Virus filtration of cell culture media

Patent metadata

Field	Value
Publication number	US-9670456-B2
Application number	US-201313921417-A
Country	US
Kind code	B2
Filing date	Jun 19, 2013
Priority date	Jun 21, 2012
Publication date	Jun 6, 2017
Grant date	Jun 6, 2017

Abstract

The invention relates to a method for removing a viral contaminant from a preparation, being a cell culture medium or at least a component of a cell culture medium. The method comprises subjecting said preparation to filtration for at least about 24 hours through a virus filter having an effective pore size of maximum about 75 nm. Further, the invention relates to the use of a virus filter in filtration of at least about 24 hours, wherein the virus filter has an effective pore size of maximum about 75 nm for the removal of viral contaminant from a preparation, being a cell culture medium or at least a component of a cell culture medium. In some embodiments the filtration according to the invention operates at a volumetric capacity of at least about 2000 L/m 2 . Further, the invention relates to the use of a preparation, being a cell culture medium or at least a component of a cell culture medium obtainable according to method of the invention for cell culture; pharmaceutical, diagnostic and/or cosmetic preparations as well as in food preparations.

First claim

The invention claimed is:

1. A method for removing a viral contaminant from a preparation, said preparation being a cell culture medium or at least one component of a cell culture medium, comprising the step of:
a) subjecting said preparation to filtration for at least about 24 hours through a virus filter having an effective pore size of maximum 75 nm, wherein the same virus filter is used for at least 24 hours and the filtration operates at a volumetric capacity of at least about 2000 L/m 2 .

2. The method of claim 1 , wherein said preparation is subjected to filtration for at least about 48 hours to about 7 months.

3. The method of claim 1 , further comprising the step:
b) feeding the filtrate to a cell culture medium or to at least one component of a cell culture medium.

4. The method of claim 1 , wherein the filtration is a continuous filtration.

5. The method of claim 1 , wherein the filtration is performed at a temperature from about 2° C. to about 60° C.

6. The method of claim 1 , wherein said virus filter achieves at least a 1 Log 10 reduction value (LRV) for a viral contaminant.

7. The method of claim 1 where the filtration is performed using two or more filters arranged in series, in parallel, or a mixture of both.

8. The method of claim 7 , wherein the filtration is performed using two filters arranged in parallel in a system of tubes comprising a Y-shaped junction and wherein each filter is in fluid communication with a branch of the Y-shaped junction and a preparation supply source.

9. The method of claim 1 , wherein the filtration is performed at a pressure ranging from about 100 mbar to about 4000 mbar.

10. The method of claim 1 , wherein said virus filter is autoclavable.

11. The method of claim 1 , wherein the cell culture medium comprises soy hydrolysate.

12. The method of claim 1 , wherein the filtration operates at a volumetric capacity of at least about 5000 L/m 2 .

13. The method of claim 2 , wherein said preparation is subjected to filtration for at least about 72 hours to about 3 months.

14. The method of claim 5 , wherein the filtration is performed at a temperature from about 15° C. to about 37° C.

15. The method of claim 9 , wherein the filtration is performed at a pressure ranging from about 1000 mbar to about 3000 mbar.

16. The method of claim 1 , wherein said preparation is subjected to filtration for at least about 48 hours to about 7 months.

17. The method of claim 4 , wherein said preparation is subjected to filtration for at least about 48 hours to about 7 months.

18. The method of claim 5 , wherein said preparation is subjected to filtration for at least about 48 hours to about 7 months.

19. The method of claim 9 , wherein said preparation is subjected to filtration for at least about 48 hours to about 7 months.

Assignees

• Baxalta GmbH
• Baxalta Inc

Inventors

• Mundt Wolfgang
• Mitterer Artur
• Reiter Manfred
• Hasslacher Meinhard
• Grillberger Leopold
• Kreil Thomas

Classifications

• A61L2/022 Primary

  Filtration · CPC title

• A61L2103/05

  Living organisms or biological materials · CPC title

• C12N5/0602 Primary

  Vertebrate cells · CPC title

• C12M29/26 Primary

  Conditioning fluids entering or exiting the reaction vessel · CPC title

• C12M37/02 Primary

  Filters · CPC title