RECOMBINANT VWF FORMULATIONS

摘要

The present invention provides long-term stable pharmaceutical formulations of recombinant von-Willebrand Factor (rVWF) and methods for making and administering said formulations.

主权项

1. A stable liquid pharmaceutical formulation of a recombinant von Willebrand Factor (rVWF) comprising: (a) a rVWF; (b) a buffering agent; (c) one or more salts; (d) optionally a stabilizing agent; and (e) optionally a surfactant;
wherein said rVWF comprises a polypeptide selected from the group consisting of: a) the amino acid sequence set out in SEQ ID NO: 3; b) a biologically active analog, fragment or variant of a); c) a polypeptide encoded by the polynucleotide set out in SEQ ID NO: 1; d) a biologically active analog, fragment or variant of c); and e) a polypeptide encoded by a polynucleotide that hybridizes to the polynucleotide set out in SEQ ID NO: 1 under moderately stringent hybridization conditions; wherein said buffer is comprised of a pH buffering agent in a range of about 0.1 mM to about 500 mM and wherein the pH is in a range of about 2.0 to about 12.0; wherein said salt is at a concentration of about 1 to 500 mM; wherein said stabilizing agent is at a concentration of about 0.1 to 1000 mM; and wherein said surfactant is at a concentration of about 0.01 g/L to 0.5 g/L.