Similarity assessment by multivariate statistics method based on the distance between biosimilar and originator

Abstract The development of biosimilar products or follow-on biologics has been flourishing in recent years because of their lower price than the originators. In this study, a multivariate data analysis method based on JMP software was proposed to assess the glycosylation pattern similarity of antib...

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Main Authors:	Jian Xu, Zhihui Shao, Xiaoxiong Han, Yingfeng Huang, Xun Zou, Yaling Shen
Format:	Article
Language:	English
Published:	SpringerOpen 2021-03-01
Series:	Bioresources and Bioprocessing
Subjects:	Biosimilar Cluster analysis Glycosylation pattern Multivariate statistics method Similarity
Online Access:	https://doi.org/10.1186/s40643-021-00378-2

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spelling	doaj-a9d889893fda4d5b9bd639b6b508cc0c2021-04-04T11:42:10ZengSpringerOpenBioresources and Bioprocessing2197-43652021-03-01811710.1186/s40643-021-00378-2Similarity assessment by multivariate statistics method based on the distance between biosimilar and originatorJian Xu0Zhihui Shao1Xiaoxiong Han2Yingfeng Huang3Xun Zou4Yaling Shen5State Key Laboratory of Bioreactor Engineering, Shanghai Collaborative Innovation Center for Biomanufacturing Technology, East China University of Science and TechnologyCAS Key Laboratory of Synthetic Biology, CAS Center for Excellence in Molecular Plant Sciences, Institute of Plant Physiology and Ecology, Chinese Academy of SciencesProcess Development Department, Dragon Sail PharmaceuticalR&D Laboratories, Dragonboat BiopharmaceuticalShanghai Sanjin Bioscience and TechnologyState Key Laboratory of Bioreactor Engineering, Shanghai Collaborative Innovation Center for Biomanufacturing Technology, East China University of Science and TechnologyAbstract The development of biosimilar products or follow-on biologics has been flourishing in recent years because of their lower price than the originators. In this study, a multivariate data analysis method based on JMP software was proposed to assess the glycosylation pattern similarity of antibody candidates from different conditions in optimization experiments with a reference. A specific distance was generated by this method and indicated the glycoform similarity between the biosimilar and the reference. This method can be applied to analyze the similarity of other physicochemical and functional characteristics between follow-on biologics and originators. Then, the design of experimental methods can be realized to optimize the conditions of cell culture to attain similar antibody candidates. A higher concentration of GlcNAc added to the basal media made the glycan of the antibody more similar to the glycan of the reference in this study.https://doi.org/10.1186/s40643-021-00378-2BiosimilarCluster analysisGlycosylation patternMultivariate statistics methodSimilarity
collection	DOAJ
language	English
format	Article
sources	DOAJ
author	Jian Xu Zhihui Shao Xiaoxiong Han Yingfeng Huang Xun Zou Yaling Shen
spellingShingle	Jian Xu Zhihui Shao Xiaoxiong Han Yingfeng Huang Xun Zou Yaling Shen Similarity assessment by multivariate statistics method based on the distance between biosimilar and originator Bioresources and Bioprocessing Biosimilar Cluster analysis Glycosylation pattern Multivariate statistics method Similarity
author_facet	Jian Xu Zhihui Shao Xiaoxiong Han Yingfeng Huang Xun Zou Yaling Shen
author_sort	Jian Xu
title	Similarity assessment by multivariate statistics method based on the distance between biosimilar and originator
title_short	Similarity assessment by multivariate statistics method based on the distance between biosimilar and originator
title_full	Similarity assessment by multivariate statistics method based on the distance between biosimilar and originator
title_fullStr	Similarity assessment by multivariate statistics method based on the distance between biosimilar and originator
title_full_unstemmed	Similarity assessment by multivariate statistics method based on the distance between biosimilar and originator
title_sort	similarity assessment by multivariate statistics method based on the distance between biosimilar and originator
publisher	SpringerOpen
series	Bioresources and Bioprocessing
issn	2197-4365
publishDate	2021-03-01
description	Abstract The development of biosimilar products or follow-on biologics has been flourishing in recent years because of their lower price than the originators. In this study, a multivariate data analysis method based on JMP software was proposed to assess the glycosylation pattern similarity of antibody candidates from different conditions in optimization experiments with a reference. A specific distance was generated by this method and indicated the glycoform similarity between the biosimilar and the reference. This method can be applied to analyze the similarity of other physicochemical and functional characteristics between follow-on biologics and originators. Then, the design of experimental methods can be realized to optimize the conditions of cell culture to attain similar antibody candidates. A higher concentration of GlcNAc added to the basal media made the glycan of the antibody more similar to the glycan of the reference in this study.
topic	Biosimilar Cluster analysis Glycosylation pattern Multivariate statistics method Similarity
url	https://doi.org/10.1186/s40643-021-00378-2
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Similarity assessment by multivariate statistics method based on the distance between biosimilar and originator

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