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Last Updated: September 23, 2020

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Patent: 8,697,848

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Summary for Patent: 8,697,848
Title:Method for reducing immunogenicity of therapeutic protein compositions
Abstract: The present invention provides methods for reducing and/or evaluating the immunogenic potential of a therapeutic protein preparation. The present invention further provides pharmaceutical compositions of therapeutic proteins and methods of treatment with the same, the compositions having low immunogenic potential and/or improved efficacy. The invention achieves these goals by evaluating therapeutic protein preparations for subvisible protein particulates, which can contribute significantly to the overall immunogenic potential of the protein preparation. Further, by maintaining the content of such subvisible protein particulates to below an immunogenic threshold level, the resulting pharmaceutical composition is less likely to result in a loss of tolerance (e.g., upon repeated administration), thereby improving both the safety and efficacy profile of the therapeutic.
Inventor(s): Seefeldt; Matthew (Denver, CO), Randolph; Theodore W. (Niwot, CO), Fradkin; Amber Haynes (Golden, CO), Carpenter; John (Denver, CO)
Assignee: The Regents of the University of Colorado (Denver, CO) Barofold, Inc. (Aurora, CO)
Application Number:13/186,169
Patent Claims:see list of patent claims

Details for Patent 8,697,848

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Immunex ENBREL etanercept VIAL; SUBCUTANEOUS 103795 001 1998-11-02   Start Trial The Regents of the University of Colorado (Denver, CO) Barofold, Inc. (Aurora, CO) 2030-07-19 RX Orphan search
Immunex ENBREL etanercept SYRINGE 103795 002 1998-11-02   Start Trial The Regents of the University of Colorado (Denver, CO) Barofold, Inc. (Aurora, CO) 2030-07-19 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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