文献类型：期刊文献

中文题名：Similarity assessment by multivariate statistics method based on the distance between biosimilar and originator

作者：Jian Xu[1];Zhihui Shao[2];Xiaoxiong Han[3];Yingfeng Huang[4];Xun Zou[5];Yaling Shen[1]

机构：[1]State Key Laboratory of Bioreactor Engineering,Shanghai Collaborative Innovation Center for Biomanufacturing Technology,East China University of Science and Technology,130 Mei Long Road,Shanghai,200237,China;[2]CAS Key Laboratory of Synthetic Biology,CAS Center for Excellence in Molecular Plant Sciences,Institute of Plant Physiology and Ecology,Chinese Academy of Sciences,Shanghai,China;[3]Process Development Department,Dragon Sail Pharmaceutical,Shanghai,China;[4]R&D Laboratories,Dragonboat Biopharmaceutical,Shanghai,China;[5]Shanghai Sanjin Bioscience and Technology,Shanghai,China

年份：2021

卷号：8

期号：1

起止页码：1578

中文期刊名：Bioresources and Bioprocessing

外文期刊名：生物资源与生物加工(英文)

语种：英文

中文关键词：Biosimilar;Cluster analysis;Glycosylation pattern;Multivariate statistics method;Similarity

摘要：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.