Freeze-dried formulation of FGF-18.

Abstract

The present invention relates to a novel formulation containing an Fibroblast Growth factor (FGF)-18 protein. More particularly, said formulation is a stable freeze-dried (or lyophilized) formulation containing FGF-18. The invention also provides methods for preparing the freeze- dried formulation according to the present invention. The freeze-dried formulation herein described may be useful, after reconstitution, for administration in the treatment of cartilage disorders. In a first aspect, the invention provides a stable freeze-dried formulation comprising or consisting of FGF-18, a buffer, a poloxamer surfactant and a sugar as stabilizing agent. In a preferred embodiment, the buffer is a phosphate buffer, the poloxamer surfactant is poloxamer 188, and the stabilizing agent is sucrose. In a further preferred embodiment the buffer keeps the pH at or about 6 to 8, and more particularly at or about 7.2. In a further preferred embodiment, the concentration of the poloxamer surfactant is at or about 0.1 to 0.4 mg / vial. Preferably, FGF-18 is selected from the group consisting of: 1) a polypeptide comprising or consisting of the mature form of human FGF-18, corresponding to the sequence comprising or consisting of residue 28(Glu) to residue 207(Ala) of SEQ ID NO: 1, 2) a polypeptide comprising or consisting of a truncated form of human FGF-18 comprising or consisting of residue 28 (Glu) to residue 196 (Lys) of SEQ ID NO:1, and 3) a polypeptide comprising or consisting of SEQ ID NO:2.