Method for reducing DNA impurities in viral compositions

• US 8,778,653 B2
• Filed: 08/12/2010
• Issued: 07/15/2014
• Est. Priority Date: 08/12/2010
• Status: Active Grant

• Current Assignee: Yisheng Biopharma Holdings Ltd.
• Original Assignee: Yisheng Biopharma Holdings Ltd.
• Inventors: Zhang, Yi, Dai, Jinming, Ni, Yajin
• Primary Examiner(s): Humphrey, Louise
• Application Number:
  US13/813,897
• Publication Number:
  US 20130203152A1
• Time in Patent Office: 1,433 Days
• US Class Current: 435/239
• CPC Class Codes: A61K 2039/525 Virus
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61P 31/14 for RNA viruses
• CPC Class Codes: C12N 2760/20134 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2760/20151 Methods of production or purification of viral material
• CPC Class Codes: C12N 7/00 Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00
• CPC Class Codes: C12N 7/02 Recovery or purification
• CPC Class Codes: C12N 7/06 Inactivation or attenuation by chemical treatment

Abstract

A method for purification of viral compositions is provided. In particular, a method for reduction of unwanted residual DNA in a viral composition while retaining the immunogenicity of the virus itself is provided. The resulting immunogenic viral composition is substantially free of residual DNA, and is useful for the manufacture of medical products, such as vaccines designed for human or animal.

Claims

1. A method for the removal of DNA impurities from viral compositions, the method comprising the steps of:

a) harvesting the virus from the cell culture supernatant without the use of a nuclease, followed by b) combining the virus with solution that has an ionic strength of between 0.5 mol/L and 3.0 mol/L followed by c) size exclusion chromatography.

2. The method according to claim 1, wherein the virus belongs to the order mononegavirales.

3. The method according to claim 1, wherein the virus is a rabies virus.

4. The method according to claim 1, wherein the virus is an envelope virus.

5. The method according to claim 1, wherein the virus is a rabies virus and the cell culture is a continuous cell line.

6. The method according to claim 1, wherein the virus is a rabies virus and the cell culture is a Vero cell.

7. The method according to claim 1, wherein the virus is a rabies virus and the cell culture is a Vero cell and the harvested rabies virus is deactivated using between 0.1% and 0.01% β

-propiolactone.