CPC C07K 16/40 (2013.01) [A61K 39/3955 (2013.01); A61K 39/39591 (2013.01); A61K 47/22 (2013.01); A61K 47/26 (2013.01); A61M 5/31513 (2013.01); A61M 5/3202 (2013.01); C07K 2317/565 (2013.01); C07K 2317/94 (2013.01)] | 3 Claims |
1. A pre-filled pen delivery device comprising a liquid pharmaceutical formulation, wherein the liquid pharmaceutical formulation consists of:
(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 or antigen-binding fragment comprises a heavy chain variable domain (HCVD) comprising SEQ ID NO:1, and a light chain variable domain (LCVD) comprising SEQ ID NO:5;
(b) 5±0.75 mM to 10±1.5 mM histidine, pH 6.0±0.3;
(c) 0.01±0.0015% w/v polysorbate 20; and
(d) 10±1.5% w/v sucrose.
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