Profiling analysis of oligosaccharides in antibody pharmaceuticals by capillary electrophoresis

Profiling analysis of oligosaccharides in antibody pharmaceuticals by capillary electrophoresis
October 2004
Satoru Kamodaa, b, Chie Nomuraa, Mitsuhiro Kinoshitaa, Saori Nishiurac, Rika Ishikawab, Kazuaki Kakehia, Nana Kawasakid and Takao Hayakawad
aFaculty of Pharmaceutical Sciences, Kinki University, Kowakae 3-4-1, Higashi-Osaka 577-8502, Japan
bKIRIN BREWRY Co., Ltd., Hagiwara-machi 100-1, Takasaki 370-0013, Japan
cKinki University Nara Hospital, Otoda-cho 1248-1, Ikoma 630-0293, Japan
dNational Institute of Health Sciences, Kamiyoga 1-18-1, Setagaya-ku 158-8501, Japan
Journal of Chromatography A, Volume 1050, Issue 2 , 1 October 2004, Pages 211-216
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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.