Anti-prolactin receptor antibody formulations
Provided are a wide concentration range, especially high concentration, substantially salt-free anti-prolactin receptor antibody formulations that are substantially isosmotic and of low viscosity.
1. An anti-PRLR antibody formulation, comprising:
10 to 70 mM histidine,
50 to 300 ppm polysorbate 80,
34 to 292 mM sucrose, and
1 to 150 mg/ml anti-PRLR antibody;
wherein said anti-PRLR antibody formulation has a pH of 5.0 to 6.5.
2. The anti-PRLR antibody formulation of claim 1 , comprising:
10 mM histidine,
80 ppm polysorbate 80,
234 mM sucrose,
60 mg/ml anti-PRLR antibody.
3. The anti-PRLR antibody formulation of claim 1 , comprising:
10 mM histidine,
75 ppm polysorbate 80,
234 mM sucrose, and
60 mg/ml anti-PRLR antibody.
4. The anti-PRLR antibody formulation of claim 1 , further comprising 133 to 270 mM glycine.
5. The anti-PRLR antibody formulation of claim 4 , comprising:
10 mM histidine,
75 ppm polysorbate 20,
88 mM sucrose,
133 mM glycine, and
60 mg/ml anti-PRLR antibody.
6. The anti-PRLR antibody formulation of claim 4 , comprising:
10 mM histidine,
200 ppm polysorbate 20,
88 mM sucrose,
133 mM glycine, and
60 mg/ml anti-PRLR antibody.
7. The anti-PRLR antibody formulation of claim 1 , comprising:
70 mM histidine,
80 ppm polysorbate 80,
200 mM sucrose, and
60 mg/ml anti-PRLR antibody.
8. The anti-PRLR antibody formulation of claim 1 , further comprising:
a) 10 to 50 mM arginine,
b) 5 to 10 mM methionine, or
c) 10 to 50 mM arginine and 5 to 10 mM methionine.
9. The anti-PRLR antibody formulation of claim 1 , further comprising 30 to 50 mM lysine.
10. The anti-PRLR antibody formulation of claim 8 , comprising:
10 mM histidine,
75 ppm polysorbate 80,
234 mM sucrose,
30 mM arginine,
10 mM methionine, and
60 mg/ml anti-PRLR antibody.
11. The anti-PRLR antibody formulation of claim 8 , comprising:
10 mM histidine,
75 ppm polysorbate 80,
234 mM sucrose,
30 mM arginine,
10 mM methionine, and
2 mg/ml anti-PRLR antibody.
12. The anti-PRLR antibody formulation of claim 8 , comprising:
10 mM histidine,
75 ppm polysorbate 80,
234 mM sucrose,
20 mM arginine,
10 mM methionine, and
150 mg/ml anti-PRLR antibody.
13. The anti-PRLR antibody formulation of claim 8 , comprising:
10 mM histidine,
75 ppm polysorbate 80,
205 mM sucrose,
20 mM arginine,
10 mM methionine, and
1 mg/ml anti-PRLR antibody.
14. The anti-PRLR antibody formulation of claim 8 , comprising:
10 mM histidine,
80 ppm polysorbate 80,
205 mM sucrose,
20 mM arginine,
10 mM methionine, and
60 mg/ml anti-PRLR antibody.
15. An anti-PRLR antibody formulation, comprising:
10 to 70 mM histidine,
50 to 300 ppm polysorbate 80,
34 to 292 mM trehalose,
10 to 50 mM arginine, and
5 to 10 mM methionine, and
1 to 150 mg/ml anti-PRLR antibody;
wherein said anti-PRLR antibody formulation has a pH of 5.0 to 6.5.
16. The anti-PRLR antibody formulation of claim 15 , comprising:
10 mM histidine,
75 ppm polysorbate 80,
205 mM trehalose,
30 mM arginine,
10 mM methionine, and
2 mg/ml anti-PRLR antibody.
17. The anti-PRLR antibody formulation of claim 8 , comprising:
10 mM histidine,
234 mM sucrose,
80 ppm polysorbate 80,
30 mM arginine,
5 mM methionine, and
7.5 mg/ml anti-PRLR antibody.
18. The anti-PRLR antibody formulation of claim 8 , comprising:
10 mM histidine,
234 mM sucrose,
80 ppm polysorbate 80,
30 mM arginine,
5 mM methionine, and
60 mg/mL anti-PRLR antibody.
19. The anti-PRLR antibody formulation of claim 8 , comprising:
10 mM histidine,
234 mM sucrose,
75 ppm polysorbate 80,
30 mM arginine,
10 mM methionine, and
60 mg/mL anti-PRLR antibody.
20. The anti-PRLR antibody formulation of claim 1 , comprising:
10 mM histidine,
263 mM sucrose,
80 ppm polysorbate 80, and
60 mg/mL anti-PRLR antibody.
21. The anti-PRLR antibody formulation of claim 1 , wherein said anti-PRLR antibody is a human IgG2 monoclonal antibody comprising a light chain sequence of SEQ ID NO: 1 and a heavy chain sequence of SEQ ID NO: 7.
22. The anti-PRLR antibody formulation of claim 1 , comprising:
30 mM histidine,
100 ppm polysorbate 80,
292 mM sucrose, and
20 mg/ml anti-PRLR antibody.
23. The anti-PRLR antibody formulation of claim 4 , comprising:
10 mM histidine,
75 ppm polysorbate 80,
88 mM sucrose,
270 mM glycine, and
60 mg/ml anti-PRLR antibody.
24. The anti-PRLR antibody formulation of claim 8 , comprising:
10 mM histidine,
75 ppm polysorbate 80,
292 mM sucrose,
10 mM arginine, and
60 mg/ml anti-PRLR antibody.
25. The anti-PRLR antibody formulation of claim 9 , comprising:
70 mM histidine,
75 ppm polysorbate 80,
176 mM sucrose,
30 mM lysine, and
60 mg/ml anti-PRLR antibody.
26. The anti-PRLR antibody formulation of claim 15 , comprising:
10 mM histidine,
75 ppm polysorbate 80,
205 mM trehalose,
20 mM arginine, and
10 mM methionine, and
60 mg/ml anti-PRLR antibody;
wherein said anti-PRLR antibody formulation has a pH ranging from pH 5.0 to pH 6.5.