Purification method for novel heparan-N-sulfatase

A comprehensive purification process for heparan-N-sulfatase using multimode chromatography and additional techniques addresses stability and impurity issues, resulting in a high-purity form suitable for therapeutic use.

JP7883678B2Active Publication Date: 2026-07-01GC BIOPHARMA CORP
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Patent Information

Application Number
JP2025540724
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2022-09-19
Filing Date
2023-09-18
Publication Date
2026-07-01
Estimated Expiration
2043-09-18

AI Technical Summary

Technical Problem

Existing methods for purifying heparan-N-sulfatase suffer from reduced stability and inadequate removal of host cell proteins (HCP) and other impurities during the purification process, compromising the quality and safety of the final product.

Method used

A multi-step purification process involving multimode chromatography, caprylic acid precipitation, and additional chromatography techniques such as anion exchange, cation exchange, and affinity chromatography, along with solvent/detergent treatment and nanofiltration, to enhance stability and purity of heparan-N-sulfatase.

Benefits of technology

The method significantly improves the stability and purity of heparan-N-sulfatase by effectively removing impurities and enhancing its stability, making it suitable for enzyme replacement therapy in treating Sanfilippo Syndrome.

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Abstract

The present invention relates to a method for purifying heparan-N-sulfatase from a heparan-N-sulfatase-containing solution containing one or more impurities, the method comprising the steps of: obtaining an eluate by multi-mode chromatography (MMC); and obtaining a supernatant by caprylic acid precipitation. The heparan-N-sulfatase purification method according to the present invention not only enables highly efficient removal of HCPs (host cell proteins), but also significantly improves the purity and stability of the purified heparan-N-sulfatase.
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Citation Information

Patent Citations

  • Methods for purifying sulfatase proteins

    JP2020532301A

  • Protein purification by caprylic acid (octanoic acid) precipitation

    US20120101262A1