Formulation of modified interleukin-7 fusion protein

1. A pharmaceutical formulation comprising:

a modified IL-7 fusion protein;

a basal buffer with a concentration of 10 to 50 mM;

a sugar with a concentration of 2.5 to 5w/v %; and

a surfactant with a concentration of 0.05 to 6w/v %,

wherein the (a) modified IL-7 fusion protein is represented by the formula:

N ′- Fc - A - IL -7- C ′ or N ′- A - IL -7- Fc - C′

wherein

N′ is the N-terminus of the modified IL-7 fusion protein;

C′ is the C-terminus of the modified IL-7 fusion protein;

A is G or an oligopeptide comprising 2 to 10 consecutive amino acid residues selected from M and G;

IL-7 is interleukin 7 comprising the amino acid sequence of SEQ ID NO: 1, 2, 3, 4, 5, or 6, or a polypeptide having sequence identity of about 95% or more to the sequence of SEQ ID NO: 1; and

Fc is a polypeptide comprising the amino acid sequence of SEQ ID NO: 7, or a variant thereof with one or more amino acid substitutions selected from the group consisting of K144G, K144S, E145G, and E145S.

2. The pharmaceutical formulation of claim 1 , wherein the oligopeptide A is selected from the group consisting of G, MM, MG, GM, GG, MMM, GMM, MGM, MMG, GGM, GMG, MGG, GGG, MMMM (SEQ ID NO:9), GMMM (SEQ ID NO:10), MGMM (SEQ ID NO:11), MMGM (SEQ ID NO:12), MMMG (SEQ ID NO:13), GGMM (SEQ ID NO:14), MGGM (SEQ ID NO:15), MMGG (SEQ ID NO:16), GMGM (SEQ ID NO: 17), MGMG (SEQ ID NO: 18), GMMG (SEQ ID NO: 19), GGGM (SEQ ID NO:20), MGGG (SEQ ID NO:21), GMGG (SEQ ID NO:22), GGMG (SEQ ID NO:23), GGGG (SEQ ID NO:24), MMMMM (SEQ ID NO:25), GMMMM (SEQ ID NO:26), GGMMM (SEQ ID NO:27), GGGMM (SEQ ID NO:28), GGGGM (SEQ ID NO:29), MGMMM (SEQ ID NO:30), MGGMM (SEQ ID NO:31), MGGGM (SEQ ID NO:32), MGGGG (SEQ ID NO:33), MMGMM (SEQ ID NO:34), MMGGM (SEQ ID NO:35), MMGGG (SEQ ID NO:36), MMMGM (SEQ ID NO:37), MMMGG (SEQ ID NO:38), MMMMG (SEQ ID NO:39), MGGGM (SEQ ID NO:40), MGMGM (SEQ ID NO:41), GMGMG (SEQ ID NO:42), GMMMG (SEQ ID NO:43), GGMGM (SEQ ID NO:44), GGMMG (SEQ ID NO:45), MGGMG (SEQ ID NO:46), MGMGG (SEQ ID NO:47), GMMGM (SEQ ID NO:48), MGMMG (SEQ ID NO:49), GMGGM (SEQ ID NO:50), MMGMG (SEQ ID NO:51), GMMGG (SEQ ID NO:52), GMGGG (SEQ ID NO:53), GGMGG (SEQ ID NO:54), GGGMG (SEQ ID NO:55) and GGGGG (SEQ ID NO:56).

3. The pharmaceutical formulation of claim 1 , wherein the modified IL-7 fusion protein is represented by the formula:

N ′- A - IL -7- Fc - C′.

4. The pharmaceutical formulation of claim 1 , wherein the basal buffer is histidine-acetate or sodium citrate.

5. The pharmaceutical formulation of claim 1 , wherein the sugar is selected from the group consisting of sucrose, trehalose, dextrose, and a mixture thereof.

6. The pharmaceutical formulation of claim 1 , wherein the surfactant is selected from the group consisting of polysorbate, polyoxyethylene alkyl ether, polyoxyethylene stearate, alkyl sulfates, polyvinyl pyridone, poloxamer and a mixture thereof.

7. The pharmaceutical formulation of claim 1 , further comprising any one amino acid selected from the group consisting of arginine, glutamate, glycine, histidine, and a mixture thereof.

8. The pharmaceutical formulation of claim 7 , wherein the concentration of the amino acid ranges from 40 to 60 mM.

9. The pharmaceutical formulation of claim 8 , wherein the concentration of the amino acid is 50 mM.

10. The pharmaceutical formulation of claim 1 , further comprising a sugar alcohol of 1 to 2w/v %.

11. The pharmaceutical formulation of claim 10 , wherein the sugar alcohol is selected from the group consisting of sorbitol, xylitol, maltitol, mannitol, and a mixture thereof.

12. The pharmaceutical formulation of claim 1 , wherein the pH of the formulation is 5.0.

13. The pharmaceutical formulation of claim 1 , wherein the formulation is a liquid formulation.