previous MS studies of intact glycoproteins have neglected the occurrence of different, isobaric PTMs,r esulting from the attachment of as ingle monosaccharide to the protein. Them ost common of these modifications in biopharmaceuticals is glycation, which typically arises from an on-enzymatic Schiff base reaction between the aldehyde group of areducing monosaccharide and aprimary amine on the protein (i.e., al ysine e-amino group or the N-terminus), proceeding to astable ketoamine via an Amadori rearrangement.…”