Compositions and methods useful for stabilizing protein-containing formulations

Abstract

The invention relates to use of non-surfactant compounds including, for example, polyoxyethylene (POE) sorbitans and polyethylene glycols (PEGs), for stabilizing protein-containing formulations and for the prevention of aggregation of proteins in such formulations.

1 - 10 . (canceled) 
     
     
         11 . A composition of matter comprising a protein and polyethylene glycol, wherein the polyethylene glycol is present at a concentration of 10,000 ppm or less. 
     
     
         12 . The composition of matter of  claim 11 , wherein the protein is an antibody. 
     
     
         13 . The composition of matter of  claim 11 , wherein the polyethylene glycol is present at a concentration of from 20 ppm to 10,000 ppm. 
     
     
         14 . The composition of matter of  claim 11 , wherein the polyethylene glycol is selected from the group consisting of PEG 1000 and PEG 6000. 
     
     
         15 . The composition of matter of  claim 11  which is free of a surfactant. 
     
     
         16 . The composition of matter of  claim 15 , wherein the surfactant is polysorbate. 
     
     
         17 . The composition of matter of  claim 11  which is in aqueous form. 
     
     
         18 . The composition of matter of  claim 11  which is in lyophilized form. 
     
     
         19 . The composition of matter of  claim 11 , which further comprises a POE sorbitan. 
     
     
         20 . An article of manufacture comprising a container holding the composition of matter of  claim 11 . 
     
     
         21 - 24 . (canceled) 
     
     
         25 . A method of preparing a stabilized protein-containing formulation, said method comprising admixing a protein with a polyethylene glycol, wherein said polyethylene glycol is present at a concentration of 10,000 ppm or less, thereby providing said stabilized protein-containing formulation. 
     
     
         26 . The method of  claim 25 , wherein said protein is an antibody. 
     
     
         27 . The method of  claim 25 , wherein the polyethylene glycol is selected from the group consisting of PEG 1000 and PEG 6000. 
     
     
         28 . The method of  claim 25  further comprising the step of lyophilizing said stabilized protein-containing formulation. 
     
     
         29 - 31 . (canceled) 
     
     
         32 . A method of increasing the stability of a protein in aqueous solution, said method comprising admixing said protein with a polyethylene glycol, wherein said polyethylene glycol is present at a concentration of 10,000 ppm or less and increases the stability of said protein in aqueous solution. 
     
     
         33 . The method of  claim 32 , wherein said protein is an antibody. 
     
     
         34 . The method of  claim 32 , wherein the polyethylene glycol is selected from the group consisting of PEG 1000 and PEG 6000. 
     
     
         35 - 37 . (canceled) 
     
     
         38 . A method of preventing or reducing the aggregation of a protein in aqueous solution, said method comprising admixing said protein with a polyethylene glycol, wherein said polyethylene glycol is present at a concentration of 10,000 ppm or less and prevents or reduces the aggregation of said protein in aqueous solution. 
     
     
         39 . The method of  claim 38 , wherein said protein is an antibody. 
     
     
         40 . The method of  claim 38 , wherein the polyethylene glycol is selected from the group consisting of PEG 1000 and PEG 6000.