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US 12,582,716 B2Granted
Stable, aqueous formulations of antibodies that bind IL5 receptor
AssigneeAstraZeneca AB
InventorsWilliam Leach, Rachael Lewus, James McGivney, Kelcy Newell, Kevin Douglas Stewart
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Abstract
The present invention relates to stable, aqueous antibody formulations. In some embodiments, the stable, aqueous formulations comprise about 2 mg/mL to about 100 mg/mL of an anti-IL5R antibody, and about 0.002% to about 0.01% polysorbate-20. Also provided are methods of making and methods of using such antibody formulations.
Claims27
An aqueous antibody formulation that has not been subjected to lyophilization comprising:
- a. about 30 mg/ml of an antibody, wherein the antibody comprises a heavy chain variable region and a light chain variable region, wherein the heavy chain variable region comprises the Kabat-defined CDR1, CDR2, and CDR3 sequences of SEQ ID NOs:
- 5-7, and wherein the light chain variable region comprises the Kabat-defined CDR1, CDR2, and CDR3 sequences of SEQ ID NOs:
- 8-10,
- b. about 0.002% to about 0.006% w/v polysorbate-20,
- c. a buffer, wherein the buffer concentration is about 10 mM to about 30 mM, and
- d. an excipient, wherein the excipient concentration is about 200 mM to about 400 mM,
- wherein the antibody formulation has a pH of about 5.5 to about 6.5, and wherein storage of the antibody formulation at 23° C. to 27° C. for 3 months results in degradation of less than 5% of the antibody as determined by high performance size exclusion chromatography (HPSEC).
4 more elements
Dependencies are inferred from the claim text.