LIQUID COMPOSITION CONTAINING A FUSION PROTEIN INCLUDING α-GALACTOSIDASE A
Patent Information
- Application Number
- RU2024121587
- Authority / Receiving Office
- RU · RU
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-03-10
- Publication Date
- 2026-09-03
Claims
1. A liquid composition comprising a fusion protein in which α-galactosidase A is fused to the Fc region of an immunoglobulin, wherein the liquid composition comprises: fusion protein in a concentration from 10 mg / ml to 90 mg / ml; a buffer for maintaining the pH of the liquid composition in the range of 5.5 to 6.5; and amino acid in a concentration of 0.5% (w / v) to 4.0% (w / v).
2. The liquid composition of claim 1, wherein the buffer comprises histidine or its salt, citric acid or its salt, acetic acid or its salt, phosphoric acid or its salt, or any combination thereof.
3. The liquid composition according to claim 1, additionally containing an isotonic agent in a concentration of 5 mM to 200 mM.
4. The liquid composition of claim 3, wherein the isotonic agent is sodium chloride.
5. The liquid composition of claim 1, wherein the amino acid is selected from the group consisting of arginine, serine, threonine, glutamine, glycine, alanine, and any combination thereof.
6. The liquid composition according to claim 1, further comprising a non-ionic surfactant in a concentration of from 0.005% (w / v) to 0.1% (w / v).
7. The liquid composition of claim 6, wherein the non-ionic surfactant is selected from poloxamer 188, polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, and any combination thereof.
8. The liquid composition according to claim 1, wherein α-galactosidase A comprises the amino acid sequence SEQ ID NO:
1.
9. The liquid composition of claim 1, wherein the fusion protein comprises the amino acid sequence of SEQ ID NO:
4.
10. The liquid composition of claim 1, wherein the fusion protein has a structure in which two molecules of α-galactosidase A are linked to each monomer of the Fc region of the immunoglobulin in dimeric form.
11. A liquid composition according to claim 1, containing: fusion protein in a concentration from 10 mg / ml to 90 mg / ml; 10 mM to 50 mM histidine; And from 1.0% (w / v) to 4.0% (w / v) serine.
12. A liquid composition according to claim 1 for use in the prevention or treatment of Fabry disease.
13. A liquid composition according to claim 1 for subcutaneous administration.