Purified LH
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.