Glycoproteomics Technologies in Glycobiotechnology
Glycosylation is a key factor determining the pharmacological properties of biotherapeutics, including their stability, solubility, bioavailability, pharmacokinetics, and immunogenicity. As such, comprehensive information about glycosylation of biotherape
- PDF / 716,172 Bytes
- 22 Pages / 439.37 x 666.142 pts Page_size
- 40 Downloads / 119 Views
Glycoproteomics Technologies in Glycobiotechnology Kathirvel Alagesan, Marcus Hoffmann, Erdmann Rapp, and Daniel Kolarich
Contents 1 Introduction 1.1 Glycosylation of Biosimilars and Regulatory Requirements 1.2 Analytical Strategies for In-Depth Glycan Characterisation of Biosimilars 2 Recent Developments in Intact Glycopeptide Characterisation 2.1 Advancements in Glycopeptide Fragmentation 2.2 Sialic Acid Linkage Differentiation on Glycopeptides 3 Conclusion References
K. Alagesan Institute for Glycomics, Griffith University, Gold Coast, QLD, Australia Max Planck Unit for the Science of Pathogens, Berlin, Germany e-mail: k.alagesan@griffith.edu.au M. Hoffmann Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg, Germany e-mail: [email protected] E. Rapp Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg, Germany glyXera GmbH, Magdeburg, Germany e-mail: [email protected] D. Kolarich (*) Institute for Glycomics, Griffith University, Gold Coast, QLD, Australia ARC Centre of Excellence in Nanoscale Biophotonics, Griffith University, Gold Coast, QLD, Australia e-mail: d.kolarich@griffith.edu.au
K. Alagesan et al.
Abstract Glycosylation is a key factor determining the pharmacological properties of biotherapeutics, including their stability, solubility, bioavailability, pharmacokinetics, and immunogenicity. As such, comprehensive information about glycosylation of biotherapeutics is critical to demonstrate similarity. Regulatory agencies also require extensive documentation of the comprehensive analyses of glycosylationrelated critical quality attributes (CQAs) during the development, manufacturing, and release of biosimilars. Mass spectrometry has catalysed tremendous advancements in the characterisation of glycosylation CQAs of biotherapeutics. Here we provide a perspective overview on the MS-based technologies relevant for biotherapeutic product characterisation with an emphasis on the recent developments that allow determination of glycosylation features such as site of glycosylation, sialic acid linkage, glycan structure, and content. Graphical Abstract
Keywords Analytics, Biopharmaceuticals, Glycoproteomics, Mass spectrometry
Abbreviations ADCC AI-ETD CE-MS CID CQA ECD EIC EIE EMA EPO ESI ETD
Antibody-dependent cell-mediated cytotoxicity Activated ion electron transfer dissociation Capillary electrophoresis–mass spectrometry Collision-induced dissociation Critical quality attribute Electron-capture dissociation Extracted-ion chromatogram Extracted ion electropherogram European Medicines Agency Erythropoietin Electrospray ionisation Electron-transfer dissociation
Glycoproteomics Technologies in Glycobiotechnology
FcγR FDA FSH FSHR FT-ICR MS HCD IgGs IM-MS LC m/z MALDI MAM MS PNGase F PSA PTM QbD RP TOF
Fc-γ receptor Food and Drug Administration Follicle-stimulating hormone Follicle-stimulating hormone receptor Fourier transform–ion cyclotron resonance mass spectrometry Higher-energy collision-induced dissociation Immunoglobulin G Ion-mobility mas
Data Loading...
