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 method for the treatment of a hemophilia disorder in a patient, said method comprising administering to said patient a therapeutically effective amount of an antibody formulation, comprising:
 a. histidine, wherein the amount of histidine is no more than 50 mM;   b. a non-ionic surfactant, wherein the amount of the non-ionic surfactant is no more than 200 ppm;   c. a sucrose sugar or a sugar alcohol wherein the amount of the sugar or the sugar alcohol is no more than 292 mM;   d. arginine, wherein the amount of arginine is 10 mM or more;   e. 0 mM to 50 mM lysine;   f. 0 mM to 133 mM glycine or alanine;   g. 0 mM to 10 mM methionine; and   h. an anti-TFPI IgG 2  monoclonal antibody comprising 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; wherein said antibody formulation contains substantially no inorganic salt.   
     
     
         2 . The method of  claim 1 , wherein said antibody formulation is administered intravenously, subcutaneously, or intramuscularly. 
     
     
         3 . The method of  claim 1 , wherein the antibody is a chimeric, humanized, or human anti-TFPI IgG 2  monoclonal antibody. 
     
     
         4 . The method of  claim 1 , wherein the antibody formulation has a pH ranging from pH 4.0 to pH 7.0. 
     
     
         5 . The method of  claim 1 , wherein the antibody formulation comprises 10 mM to 30 mM histidine. 
     
     
         6 . The method of  claim 1 , wherein the antibody formulation comprises 50 ppm to 200 ppm of the non-ionic surfactant. 
     
     
         7 . The method of  claim 1 , wherein the antibody formulation comprises 88 mM to 292 mM of the sugar or the sugar alcohol. 
     
     
         8 . The method of  claim 1 , wherein the antibody formulation comprises 10 mM to 50 mM arginine. 
     
     
         9 . The method of  claim 1 , wherein the antibody formulation comprises lysine. 
     
     
         10 . The method of  claim 1 , wherein the antibody formulation comprises glycine or alanine. 
     
     
         11 . The method of  claim 1 , wherein the antibody formulation comprises methionine. 
     
     
         12 . A method for the treatment of a hemophilia disorder in a patient, said method comprising administering to said patient a therapeutically effective amount of an antibody formulation, comprising:
 a. 10 mM to 30 mM histidine;   b. 50 ppm to 200 ppm a non-ionic surfactant;   c. 88 mM to 292 mM of a sucrose sugar or a sugar alcohol   e. 0 mM to 50 mM lysine;   f. 0 mM to 133 mM glycine or alanine;   g. 0 mM to 10 mM methionine; and   h. a chimeric, humanized, or human anti-TFPI IgG2 monoclonal antibody   
       comprising 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; 
       wherein said antibody formulation has a pH ranging from pH 4.0 to pH 6.0; and 
       wherein said antibody formulation contains substantially no inorganic salt. 
     
     
         13 . A method for the treatment of hemophilia A or hemophilia B in a patient, said method comprising administering to said patient a therapeutically effective amount of an antibody formulation, comprising:
 a. histidine, wherein the amount of histidine is no more than 50 mM;   b. a non-ionic surfactant, wherein the amount of the non-ionic surfactant is no more than 200 ppm;   c. a sucrose sugar or a sugar alcohol wherein the amount of the sugar or the sugar alcohol is no more than 292 mM;   d. arginine, wherein the amount of arginine is 10 mM or more;   e. 0 mM to 50 mM lysine;   f. 0 mM to 133 mM glycine or alanine;   g. 0 mM to 10 mM methionine; and   h. an anti-TFPI IgG2 monoclonal antibody comprising 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; 
 wherein said antibody formulation contains substantially no inorganic salt. 
   
     
     
         14 . The method of  claim 13 , wherein said antibody formulation is administered intravenously, subcutaneously, or intramuscularly. 
     
     
         15 . The method of  claim 13 , wherein the antibody is a chimeric, humanized, or human anti-TFPI IgG 2  monoclonal antibody. 
     
     
         16 . The method of  claim 13 , wherein the antibody formulation has a pH ranging from pH 4.0 to pH 7.0. 
     
     
         17 . The method of  claim 13 , wherein the antibody formulation comprises 10 mM to 30 mM histidine. 
     
     
         18 . The method of  claim 13 , wherein the antibody formulation comprises 50 ppm to 200 ppm of the non-ionic surfactant. 
     
     
         19 . The method of  claim 13 , wherein the antibody formulation comprises 88 mM to 292 mM of the sugar or the sugar alcohol. 
     
     
         20 . The method of  claim 13 , wherein the antibody formulation comprises 10 mM to 50 mM arginine. 
     
     
         21 . The method of  claim 13 , wherein the antibody formulation comprises lysine. 
     
     
         22 . The method of  claim 13 , wherein the antibody formulation comprises glycine or alanine. 
     
     
         23 . The method of  claim 13 , wherein the antibody formulation comprises methionine. 
     
     
         24 . A method for the treatment of hemophilia A or hemophilia B in a patient, said method comprising administering to said patient a therapeutically effective amount of an antibody formulation, comprising:
 a. 10 mM to 30 mM histidine;   b. 50 ppm to 200 ppm of a non-ionic surfactant;   c. 88 mM to 292 mM of a sucrose sugar or a sugar alcohol;   d. 10 mM to 50 mM arginine;   e. 0 mM to 50 mM lysine;   f. 0 mM to 133 mM glycine or alanine;   g. 0 mM to 10 mM methionine; and   h. a chimeric, humanized, or human anti-TFPI IgG 2  monoclonal antibody comprising 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;   wherein said antibody formulation has a pH ranging from pH 4.0 to pH 6.0; and   wherein said antibody formulation contains substantially no inorganic salt.