Nova Patents
CA2882907C

Anti-tnf-alpha antibodies in solution and uses thereof

Abstract

A liquid aqueous pharmaceutical formulation is described which has a high protein concentration, a pH of between about 4 and about 8, and enhanced stability.

CA2882907C, drawing sheet 1
Sheet 1 of 1

Term

Term ended

Expired 15 August 2023, 3.1 years ago.

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28 claims: 1 independent, 27 dependent

  1. 1
    CA 02882907 2015-02-24 -32What is claimed is:1. A stable liquid aqueous pharmaceutical formulation comprising (a) a human IgGl anti-human Tumor Necrosis Factor alpha (TNFa) antibody, or an antigen-binding portion thereof, at a concentration of 45 to 105 mg/ml, (b) a polyol, (c) a polysorbate at a concentration of 0.1 to 10 mg/ml, and (d) a buffer system comprising succinate and having a pH of 4.5 to 7.0, wherein the antibody comprises the light chain variable region and the heavy chain variable region of D2E7.
  2. 21
    A stable liquid aqueous pharmaceutical formulation comprising (a) 45 to 105 mg/ml of a human IgGl anti-human Tumor Necrosis Factor alpha (hTNFa) antibody, (b) trehalose, (c) 0.1-10 mg/ml of poly sorbate 80, and (d) a buffer system comprising succinate and having a pH of 4.5 to 7.0, wherein the antibody comprises the light chain variable region and the heavy chain variable region of D2E7. CA 02882907 2015-02-24 -3422. The formulation of claim 21, wherein the concentration of the antibody is from 50100 mg/ml.
Independent claims2