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Stabilized formulations containing anti-Ang2 antibodies

  • US 9,402,898 B2
  • Filed: 01/22/2013
  • Issued: 08/02/2016
  • Est. Priority Date: 01/23/2012
  • Status: Active Grant
First Claim
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1. A stable pharmaceutical formulation comprising:

  • (i) an antibody at a concentration of from 20±

    3 mg/ml to 60±

    9 mg/ml that binds specifically to human angiopoietin 2 (human Ang-2), wherein the antibody comprises a heavy chain variable domain (HCVD) having the amino acid sequence of SEQ ID NO;

    18 and a light chain variable domain (LCVD) having the amino acid sequence of SEQ ID NO;

    20;

    (ii) histidine at a concentration of 10±

    1.5 mM;

    (iii) polysorbate 20 in an amount of 0.2% w/v±

    0.03% w/v; and

    (iv) sucrose in an amount of 10% w/v±

    1.5% w/v,wherein the formulation has a pH of 6±

    0.3, and at least 92% of the antibody has native conformation when the formulation is kept at about 45°

    C. for up to about 28 days.

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