METHODS AND FORMULATIONS WHICH ALLOW THE MODULATION OF IMMUNE RESPONSES RELATED TO THE ADMINISTRATION OF A BIOPHARMACEUTICAL DRUG
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United States of America Patent
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Jun 2, 2016
app pub date -
Jul 21, 2014
filing date -
Jul 21, 2014
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The present invention is related to methods of preparing a pharmaceutical formulation comprising a biopharmaceutical drug, which methods allows the modulation of immune responses related to the administration thereof. The formulation comprises a buffer comprising hexanedioic acid or at least one salt thereof, and/or citric acid or at least one salt thereof. The present invention further relates to method of using hexanedioic acid or at least one salt thereof, and/or citric acid or at least one salt thereof, to modulate the immunogenicity of a pharmaceutical formulation, to a pharmaceutical formulation as such, and to methods of modulating or determining immune responses related to the administration of a pharmaceutical formulation (FIG. 4).
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