Anti-prolactin receptor antibody formulations

Abstract

Provided are a wide concentration range, especially high concentration, substantially salt-free anti-prolactin receptor antibody formulations that are substantially isosmotic and of low viscosity.

1 . An anti-PRLR antibody formulation, comprising:
 a. 0 mM to 70 mM histidine;   b. 50 ppm to 300 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. 1 mg/ml to 150 mg/ml of an anti-PRLR antibody; wherein said anti-PRLR antibody formulation has a pH ranging from pH 5.0 to pH 6.5.   
     
     
         2 . The anti-PRLR antibody formulation of  claim 1  wherein said anti-PRLR formulation contains substantially no inorganic salt other than an organic salt or an inorganic salt that buffers said formulation. 
     
     
         3 . The anti-PRLR antibody formulation of  claim 1  wherein said anti-PRLR formulation contains substantially no inorganic salt selected from the group consisting of sodium chloride (NaCl), sodium sulfate (Na 2 SO 4 ), sodium thiocyanate (NaSCN), magnesium chloride (MgCl), magnesium sulfate (MgSO 4 ), ammonium thiocyanate (NH 4 SCN), ammonium sulfate ((NH 4 ) 2 SO 4 ), ammonium chloride (NH 4 Cl), calcium chloride (CaCl 2 ), calcium sulfate (CaSO 4 ), and zinc chloride (ZnCl 2 ). 
     
     
         4 . The anti-PRLR antibody formulation of  claim 1  wherein said formulation has a viscosity ranging from 1 to 8 mPa-S at 22° C.-23° C. 
     
     
         5 . The anti-PRLR antibody formulation of  claim 1  wherein said formulation has and osmolality ranging from 240 to 380 mmol/kg. 
     
     
         6 . The anti-PRLR antibody formulation of any of  claim 1  wherein said non-ionic surfactant is a polysorbate selected from polysorbate 20 and polysorbate 80. 
     
     
         7 . The anti-PRLR antibody formulation of  claim 1  wherein said sugar is sucrose or trehalose. 
     
     
         8 . The anti-PRLR antibody formulation of  claim 1  comprising between 10 mM and 50 mM arginine. 
     
     
         9 - 28 . (canceled) 
     
     
         29 . The anti-PRLR antibody formulation of  claim 1  wherein said anti-PRLR antibody is a human IgG2 monoclonal antibody. 
     
     
         30 . (canceled) 
     
     
         31 . (canceled) 
     
     
         32 . 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 70 mM histidine, 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 1 mg/ml and 150 mg/ml of a protein or antibody at a pH of between pH 5.0 and pH 6.5, wherein said anti-PRLR antibody formulation contains substantially no inorganic salt. 
     
     
         33 . The method of  claim 32  wherein said anti-PRLR antibody formulation is administered intravenously, subcutaneously, or intramuscularly. 
     
     
         34 . The method of  claim 33  wherein said anti-PRLR antibody is a human IgG2 monoclonal antibody. 
     
     
         35 . (canceled) 
     
     
         36 . The method of claim  15  wherein said human IgG2 monoclonal antibody comprises a light chain sequence of SEQ ID NO: 1 and a heavy chain sequence of SEQ ID NO: 7.