title: Glycan analysis of therapeutic glycoproteins.
abstract: Therapeutic monoclonal antibodies (mAbs) are glycoproteins produced by living cell systems. The glycan moieties attached to the proteins can directly affect protein stability, bioactivity, and immunogenicity. Therefore, glycan variants of a glycoprotein product must be adequately analyzed and controlled to ensure product quality. However, the inherent complexity of protein glycosylation poses a daunting analytical challenge. This review provides an update of recent advances in glycan analysis, including the potential utility of lectin-based microarray for high throughput glycan profiling. Emphasis is placed on comparison of the major types of analytics for use in determining unique glycan features such as glycosylation site, glycan structure, and content.
authors.affiliation: a Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring , Maryland.
authors.forename: Lei
authors.initials: L
authors.lastname: Zhang
authors.affiliation: a Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring , Maryland.
authors.forename: Shen
authors.initials: S
authors.lastname: Luo
authors.affiliation: a Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring , Maryland.
authors.forename: Baolin
authors.initials: B
authors.lastname: Zhang
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000032:analysis* / Q000627:therapeutic use; D006801:Humans; D037102:Lectins / Q000737:chemistry*; D011134:Polysaccharides / Q000032:analysis*; D040081:Protein Array Analysis / Q000379:methods
chemical_list: D000911:Antibodies, Monoclonal; D037102:Lectins; D011134:Polysaccharides
keywords: Analytics; biopharmaceuticals; glycan profiling; glycosylation; lectin microarray; monoclonal antibodies; therapeutic proteins