Patent ID: 11926670
Assignee: REGENERON PHARMACEUTICALS, INC.
Field: Pharmaceuticals (Chemistry)
Classification: CPC C  A | IPC A  C

Claim 0:
1. A pharmaceutical formulation comprising:
(i) a human antibody at a concentration of about 100 mg/ml to about 200 mg/ml that specifically binds to human interleukin-4 receptor alpha (hIL-4Ra), wherein the antibody comprises (a) a heavy chain variable region (HCVR) comprising heavy chain complementarity determining regions 1, 2 and 3 (HCDR1-HCDR2-HCDR3) that comprise the amino acid sequences of SEQ ID NO:2, SEQ ID NO:3, and SEQ ID NO:4, respectively; and (b) a light chain variable region (LCVR) comprising light chain complementarity determining regions 1, 2 and 3 (LCDR1-LCDR2-LCDR3) that comprise the amino acid sequences of SEQ ID NO:6, SEQ ID NO:7, and SEQ ID NO:8, respectively;
(ii) acetate at a concentration of about 2.5 mM to about 22.5 mM;
(iii) histidine at a concentration of about 10 mM to about 30 mM;
(iv) an organic cosolvent that is a nonionic polymer containing a polyoxyethylene moiety at a concentration of from 0.2% w/v to 1% w/v; and
(v) a sugar or a sugar alcohol at a concentration of about 2.5% w/v to about 10% w/v,
wherein the formulation has a pH of from 5.6 to 6.2, and wherein at least about 92% of the antibody is in its native conformation after two weeks of storage at about 45° C., as determined by size exclusion chromatography.