Stable aqueous formulations of adalimumab

1. An aqueous formulation of adalimumab comprising:

(a) adalimumab;

(b) a buffer selected from the group consisting of citrate, phosphate, histidine, succinate, tartrate, maleate and acetate, and combinations thereof, provided the combinations do not include a combination of citrate buffer and phosphate buffer;

(c) a polyol;

(d) a salt selected from the group consisting essentially of sodium chloride, sodium sulfate, and potassium chloride; and

(e) a surfactant,

wherein the formulation has pH of 4 to 8.

2. The formulation of claim 1 , wherein the buffer comprises a citrate buffer.

3. The formulation of claim 1 , wherein the polyol is mannitol, trehalose or sorbitol.

4. The formulation of claim 1 , wherein the surfactant is PS80.

5. The formulation of claim 1 , wherein the formulation does not comprise phosphate.

6. The formulation of claim 1 , wherein the salt is sodium chloride.

7. An aqueous formulation of adalimumab comprising:

(a) 20 to 150 mg/ml of adalimumab;

(b) a citrate buffer;

(c) mannitol in an amount of 1 to 10% weight by volume of the total formulation (w/v);

(d) sodium chloride in an amount of 5 to 150 mM; and

(e) PS80 in amount of 1 to 50 μM;

wherein the formulation has a pH of 4 to 8 and does not contain phosphate.

8. The formulation of claim 7 , wherein the amount of citrate buffer is 10 to 20 mM; the amount of mannitol is 65 mM; the amount of sodium chloride is 100 mM; the amount of PS80 is 0.1% and the amount of adalimumab is 30 to 50 mg.

9. The formulation of claim 7 , wherein the amount of sodium chloride is less than about 100 mM.

10. The formulation of claim 1 , wherein the formulation does not comprise sodium phosphate monobasic monohydrate.

11. The formulation of claim 1 , wherein the formulation does not comprise phosphate selected from the group consisting of Fisher phosphate Lot Number: 103372 and Fisher phosphate Lot Number: 113670.