Method for purifying fusion proteins containing an IgG Fc domain

The method of multimodal and cation exchange chromatography addresses inefficiencies in purifying fusion proteins with an IgG Fc domain, achieving low endotoxin levels and high purity through a streamlined process.

JP2026094217APending Publication Date: 2026-06-09ALTEOGEN INC

Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
ALTEOGEN INC
Filing Date
2026-02-20
Publication Date
2026-06-09

AI Technical Summary

Technical Problem

Existing methods for purifying fusion proteins with an IgG Fc domain are inefficient in removing endotoxins and achieving high purity, particularly in large-scale production.

Method used

A method involving multimodal chromatography and cation exchange chromatography without anion exchange, including steps of culturing, primary chromatography, and subsequent purification using multimodal and cation exchange chromatography, to achieve endotoxin levels below 0.05 EU/mg and size exclusion HPLC purity of 98% or higher.

Benefits of technology

Enables efficient and large-scale production of high-purity fusion proteins with an IgG Fc domain, effectively removing impurities and maintaining protein integrity.

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Abstract

This invention provides a method for effectively purifying fusion proteins containing an IgG Fc domain. [Solution] A method for purifying a fusion protein having an IgG Fc domain, which yields a fusion protein having an IgG Fc domain with endotoxin <0.05 EU / mg or a size exclusion HPLC purity of 98% or higher. The method comprises the steps of: a) culturing cells that produce a fusion protein having an IgG Fc domain; b) recovering the protein from the cells cultured in a); c) purifying the protein recovered in b) by primary chromatography; and d) purifying the protein purified in c) by primary chromatography by multimodal chromatography and cation exchange chromatography, without using anion exchange chromatography.
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