Stabilizing polypeptides which have been exposed to urea

Abstract

Methods for stabilizing polypeptides, such as anti-HER2 antibodies, which have been exposed to urea.

1 - 6 . (canceled) 
     
     
         7 . A process for preventing or inhibiting carbamylation of a polypeptide resulting from exposure to urea, comprising exposing the polypeptide to urea, or cyanate formed by decomposition of urea, in the presence of an amine containing solution. 
     
     
         8 . The process of  claim 7  wherein said amine containing solution comprises a constituent comprising an amino acid. 
     
     
         9 . The process of  claim 8  wherein the amino acid in the constituent is glycine. 
     
     
         10 . The process of any one of  claims 7  to  9  wherein the amine in said amine containing solution functions as a cyanate scavenger. 
     
     
         11 . The process of  claim 10  wherein the cyanate scavenger is present in an amount effective to prevent or inhibit carbamylation of the polypeptide. 
     
     
         12 . The process of  claim 7  wherein the final concentration of the amine containing solution is from about 20 mM to about 1 M. 
     
     
         13 . The process of  claim 7  wherein the final concentration of the amine containing solution is from about 200 mM to about 400 mM.