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| The Glycosylation Design and Control of Monoclonal Antibody by Cell Culture |
JIANG Yi-fan1,JIA Yu1,Wang Long2,WANG Zhi-ming1,*( ) |
1 New Drug Research and Development Company Limited, North China Pharmaceutical Corporation, State Key Laboratory of Antibody Drug Development, Shijiazhuang 050015, China
2 Shanghai Duoning Biotechnology Co. Ltd., Shanghai 201619, China |
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Abstract In monoclonal antibody drug production process, its glycosylation modification may be affected by a variety of process parameters, therefore come into being heterogeneity easily, and Antibody glycosylation is closely related to antibody half-life, immunogenicity, ADCC, CDC, and so on, so glycosylation is an important quality index for monoclonal antibody drugs, It is necessary to pay attention to and regulate the development of biological drugs, especially in the development of biosimilar. This paper strengthens the understanding of stable and consistent glycosylation by discussing the influence of various important control indicators in the culture process, such as pH, DO, osmolarity and temperature, to guide the efficacy and safety of monoclonal antibody drugs.
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Received: 03 January 2019
Published: 18 September 2019
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Corresponding Authors:
Zhi-ming WANG
E-mail: wzm3994@163.com
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