Buffer formulations for enhanced antibody stability
The disclosure provides buffered formulations of adalimumab. The formulations comprise a buffer comprising an acetate salt, sorbitol, histidine and/or a histidine salt and optionally arginie and/or an arginine salt, and polysorbate 80. The formulations have an acidic pH, and enhance the thermal, conformational and colloidal stability of antibodies, including the adalimumab antibody.
1. A buffered antibody formulation, comprising
(a) an antibody comprising a heavy chain comprising the amino acid sequence of SEQ ID NO: 1 and a light chain comprising the amino acid sequence of SEQ ID NO: 2;
(b) a buffer comprising
(1) 15 mM to 25 mM of an acetate salt,
(2) 15 mM to 25 mM of histidine and/or a histidine salt,
(3) 201 mM to 205 mM of sorbitol, and
(c) 0.08% (v/v) to 0.12% (v/v) of polysorbate 80,
wherein the antibody formulation has a pH of from 5.1 to 5.3, and
wherein the formulation comprises from 35 mg to 45 mg of the antibody.
2. The buffered antibody formulation of claim 1 , wherein the acetate salt comprises sodium acetate trihydrate.
3. The buffered antibody formulation of claim 1 , wherein the pH is 5.2.
4. The buffered antibody formulation of claim 1 , wherein the formulation comprises from 37 mg to 43 mg of the antibody.
5. The buffered antibody formulation of claim 1 , wherein the formulation comprises 40 mg of the antibody.
6. The buffered antibody formulation of claim 1 , wherein the formulation does not comprise NaCl, a citrate, or a phosphate.
7. The buffered antibody formulation of claim 1 , wherein the buffer comprises 20 mM of the acetate salt.
8. The buffered antibody formulation of claim 1 , wherein the buffer comprises 20 mM of the histidine and/or a histidine salt.
9. The buffered antibody formulation of claim 1 , wherein the buffer comprises 203 mM of sorbitol.
10. The buffered antibody formulation of claim 1 , wherein the formulation comprises from 0.09% (v/v) to 0.11% (v/v) of polysorbate 80.
11. The buffered antibody formulation of claim 1 , wherein the formulation comprises 0.1% (v/v) of polysorbate 80.
12. The buffered antibody formulation of claim 1 , wherein the buffer of (b) further comprises from 0.1 to 30 mM of arginine and/or an arginine salt.
13. The buffered antibody formulation of claim 12 , wherein the buffer comprises from 10 mM to 30 mM of arginine and/or an arginine salt.
14. The buffered antibody formulation of claim 12 , wherein the buffer comprises from 18 mM to 20 mM of arginine and/or an arginine salt.
15. The buffered antibody formulation of claim 12 , wherein the buffer comprises 19 mM of arginine and/or an arginine salt.