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US 2021/0230283 A1Published application
Stabilized Formulations Containing Anti-Interleukin-6 Receptor (IL-6R) Antibodies
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsDaniel B. Dix, Kenneth S. Graham, Douglas Kamen, Scott M. Walsh
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Abstract
The present invention provides pharmaceutical formulations comprising a human antibody that specifically binds to human interleukin-6 receptor (hIL-6R). The formulations may contain, in addition to an anti-hIL-6R antibody, at least one amino acid, at least one sugar, and/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.
Claims31
A pharmaceutical formulation comprising:
- (i) a human antibody that specifically binds to human interleukin-6 receptor (hIL-6R);
- (ii) histidine;
- and (iii) a carbohydrate.
A pharmaceutical formulation comprising:
- (i) about 5 to 200 mg/mL of a human antibody that specifically binds to human interleukin-6 receptor (hIL-6R);
- (ii) about 5 to 50 mM histidine;
- and (iii) about 1 to 20% sucrose.
A pharmaceutical formulation comprising:
- (i) about 175 mg/mL of a human antibody that specifically binds to human interleukin-6 receptor (hIL-6R), wherein said antibody comprises a heavy chain and light chain variable region (HCVR/LCVR) amino acid sequence pair of SEQ ID NOs:18/26;
- (ii) about 25 mM histidine;
- (iii) about 5% sucrose;
- (iv) about 0.2% polysorbate 20;
- and (v) about 50 mM arginine.
2 more elements
Dependencies are inferred from the claim text.