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US 2021/0069334 A1Published application
Pharmaceutical formulations
AssigneeAmgen Inc.
InventorsTiansheng LI, Christopher James SLOEY
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Abstract
A method of stabilizing an aqueous protein or antibody formulation is disclosed herein. Additionally, stable pharmaceutical formulations are contemplated which comprise a biologically active protein, a destabilizing concentration of preservative and a stabilizing concentration of osmolyte.
Claims3
1-32. (canceled)
A method for screening for optimal stabilizing concentration of osmolyte comprising the steps of
- a) assessing the stability of a first aqueous solution comprising a first concentration of osmolyte, a therapeutic protein, and a preservative;
- b) assessing the stability of a second aqueous solution comprising a different second concentration of osmolyte, a therapeutic protein, and a preservative;
- and
- c) determining that the first concentration of osmolyte is more optimal than the second concentration of osmolyte if the first aqueous solution is more stable.
1 more element
Dependencies are inferred from the claim text.