文献类型：期刊文献

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

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

机构：[1]East China Univ Sci & Technol, Shanghai Collaborat Innovat Ctr Biomfg Technol, State Key Lab Bioreactor Engn, 130 Mei Long Rd, Shanghai 200237, Peoples R China;[2]Chinese Acad Sci, CAS Key Lab Synthet Biol, CAS Ctr Excellence Mol Plant Sci, Inst Plant Physiol & Ecol, Shanghai, Peoples R China;[3]Dragon Sail Pharmaceut, Proc Dev Dept, Shanghai, Peoples R China;[4]Dragonboat Biopharmaceut, R&D Labs, Shanghai, Peoples R China;[5]Shanghai Sanjin Biosci & Technol, Shanghai, Peoples R China

年份：2021

卷号：8

期号：1

外文期刊名：BIORESOURCES AND BIOPROCESSING

收录：;EI(收录号：20224513086881);WOS:【SCI-EXPANDED(收录号:WOS:000634826600001)】；

语种：英文

外文关键词：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.