Novel stem cell factor formulations and methods

Abstract

The present invention relates to novel formulations of freeze dried SCF which include amino acid buffers. Preferred forms of the present formulations are those in which pH is adjusted by combining histidine and glutamic acid. The present formulations may optionally include additional stabilizers such as sucrose. Such formulations may also optionally include a bulking agent, and/or an osmolarity regulating agent, such as mannitol.

What is claimed is:  
     
         1 . A lyophilized SCF formulation containing histidine.  
     
     
         2 . A lyophilized SCF formulation containing glutamic acid.  
     
     
         3 . A lyophilized SCF formulation of claims  1  or  2  wherein said formulation contains sucrose.  
     
     
         4 . A lyophilized SCF formulation of claims  1  or  2  wherein said formulation contains mannitol.  
     
     
         5 . A lyophilized SCF formulation containing histidine and glutamic acid.  
     
     
         6 . A lyophilized SCF formulation of  claim 5  further containing sucrose.  
     
     
         7 . A lyophilized SCF formulation of  claim 5  further containing mannitol.  
     
     
         8 . A lyophilized SCF formulation containing 10 mM histidine, 5 mM glutamic acid and optionally 0.5% sucrose, and 4.5% mannitol.  
     
     
         9 . A method for preparing a lyophilized SCF formulation comprised of the steps of: 
 (a) mixing said SCF in a buffer containing an amino acid or amino acids selected from the group consisting of histidine and glutamic acid; and,    (b) lyophilizing said SCF.    
     
     
         10 . A method of  claim 9  further comprising adjusting the pH of said formulation to between pH 5.0 and pH 6.0 prior to lyophilization.  
     
     
         11 . A method of  claim 10  further comprising adding sucrose to said formulation prior to lyophilizing.  
     
     
         12 . A method of  claim 11  further comprising adding at least one agent selected from a bulking agent and an osmolarity regulating agent to said formulation prior to lyophilization.  
     
     
         13 . A method of  claim 12  wherein said agent is mannitol.