Anionic membrane-based purification method for antibody-drug conjugate, and antibody-drug conjugate

WO2025251432A1PCT designated stage Publication Date: 2025-12-11TOT BIOPHARM CO LTD
4 Cites 0 Cited by

Patent Information

Application Number
PCT/CN2024/114274
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-06-05
Filing Date
2024-08-23
Publication Date
2025-12-11

AI Technical Summary

Technical Problem

Existing technologies are insufficient to effectively remove free toxin linkers from antibody-drug conjugates, resulting in products that do not meet quality requirements. Furthermore, traditional purification methods are complex, costly, and inefficient.

Method used

Anion exchange membrane chromatography was used to induce negative charges in toxin linkers using negatively charged derivatizing reagents. The negatively charged or uncharged toxin linkers were then adsorbed by the anion exchange membrane under weakly acidic conditions, and purification was carried out using a buffer flow-through method.

Benefits of technology

This method enables efficient removal of free toxin linkers from antibody-drug conjugates, simplifies the process, reduces production costs, improves production efficiency, and is suitable for large-scale production.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure PCTCN2024114274-FTAPPB-I100001
    Figure PCTCN2024114274-FTAPPB-I100001
  • Figure PCTCN2024114274-FTAPPB-I100002
    Figure PCTCN2024114274-FTAPPB-I100002
  • Figure PCTCN2024114274-FTAPPB-I100003
    Figure PCTCN2024114274-FTAPPB-I100003
Patent Text Reader

Abstract

The present invention provides an anionic membrane-based purification method for an antibody-drug conjugate, and an antibody-drug conjugate. The method comprises: purifying an antibody-drug conjugate by using an anionic membrane, the antibody-drug conjugate containing free toxin linkers. The purification method of the present invention achieves a good impurity removal effect, and is carried out in an antibody-drug conjugate flow-through mode, with a high loading capacity (the treatment capacity of the antibody-drug conjugate is greater than 10 kg / L), and after purification, the level of free toxin linkers is below the limit of detection.
Need to check novelty before this filing date? Find Prior Art

Citation Information

Patent Citations

  • Method for preparing antibody-maytansine alkaloid medicine conjugate

    CN103254311A

  • Use of an ion exchange membrane to remove impurities from cell-binding agent cytotoxic agent conjugates

    CN105208876A

  • Antibody-high-activity cytotoxic small-molecule drug coupling drug as well as preparation and application thereof

    CN112691190A

  • Method for purifying antibody-conjugated drug based on anionic membrane and antibody-conjugated drug

    CN118290514A