High-Purity Recombinant Human Albumin Preparation Method
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
- Monitor for USPTO patent grant proceedings
- Review patent claims for potential freedom-to-operate implications
Archived snapshot
Apr 12, 2026GovPing 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.
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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