THERAPEUTIC PROTEIN COMPOSITIONS HAVING REDUCED IMMUNOGENICITY AND/OR IMPROVED EFFICACY
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United States of America Patent
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Issued Date -
Jan 7, 2016
app pub date -
Feb 21, 2014
filing date -
Jul 19, 2010
priority date (Note) -
Abandoned
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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.
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