Recombinant or transgenic factor VII composition, each factor VII molecule having two N-glycosylation sites with defined glycan units

1. A composition comprising recombinant Factor VII (FVII), produced by a transgenic female rabbit,

wherein each molecule of FVII of the composition exhibits glycan moieties and two N-glycosylation sites,

wherein among all the molecules of FVII of the composition, the proportion of Galα1,3Gal glycan moieties is between 0 and 4%,

wherein the molecules of FVII of the composition do not comprise sialic acid bound in α2-3 links,

wherein among all the glycan moieties bound to N-glycosylation sites of the FVII of the composition, more than 50% of the glycan moieties are biantennary, monosialylated, glycan moieties,

wherein the molecules of FVII of the composition exhibit two O-glycosylation sites at position Ser52 and Ser60

wherein the molecules of FVII of the composition exhibit nine γ-carboxylated N-terminal glutamic acids, and

wherein the molecules of FVII of the composition exhibit 12 specific disulfide bridges.

2. A composition according to claim 1 , wherein among all the molecules of FVII of said composition at least 65% of sialic acids of the FVII are bound in α2-6 links.

3. A composition according to claim 2 , wherein all of the sialic acids of the FVII are bound in α2-6 links.

4. A composition according to claim 1 , wherein among the biantennary, monosialylated glycan moieties of the FVII, more than 50% of the glycan moieties are non-fucosylated.

5. A composition according to claim 4 , wherein the proportion of fucosylation of FVII is between 20% and 50%.

6. A composition according to claim 1 , further comprising a pharmaceutically acceptable excipient or carrier.

7. A method for treating haemophilia comprising administering to a patient a composition comprising recombinant Factor VII (FVII), produced by a transgenic rabbit, and a pharmaceutically acceptable excipient or carrier,

wherein each molecule of FVII of the composition exhibits glycan moieties and two N-glycosylation sites,

wherein among all the molecules of FVII of the composition, the proportion of Galα1,3Gal glycan moieties is between 0 and 4%, wherein the molecules of FVII of the composition do not comprise sialic acid bound in α2-3 links,

wherein among all the glycan moieties bound to N-glycosylation sites of the FVII of the composition, more than 50% of the glycan moieties are biantennary, monosialylated, glycan moieties,

wherein the molecules of FVII of the composition exhibit two O-glycosylation sites at position Ser52 and Ser60,

wherein the molecules of FVII of the composition exhibit nine γ-carboxylated N-terminal glutamic acids, and

wherein the molecules of FVII of the composition exhibit 12 specific disulfide bridges.

8. A method for treating multiple hemorrhagic traumas comprising administering to a patient a composition comprising recombinant Factor VII (FVII), produced by a transgenic rabbit, and a pharmaceutically acceptable excipient or carrier,

wherein each molecule of FVII of the composition exhibits glycan moieties and two N-glycosylation sites,

wherein among all the molecules of FVII of the composition, the proportion of Galα1,3Gal glycan moieties is between 0 and 4%,

wherein the molecules of FVII of the composition do not comprise sialic acid bound in α2-3 links,

wherein among all the glycan moieties bound to N-glycosylation sites of the FVII of the composition, more than 50% of the glycan moieties are biantennary, monosialylated, glycan moieties;

wherein the molecules of FVII of the composition exhibit two O-glycosylation sites at position Ser52 and Ser60,

wherein the molecules of FVII of the composition exhibit nine γ-carboxylated N-terminal glutamic acids, and

wherein the molecules of FVII of the composition exhibit 12 specific disulfide bridges.

9. A method for treating uncontrollable massive bleedings by surgical haemostasis comprising administering to a patient a composition comprising recombinant Factor VII (FVII), produced by a transgenic rabbit, and a pharmaceutically acceptable excipient or carrier,

wherein each molecule of FVII of the composition exhibits glycan moieties and two N-glycosylation sites,

wherein among all the molecules of FVII of the composition, the proportion of Galα1,3Gal glycan moieties is between 0 and 4%,

wherein the molecules of FVII of the composition do not comprise sialic acid bound in α2-3 links,

wherein among all the glycan moieties bound to N-glycosylation sites of the FVII of the composition, more than 50% of the glycan moieties are biantennary, monosialylated, glycan moieties,

wherein the molecules of FVII of the composition exhibit two O-glycosylation sites at position Ser52 and Ser60,

wherein the molecules of FVII of the composition exhibit nine γ-carboxylated N-terminal glutamic acids, and

wherein the molecules of FVII of the composition exhibit 12 specific disulfide bridges.

10. A method for treating of bleedings or hemorrhages due to an overdose of anticoagulants comprising administering to a patient a composition comprising recombinant Factor VII (FVII), produced by a transgenic rabbit, and a pharmaceutically acceptable excipient or carrier,

wherein each molecule of FVII of the composition exhibits glycan moieties and two N-glycosylation sites,

wherein among all the molecules of FVII of the composition, the proportion of Galα1,3Gal glycan moieties is between 0 and 4%,

wherein the molecules of FVII of the composition do not comprise sialic acid bound in α2-3 links,

wherein among all the glycan moieties bound to N-glycosylation sites of the FVII of the composition, more than 50% of the glycan moieties are biantennary, monosialylated, glycan moieties,

wherein the molecules of FVII of the composition exhibit two O-glycosylation sites at position Ser52 and Ser60,

wherein the molecules of FVII of the composition exhibit nine γ-carboxylated N-terminal glutamic acids, and

wherein the molecules of FVII of the composition exhibit 12 specific disulfide bridges.

11. The composition according to claim 1 , wherein the FVII is activated.