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

2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Jian Xu ◽  
Zhihui Shao ◽  
Xiaoxiong Han ◽  
Yingfeng Huang ◽  
Xun Zou ◽  
...  
Keyword(s):  
Cell Culture ◽  
Data Analysis ◽  
Multivariate Statistics ◽  
Multivariate Data Analysis ◽  
Experimental Methods ◽  
Analysis Method ◽  
Glycosylation Pattern ◽  
Pattern Similarity ◽  
Basal Media ◽  
Specific Distance

AbstractThe 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.

scholarly journals Similarity Assessment by Multivariate Statistics Method Based on Distance Between Biosimilar and Originator

2020 ◽  
Author(s):  
Jian Xu ◽  
Zhihui Shao ◽  
Xiaoxiong Han ◽  
Yingfeng Huang ◽  
Xun Zou ◽  
...  
Keyword(s):  
Cell Culture ◽  
Data Analysis ◽  
Design Of Experiments ◽  
Multivariate Data Analysis ◽  
Culture Conditions ◽  
Analysis Method ◽  
Glycosylation Pattern ◽  
Pattern Similarity ◽  
And Function ◽  
Specific Distance

Abstract The development of biosimi lar products or follow on biologics has been flourishing in recent years because of lower price than originators. In th is study, a multivariate data analysis method based on JMP software was proposed to assess the glycosylation pattern similarity of antibo dy candidates from different conditions in optimization experiment with reference. A specific distance was generated by t specific distance was generated by this method and indicated the glycoform similarity his method and indicated the glycoform similarity between biosimilar and reference. This method can be applied to analyze the similaritbetween biosimilar and reference. This method can be applied to analyze the similarity of y of other physicochemical and function characters between followother physicochemical and function characters between follow--on biologics and originators. on biologics and originators. Then the design of experiThen the design of experiments method can be realized to optimize culture conditions of cellments method can be realized to optimize culture conditions of cell culture to attain similar antibody candidatesculture to attain similar antibody candidates..

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