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AssigneesThe Regents of the University of Colorado, a body corporate, Barofold, Inc.
InventorsMatthew SEEFELDT, Theodore W. RANDOLPH, Amber Haynes FRADKIN, John CARPENTER
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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.
A method for reducing immunogenicity of a therapeutic protein, comprising:
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A method for formulating a therapeutic protein, comprising:
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A pharmaceutical composition comprising a therapeutic protein, wherein subvisible particulates of the therapeutic protein having a size in the range of about 0.1 to about 10 microns, are present below an immunogenic threshold level.
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A method for reducing the immunogenicity of a protein preparation comprising:
A method for producing an etanercept preparation with reduced aggregate content, comprising:
Dependencies are inferred from the claim text.