Method for inactivating viruses using electron beams

Patent metadata

Field	Value
Publication number	US-10080795-B2
Application number	US-201414903997-A
Country	US
Kind code	B2
Filing date	Jul 25, 2014
Priority date	Jul 26, 2013
Publication date	Sep 25, 2018
Grant date	Sep 25, 2018

Abstract

The invention relates to a method for inactivating viruses, characterized in that an immunogenic composition or vaccine comprising at least one virus is irradiated with electron beams, said immunogenic composition or vaccine comprising at least one virus (i) being liquid, in particular being a suspension and (ii) comprising at least one viral immunogen, wherein the antigen structure is preferably substantially retained.

First claim

The invention claimed is:

1. A method for inactivating viruses, characterized in that an immunogenic composition or vaccine comprising at least one virus is irradiated with electron beams with an electron beam dose in the range of 15 kGy to 300 kGy, said immunogenic composition or vaccine comprising at least one virus
(i) being liquid, and
(ii) comprising at least one viral immunogen.

2. The method as claimed in claim 1 , characterized in that the immunogenic composition or vaccine is a suspension.

3. The method as claimed in claim 1 , characterized in that the at least one virus is selected from:
(i) an enveloped virus or non-enveloped virus, and/or
(ii) a dsDNA virus, dsRNA virus, ssRNA virus or ssDNA virus, and/or
(iii) a human pathogenic and/or animal pathogenic virus.

4. The method as claimed in claim 3 , characterized in that the at least one virus is selected from a human pathogenic and/or animal pathogenic enveloped dsRNA virus, enveloped ss(−)RNA virus or enveloped ss(+)RNA virus.

5. The method as claimed in claim 1 , characterized in that the vaccine or immunogenic composition (i) comprises one virus or (ii) two or more different viruses.

6. The method as claimed in claim 1 , characterized in that the electron beams are accelerated at low energy or moderate energy and/or are applied under pressure of 1 bar +/−0.1 bar.

7. The method as claimed in claim 1 , characterized in that the immunogenic composition or vaccine comprising at least one virus is irradiated with an electron beam dose in the range of 50 kGy to 300 kGy.

8. The method as claimed in claim 1 , characterized in that the activity of the at least one virus after irradiation is less than 5% of the activity prior to irradiation.

9. The method as claimed in claim 1 , characterized in that the at least one virus is an enveloped virus.

10. The method as claimed in claim 1 , characterized in that
(a) the irradiation is carried out using a device for generating electron beams,
(i) which is operated continuously or rapidly pulsed,
and/or
(ii) which provides electrons according to the cold or hot cathode principle and/or
(iii) which is embodied as an axial emitter (scanner) or linear broadband emitter,
and/or
(iv) the electrons, after discharge through an emission window of the evacuated generating chamber of the device are applied to the immunogenic composition or vaccine and/or
(v) the immunogenic composition or vaccine is incorporated statically in the device, or is continuously transported through the electron beam,
and/or

(b) a dose rate is in the range of 1 kGy/0.1 sec to 150 kGy/1000 sec and/or
(c) the irradiation time is between 0.1 sec to 1000 sec, and/or
(d) the temperature of the immunogenic composition or vaccine prior to irradiation is between 1° C. and 40° C., and/or
(e) the temperature increase of the immunogenic composition or vaccine after irradiation compared to before irradiation is between 1° C. and 15° C., and/or
(f) the temperature of the immunogenic composition or vaccine after irradiation is between 2° C. and 41° C., and/or
(g) the density of the immunogenic composition or vaccine is between 0.9 and 2 g/cm 3 , and/or
(h) the immunogenic composition or vaccine comprising at least one virus is a liquid suspension comprising water.

11. The method as claimed in claim 1 , characterized in that the immunogenic composition or vaccine comprises
(a) one or more adjuvants, and/or
(b) pharmaceutically acceptable excipients and/or auxiliaries
and/or
(c) one or more further immunogens.

12. The method as claimed in claim 11 , characterized in that one or more further immunogens is selected from
(a) an organic substance, and
(b) a virus or a living organism.

13. A method for preparing a vaccine comprising at least one viral immunogen characterized in that:
(a) an immunogenic composition comprising at least one virus is irradiated with electron beams with an electron beam dose in the range of 15 kGy to 300 kGy, said immunogenic composition comprising at least one virus (i) being liquid and (ii) comprising at least one viral immunogen, and
(b)
(b1) one or more adjuvants are optionally added to the immunogenic composition comprising at least one virus, and/or
(b2) one or more pharmaceutically acceptable excipients and/or auxiliaries are optionally added to the immunogenic composition comprising at least one virus, and/or
(b3) one or more further immunogens are optionally added to the immunogenic composition comprising at least one virus,

wherein the steps (a) to (b3) are carried out in any sequence.

14. The method for preparing a vaccine as claimed in claim 13 , characterized in that the immunogenic composition or vaccine in step (a) is a suspension.

15. The method for preparing a vaccine as claimed in claim 13 , characterized in that the following further steps are carried out:
(c) sterilizing the immunogenic composition, and/or
(d) filling the immunogenic composition in a container,
wherein steps (a) to (d) may be carried out in any sequence,
and following steps (a) to (d) the vaccine is optionally dried, freeze-dried or frozen.

16. The method as claimed in claim 1 , characterized in that the immunogenic composition or vaccine comprising at least one virus is irradiated with an electron beam dose in the range of 50 kGy to 200 kGy.

Assignees

• Fraunhofer Ges Forschung

Inventors

• Ulbert Sebastian
• Wetzel Christiane

Classifications

• A61L2/087 Primary

  Particle radiation, e.g. electron-beam, alpha or beta radiation · CPC title

• A61K41/10

  Inactivation or decontamination of a medicinal preparation prior to administration to an animal or a person · CPC title

• A61L2103/05

  Living organisms or biological materials · CPC title

• A61K39/145 Primary

  Orthomyxoviridae, e.g. influenza virus · CPC title

• A61K2039/5252

  inactivated (killed) · CPC title