Gonadotrophins for folliculogenesis
The invention provides an FSH preparation having a high degree of sialylation, and showing increased efficacy.
1 . An FSH preparation, wherein the Z-number of the preparation is at least at or about 200.
2 . The FSH preparation of claim 1 , wherein the Z-number of the preparation is at least at or about 210.
3 . The FSH preparation of claim 1 , wherein the Z-number of the preparation is at least at or about 220.
4 . The FSH preparation of claim 1 , wherein the Z-number of the preparation is at least at or about 230.
5 . The FSH preparation of claim 1 , wherein the Z-number of the preparation is at least at or about 240.
6 . The FSH preparation of claim 1 , wherein the Z-number of the preparation is at least at or about 250.
7 . The FSH preparation of claim 1 , wherein the Z-number of the preparation is at least at or about 260.
8 . A pharmaceutical composition comprising FSH, wherein the FSH has a Z-number that is at least at or about 200.
9 . The pharmaceutical composition of claim 8 , wherein the FSH has a Z-number that is at least at or about 210.
10 . The pharmaceutical composition of claim 8 , wherein the FSH has a Z-number that is at least at or about 220.
11 . The pharmaceutical composition of claim 8 , wherein the FSH has a Z-number that is at least at or about 230.
12 . The pharmaceutical composition of claim 8 , wherein the FSH has a Z-number that is at least at or about 240.
13 . The pharmaceutical composition of claim 8 , wherein the FSH has a Z-number that is at least at or about 250.
14 . The pharmaceutical composition of claim 8 , wherein the FSH has a Z-number that is at least at or about 260.
15 . In a method of using a pharmaceutical composition in controlled ovarian hyperstimulation, the improvement wherein said pharmaceutical composition is the composition any one of claims 8 to 14 .
16 . In a method of using an FSH preparation in folliculogenesis, the improvement wherein the FSH has a Z-number that is at least at or about 200.
17 . The method according to claim 16 , wherein the FSH has a Z-number that is at least at or about 210.
18 . The method according to claim 16 , wherein the FSH has a Z-number that is at least at or about 220.
19 . The method according to claim 16 , wherein the FSH has a Z-number that is at least at or about 230.
20 . The method according to claim 16 , wherein the FSH has a Z-number that is at least at or about 240.
21 . The method according to claim 16 , wherein the FSH has a Z-number that is at least at or about 250.
22 . The method according to claim 16 , wherein the FSH has a Z-number that is at least at or about 260.
23 - 29 . (canceled)
30 . A method for preparing an FSH preparation having a Z-number that is at least at or about 200, the method comprising the step of reacting FSH with a sialic acid donor in the presence of 2,3-sialyltransferase.
31 . The method of claim 30 , wherein the FSH has a Z-number that is at least at or about 210.
32 . The method of claim 30 , wherein the FSH has a Z-number that is at least at or about 220.
33 . The method of claim 30 , wherein the FSH has a Z-number that is at least at or about 230.
34 . The method of claim 30 , wherein the FSH has a Z-number that is at least at or about 240.
35 . The method of claim 30 , wherein the FSH has a Z-number that is at least at or about 250.
36 . The method of claim 30 , wherein the FSH has a Z-number that is at least at or about 260.
37 . The method of any one of claims 30 to 36 , wherein the sialic acid donor is CMP-sialic acid.
38 . The method of any one of claims 30 to 36 , wherein the sialyltransferase is rat ST3Gal III.
39 . A method for preparing an FSH preparation having a Z-number that is at least at or about 200, the method comprising a step of ion-exchange chromatography.
40 . The method of claim 37 wherein the sialyltransferase is rat ST3Gal III.