Method for reconstituting lyophilized proteins

• US 20040005310A1
• Filed: 03/11/2003
• Published: 01/08/2004
• Est. Priority Date: 03/13/2002
• Status: Abandoned Application

• Current Assignee: CSL Behring GmbH (CSL Limited)
• Original Assignee: CSL Behring GmbH (CSL Limited)
• Inventors: Grandgeorge, Michel, Rapp, Mirna
• Application Number:
  US10/384,748
• Publication Number:
  US 20040005310A1
• Time in Patent Office: Days
• US Class Current: 424/94.63
• CPC Class Codes: A61K 38/37 Factors VIII
• CPC Class Codes: A61K 9/19 lyophilised , i.e. freeze-dried, solutions or dispersions lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00
• CPC Class Codes: A61P 7/00 Drugs for disorders of the blood or the extracellular fluid

Abstract

A method for reconstituting lyophilized proteins, in which the reconstitution takes place in a receptacle in which the gas pressure is between 1 mbar and atmospheric pressure, is described. In the lyophilized protein-containing receptacle, the gas pressure of between 1 mbar and atmospheric pressure, which gas pressure is required in accordance with the invention, is set by introducing air or an inert gas, and the quantity of water for injection purposes which is required for dissolving the protein is added. The method is particularly suitable for blood coagulation factors, the von Willebrand factor and albumin.

Claims

1. Method for reconstituting lyophilized proteins, characterized in that the reconstitution takes place in a receptacle in which the gas pressure is between 1 mbar and atmospheric pressure.

2. Method according to claim 1, characterized in that the reconstitution takes place in a receptacle in which the gas pressure is between 100 mbar and atmospheric pressure.

3. Method according to claims 1 and 2, characterized in that, after the lyophilization has been completed under high vacuum, the gas pressure in the protein-containing receptacle is adjusted to between 1 mbar and atmospheric pressure by introducing air or an inert gas, and the quantity of solvent which is required for dissolving the protein is added to the receptacle.

4. Method according to claim 3, characterized in that the air or the inert gas which is employed for adjusting the gas pressure in the receptacle is conducted through a sterilizing filter.

5. Method according to claims 1 to 4, characterized in that the protein employed is a plasma protein.

6. Method according to claims 1 to 5, characterized in that the plasma protein employed is a blood coagulation factor, the von Willebrand factor or albumin.

7. Method according to claims 1 and 2, characterized in that, after the lyophilization has been completed under high vacuum, the gas pressure in the protein-containing receptacle is adjusted to between 1 mbar and atmospheric pressure by appropriate choice of the program conditions in the freeze drying unit, and the quantity of water for injection purposes which is required for dissolving the protein is added to the receptacle.

8. Kit for preparing an injectable solution of at least one therapeutic protein, characterized in that it comprises a receptacle which contains the therapeutic protein(s) and in which the air pressure has been reduced to not less than 1 mbar.

9. Kit according to claim 8, in which the receptacle contains a protective gas.

10. Kit according to claim 8 or 9, in which the air pressure in the receptacle is between 100 and 300 mbar.

11. Kit according to one of claims 8 to 10, which additionally comprises a receptacle containing a physiological solvent.

12. Kit according to one of claims 8 to 11, in which the therapeutic protein is natural or recombinantly obtained factor VIII or a mutant of factor VIII.