Method for removing impurities through caprylic acid and depth filtration

The method using caprylic acid and chromatography effectively reduces host cell proteins in biopharmaceuticals, enhancing purification yield and reducing adverse reactions by precipitating and removing impurities.

WO2026142300A1PCT designated stage Publication Date: 2026-07-02SAMSUNG BIOEPIS CO LTD

Patent Information

Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
SAMSUNG BIOEPIS CO LTD
Filing Date
2025-12-23
Publication Date
2026-07-02

AI Technical Summary

Technical Problem

Existing methods struggle to effectively reduce host cell protein (HCP) content in biopharmaceuticals while maintaining purification process yield, as even small amounts of HCP can cause adverse reactions such as immune responses or formation of anti-drug antibodies.

Method used

A method involving mixing a target protein sample with caprylic acid or its salt, followed by depth filtration and subsequent chromatography using cation exchange or mixed-mode chromatography to precipitate and remove impurities.

Benefits of technology

Significantly reduces HCP content to less than 100 ppm, ensuring the purity of the target protein and minimizing potential adverse reactions.

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Abstract

The present invention relates to a method for purifying a target protein to remove impurities such as host cell proteins (HCPs), a method for producing a target protein using same, and a hyaluronidase or a variant thereof obtained by using the method. When a target protein is purified using the method according to one aspect, HCPs can be effectively removed while improving the yield and / or purity of the target protein, and thus the method can be applied in a process of producing a recombinant protein such as a hyaluronidase or a variant thereof.
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