PURIFIED hCG

Abstract

A process for the purification of recombinant human Chorionic Gonadotropin (hCG) from a sample of crude recombinant hCG in the supernatant of CHO cells comprises the combined use of ion-exchange chromatography and reverse phase HPLC. The ion-exchange chromatography is performed twice and the final use of a size exclusion chromatography allows the purification from any residual traces of contaminants. The specific bioactivity of the highly purified hCG obtained form the process is particularly high, amounting to about 25,000 IU/mg.

1 . A recombinant human chorionic gonadotropin (hCG) having a specific bioactivity in the range of 23,000 to 28,000 IU/mg.  
   
   
       2 . A pharmaceutical composition comprising the recombinant hCG of  claim 1 , and suitable excipients.  
   
   
       3 . The pharmaceutical composition according to  claim 2  for subcutaneous administration.  
   
   
       4 . A pharmaceutical composition according to  claim 2 , wherein the excipient is sucrose.  
   
   
       5 . The pharmaceutical composition according to  claim 4  for subcutaneous administration.  
   
   
       6 . A pharmaceutical composition according to  claim 4 , which is a freeze-dried composition.  
   
   
       7 . The pharmaceutical composition according to  claim 6  for subcutaneous administration.  
   
   
       8 . A pharmaceutical composition according to  claim 2 , wherein the excipient is mannitol.  
   
   
       9 . The pharmaceutical composition according to  claim 8  for subcutaneous administration.  
   
   
       10 . A pharmaceutical composition according to  claim 8 , which is a liquid composition.  
   
   
       11 . The pharmaceutical composition according to  claim 10  for subcutaneous administration.