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KMID : 1142220100050010013
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Regulatory Research on Food, Drug & Cosmetic
2010 Volume.5 No. 1 p.13 ~ p.21
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Guideline on Characterization and Specification of Glycan Structure in Glycoprotein Products
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Kwon Oh-Seok
Suh Soo-Kyung
Kang Hyun-Ah
Kim Soo-Hyun
Kim Eun-Jeong
Kim Ha-Hyung
Park Beom-Soo
Park Yong-Il
Suh Jung-Keun
Oh Doo-Byoung
Lee Seung-Joo
Jung Chul-Ho
Shon Yeo-Won
Hong Seung-Hwa
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Abstract
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Glycoprotein products are over 60% of protein products in the world market. Recently, the emerging market is the recombinant monoclonal antibody products and they are also glycoprotein products. Glycans in glycoproteins play important roles in the activity, pharmacokinetics, and immunogenecity. Even if the same cell line is used for manufacturing the glycoprotein products, the glycoforms can be changed easily according to the manufacturing conditions such as cell culture parameters, production scale, and purification parameters. So glycans should be controlled not to affect the quality of final protein product due to the heterogeneity of glycoform. Although quality control of glycan analysis is considered to be important, any guideline explaining the specific requirements for glycan analysis is not prepared worldwide until now. We established a “Guideline on Characterization and Specification of Glycan Structure in Glycoprotein Products” for the researchers developing a glycoprotein product. In this guideline, confirmation of glycosylation, monosaccharide composition analysis, glycan structure analysis, glycan profile analysis on each glycosylation site are required for characterization of the glycoprotein products, and sialic acid analysis, glycan mapping analysis are required for specification. By suggesting the details of requirement for glycan analysis, we hope this guideline facilitates the development of glycoprotein products and provides the scientific rationale of the glycan structure analysis.
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KEYWORD
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Protein products, Glycoprotein products, Glycan, Characterization, Specification
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