Stabilized formulations containing anti-interleukin-4 receptor (IL-4R) antibodies

摘要

The present invention provides pharmaceutical formulations comprising a human antibody that specifically binds to human interleukin-4 receptor (hIL-4R). The formulations may contain, in addition to an anti-hIL-4R antibody, at least one amino acid, at least one sugar, or at least one non-ionic surfactant. The pharmaceutical formulations of the present invention exhibit a substantial degree of antibody stability after storage for several months.

主权项

1. A pre-filled syringe composition comprising a liquid pharmaceutical formulation, wherein the liquid pharmaceutical formulation comprises:
(a) 100±10 mg/mL to 200±20 mg/mL of an antibody or antigen-binding fragment thereof that specifically binds human interleukin-4 receptor alpha (hIL-4Rα), wherein the antibody comprises a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO: 1, and a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO:5; (b) 10 mM to 15 mM acetate; (c) 15 mM to 25 mM histidine; (d) 2.5% w/v to 10% w/v sucrose; (e) 0.1% w/v to 0.3% w/v polysorbate; and (f) 20 mM to 100 mM arginine; wherein said liquid pharmaceutical formulation has a pH of from 5.6 to 6.2 and is contained within a syringe.