Methods for chromatography and chromatography medium reuse

The method of loading high-density protein and impurity compositions onto chromatography media and cleaning with a linear salt gradient addresses the challenge of impurity separation and media longevity, enabling efficient and cost-effective reuse of chromatography media.

WO2024263504A2PCT designated stage expired Publication Date: 2024-12-26AMGEN INC
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Patent Information

Application Number
PCT/US2024/034277
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-06-20
Filing Date
2024-06-17
Publication Date
2024-12-26

AI Technical Summary

Technical Problem

Current chromatography methods face challenges in achieving high loading densities and robustly separating impurities and contaminants from proteins during downstream purification processes, particularly due to increased product titers and culture volumes, which limits the reuse and longevity of chromatography media.

Method used

A method involving loading a protein and impurity composition onto chromatography media at high densities, followed by cleaning with a linear salt gradient to regenerate the media, allowing for multiple cycles of use, using a combination of buffers and denaturing solutions to maintain performance.

Benefits of technology

Enables the reuse of chromatography media for extended cycles while maintaining product quality and purity, improving process efficiency and reducing costs by extending the media's lifespan and reducing buffer consumption.

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Abstract

Disclosed herein are methods for chromatography, including cleaning methods for chromatography medium that make use of a linear salt gradient. The disclosed methods may be used for frontal chromatography operations and for cleaning frontal chromatography media for reuse in biologics manufacturing.
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Citation Information

Patent Citations

  • Methods for harvesting mammalian cell cultures

    US11384378B2

  • Methods of constructing camel antibody libraries

    US20050037421A1

  • Binding constructs and methods for use thereof

    US20050136049A1

  • Animal cell culture

    US5672502A

  • Protein fragment complementation assays for the detection of biological or drug interactions

    US6270964B1

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