METHODS AND FORMULATIONS WHICH ALLOW THE MODULATION OF IMMUNE RESPONSES RELATED TO THE ADMINISTRATION OF A BIOPHARMACEUTICAL DRUG

摘要

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).

主权项

1. A method of preparing a pharmaceutical formulation comprising a biopharmaceutical drug, which method allows the modulation of immune responses related to the administration thereof,
said method comprising the steps of: (i) providing a buffer comprising
hexanedioic acid or at least one salt thereof, and/orcitric acid or at least one salt thereof (ii) contacting said buffer with a biopharmaceutical drug (iii) optionally lyophilising the formulation, and (iv) obtaining the formulation or suspension of (ii) and/or the lyophilised formulation of (iii).