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Removal of residual cell culture impurities

Inactive Publication Date: 2016-10-06
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The invention provides methods for increasing the yield, purity, and safety of biological products made from cell culture. These methods involve adding an anionic detergent to a solution containing proteins and DNA, followed by a purification step using an ion exchange matrix. This process helps to remove DNA and other impurities from the desired product. The result is a better purity and yield of the biological product. The invention also recognizes that the removal of residual DNA from influenza viruses can be improved by using an ion exchange chromatography in the presence of an anionic detergent. Overall, this patent offers a more efficient way to produce high-quality biological products from cell culture.

Problems solved by technology

The problem to be solved might relate to the inefficiency of separation of negatively charged DNA impurities from proteins of interest on a positively charged ion exchange matrix.

Method used

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  • Removal of residual cell culture impurities
  • Removal of residual cell culture impurities
  • Removal of residual cell culture impurities

Examples

Experimental program
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embodiment 1

2. The method of embodiment 1, wherein the first solution is selected from the group consisting of: cell or tissue lysates, culture media, cell culture supernatants, plasma, and partially purified protein solutions.

3. The method of any one of the preceding embodiments, wherein the protein of interest is selected from the group consisting of: therapeutic proteins, immunogenic proteins (e.g., viral antigens), and antibodies or antigen-binding fragments thereof.

4. The method of any one of the preceding embodiments, wherein the anionic detergent is selected from the group consisting of: fatty acid detergents.

5. The method of any one of the preceding embodiments, wherein the anionic detergent is different from any other detergent used in a process of protein purification.

6. The method of any one of the preceding embodiments, wherein the anionic detergent does not include deoxycholate and / or sodium lauryl sulfate.

7. The method of any one of the preceding embodiments, wherein the ion excha...

embodiment 17

18. The method of embodiment 17, wherein the sterile closed system is selected from the group consisting of: vials, syringes, and containers.

19. The method of embodiment 17 or 18, wherein the sterile closed system is plastic or glass.

20. The method of any one of embodiments 17-19, wherein the sterile closed system comprises a siliconized surface.

21. A use of the pharmaceutical composition of any one of embodiments 12-20, for the manufacture of a medicament for administering a subject in need thereof.

22. The pharmaceutical composition of any one of embodiments 12-20 for use as a medicament for administering to a subject.

23. A method comprising administering to a subject the pharmaceutical composition of any one of embodiments 12-20.

24. A viral vaccine comprising no more than 5 ng of residual DNA and no more than 1.0 μg nucleoprotein per dose.

embodiment 24

25. The viral vaccine of embodiment 24, comprising no more than 1 ng of residual DNA and no more than 0.5 μg nucleoprotein per dose.

26. The viral vaccine of embodiment 24, comprising no more than 1 ng of residual DNA and no more than 0.1 μg nucleoprotein per dose.

27. The viral vaccine of any one of embodiments 24-26, wherein the viral vaccine is an influenza vaccine.

28. The viral vaccine of any one of embodiments 24-27, further comprising an adjuvant.

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Abstract

The present application discloses methods for removing residual impurities from protein preparations. Such methods include addition of an anionic detergent to a solution comprising proteins of interest and cellular contaminants under non-precipitating conditions and passing the solution through an ion exchange column.

Description

RELATED APPLICATIONS[0001]This international patent application claims priority to U.S. Provisional Application 61 / 904,747 filed Nov. 15, 2013 and European Application 13199257.0 filed Dec. 20, 2013, the contents of each of which are hereby incorporated by reference in its entirety.FIELD OF THE INVENTION[0002]This invention relates to production of proteins in host cells and improved purification methods thereof.BACKGROUND OF THE INVENTION[0003]Various methods for producing vaccines and other biologics in cell cultures have been pre-described. If continuous cell lines are used for the production, there is the risk that residual DNA of the cell line could be oncogenic. It is therefore required to destroy and remove residual DNA from therapeutic proteins of interests. For viral vaccines the FDA currently recommends a DNA amount of less than 10 ng / dose and a fragment size of less than 200 base pairs (Guidance of Industry. Characterization and Qualification of Cell Substrates and other ...

Claims

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Application Information

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IPC IPC(8): A61K39/145C12N7/00
CPCA61K39/145C12N7/00A61K2039/53C12N2760/16151C12N2760/16134C07K1/18A61K39/12A61P31/16A61P37/04B01D15/361C07K14/005
Inventor NORMAN, CARNLEYSUDA, ERICDOWLESS, KAYLAASTIGARRAGA, RUIZBASTEK, PATRICKYANNONE, VAISHALI
Owner NOVARTIS AG
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