Anti-prolactin receptor antibody formulations
AssigneeBayer HealthCare LLC
InventorsXINGHANG MA, JIANJIE NIU
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Abstract
Provided are a wide concentration range, especially high concentration anti-prolactin receptor antibody formulations that are substantially isosmotic and of low viscosity.
Claims22
An anti-PRLR antibody formulation, comprising:
- a. 0 mM to 30 mM phosphate;
- b. 50 ppm to 200 ppm of a non-ionic surfactant;
- c. 34 mM to 292 mM of a sugar selected from mannitol, dextrose, glucose, trehalose, and sucrose;
- d. 0 mM to 50 mM arginine;
- e. 0 mM to 50 mM lysine;
- f. 0 mM to 270 mM glycine or alanine;
- g. 0 mM to 10 mM methionine;
- and
- h. 0.1 mg/ml to 150 mg/ml of an anti-PRLR antibody;
- wherein said anti-PRLR antibody formulation has a pH ranging from pH 5.5 to pH 6.5.
A method for the non-hormonal treatment of endometriosis in a patient, said method comprising administering to said patient a therapeutically effective amount of an anti-PRLR antibody formulation comprising between 0 mM and 30 mM phosphate, between 50 ppm and 200 ppm polysorbate 80 or polysorbate 20, between 34 mM and 292 mM sucrose or trehalose, between 0 mM and 50 mM arginine, between 0 mM and 50 mM lysine, between 0 mM and 270 mM glycine or alanine, between 0 mM and 10 mM methionine, and between 0.1 mg/ml and 150 mg/ml of a protein or antibody at a pH of between pH 5.5 and pH 6.5, wherein said anti-PRLR antibody formulation contains substantially no inorganic salt.
Dependencies are inferred from the claim text.