Antibody and protein formulations

Abstract

Provided are salt-free antibody and other protein formulations that are substantially isosmotic and of low viscosity. Also provided are methods for the treatment of diseases using the disclosed formulations.

1 : A salt-free protein or antibody formulation, comprising:
 a. histidine;   b. a non-ionic surfactant;   c. a sugar or sugar alcohol selected from mannitol, dextrose, glucose, trehalose, and sucrose;   d. arginine;   e. lysine;   f. glycine or alanine;   g. methionine; and   h. a protein or an antibody;   wherein said protein or antibody formulation has a pH ranging from pH 4.0 to pH 6.0 and wherein said protein formulation contains substantially no inorganic salt.   
     
     
         2 : The salt-free protein or antibody formulation of  claim 1  wherein said formulation has a viscosity ranging from 1 to 8 mPa-S at 22° C. 
     
     
         3 : The salt-free protein or antibody formulation of  claim 1  wherein said formulation has and osmolality ranging from 240 to 380 mmol/kg. 
     
     
         4 : The salt-free protein or antibody formulation of any of  claim 1  wherein said non-ionic surfactant is a polysorbate selected from polysorbate 20 and polysorbate 80. 
     
     
         5 : The salt-free protein or antibody formulation of  claim 1  wherein said sugar is sucrose. 
     
     
         6 : The salt-free protein or antibody formulation of  claim 1  comprising between 10 mM and 50 mM arginine. 
     
     
         7 - 14 . (canceled) 
     
     
         15 : The salt-free protein or antibody formulation of  claim 1 , comprising 5 mM to 10 mM methionine. 
     
     
         16 . (canceled) 
     
     
         17 : A salt-free anti-TFPI antibody formulation, comprising:
 a. histidine,   b. a non-ionic surfactant,   c. a sugar or sugar alcohol selected from mannitol, dextrose, glucose, trehalose and sucrose,   d. arginine,   e. lysine,   f. glycine or alanine   g. methionine, and   h. an anti-TFPI antibody;   wherein said anti-TFPI antibody formulation has a pH of pH 4.0 to pH 6.0 and wherein said anti-TFPI antibody formulation contains substantially no inorganic salt.   
     
     
         18 : The salt-free anti-TFPI antibody formulation of  claim 17  wherein said formulation has a viscosity ranging from 1 to 8 mPa-S at 22° C. 
     
     
         19 : The salt-free anti-TFPI antibody formulation of  claim 17  wherein said formulation has and osmolality ranging from 240 to 380 mmol/kg. 
     
     
         20 : The salt-free anti-TFPI antibody formulation of  claim 17  wherein said non-ionic surfactant is a polysorbate selected from polysorbate 20 and polysorbate 80. 
     
     
         21 : The salt-free anti-TFPI antibody formulation of  claim 17  wherein said sugar is sucrose. 
     
     
         22 . (canceled) 
     
     
         23 : The salt-free anti-TFPI antibody formulation of  claim 17  wherein said anti-TFPI antibody is a human IgG 2  monoclonal antibody. 
     
     
         24 : The salt-free anti-TFPI antibody formulation of  claim 17  wherein said human IgG 2  monoclonal antibody comprises a light chain comprising the amino acid sequence of SEQ ID NO: 1 and a heavy chain comprising the amino acid sequence of SEQ ID NO: 2. 
     
     
         25 : A method for the treatment of a disorder in a patient, said method comprising administering to said patient a therapeutically effective amount of a protein or antibody formulation comprising histidine, ppm polysorbate 80 or polysorbate 20, sucrose, arginine, lysine, glycine, methionine, and a protein or antibody at a pH of between pH 4.0 and pH 6.0, wherein said protein or antibody formulation contains substantially no inorganic salt. 
     
     
         26 : The method of  claim 25  wherein said protein or antibody formulation is administered intravenously, subcutaneously, or intramuscularly. 
     
     
         27 . (canceled) 
     
     
         28 : The method of  claim 25  wherein said protein or antibody is an anti-TFPI human monoclonal antibody. 
     
     
         29 : The method of  claim 28  wherein said human monoclonal antibody comprises a light chain comprising the amino acid sequence of SEQ ID NO: 1 and a heavy chain comprising the amino acid sequence of SEQ ID NO: 2. 
     
     
         30 . (canceled)