Afucosylation modification

Partial knockout of the FX gene in host cells and strategic fucose addition during production allow for efficient and reproducible production of monoclonal antibodies with a desired afucosylation ratio, addressing inefficiencies in existing methods and ensuring consistent product quality.

WO2026117415A1PCT designated stage Publication Date: 2026-06-04GENENTECH INC
View PDF 27 Cites 0 Cited by

Patent Information

Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
GENENTECH INC
Filing Date
2025-11-19
Publication Date
2026-06-04

AI Technical Summary

Technical Problem

Current methods for producing monoclonal antibodies with a predetermined ratio of fucosylated to afucosylated forms are inefficient and require multiple manufacturing runs, posing challenges in maintaining product quality attributes and meeting drug supply demands.

Method used

Utilizing partial knockout (FXpKO) host cells and strategic fucose addition during the production process to achieve a desired ratio of fucosylated and afucosylated monoclonal antibodies without altering production parameters, and employing FACS analysis for clone screening to identify clones with varying levels of FX gene knockout.

Benefits of technology

Enables the reproducible production of monoclonal antibodies with a desired afucosylation level from a single production run, reducing the need for multiple manufacturing runs and ensuring consistent product quality.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure US2025056055_04062026_PF_FP_ABST
    Figure US2025056055_04062026_PF_FP_ABST
Patent Text Reader

Abstract

The present application relates to methods of producing a protein in fucosylated and afucosylated forms at a predetermined ratio by partially or completely inactivating GDP-keto-6-deoxymannose-3,5-epimerase, 4-reductae (GDP-L-fucose synthase, EC 1.1.1.271) and additionally by adjusting the presence or absence of fucose source during culturing.
Need to check novelty before this filing date? Find Prior Art

Citation Information

Patent Citations

  • Interleukin-4 receptors

    EP0367566A1

  • Type II interleukin-1 receptors

    EP0460846A1

  • Thomas l

    US30985A

  • Serum-free cell culture medium and process for making same

    US4560655A

  • Serum-free, synthetic, completely chemically defined tissue culture media

    US4657866A