RU-2024133374-A - Pharmaceutical composition of an antibody to TSLP

Inventors

• Суетина Надежда Владимировна
• Овчаренко Екатерина Владиславовна
• Теплухина Ксения Алексеевна
• Морозов Дмитрий Валентинович

Assignees

• Акционерное общество "БИОКАД"

Dates

Publication Date

20260507

Application Date

20241107

Claims (20)

1. 1. A pharmaceutical composition comprising:
2. a. an antibody to TSLP that comprises LCDR1, LCDR2 and LCDR3 with the amino acid sequences indicated in SEQ ID NO: 1, SEQ ID NO: 2 and SEQ ID NO: 3, respectively, and HCDR1, HCDR2 and HCDR3 with the amino acid sequences indicated in SEQ ID NO: 4, SEQ ID NO: 5 and SEQ ID NO: 6, respectively;
3. b. acetate buffer;
4. c. stabilizer;
5. d. osmotic agent;
6. e. water.
7. 2. The pharmaceutical composition according to claim 1, wherein the antibody to TSLP comprises the amino acid sequences of the variable region of the light chain of SEQ ID NO: 7 and the heavy chain of SEQ ID NO: 8.
8. 3. The pharmaceutical composition according to claim 1, wherein the antibody to TSLP comprises the amino acid sequence of the light chain of SEQ ID NO: 9 and the heavy chain of SEQ ID NO: 10.
9. 4. The pharmaceutical composition according to claim 1, wherein the antibody to TSLP is in a concentration of 100 mg/ml to 200 mg/ml.
10. 3. The pharmaceutical composition according to claim 4, wherein the antibody to TSLP is in a concentration of 120 mg/ml to 180 mg/ml, or 130 mg/ml to 170 mg/ml, or 140 mg/ml to 160 mg/ml, or 100 mg/ml to 120 mg/ml, or 120 mg/ml to 140 mg/ml, or 145 mg/ml to 155 mg/ml, or 155 mg/ml to 160 mg/ml, or 160 mg/ml to 180 mg/ml, or 180 mg/ml to 200 mg/ml.
11. 6. The pharmaceutical composition according to claim 5, wherein the antibody to TSLP is at a concentration of 100 mg/ml, or 105 mg/ml, or 110 mg/ml, or 115 mg/ml, or 120 mg/ml, or 125 mg/ml, or 130 mg/ml, or 135 mg/ml, or 140 mg/ml, or 145 mg/ml, or 150 mg/ml, or 155 mg/ml, or 160 mg/ml, or 165 mg/ml, or 170 mg/ml, or 175 mg/ml, or 180 mg/ml, or 185 mg/ml, or 190 mg/ml, or 195 mg/ml, or 200 mg/ml.
12. 7. The pharmaceutical composition according to claim 1, wherein the acetate buffer is at a concentration of 1 mM to 35 mM, or 1 mM to 30 mM, or 1 mM to 25 mM, or 1 mM to 20 mM, or 1 mM to 15 mM, or 1 mM to 10 mM, or 2 mM to 8 mM, or 3 mM to 7 mM, or 4 mM to 6 mM, or 4.5 mM to 5.5 mM, or 4.7 mM to 5.2 mM.
13. 8. The pharmaceutical composition according to claim 1, wherein the acetate buffer consists of sodium acetate and glacial acetic acid.
14. 9. The pharmaceutical composition according to claim 8, wherein the sodium acetate is sodium acetate trihydrate.
15. 10. The pharmaceutical composition according to paragraphs 8, 9, where
16. (i) sodium acetate trihydrate at a concentration of 0.2 mg/ml to 1.9 mg/ml; or
17. (ii) sodium acetate at a concentration of 0.05 mg/ml to 1.5 mg/ml.
18. 11. The pharmaceutical composition according to claim 10, where
19. (i) sodium acetate trihydrate at a concentration of from 0.2 mg/ml to 0.8 mg/ml, or from 0.3 mg/ml to 0.7 mg/ml, or from 0.3 mg/ml to 0.6 mg/ml, or from 0.2 mg/ml to 0.4 mg/ml, or from 0.4 mg/ml to 6.5 mg/ml, or from 0.41 mg/ml to 0.46 mg/ml, or from 0.5 mg/ml to 0.7 mg/ml, or from 0.7 mg/ml to 0.9 mg/ml, or from 0.9 mg/ml to 1.1 mg/ml, or from 1.1 mg/ml to 1.3 mg/ml, or from 1.3 mg/ml to 1.5 mg/ml, or from 1.5 mg/ml to 1.7 mg/ml, or from 1.7 mg/ml to 1.9 mg/ml; or
20. (ii) sodium acetate at a concentration of 0.05 mg/ml to 1 mg/ml, or 0.1 mg/ml to 0.5 mg/ml, or 0.2 mg/ml to 0.3 mg/ml, or 0.05 mg/ml to 0.1 mg/ml, or 0.1 mg/ml to 0.2 mg/ml, or 0.3 mg/ml to 0.4 mg/ml, or 0.4 mg/ml to 0.6 mg/ml, or 0.6 mg/ml to 0.8 mg/ml, or 0.8 mg/ml to 1.0 mg/ml, or 1.0 mg/ml to 1.2 mg/ml, or 1.2 mg/ml to 1.4 mg/ml, or 1.4 mg/ml to 1.5 mg/ml.