METHOD FOR INACTIVATING VIRUSES USING ELECTRON BEAMS
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IPC분류정보
국가/구분
United States(US) Patent
공개
국제특허분류(IPC7판)
A61K-039/145
A61L-002/00
A61K-041/00
A61K-039/00
출원번호
US-0107410
(2018-08-21)
공개번호
US-0353594
(2018-12-13)
우선권정보
DE-102013012455.7 (2013-07-26)
발명자
/ 주소
ULBERT, Sebastian
WETZEL, Christiane
출원인 / 주소
ULBERT, Sebastian
인용정보
피인용 횟수 :
0인용 특허 :
0
초록▼
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 suspe
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.
대표청구항▼
1. 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) compris
1. 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. 2. 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, the at least one virus preferably being selected from a human pathogenic and/or animal pathogenic enveloped dsRNA virus, enveloped ss(−)RNA virus or enveloped ss(+)RNA virus,particularly preferablya) that the at least one virus is selected from a human pathogenic and/or animal pathogenic ss(+)RNA virus, very particularly preferably that the at least one virus is selected from a virus of the Arterividae family, and even more preferably that the at least one virus is a porcine reproductive and respiratory syndrome virus (PRRS virus),orb) that the at least one virus is selected from an animal pathogenic virus, the influenza A and B virus, the TBEV virus, the IPV virus and the hepatitis A virus. 3. The method as claimed in either of claim 1 or 2, characterized in that the vaccine or immunogenic composition (i) comprises one virus or (ii) two or more different viruses. 4. The method as claimed in any of claims 1 to 3, characterized in that the electron beams are accelerated at low energy or moderate energy, preferably accelerated with an acceleration energy of between 150 key and 700 keV, more preferably of between 200 keV and 500 keV, even more preferably of between 250 keV and 400 keV and/or are applied essentially under standard atmospheric pressure, preferably wherein the standard atmospheric pressure is present as atmospheric oxygen, nitrogen or carbon dioxide gas. 5. The method as claimed in any of claims 1 to 4, 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, preferably 50 kGy to 200 kGy, further preferably 50 kGy to 150 kGy, more preferably 50 kGy to 120 kGy, even more preferably 50 kGy to 110 kGy. 6. The method as claimed in any of claims 1 to 5, characterized in that the activity of the at least one virus after irradiation, preferably measured as a TCID50 value, is less than 5%, preferably less than 1%, more preferably less than 0.1% of the activity prior to irradiation, even more preferably that no activity of the at least one virus is still detectable after irradiation. 7. The method as claimed in any of claims 1 to 6, characterized in that the at least one virus is an enveloped virus. 8. The method as claimed in any of claims 1 to 7, characterized in that the antigen structure of the viruses of the immunogenic composition or vaccine is substantially retained after irradiation, preferably that the binding of a polyclonal serum directed against the non-inactivated virus to the at least one virus of the irradiated immunogenic composition or vaccine is at least 40%, preferably at least 70%, more preferably at least 80%, even more preferably at least 90% of the binding of the polyclonal serum to the at least one virus of the immunogenic composition or vaccine prior to irradiation, in particular wherein the binding of the polyclonal serum to the at least one virus of the immunogenic composition or vaccine is determined by ELISA. 9. The method as claimed in any of claims 1 to 8, characterized in that the virus structure of the viruses is substantially retained after irradiation. 10. The method as claimed in any of claims 1 to 9, characterized in that (a) the irradiation is carried out using a device for generating electron beams, (i) which is operated preferably continuously or rapidly pulsed,and/or(ii) which provides electrons preferably 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, preferably are applied to the immunogenic composition or vaccine, wherein the immunogenic composition or vaccine is preferably in a container, and/or(v) the immunogenic composition or vaccine is preferably incorporated statically in the device, or is continuously transported through the electron beam,and/or(b) the 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, preferably between 1 and 100 sec, and/or(d) the temperature of the immunogenic composition or vaccine prior to irradiation is between 1° C. and 40° C., preferably between 5° C. and 37° C., more preferably between 10° C. and 32° C., even more preferably between 15° C. and 30° 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., preferably between 2° C. and 10° C., and/or(f) the temperature of the immunogenic composition or vaccine after irradiation is between 2° C. and 41° C., preferably between 6° C. and 38° C., more preferably between 11° C. and 33° C., even more preferably between 16° C. and 31° C., and/or(g) the density of the immunogenic composition or vaccine is between 0.9 and 2 g/cm3, preferably between 1.0 and 1.8 g/cm3, and/or(h) the immunogenic composition or vaccine comprising at least one virus is a liquid suspension comprising water, preferably is a suspension of the at least one virus in an aqueous solution, wherein the aqueous solution particularly preferably comprises one or more buffer substances. 11. The method as claimed in any of the preceding claims, characterized in that the immunogenic composition or vaccine comprises (a) one or more adjuvants, and/or(b) pharmaceutically acceptable excipients and/or auxiliariesand/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, particularly a protein, which may be glycosylated or non-glycosylated, a nucleic acid, a toxin, or a sugar molecule which is optionally bound to a support, and(b) a virus or a living organism, particularly a bacterium, wherein the virus or living organism may be active or inactivated. 13. A method for preparing a vaccine comprising at least one viral immunogen, particularly a vaccine comprising a viral whole particle vaccine, characterized in that: (a) the method is carried out as claimed in any of claims 1 to 11,(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 following further steps are carried out: (c) sterilising 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. 15. An immunogenic composition or vaccine, preferably vaccine, particularly preferably comprising an inactivated viral whole particle vaccine, which may be prepared by a method of claims 1 to 14. 16. An immunogenic composition or vaccine, preferably vaccine, comprising an inactivated viral whole particle vaccine for an enveloped or non-enveloped virus, characterized in that (a) the activity of the virus in the immunogenic composition or vaccine is less than 10%, preferably less than 1%, more preferably less than 0.1% of the activity of the same number of non-inactivated viruses, and(b) the antigen structure of the inactivated viruses in the immunogenic composition or vaccine is substantially the same compared to the same number of non-inactivated viruses. 17. The immunogenic composition or vaccine as claimed in claim 16, (a) wherein the virus structure of the inactivated viruses is substantially the same compared to the same number of non-inactivated viruses, and/or(b) wherein the immunogenic composition or vaccine has been irradiated with an electron beam, and/or(c) wherein no activity of the at least one virus is detectable in the immunogenic composition or vaccine. 18. The immunogenic composition or vaccine as claimed in any of claims 15 to 17, wherein the immunogenic composition or vaccine has been irradiated with an electron beam dose in the range of 50 kGy to 300 kGy, preferably 50 kGy to 200 kGy, further preferably 50 kGy to 150 kGy, more preferably 50 kGy to 120 kGy, even more preferably 50 kGy to 110 kGy. 19. The immunogenic composition, preferably vaccine, as claimed in any of claims 15 to 18, for use as a vaccine, in particular for preventing or treating viral infections or disorders caused by the virus. 20. The use of electron beams (a) for inactivating viruses in an immunogenic composition or vaccine comprising at least one virus, said immunogenic composition or vaccine (i) being liquid, in particular being a suspension, and(ii) comprising at least one viral immunogen, and/or(b) for preparing an inactivated viral whole particle vaccine. 21. The use as claimed in claim 20, whereinthe electron beams are accelerated at low energy or moderate energy, preferably accelerated with an acceleration energy of between 150 keV and 700 keV, more preferably of between 200 keV and 500 keV, even more preferably of between 250 keV and 400 keV and/or are applied essentially under standard atmospheric pressure, wherein the standard atmospheric pressure is present as atmospheric oxygen, nitrogen or carbon dioxide gasand/or the electron beam dose is in the range of 50 kGy to 300 kGy, preferably 50 kGy to 200 kGy, further preferably 50 kGy to 150 kGy, more preferably 50 kGy to 120 kGy, even more preferably 50 to 110 kGy. 22. The use of a device for generating electron beams (a) for inactivating viruses in liquid immunogenic compositions, more preferably liquid vaccines, and/or(b) for preparing an inactivated viral whole particle vaccine. 23. The use as claimed in claim 22, wherein the devicea) is suitable for emitting electron beams accelerated at low energy or moderate energy, preferably accelerated with an acceleration energy of between 150 keV and 700 keV, more preferably of between 200 keV and 500 keV, even more preferably are accelerated between 250 keV and 400 keV and/or for applying electron beams essentially under standard atmospheric pressure,and/orb) is suitable for delivering an electron beam dose of 50 kGy to 300 kGy, preferably 50 kGy to 200 kGy, further preferably 50 kGy to 150 kGy, more preferably 50 kGy to 120 kGy, even more preferably 50 to 110 kGy. 24. The use of a method as claimed in any of claims 1 to 14 for preparing an inactivated viral whole particle vaccine.
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