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.
Highlights
IntroductionDuring the past two decades, biologic products ( termed “biopharmaceuticals”) have been developed intensively by companies for treating cancer and autoimmune diseases such as rheumatoid arthritis
During the past two decades, biologic products have been developed intensively by companies for treating cancer and autoimmune diseases such as rheumatoid arthritis
It is difficult to recognize the effect of the supplements, and the effect cannot be tested by a statistical method, because a specific number to represent the similarity is lacking
Summary
During the past two decades, biologic products ( termed “biopharmaceuticals”) have been developed intensively by companies for treating cancer and autoimmune diseases such as rheumatoid arthritis. Six of the top pharmaceutical product sales in 2019 were biologic products (Table S1, Additional file 1). There has been an increasing trend toward the development of biosimilars, considering market interest and improved access to biologics. Biosimilar products can offer lower prices to optimize efficiencies across healthcare systems. Biopharmaceuticals typically involve the expression of the gene using living cells followed by purification and formulation to acquire stable drug products. They are large, complex and heterogeneous compared to
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