Recombinant antibodies having a unique glycan spectrum, produced from genome-edited CHO host cells, and methods for producing the same.

Editing the FUT8 gene in CHO cells using CRISPR/Cas9 solved the problem of glycan heterogeneity in the production of recombinant antibodies in CHO cells, achieving a highly uniform glycan structure and enhanced ADCC activity, thereby improving the drug stability and biological activity of the antibody.

JP2026113676APending Publication Date: 2026-07-07BIO THERA SOLUTIONS LTD

Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
BIO THERA SOLUTIONS LTD
Filing Date
2026-04-08
Publication Date
2026-07-07

AI Technical Summary

Technical Problem

When CHO cells are used to produce recombinant antibodies, the type and content of glycans are mismatched, leading to fluctuations in drug stability and bioactivity. In addition, traditional gene editing methods suffer from low efficiency and poor stability.

Method used

The FUT8 gene in CHO cells was edited using CRISPR/Cas9 technology. By knocking out the FUT8 enzyme activity, the glycan structure of the antibody was controlled, and recombinant antibodies with unique glycan profiles were prepared.

Benefits of technology

This study achieved a highly uniform glycan structure for the antibody, improved ADCC activity and drug stability, enhanced FcγRIIIA receptor binding affinity, reduced glycan heterogeneity, and improved the antibody's biological activity and efficacy.

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Abstract

Unique glycan specs produced from genome-edited CHO host cells The present invention provides recombinant antibodies having a cleavage molecule and a method for producing the same. [Solution] The present invention relates to a method for producing recombinant antibodies having a unique glycan spectrum from genome-edited CHO host cells. The method of the present invention is a method for producing recombinant antibodies having a unique glycan spectrum from edited CHO host cells by editing the fut8 gene in CHO cells suitable for suspension culture in serum-free medium using TALEN technology. The unique glycan spectrum is characterized by having mainly non-fucosylated N-linked oligosaccharide chains, a low degree of N-glycosylation heterogeneity, and uniform glycans. Antibodies prepared by the method of the present invention have increased ADCC activity and antibody stability.
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