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Stabilized formulations containing anti-PCSK9 antibodies

  • US 8,795,669 B2
  • Filed: 07/27/2012
  • Issued: 08/05/2014
  • Est. Priority Date: 07/28/2011
  • Status: Active Grant
First Claim
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1. A liquid pharmaceutical formulation comprising:

  • (a) 50±

    7.5 mg/mL to 250±

    37.5 mg/mL of an antibody or antigen-binding fragment thereof that specifically binds human proprotein convertase subtilisin kexin-9 (PCSK9), wherein the antibody comprises a heavy chain complementarity determining region (HCDR) 1 of SEQ ID NO;

    2, an HCDR2 of SEQ ID NO;

    3, an HCDR3 of SEQ ID NO;

    4, a light chain complementarity determining region (LCDR) 1 of SEQ ID NO;

    6, an LCDR2 of SEQ ID NO;

    7, and an LCDR3 of SEQ ID NO;

    8;

    (b) 10±

    1.5 mM histidine (pH 6.0±

    0.3);

    (c) 0.01±

    0.0015% w/v polysorbate 20; and

    (d) 10±

    1.5% sucrose.

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