Lyophilized recombinant VWF formulations

A method of preparing a stable lyophilized pharmaceutical formulation of a recombinant von Willebrand Factor (rVWF) wherein the method comprises:

• (a) adding a buffer, one or more amino acids, one or more stabilizing agents, and one or more surfactants to a rVWF to obtain a solution;
• and
• (b) lyophilizing said solution from step (a);
• wherein said rVWF comprises a polypeptide selected from the group consisting of:
• i) the amino acid sequence set out in SEQ ID NO:
• 3;
• and
• ii) a biologically active fragment comprising the region of SEQ ID NO:3 from Val449 to Asn730 which causes agglutination of stabilized platelets in the presence of ristocetin, which has the activity to stabilize Factor VIII, or which binds to glycoprotein 1b (GP1b), collagen or heparin;
• wherein said buffer comprises a pH buffering agent selected from the group consisting of citrate and HEPES at 15 mM and said pH is in a range of about 2.0 to about 12.0;
• wherein said one or more amino acids is selected from the group consisting of glycine, lysine, and histidine at a concentration of about 1 to about 500 mM;
• wherein said one or more stabilizing agents is at a concentration of about 0.1 to about 1000 mM and is selected from the group consisting of mannitol, lactose, sorbitol, xylitol, sucrose, trehalose, mannose, maltose, glucose, raffinose, cellobiose, gentiobiose, isomaltose, arabinose, glucosamine, fructose and combinations of these stabilizing agents;
• and
• wherein said one or more surfactants is at a concentration of about 0.01 g/L to about 0.5 g/L.