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High-Purity Recombinant Human Albumin Preparation Method

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Summary

Tonghua Anrate Biopharmaceutical Co., Ltd. has filed USPTO Patent Application US20260098079A1 for a method of preparing high-purity recombinant human albumin using medium-long-chain fatty acid ligands and ion exchange chromatography. The application discloses a process where oleic acid, myristic acid, sodium palmitate, and sodium stearate are combined with recombinant human albumin in defined molar ratios with poloxamer to achieve high stability and purity through sequential anion and/or cation chromatography to remove truncated and modified albumins.

What changed

Tonghua Anrate Biopharmaceutical Co., Ltd. has filed USPTO Patent Application US20260098079A1, published April 9, 2026, covering a method for preparing high-purity and high-stability recombinant human albumin. The invention involves adding a fatty acid mixture (oleic acid, myristic acid, sodium palmitate, sodium stearate in molar ratios of 0.3:0.3:0.3:0.5 to recombinant human albumin) along with poloxamer, followed by sequential ion exchange chromatography to remove charge-heterogeneous and modified albumin variants. The application claims priority to filing date August 28, 2023.

For biopharmaceutical companies developing or manufacturing recombinant albumin-based therapeutics, this patent application signals potential intellectual property constraints on albumin purification methods. Competitors should monitor the prosecution history and eventual grant of this patent to assess freedom-to-operate for albumin-related processes.

What to do next

  1. Monitor for USPTO patent grant proceedings
  2. Review patent claims for potential freedom-to-operate implications

Archived snapshot

Apr 12, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← USPTO Patent Applications

METHOD FOR PREPARING HIGH-PURITY AND HIGH-STABILITY PROTEIN

Application US20260098079A1 Kind: A1 Apr 09, 2026

Assignee

TONGHUA ANRATE BIOPHARMACEUTICAL CO., LTD

Inventors

Wei XIANG, Zhilei YUE, Wenwen DONG, Tingchen GUAN

Abstract

The present invention provides a method for obtaining high-purity and high-stability recombinant human albumin, wherein medium-long-chain fatty acid ligands are added and proteins of charge heterogeneity are removed through anion and/or cation chromatography. An inventiveness of the present invention is that the mixed solution contains a fatty acid mixture and poloxamer, and the molar ratio of oleic acid, myristic acid, sodium palmitate, sodium stearate to recombinant human albumin is 0.3:0.3:0.3:0.5:1. Sequential use of ion exchange chromatography can effectively remove truncated albumins, mismatched or modified albumins from recombinant albumins, to remove albumins of charge heterogeneity and modified albumins, to obtain high-purity and high-stability human albumin.

CPC Classifications

C07K 14/765

Filing Date

2023-08-28

Application No.

19112951

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Last updated

Classification

Agency
USPTO
Published
April 9th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Substantive
Document ID
US20260098079A1
Docket
19112951

Who this affects

Applies to
Pharmaceutical companies Drug manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Patent examination IP licensing Recombinant protein manufacturing
Geographic scope
United States US

Taxonomy

Primary area
Intellectual Property
Operational domain
Legal
Topics
Pharmaceuticals Biotechnology

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