Stabilized formulations containing anti-angptl3 antibodies
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsDingjiang LIU, Andria SKINNER
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Abstract
The present invention provides stable pharmaceutical formulations comprising a human antibody that specifically binds to human angiopoietin-like protein 3 (ANGPTL3). The formulations may contain, in addition to an anti-ANGPTL3 antibody, a buffer; an organic cosolvent; at least one viscosity modifier, and optionally at least one amino acid. The pharmaceutical formulations of the present invention can be administered via intravenous infusion or subcutaneously and exhibit a substantial degree of antibody stability after storage for several months.
Claims40
A liquid pharmaceutical formulation comprising:
- (a) an antibody or antigen-binding fragment that binds specifically to human angiopoietin-like protein 3 (ANGPTL3);
- (b) a buffer;
- (c) an organic cosolvent;
- and (d) at least one viscosity modifier, wherein the formulation has a pH of 6.0±0.3.
A liquid pharmaceutical formulation comprising:
- i) 150 mg/mL±22.25 mg/mL anti-ANGPT3 antibody or an antigen-binding fragment thereof;
- ii) from 5 mM±1 mM to 20 mM±4 mM histidine;
- iii) from 0.1% w/v±0.05% to 0.5% w/v±0.25% polysorbate 80;
- iv) from 50 mM to 75 mM arginine-HCL;
- and v) from 1%±0.2% to 5%±1% w/v proline, at pH 6.0±0.3.
Dependencies are inferred from the claim text.