Developing a medium combination to attain similar glycosylation profile to originator by DoE and cluster analysis method

Abstract Glycosylation is critical for monoclonal antibody production because of its impact on pharmacokinetics and pharmacodynamics. Modulation of glycan profile is frequently needed in biosimilar development. However, glycosylation profile is not a single value like that of cell culture titer, hen...

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Autores principales:	Jian Xu, Zhihui Shao, Zhanqing Wang, Yingfeng Huang, Xun Zou, Yaling Shen
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/f5d25ef0fbbe444bbb4889a4a3d4babe
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spelling	oai:doaj.org-article:f5d25ef0fbbe444bbb4889a4a3d4babe2021-12-02T14:25:09ZDeveloping a medium combination to attain similar glycosylation profile to originator by DoE and cluster analysis method10.1038/s41598-021-86447-02045-2322https://doaj.org/article/f5d25ef0fbbe444bbb4889a4a3d4babe2021-03-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-86447-0https://doaj.org/toc/2045-2322Abstract Glycosylation is critical for monoclonal antibody production because of its impact on pharmacokinetics and pharmacodynamics. Modulation of glycan profile is frequently needed in biosimilar development. However, glycosylation profile is not a single value like that of cell culture titer, hence making it challenging for the Design of Experiment (DoE) methodology to be directly applied. In this study, a Her2-binding antibody was developed as a biosimilar to Herceptin. Cluster analysis was introduced to demonstrate the similarity of glycan profiles between the samples and the reference with specific value—distance. The glycosylation was subsequently optimized with the DoE method. Basal medium and feed medium were found to be the significant factors to the glycosylation pattern. Moreover, a combination of medium and feed strategy was developed to attain the most similar glycoprotein molecule to that of the originator biologic drug. This study may provide an additional option to evaluate multivariable factors and assess biosimilarity and/or comparability in monoclonal antibody production.Jian XuZhihui ShaoZhanqing WangYingfeng HuangXun ZouYaling ShenNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Jian Xu Zhihui Shao Zhanqing Wang Yingfeng Huang Xun Zou Yaling Shen Developing a medium combination to attain similar glycosylation profile to originator by DoE and cluster analysis method
description	Abstract Glycosylation is critical for monoclonal antibody production because of its impact on pharmacokinetics and pharmacodynamics. Modulation of glycan profile is frequently needed in biosimilar development. However, glycosylation profile is not a single value like that of cell culture titer, hence making it challenging for the Design of Experiment (DoE) methodology to be directly applied. In this study, a Her2-binding antibody was developed as a biosimilar to Herceptin. Cluster analysis was introduced to demonstrate the similarity of glycan profiles between the samples and the reference with specific value—distance. The glycosylation was subsequently optimized with the DoE method. Basal medium and feed medium were found to be the significant factors to the glycosylation pattern. Moreover, a combination of medium and feed strategy was developed to attain the most similar glycoprotein molecule to that of the originator biologic drug. This study may provide an additional option to evaluate multivariable factors and assess biosimilarity and/or comparability in monoclonal antibody production.
format	article
author	Jian Xu Zhihui Shao Zhanqing Wang Yingfeng Huang Xun Zou Yaling Shen
author_facet	Jian Xu Zhihui Shao Zhanqing Wang Yingfeng Huang Xun Zou Yaling Shen
author_sort	Jian Xu
title	Developing a medium combination to attain similar glycosylation profile to originator by DoE and cluster analysis method
title_short	Developing a medium combination to attain similar glycosylation profile to originator by DoE and cluster analysis method
title_full	Developing a medium combination to attain similar glycosylation profile to originator by DoE and cluster analysis method
title_fullStr	Developing a medium combination to attain similar glycosylation profile to originator by DoE and cluster analysis method
title_full_unstemmed	Developing a medium combination to attain similar glycosylation profile to originator by DoE and cluster analysis method
title_sort	developing a medium combination to attain similar glycosylation profile to originator by doe and cluster analysis method
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/f5d25ef0fbbe444bbb4889a4a3d4babe
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Developing a medium combination to attain similar glycosylation profile to originator by DoE and cluster analysis method

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