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Formulation of human antibodies for treating TNF-α associated disorders

  • US 9,302,011 B2
  • Filed: 10/15/2015
  • Issued: 04/05/2016
  • Est. Priority Date: 08/16/2002
  • Status: Expired due to Term
First Claim
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1. A stable liquid aqueous pharmaceutical formulation comprising(a) 50 mg/ml of a human IgG1 anti-human Tumor Necrosis Factor alpha (TNFα

  • ) antibody, wherein the antibody comprises a light chain variable region comprising the amino acid sequence of SEQ ID NO;

    1and a heavy chain variable region comprising the amino acid sequence of SEQ ID NO;

    2;

    (b) a polyol;

    (c) a polysorbate; and

    (d) a buffer system comprising an organic acid;

    wherein the formulation has a pH of 4 to 8, and wherein the formulation is suitable for subcutaneous injection.

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