IP Library › Granted Patent US 12,318,442
Granted Patent B2
US 12,318,442 · App. 17/151,840 · Granted Jun 3, 2025

Preparation of influenza virus vaccine antigens

Inventors: Christoph Haussmann (Marburg, DE); Frank Hauschild (Marburg, DE); Bjorn Jobst (Marburg, DE)
Assignee: Seqirus UK Limited
A61K39/145A61K39/12C12N7/00A61K2039/5252C12N2760/16034C12N2760/16051C12N2760/16134C12N2760/16163
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Quick Facts
Patent No.
US 12,318,442
App. No.
17/151,840
Granted
Jun 3, 2025
Kind
B2
Abstract

A number of improvements for preparing vaccine antigens from disintegrated influenza viruses are disclosed. A splitting step can be followed by detergent exchange. Splitting can take place in the presence of a buffer with a higher ionic strength and/or in the presence of phosphate buffer.

Claims (28)

1. A method for disrupting influenza virions, the method comprising steps of:

(i) obtaining a composition comprising influenza virions prepared from a cell culture,

(ii) capturing the influenza virions in the composition via filtration;

(iii) adding a first detergent to the filtered composition without splitting the virions;

(iv) inactivating the influenza virions to obtain inactivated virions; and

(v) splitting the inactivated virions in the presence of a second detergent different from the first detergent;

wherein disrupting the influenza virions is a process with a phosphate buffer having a pH between 6.5 and 8.5 and an ionic strength of from 100 mM to 800 mM, the higher ionic strength being achieved by monovalent ions, divalent ions, or trivalent ions.

2. The method of claim 1 , wherein the influenza virions are from an influenza A virus.

3. The method of claim 1 , wherein the influenza virions are from an influenza A virus of H4 hemagglutinin subtype.

4. The method of claim 1 , wherein the cell culture is a mammalian cell culture or an avian cell culture.

5. A method for manufacturing an influenza vaccine, the method comprising steps of:

carrying out the method of claim 1 ,

obtaining a bulk antigen preparation from the disrupted virions of step (iii), and

formulating the bulk antigen preparation into an influenza vaccine.

6. The method of claim 5 , wherein the influenza virions are from an influenza A virus.

7. The method of claim 5 , wherein the influenza virions are from an influenza A virus of H5 hemagglutinin subtype.

8. The method of claim 5 , wherein the cell culture is a mammalian cell culture or an avian cell culture.

9. The method of claim 5 , wherein the influenza vaccine contains less than 10 ng host cell DNA.

10. The method of claim 5 , wherein the influenza vaccine is a monovalent or trivalent influenza vaccine.

11. The method of claim 5 , wherein the influenza vaccine comprises hemagglutinin from at least one B strain.

12. The method of claim 5 , wherein the influenza vaccine comprises from about 3.75 μg to about 15 μg hemagglutinin, per strain, per dose.

13. The method of claim 5 , wherein the step of formulating comprises combining the bulk antigen preparation with an adjuvant.

14. The method of claim 13 , wherein the adjuvant is an oil-in-water emulsion.

15. The method of claim 1 , wherein the buffer has an ionic strength of from 100 mM to 200 mM.

16. The method of claim 1 , wherein the buffer has an ionic strength of at least 200 mM.

17. The method of claim 1 , wherein the buffer has a pH of from 7.0 to 8.0.

18. The method of claim 1 , wherein the buffer has a pH of from 7.0 to 7.8.

19. The method of claim 1 , wherein the method results in a higher than 20-fold increase in antigen yield.

Continuity (4)
Continuation 14961778 · Dec 7, 2015
Continuation 12933379
Provisional Application 61069868 · Mar 18, 2008
Related Publication 20210205438A1 · Jul 8, 2021
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