Process for producing influenza vaccine

Patent metadata

Field	Value
Publication number	US-10398771-B2
Application number	US-201715467446-A
Country	US
Kind code	B2
Filing date	Mar 23, 2017
Priority date	Oct 27, 2009
Publication date	Sep 3, 2019
Grant date	Sep 3, 2019

Abstract

A process for producing a split influenza virus preparation or subunit influenza preparation comprising the steps of: (i) providing a whole virus preparation; (ii) splitting the whole virus preparation in the presence of a first detergent; (iii) adding t-octylphenoxypolyethoxyethanol (TRITON X-100™) to the resulting split virus preparation; and (iv) filtering the split virus preparation.

First claim

We claim:

1. A split influenza virus preparation or subunit influenza virus preparation obtained or obtainable by a process comprising the steps of: (i) providing a whole virus preparation; (ii) splitting the whole virus preparation in the presence of a first detergent, wherein the first detergent is not t-octylphenoxypolyethoxyethanol, thereby producing a split virus preparation; (iii) adding t-octylphenoxypolyethoxyethanol to the split virus preparation, wherein t-octylphenoxypolyethoxyethanol is present in an amount of 0.1-0.4% (w/v); and (iv) filtering the split virus preparation in the presence of t-octylphenoxypolyethoxyethanol.

2. The split influenza virus preparation or subunit influenza virus preparation of claim 1 , wherein t-octylphenoxypolyethoxyethanol is present in an amount of 0.25% (w/v).

3. The split influenza virus preparation or subunit influenza virus preparation of claim 1 , wherein the first detergent is selected from the group consisting of: cetyl trimethyl ammonium bromide (CTAB), laurylsulfate, taurodeoxycholate, polyoxyethylene sorbitan monooleate and sodium deoxycholate.

4. The split influenza virus preparation or subunit influenza virus preparation of claim 1 , wherein the first detergent is sodium deoxycholate.

5. A process for preparing a pharmaceutical or immunogenic composition, comprising the steps of: (a) providing a split influenza virus preparation or subunit influenza virus preparation by a process comprising the steps of: (i) providing a whole virus preparation; (ii) splitting the whole virus preparation in the presence of a first detergent, wherein the first detergent is not t-octylphenoxypolyethoxyethanol, thereby producing a split virus preparation; (iii) adding t-octylphenoxypolyethoxyethanol to the split virus preparation, wherein t-octylphenoxypolyethoxyethanol is present in an amount of 0.1-0.4% (w/v); and (iv) filtering the split virus preparation in the presence of t-octylphenoxypolyethoxyethanol; and
(b) admixing said split influenza virus preparation or subunit influenza virus preparation with a pharmaceutically acceptable carrier to prepare the pharmaceutical or immunogenic composition.

6. The process of claim 5 , wherein t-octylphenoxypolyethoxyethanol is present in an amount of 0.25% (w/v).

7. The process of claim 5 , wherein the first detergent is selected from the group consisting of: cetyl trimethyl ammonium bromide (CTAB), laurylsulfate, taurodeoxycholate, polyoxyethylene sorbitan monooleate and sodium deoxycholate.

8. The process of claim 5 , wherein the first detergent is sodium deoxycholate.

9. The process of claim 5 further comprising a step wherein the split influenza virus preparation or subunit influenza preparation of step (a) is diluted to reach the desired HA concentration before step (b).

10. A pharmaceutical or immunogenic composition obtained or obtainable by the process of claim 5 .

11. The pharmaceutical or immunogenic composition of claim 10 additionally comprising an adjuvant.

12. The pharmaceutical or immunogenic composition of claim 11 wherein the adjuvant is an oil in water emulsion.

13. A method of treating or preventing a disease caused by influenza, the method comprising administering the pharmaceutical or immunogenic composition of claim 10 to a human subject in need thereof.

14. A vaccine comprising one or more split influenza virus preparations or subunit influenza virus preparations prepared according to a process comprising the steps of: (i) providing a whole virus preparation; (ii) splitting the whole virus preparation in the presence of a first detergent, wherein the first detergent is not t-octylphenoxypolyethoxyethanol, thereby producing a split virus preparation; (iii) adding t-octylphenoxypolyethoxyethanol to the split virus preparation, wherein t-octylphenoxypolyethoxyethanol is present in an amount of 0.1-0.4% (w/v); and (iv) filtering the split virus preparation in the presence of t-octylphenoxypolyethoxyethanol.

15. The vaccine of claim 14 , wherein t-octylphenoxypolyethoxyethanol is present in an amount of 0.25% (w/v).

16. The vaccine of claim 14 , wherein the first detergent is selected from the group consisting of: cetyl trimethyl ammonium bromide (CTAB), laurylsulfate, taurodeoxycholate, polyoxyethylene sorbitan monooleate and sodium deoxycholate.

17. The vaccine of claim 14 , wherein the first detergent is sodium deoxycholate.

Assignees

• Glaxosmithkline Biologicals Sa
• Glaxosmithkline Biologicals Niederlassung Der Smithkline Beecham Pharma Gmbh & Co Kg
• Glaxosmithkline Biological S A

Inventors

• D'Hondt Erik Jozef
• Engelmann Hans Bernd

Classifications

• A61P37/04

  Immunostimulants · CPC title

• A61P31/16

  for influenza or rhinoviruses · CPC title

• C12N2760/16151

  Methods of production or purification of viral material · CPC title

• A61K2039/5252

  inactivated (killed) · CPC title

• C12N2760/16134

  Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein · CPC title