title: The use of lectin microarray for assessing glycosylation of therapeutic proteins.
abstract: Glycans or carbohydrates attached to therapeutic glycoproteins can directly affect product quality, safety and efficacy, and therefore must be adequately analyzed and controlled throughout product life cycles. However, the complexity of protein glycosylation poses a daunting analytical challenge. In this study, we evaluated the utility of a lectin microarray for assessing protein glycans. Using commercial lectin chips, which contain 45 lectins toward distinct glycan structures, we were able to determine the lectin binding patterns of a panel of 15 therapeutic proteins, including 8 monoclonal antibodies. Lectin binding signals were analyzed to generate glycan profiles that were generally consistent with the known glycan patterns for these glycoproteins. In particular, the lectin-based microarray was found to be highly sensitive to variations in the terminal carbohydrate structures such as galactose versus sialic acid epitopes. These data suggest that lectin microarray could be used for screening glycan patterns of therapeutic glycoproteins.
authors.affiliation: a Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring , MD , USA.
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 , MD , USA.
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 , MD , USA.
authors.forename: Baolin
authors.initials: B
authors.lastname: Zhang
mesh_terms: D000911:Antibodies, Monoclonal / Q000032:analysis* / Q000737:chemistry; D006031:Glycosylation; D006801:Humans; D037102:Lectins / Q000737:chemistry*; D040081:Protein Array Analysis / Q000379:methods*
chemical_list: D000911:Antibodies, Monoclonal; D037102:Lectins
keywords: Glycan analysis; lectin microarray; monoclonal antibodies; therapeutic glycoproteins