RU-2023105782-A - SIALLYLATED GLYCOPROTEINS

Inventors

• Патил Сиддхеш

Assignees

• МОМЕНТА ФАРМАСЬЮТИКЛЗ, ИНК.

Dates

Publication Date

20260508

Application Date

20210820

Priority Date

20200820

Claims (20)

1. 1. A liquid pharmaceutical composition comprising immunoglobulins in about 10 mM sodium acetate, about 0.02% (w/v) polysorbate 20 and at least one of about 250 mM glycine or about 5% (w/v) sorbitol, wherein at least 50% of the branched glycans in the Fc region of the immunoglobulins are disialylated via NeuAc-α 2,6-Gal terminal bonds, wherein the pH of the composition is 4-7.
2. 2. A liquid pharmaceutical composition according to claim 1, containing 250 mM glycine.
3. 3. A liquid pharmaceutical composition according to claim 1, containing 5% (w/v) sorbitol.
4. 4. A liquid pharmaceutical composition according to claim 1, in which the concentration of immunoglobulins is 50-275 mg/ml.
5. 5. A liquid pharmaceutical composition according to claim 1, in which the concentration of immunoglobulins is 50-250 mg/ml.
6. 6. A liquid pharmaceutical composition according to claim 3, in which the concentration of immunoglobulins is 100-275 mg/ml.
7. 7. A liquid pharmaceutical composition according to claim 3, wherein the concentration of immunoglobulins is 70-130 mg/ml, 90-110 mg/ml or 80-120 mg/ml.
8. 8. A liquid pharmaceutical composition according to any one of claims 1 to 7, wherein at least 60%, 70%, 80%, 90% or 95% of the branched glycans in the Fc domain of the immunoglobulins are disialylated via NeuAc-α 2,6-Gal terminal bonds.
9. 9. A liquid pharmaceutical composition according to any one of claims 1 to 8, wherein at least 60%, 70%, 80%, 90% or 95% of the branched glycans in the immunoglobulins are disialylated via NeuAc-α 2,6-Gal terminal bonds.
10. 10. A liquid pharmaceutical composition according to any one of claims 1 to 9, wherein at least 60%, 70%, 80%, 90% or 95% of the branched glycans in the Fab domain of the immunoglobulins are disialylated via NeuAc-α 2,6-Gal terminal bonds.
11. 11. A liquid pharmaceutical composition according to any one of claims 1 to 10, wherein at least 90% of the immunoglobulins are IgG immunoglobulins.
12. 12. The liquid pharmaceutical composition of claim 11, wherein at least 95% of the immunoglobulins are IgG immunoglobulins.
13. 13. A liquid pharmaceutical composition according to any one of claims 1-12, wherein 5-20% of the immunoglobulins are dimers.
14. 14. A liquid pharmaceutical composition according to claim 13, wherein 5-10% of the immunoglobulins are dimers.
15. 15. A liquid pharmaceutical composition according to any one of claims 1 to 14, wherein at least 80% of the immunoglobulins are monomers or dimers.
16. 16. A liquid pharmaceutical composition according to claim 15, wherein at least 85% of the immunoglobulins are monomers or dimers.
17. 17. A liquid pharmaceutical composition according to claim 16, wherein at least 90% of the immunoglobulins are monomers or dimers.
18. 18. A liquid pharmaceutical composition according to any one of claims 1-17, wherein 5-20% of the IgG immunoglobulins are dimers.
19. 19. A liquid pharmaceutical composition according to claim 18, wherein 5-10% of the IgG immunoglobulins are dimers.
20. 20. A liquid pharmaceutical composition according to any one of claims 1-19, wherein at least 80% of the IgG immunoglobulins are monomers or dimers.