title: Analytical detection and characterization of biopharmaceutical glycosylation by MS.
abstract: Glycosylation plays an important role in ensuring the proper structure and function of most biotherapeutic proteins. Even small changes in glycan composition, structure, or location can have a drastic impact on drug safety and efficacy. Recently, glycosylation has become the subject of increased focus as biopharmaceutical companies rush to create not only biosimilars, but also biobetters based on existing biotherapeutic proteins. Against this backdrop of ongoing biopharmaceutical innovation, updated methods for accurate and detailed analysis of protein glycosylation are critical for biopharmaceutical companies and government regulatory agencies alike. This review summarizes current methods of characterizing biopharmaceutical glycosylation, including compositional mass profiling, isomer-specific profiling and structural elucidation by MS and hyphenated techniques.
authors.affiliation: Graduate School of Analytical Science & Technology, Chungnam National University, Daejeon, Korea.|Asia Glycomics Reference Site, Daejeon, Korea.
authors.forename: Myung Jin
authors.initials: MJ
authors.lastname: Oh
authors.affiliation: Asia Glycomics Reference Site, Daejeon, Korea.
authors.forename: Serenus
authors.initials: S
authors.lastname: Hua
authors.affiliation: Graduate School of Analytical Science & Technology, Chungnam National University, Daejeon, Korea.|Asia Glycomics Reference Site, Daejeon, Korea.
authors.forename: Unyong
authors.initials: U
authors.lastname: Kim
authors.affiliation: Graduate School of Analytical Science & Technology, Chungnam National University, Daejeon, Korea.|Asia Glycomics Reference Site, Daejeon, Korea.
authors.forename: Hyun Joong
authors.initials: HJ
authors.lastname: Kim
authors.affiliation: Graduate School of Analytical Science & Technology, Chungnam National University, Daejeon, Korea.|Asia Glycomics Reference Site, Daejeon, Korea.
authors.forename: Jua
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Food & Nutrition, Chungnam National University, Daejeon, Korea.
authors.forename: Jae-Han
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Graduate School of Analytical Science & Technology, Chungnam National University, Daejeon, Korea.|Asia Glycomics Reference Site, Daejeon, Korea.
authors.forename: Hyun Joo
authors.initials: HJ
authors.lastname: An
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000032:analysis* / Q000378:metabolism; D002851:Chromatography, High Pressure Liquid; D006020:Glycopeptides / Q000032:analysis*; D006031:Glycosylation; D006801:Humans; D057927:Hydrophobic and Hydrophilic Interactions; D011134:Polysaccharides / Q000032:analysis* / Q000302:isolation & purification; D011994:Recombinant Proteins / Q000032:analysis / Q000378:metabolism; D012709:Serum Albumin / Q000737:chemistry / Q000378:metabolism; D052616:Solid Phase Extraction; D019032:Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization
chemical_list: D059451:Biosimilar Pharmaceuticals; D006020:Glycopeptides; D011134:Polysaccharides; D011994:Recombinant Proteins; D012709:Serum Albumin
keywords: MS; biobetters; biosimilars; biotherapeutics; glycan; glycoprotein; glycosylation