Purified LH

Abstract

Recombinant human luteinizing hormone (LH) having a specific bioactivity of from 20,522 to 31,229 IU/mg and obtainable from a process for the purification of recombinant LH from a sample of crude recombinant LH in the supernatant of CHO cells which comprises the combined use of ion-exchange chromatography and reverse phase HPLC. The ion-exchange chromatography and the reverse phase HPLC are performed twice and the final use of a gel permeation column allows the purification from any residual traces of contaminants. The recombinant LH can be formulated into a pharmaceutical composition and used for treating a fertility disorder.

1 . The recombinant LH of  claim 10  having a specific bioactivity of from 20,522 to 31,229 IU/mg and obtainable by a process which comprises: 
 subjecting said sample to ion-exchange chromatography with an anion exchange resin;    subjecting said sample to reverse phase HPLC; and    isolating the recombinant LH.    
     
     
         2 . The recombinant LH of  claim 10 , having a specific bioactivity of about 25,000 IU/mg.  
     
     
         3 . A pharmaceutical composition, comprising a therapeutically effective amount of the recombinant LH of  claim 2  and suitable excipients thereof.  
     
     
         4 . The pharmaceutical composition of  claim 3 , wherein the excipient is sucrose.  
     
     
         5 . A pharmaceutical composition of  claim 3 , for subcutaneous administration.  
     
     
         6 . A pharmaceutical composition, comprising a therapeutically effective amount of the recombinant LH of  claim 10  and suitable excipients thereof.  
     
     
         7 . The pharmaceutical composition of  claim 6 , wherein the excipient is sucrose.  
     
     
         8 . A pharmaceutical composition of  claim 6 , for subcutaneous administration.  
     
     
         9 . A method for treating a fertility disorder, comprising administering to a patient in need thereof an effective amount of the recombinant LH of  claim 1 .  
     
     
         10 . A recombinant LH having a specific bioactivity of from 20,522 to 31,229 IU/mg.