Protein Formulations with Reduced Viscosity and Uses Thereof

Abstract

Protein formulations and methods for reducing the viscosity of a protein formulation are provided. The method for reducing the viscosity of a protein formulation comprises adding a viscosity reducing agent, such as calcium chloride or magnesium chloride to the protein formulation.

1 . A reduced viscosity formulation, comprising:
 (i) an antibody or an antigen binding fragment thereof;   (ii) magnesium chloride at a concentration of between about 0.5 mM and about 25 mM in the formulation; and   (iii) a buffer;   wherein the pH of the formulation is about 5.5 to about 6.5.   
     
     
         2 . The reduced viscosity formulation of  claim 1 , further comprises at least one of an antioxidant, a surfactant, and a cryoprotectant. 
     
     
         3 . The reduced viscosity formulation of  claim 1 , wherein the antibody is an anti-myostatin antibody. 
     
     
         4 . The reduced viscosity formulation of  claim 3 , wherein the anti-myostatin antibody is MYO-022, MYO-028, or MYO-029. 
     
     
         5 . The reduced viscosity formulation of  claim 1 , wherein the antibody is an anti-IL-12 antibody. 
     
     
         6 . The reduced viscosity formulation of  claim 5 , wherein the anti-IL-12 antibody is J695. 
     
     
         7 . The reduced viscosity formulation of  claim 1 , wherein the antibody is an anti-IL-13 antibody. 
     
     
         8 . The reduced viscosity formulation of  claim 7 , wherein the anti-IL-13 antibody is IMA-638. 
     
     
         9 . The reduced viscosity formulation of  claim 1 , wherein magnesium chloride is at a concentration of about 1 mM in the formulation. 
     
     
         10 . The reduced viscosity formulation of  claim 1 , wherein the magnesium chloride is at a concentration of about 2.5 mM in the formulation. 
     
     
         11 . The reduced viscosity formulation of  claim 1 , wherein the magnesium chloride is at a concentration of about 5 mM in the formulation. 
     
     
         12 . The reduced viscosity formulation of  claim 1 , wherein the magnesium chloride is at a concentration of about 10 mM in the formulation. 
     
     
         13 . The reduced viscosity formulation of  claim 1 , wherein the magnesium chloride is at a concentration of about 15 mM in the formulation. 
     
     
         14 . The reduced viscosity formulation of  claim 1 , wherein the magnesium chloride is at a concentration of about 20 mM in the formulation. 
     
     
         15 . The reduced viscosity formulation of  claim 1 , wherein the magnesium chloride is at a concentration of about 25 mM in the formulation. 
     
     
         16 . The reduced viscosity formulation of  claim 1 , wherein the buffer is histidine buffer. 
     
     
         17 . The reduced viscosity formulation of  claim 16 , wherein the histidine buffer is at a concentration of about 4 mM to about 60 mM. 
     
     
         18 . The reduced viscosity formulation of  claim 1 , wherein the pH of the formulation is 6.0. 
     
     
         19 . A reduced viscosity formulation, comprising:
 (i) an antibody or an antigen binding fragment thereof, wherein the antibody is selected from the group consisting of an anti-myostatin antibody, an IL-12 antibody, an IL-13 antibody, and a combination thereof;   (ii) a viscosity reducing agent at a concentration of between about 0.5 mM and about 25 mM in the formulation, wherein the viscosity reducing agent is not sodium chloride or sodium biphosphate; and   (iii) a buffer;   wherein the pH of the reduced viscosity formulation is about 5.5 to about 6.5.   
     
     
         20 . The reduced viscosity formulation of  claim 19 , wherein the viscosity reducing agent is calcium chloride or magnesium chloride.