title: Profiling analysis of oligosaccharides in antibody pharmaceuticals by capillary electrophoresis.
abstract: Carbohydrate chains in glycoprotein pharmaceuticals have important roles for the expression of their biological activities. Therefore, development of an assessment method for the carbohydrate chains is an important parameter for quality control of glycoprotein pharmaceuticals such as newly developed therapeutic antibodies. In this report, we applied capillary electrophoresis with laser-induced fluorescence detection to the analysis of carbohydrate chains after releasing with glycoamidase followed by derivatization with 3-aminobenzoic acid. We found that four major oligosaccharides present in antibody pharmaceuticals were successfully separated with good resolution. The present method showed good precision in both migration times and relative peak areas, and gave comparable accuracy with that using a derivatization method with 8-aminopyrene-1,3,6-trisulfonate.
authors.affiliation: Faculty of Pharmaceutical Sciences, Kinki University, Kowakae 3-4-1, Higashi-Osaka 577-8502, Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Kamoda
authors.forename: Chie
authors.initials: C
authors.lastname: Nomura
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Kinoshita
authors.forename: Saori
authors.initials: S
authors.lastname: Nishiura
authors.forename: Rika
authors.initials: R
authors.lastname: Ishikawa
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Kakehi
authors.forename: Nana
authors.initials: N
authors.lastname: Kawasaki
authors.forename: Takao
authors.initials: T
authors.lastname: Hayakawa
mesh_terms: D062365:Aminobenzoates / Q000032:analysis; D000911:Antibodies, Monoclonal / Q000032:analysis*; D061067:Antibodies, Monoclonal, Humanized; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents / Q000032:analysis*; D019075:Electrophoresis, Capillary; D005456:Fluorescent Dyes; D009844:Oligosaccharides / Q000032:analysis*; D011721:Pyrenes / Q000032:analysis; D000069283:Rituximab; D000068878:Trastuzumab; D062368:meta-Aminobenzoates
chemical_list: C103430:8-aminopyrene-1,3,6-trisulfonic acid; D062365:Aminobenzoates; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D005456:Fluorescent Dyes; D009844:Oligosaccharides; D011721:Pyrenes; D062368:meta-Aminobenzoates; D000069283:Rituximab; C044855:3-aminobenzoic acid; D000068878:Trastuzumab