title: Analysis of an antibody pharmaceutical, tocilizumab, by capillary electrophoresis using a carboxylated capillary.
abstract: Antibody pharmaceuticals are becoming more and more prevalent due to their excellent effectiveness in clinical medications, and are expected to allow tailor-made medical treatment for rheumatic diseases, immunosuppression in cardiac transplantation, and cancer. Antibody-type pharmaceuticals of immunoglobulin G (IgG) commonly have N-glycosylated carbohydrate chains attached to heavy chains. The carbohydrate chains play important roles in the effectiveness of antibodies. Therefore evaluation of a glycosylated species is important in the first step of quality control of antibody pharmaceuticals. In the present work, we examined capillary electrophoresis with a newly developed, chemically modified capillary, the inner surface of which is modified with carboxyl groups, for evaluation of IgG molecular species which have carbohydrate chains; tocilizumab was used as a model. The analytical system developed in the present study is useful for determining the content of non-glycosylated peptides. In the analysis of tocilizumab, the ratio of non-glycosylated peptide was estimated to be 1.23% with a relative standard deviation of 3.05%. The method affords high reproducibility with simple operation, and analysis can be completed within 6 min.
authors.affiliation: School of Pharmacy, Kinki University, Higashi-osaka, Japan. punk@phar.kindai.ac.jp
authors.forename: Atsushi
authors.initials: A
authors.lastname: Taga
authors.forename: Soichiro
authors.initials: S
authors.lastname: Kita
authors.forename: Kaori
authors.initials: K
authors.lastname: Nishiura
authors.forename: Tomonori
authors.initials: T
authors.lastname: Hayashi
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Kinoshita
authors.forename: Atsushi
authors.initials: A
authors.lastname: Sato
authors.forename: Kentaro
authors.initials: K
authors.lastname: Suzuki
authors.forename: Shuji
authors.initials: S
authors.lastname: Kodama
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Kakehi
mesh_terms: D000911:Antibodies, Monoclonal / Q000032:analysis* / Q000737:chemistry; D061067:Antibodies, Monoclonal, Humanized; D002264:Carboxylic Acids / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D019075:Electrophoresis, Capillary / Q000379:methods*; D006863:Hydrogen-Ion Concentration; D007074:Immunoglobulin G / Q000032:analysis / Q000737:chemistry; D015203:Reproducibility of Results; D013997:Time Factors
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D002264:Carboxylic Acids; D007074:Immunoglobulin G; C502936:tocilizumab