Antibody glycosylation modification regulation and control method, device and application

By constructing engineered glycosyltransferase strains and optimizing the fermentation culture system, combined with an online monitoring system for precise reaction control, the problems of low efficiency and poor specificity of existing antibody glycosylation modification methods have been solved. This has enabled highly efficient and specific glycosylation modification, which is suitable for large-scale production and improves the biological activity and stability of antibody drugs.

CN122464987APending Publication Date: 2026-07-28义翘神州(泰州)科技有限公司
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Patent Information

Application Number
CN202610572069.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-04-28
Publication Date
2026-07-28

AI Technical Summary

Technical Problem

Existing antibody glycosylation modification methods suffer from low modification efficiency, poor specificity, difficulty in large-scale production, and inability to meet the regulatory requirements of novel antibody drugs such as bispecific antibodies.

Method used

By constructing engineered glycosyltransferase strains, optimizing the fermentation culture system, and combining it with an online monitoring system for precise reaction regulation, antibody glycosylation modification was achieved.

Benefits of technology

It achieves efficient and highly specific glycosylation modification, with a target glycan modification rate of over 90% and batch-to-batch variation of less than 3%, making it suitable for large-scale production, significantly reducing costs, and improving the biological activity and stability of antibody drugs.

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Abstract

The invention discloses an antibody glycosylation modification regulation and control method, an antibody glycosylation modification regulation and control device and application, and relates to the technical field of biological pharmacy and protein engineering.According to the method, a glycosyl transferase engineering strain is constructed, a fermentation culture system is optimized, and modification reaction conditions are precisely regulated and controlled; directional regulation and control on modification types, modification sites and modification proportions of N-carbohydrate chains and O-carbohydrate chains of the antibody are realized; the technical problems that an existing modification method is low in modification efficiency, poor in specificity and insufficient in product uniformity are solved, the target carbohydrate chain modification proportion can be increased to 90% or above, the purity of a modified product is larger than or equal to 98%, and the method is suitable for glycosylation modification optimization of therapeutic monoclonal antibodies, bispecific antibodies and antibody drug conjugates and has good application prospects. According to the method, the bioactivity and pharmacokinetic performance of the antibody are remarkably improved, the ADCC activity is improved by 3-5 times, the CDC activity is improved by 2-4 times, and the method has the advantages of being high in operation controllability, good in large-scale production adaptability and high in cost effectiveness.
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