Pharmaceutical formulation comprising antibodies which bind colony stimulating factor-1 receptor (CSF1R)
The current invention relates to a new pharmaceutical formulation, in particular to a pharmaceutical formulation comprising a protein, more particularly an antibody as an active ingredient.
1. A liquid pharmaceutical formulation comprising an antibody as an active ingredient, glycine and sucrose, wherein the antibody specifically binds colony stimulating factor-1 receptor (CSF1R) and wherein the antibody comprises:
a) a light chain comprising CDR1, CDR2 and CDR3 as defined in SEQ ID NO: 1, SEQ ID NO: 2, and SEQ ID NO: 3, respectively; and
b) a heavy chain comprising CDR1, CDR2, and CDR3 as defined in SEQ ID NO: 4, SEQ ID NO: 5 and SEQ ID NO: 6, respectively.
2. A liquid pharmaceutical formulation according to claim 1 comprising glycine at a concentration of 20 mM to 200 mM.
3. A liquid pharmaceutical formulation according to claim 1 comprising sucrose at a concentration of 20 mM to 200 mM.
4. A liquid pharmaceutical formulation according to claim 1 comprising at least 50 mg/ml antibody.
5. A liquid pharmaceutical formulation according to claim 1 comprising a surfactant.
6. A liquid pharmaceutical formulation according to claim 5 comprising 0.01% to 10% Polysorbate 80.
7. A liquid pharmaceutical formulation according to claim 1 wherein the antibody specifically binds human CSF1R.
8. A liquid pharmaceutical formulation according to claim 1 wherein the antibody neutralizes CSF1R.
9. A liquid pharmaceutical formulation according to claim 1 wherein the antibody is a humanized or human antibody.
10. A liquid pharmaceutical formulation according to claim 1 wherein the antibody comprises a variable light chain as defined in SEQ ID NO: 7 and a variable heavy chain as defined in SEQ ID NO: 11.
11. A liquid pharmaceutical formulation according to claim 1 comprising:
40-60 mM citrate buffer at pH 5;
100-150 mM glycine;
100-150 mM sucrose; and
0.02-0.1% polysorbate 80.
12. A liquid pharmaceutical formulation according to claim 11 , wherein the antibody specifically binds human CSF1R.
13. A liquid pharmaceutical formulation according to claim 11 wherein the antibody neutralizes CSF1R.
14. A liquid pharmaceutical formulation according to claim 11 wherein the antibody is a humanized or human antibody.
15. A liquid pharmaceutical formulation according to claim 11 wherein the antibody comprises a variable light chain as defined in SEQ ID NO: 7 and a variable heavy chain as defined in SEQ ID NO: 11.