A comparative study of monosaccharide composition analysis as a carbohydrate test for biopharmaceuticals

被引：68

作者：

Harazono, Akira ^{[1
]}

Kobayashi, Tetsu ^{[1
]}

Kawasaki, Nana ^{[1
]}

Itoh, Satsuki ^{[1
]}

Tada, Minoru ^{[1
]}

Hashii, Noritaka ^{[1
]}

Ishii, Akiko ^{[1
]}

Arato, Teruyo ^{[2
]}

Yanagihara, Shigehiro ^{[3
]}

Yagi, Yuki ^{[3
]}

Koga, Akiko ^{[4
]}

Tsuda, Yuriko ^{[4
]}

Kimura, Mikiko ^{[4
]}

Sakita, Masashi ^{[4
]}

Kitamura, Satoshi ^{[5
]}

Yamaguchi, Hideto ^{[5
]}

Mimura, Hisashi ^{[5
]}

Murata, Yoshimi ^{[5
]}

Hamazume, Yasuki ^{[6
]}

Sato, Takayuki ^{[6
]}

Natsuka, Shunji ^{[7
]}

Kakehi, Kazuaki ^{[8
]}

Kinoshita, Mitsuhiro ^{[8
]}

Watanabe, Sakie ^{[8
]}

Yamaguchi, Teruhide ^{[1
]}

机构：

[1] Natl Inst Hlth Sci, Div Biol Chem & Biol, Setagaya Ku, Tokyo 1588501, Japan

[2] Pharmaceut & Med Device Agcy, Chiyoda Ku, Tokyo 1000013, Japan

[3] Kyowa Hakko Kirin Co Ltd, Prod Div, Takasaki, Gunma 3700013, Japan

[4] Chugai Pharmaceut Co Ltd, Analyt Technol Res Dept, Kita Ku, Tokyo 1158543, Japan

[5] Astellas Pharma Inc, Pharmaceut Res & Technol Labs, Pharmaceut Anal, Yaizu City, Shizuoka 4250072, Japan

[6] Dainippon Sumitomo Pharma Co Ltd, Technol Res & Dev, Ibaraki, Osaka 5670878, Japan

[7] Niigata Univ, Coll Sci, Nishi Ku, Niigata 9502181, Japan

[8] Kinki Univ, Sch Pharm, Higashiosaka, Osaka 5778502, Japan

来源：

BIOLOGICALS | 2011年 / 39卷 / 03期

关键词：

Monosaccharide composition analysis; Glycoprotein; HPLC; PERFORMANCE LIQUID-CHROMATOGRAPHY; ANION-EXCHANGE CHROMATOGRAPHY; PULSED AMPEROMETRIC DETECTION; SIALIC ACIDS; QUANTITATIVE-DETERMINATION; MASS-SPECTROMETRY; GLYCOPROTEINS; OLIGOSACCHARIDES; SUGARS; ELECTROPHORESIS;

D O I：

10.1016/j.biologicals.2011.04.002

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

The various monosaccharide composition analysis methods were evaluated as monosaccharide test for glycoprotein-based pharmaceuticals. Neutral and amino sugars were released by hydrolysis with 4-7 N trifluoroacetic acid. The monosaccharides were N-acetylated if necessary, and analyzed by high-performance liquid chromatography (HPLC) with fluorometric or UV detection after derivatization with 2-aminopyridine, ethyl 4-aminobenzoate, 2-aminobenzoic acid or 1-phenyl-3-methyl-5-pyrazolone, or high pH anion exchange chromatography with pulsed amperometric detection (HPAEC-PAD). Sialic acids were released by mild acid hydrolysis or sialidase digestion, and analyzed by HPLC with fluorometric detection after derivatization with 1,2-diamino-4,5-methylenedioxybenzene, or HPAECPAD. These methods were verified for resolution, linearity, repeatability, and accuracy using a monosaccharide standard solution, a mixture of epoetin alfa and beta, and alteplase as models. It was confirmed that those methods were useful for ensuring the consistency of glycosylation. It is considered essential that the analytical conditions including desalting, selection of internal standards, release of monosaccharides, and gradient time course should be determined carefully to eliminate interference of sample matrix. Various HPLC-based monosaccharide analysis methods were evaluated as a carbohydrate test for glycoprotein pharmaceuticals by an inter-laboratory study. (C) 2011 The International Alliance for Biologicals. Published by Elsevier Ltd. All rights reserved.

引用

页码：171 / 180

页数：10

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