Formulations for TACI-immunoglobulin fusion proteins

1. A pharmaceutical composition comprising:

a. a therapeutically active TACI-immunoglobulin (TACI-Ig) fusion protein comprising the sequence set forth in SEQ ID NO:3;

b. an acetate buffer buffering the formulation at a pH ranging between 4.9 and 5.1; and,

c. trehalose in a concentration ranging from 60 to 100 mg/ml.

2. The pharmaceutical composition according to claim 1 , having a pH of 5.0.

3. The pharmaceutical composition according to claim 1 , wherein said acetate buffer is sodium acetate.

4. The pharmaceutical composition according to claim 3 , wherein said sodium acetate has a concentration of 5 to 25 mM.

5. The pharmaceutical composition according to claim 1 , wherein said trehalose is in a concentration of 80 mg/ml.

6. The pharmaceutical composition according to claim 1 , wherein the concentration of said TACI-Ig fusion protein is comprised between 70 and 180 mg/mL, the concentration of said trehalose is comprised between 80 and 100 mg/mL, and wherein said buffer is a 10 mM sodium acetate buffer.

7. The pharmaceutical composition according to claim 1 , further comprising a preservative.

8. The pharmaceutical composition according to claim 7 , wherein the preservative is a combination of benzyl alcohol and benzalconium chloride.

9. The pharmaceutical composition according to claim 1 , wherein said TACI-Ig fusion protein is in a concentration ranging from 20 mg/mL to 180 mg/mL.

10. The pharmaceutical composition according to claim 1 , wherein the formulation is in liquid form.

11. A process for the preparation of a pharmaceutical composition comprising a therapeutically active TACI-immunoglobulin (TACI-Ig) fusion protein comprising the step of preparing a liquid solution of a TACI-Ig fusion protein in an acetate buffer and adjusting the pH of said liquid solution in the range between 4.9 to 5.1 and adjusting the trehalose concentration to a range between 60 to 100 mg/ml; wherein said TACI-Ig fusion protein comprises the sequence set forth in SEQ ID NO:3.

12. The process for preparation of a pharmaceutical composition according to claim 11 , further comprising the step of placing a predetermined amount of the pharmaceutical composition into a sterile container.

13. The process according to claim 12 , wherein said container is a glass vial or a pre-filled syringe.

14. The pharmaceutical composition of claim 1 , wherein said acetate buffer is in a concentration of 5 to 25 mM.

15. The pharmaceutical composition of claim 14 , wherein said acetate buffer is in a concentration of 10 mM.

16. The pharmaceutical composition of claim 9 , wherein said TACI-Ig fusion protein is in a concentration of 70, 75, 100, 125 or 150 mg/ml.

17. The pharmaceutical composition of claim 1 , wherein said pharmaceutical composition comprises said TACI-Ig fusion protein in a concentration between 70 and 180 mg/ml and acetate buffer in a concentration of 10 mM.

18. The method of claim 11 , wherein the pH of said liquid solution is adjusted to a pH of 5.0.

19. The method of claim 11 , wherein said acetate buffer is sodium acetate.

20. The method of claim 19 , wherein said sodium acetate has a concentration of 5 to 25 mM.

21. The method of claim 11 , wherein the concentration of said TACI-Ig fusion protein is between 70 and 180 mg/mL, the said trehalose concentration is between 80 and 100 mg/mL, and wherein said acetate buffer is a 10 mM sodium acetate buffer.