stable aqueous pharmaceutical formulations, their use, article of manufacture, methods of reducing aggregation of a therapeutic monoclonal antibody, and method of producing a pharmaceutical formulation.

摘要

patent summary: "antibody formulations". The present invention relates to stable aqueous pharmaceutical formulations comprising a therapeutic antibody, trehalose, a buffer, and optional surfactant, and having a ph ranging from about 5.5 to about 7.0. The invention also provides methods for producing such formulations and methods of using such formulations. In recent years, advances in biotechnology have made it possible to produce a variety of proteins for pharmaceutical applications using recombinant DNA techniques.