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US 2013/0172269 A1Published application
Lyophilized recombinant vwf formulations
AssigneesBaxter Healthcare S.A., Baxter International Inc.
InventorsKurt Schnecker, Eva Haidweger, Peter Turecek
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Abstract
The present invention provides long-term stable pharmaceutical formulations of lyophilized recombinant von-Willebrand Factor (rVWF) and methods for making and administering said formulations.
Claims17
A stable lyophilized pharmaceutical formulation of a recombinant von Willebrand Factor (rVWF) comprising:
- (a) a rVWF;
- (b) one or more buffering agents;
- (c) one or more amino acids;
- (d) one or more stabilizing agents;
- and (e) one or more surfactants;
- said rVWF comprising 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;
- said buffer is comprising of a pH buffering agent in a range of about 0.1 mM to about 500 mM and said pH is in a range of about 2.0 to about 12.0;
- said amino acid is at a concentration of about 1 to about 500 mM;
- said stabilizing agent is at a concentration of about 0.1 to about 1000 mM;
- and
- said surfactant is at a concentration of about 0.01 g/L to about 0.5 g/L.
17 more elements
Dependencies are inferred from the claim text.