KR920021162A - 백신 및 그의 제조방법 - Google Patents
백신 및 그의 제조방법 Download PDFInfo
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- KR920021162A KR920021162A KR1019920008346A KR920008346A KR920021162A KR 920021162 A KR920021162 A KR 920021162A KR 1019920008346 A KR1019920008346 A KR 1019920008346A KR 920008346 A KR920008346 A KR 920008346A KR 920021162 A KR920021162 A KR 920021162A
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- South Korea
- Prior art keywords
- virus
- vaccine
- inactivating
- propiolactone
- ethyleneimine
- Prior art date
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- 229960005486 vaccine Drugs 0.000 title claims 12
- 238000002360 preparation method Methods 0.000 title claims 3
- 241000700605 Viruses Species 0.000 claims 25
- 238000000034 method Methods 0.000 claims 16
- 230000000415 inactivating effect Effects 0.000 claims 7
- NOWKCMXCCJGMRR-UHFFFAOYSA-N Aziridine Chemical compound C1CN1 NOWKCMXCCJGMRR-UHFFFAOYSA-N 0.000 claims 6
- VEZXCJBBBCKRPI-UHFFFAOYSA-N beta-propiolactone Chemical compound O=C1CCO1 VEZXCJBBBCKRPI-UHFFFAOYSA-N 0.000 claims 5
- 229960000380 propiolactone Drugs 0.000 claims 5
- 239000002245 particle Substances 0.000 claims 4
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 claims 3
- 239000003795 chemical substances by application Substances 0.000 claims 3
- 230000000087 stabilizing effect Effects 0.000 claims 3
- QRLVDLBMBULFAL-UHFFFAOYSA-N Digitonin Natural products CC1CCC2(OC1)OC3C(O)C4C5CCC6CC(OC7OC(CO)C(OC8OC(CO)C(O)C(OC9OCC(O)C(O)C9OC%10OC(CO)C(O)C(OC%11OC(CO)C(O)C(O)C%11O)C%10O)C8O)C(O)C7O)C(O)CC6(C)C5CCC4(C)C3C2C QRLVDLBMBULFAL-UHFFFAOYSA-N 0.000 claims 2
- 102100034343 Integrase Human genes 0.000 claims 2
- 239000002671 adjuvant Substances 0.000 claims 2
- UVYVLBIGDKGWPX-KUAJCENISA-N digitonin Chemical compound O([C@@H]1[C@@H]([C@]2(CC[C@@H]3[C@@]4(C)C[C@@H](O)[C@H](O[C@H]5[C@@H]([C@@H](O)[C@@H](O[C@H]6[C@@H]([C@@H](O[C@H]7[C@@H]([C@@H](O)[C@H](O)CO7)O)[C@H](O)[C@@H](CO)O6)O[C@H]6[C@@H]([C@@H](O[C@H]7[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O7)O)[C@@H](O)[C@@H](CO)O6)O)[C@@H](CO)O5)O)C[C@@H]4CC[C@H]3[C@@H]2[C@@H]1O)C)[C@@H]1C)[C@]11CC[C@@H](C)CO1 UVYVLBIGDKGWPX-KUAJCENISA-N 0.000 claims 2
- UVYVLBIGDKGWPX-UHFFFAOYSA-N digitonine Natural products CC1C(C2(CCC3C4(C)CC(O)C(OC5C(C(O)C(OC6C(C(OC7C(C(O)C(O)CO7)O)C(O)C(CO)O6)OC6C(C(OC7C(C(O)C(O)C(CO)O7)O)C(O)C(CO)O6)O)C(CO)O5)O)CC4CCC3C2C2O)C)C2OC11CCC(C)CO1 UVYVLBIGDKGWPX-UHFFFAOYSA-N 0.000 claims 2
- 239000003937 drug carrier Substances 0.000 claims 2
- 208000015181 infectious disease Diseases 0.000 claims 2
- 230000003612 virological effect Effects 0.000 claims 2
- 238000002965 ELISA Methods 0.000 claims 1
- SXRSQZLOMIGNAQ-UHFFFAOYSA-N Glutaraldehyde Chemical compound O=CCCCC=O SXRSQZLOMIGNAQ-UHFFFAOYSA-N 0.000 claims 1
- 108010061833 Integrases Proteins 0.000 claims 1
- 241000124008 Mammalia Species 0.000 claims 1
- 108010092799 RNA-directed DNA polymerase Proteins 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 210000001744 T-lymphocyte Anatomy 0.000 claims 1
- 108020000999 Viral RNA Proteins 0.000 claims 1
- 208000036142 Viral infection Diseases 0.000 claims 1
- 238000004458 analytical method Methods 0.000 claims 1
- 238000010171 animal model Methods 0.000 claims 1
- 230000000890 antigenic effect Effects 0.000 claims 1
- FUSUHKVFWTUUBE-UHFFFAOYSA-N buten-2-one Chemical group CC(=O)C=C FUSUHKVFWTUUBE-UHFFFAOYSA-N 0.000 claims 1
- 210000004027 cell Anatomy 0.000 claims 1
- 238000004113 cell culture Methods 0.000 claims 1
- 238000005119 centrifugation Methods 0.000 claims 1
- 229940099352 cholate Drugs 0.000 claims 1
- BHQCQFFYRZLCQQ-OELDTZBJSA-N cholic acid Chemical compound C([C@H]1C[C@H]2O)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CCC(O)=O)C)[C@@]2(C)[C@@H](O)C1 BHQCQFFYRZLCQQ-OELDTZBJSA-N 0.000 claims 1
- 230000015271 coagulation Effects 0.000 claims 1
- 238000005345 coagulation Methods 0.000 claims 1
- 239000003431 cross linking reagent Substances 0.000 claims 1
- 239000012228 culture supernatant Substances 0.000 claims 1
- 239000003599 detergent Substances 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 229960000587 glutaral Drugs 0.000 claims 1
- 238000000227 grinding Methods 0.000 claims 1
- 230000028993 immune response Effects 0.000 claims 1
- 238000003119 immunoblot Methods 0.000 claims 1
- 230000005847 immunogenicity Effects 0.000 claims 1
- 230000002779 inactivation Effects 0.000 claims 1
- 230000000937 inactivator Effects 0.000 claims 1
- 238000011534 incubation Methods 0.000 claims 1
- 230000002458 infectious effect Effects 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 210000003819 peripheral blood mononuclear cell Anatomy 0.000 claims 1
- 238000003752 polymerase chain reaction Methods 0.000 claims 1
- 230000000644 propagated effect Effects 0.000 claims 1
- 102000004169 proteins and genes Human genes 0.000 claims 1
- 108090000623 proteins and genes Proteins 0.000 claims 1
- 208000008864 scrapie Diseases 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
- 230000009469 supplementation Effects 0.000 claims 1
- 230000004083 survival effect Effects 0.000 claims 1
- 230000009385 viral infection Effects 0.000 claims 1
- 210000002845 virion Anatomy 0.000 claims 1
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- A61K39/12—Viral antigens
- A61K39/145—Orthomyxoviridae, e.g. influenza virus
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- A61K39/21—Retroviridae, e.g. equine infectious anemia virus
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Abstract
내용 없음.
Description
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음
Claims (21)
- (a) 바이러스를 일반적인 불활성화제로 처리하는 단계; (b) 상기 바이러스를 적당한 용매 또는 디터전트로 분해하는 단계; (c) 상기 바이러스를 PNA 및/또는 DNA불화성화제로 처리하는 단계; 및 (d) 적당한 가교제로 상기 바이러스를 안정화시키는 단계가 순차적으로 진행되는 것을 특징으로 하는 백신용 바이러스 입자의 제조방법.
- 제1항에 있어서, 상기 제제가 위험한 바이러스의 제제인 것을 특징으로 하는 상기 백신용 바이러스 제제의 제조방법.
- 제2항에 있어서, 상기 바이러스가 HIV 및 그것의 균주로 구성된 그룹중에서 선택되는 것을 특징으로 하는 상기 백신용 바이러스 제제의 제제방법.
- 제2항에 있어서, 상기 바이러스가 열 및/또는 화학물질 내성 바이러스로 구성된 그룹중에서 선택되는 것을 특징으로 하는 상기 백신용 바이러스 제제의 제조방법.
- 제4항에 있어서, 상기 바이러스가 스크레피 및 BSE로 구성된 그룹중에서 선택되는 것을 특징으로 하는 상기 백신용 바이러스 제제의 제조방법.
- 제1항에 있어서, 상기 바이러스가 상기 바이러스 균주의 대표적인 선택을 포함하는 것을 특징으로 하는 상기 백신용 바이러스 제제의 제조방법.
- 제6항에 있어서, 상기 대표적인 균주 선택은 상기 바이러스 균주가 상기 바이러스 입자로부터 제조된 백신에 의해 야기되는 면역반응에 영향을 받도록 선택되는 것을 특징으로 하는 상기 백신용 바이러스 제제의 제조방법.
- 제1항에 있어서, 상기 a) 단계의 불활성화제가 β-프로피오락톤을 포함하는 것을 특징으로 하는 상기 백신용 바이러스 제제의 제조방법.
- 제8항에 있어서, β-프로피오락톤으로 처리하는 것이 반복되는 것을 특징으로 하는 상기 백신용 바이러스 제제의 제조방법.
- 제8항에 있어서, β-프로피오락톤을 약 37℃내지 약40℃온도에서 사용하는 것을 특징으로 하는 상기 백신용 바이러스 제제의 제조방법.
- 제8항에 있어서, β-프로피오락톤이 약 0.1% v/v농도로 사용되는 것을 특징으로 하는 상기 백신용 바이러스 제제의 제조방법.
- 제1항에 있어서, 상기 바이러스가 단계 a) 이후에 정제되는 것을 특징으로 하는 상기 백신용 바이러스 제제의 제조방법.
- 제1항에 있어서, 상기 c) 단계에서 에틸렌이민을 RNAse 및/또는 DNAse에 추가하여 사용하는 것을 특징으로 하는 상기 백신용 바이러스 제제의 제조방법.
- 제13항에 있어서, 상기 에틸렌 이민이 아세틸-에틸렌 이민 또는 이성분 에틸렌 이민인 것을 특징으로 하는 상기 백신용 바이러스 제제의 제조방법.
- 제13항에 있어서, 상기 에틸렌이민이 이성분-에틸렌이민인 것을 특징으로 하는 상기 백신용 바이러스 제제의 제조방법.
- 제1항에 의해 제조된 바이러스 입자와 그것의 제약학적 허용 담체와로 구성되는 백신.
- 보강제로서 작용하기에 충분한 양의 디지토닌을 포함하는 백신.
- 제1항에 의해 제조된 바이러스 입자, 그것의 제약학적 허용 담체 및 보강제로서 작용하기에 충분한 양의 디지토닌을 함께 포함하는 백신.
- 제1항에 있어서, 유전 물질을 불활성화시킨 이후 및 분해된 바이러스를 안정화시키기 이전에 디지토닌이 첨가되는 것을 특징으로 하는 상기 백신용 바이러스 제제의 제조방법.
- a) 감염군으로부터 수득한 바이러스를 지속적으로 증식된 T-세포주에 가하는 단계; b) 미정제 배양 상청액을 2단계의 β-프로피오락톤으로 불활성화시키는 단계; ba) 세포 배양액의 급속한 합포체 분석으로 감염성 바이러스를 보충시험하는 단계; c) 슈크로즈 구배로 원심분리하여 바이러스를 정제하는 단계; d) 바이러스를 콜레이트로 분해, 확대(ballooning) 및 더 불활성화시키는 단계; e) 개방된 코어를 이성분 에틸렌이민으로 불활성화시키는 단계 ; f) 바이러스 RNA와 오염성 숙주 세포 DNA를 RNAse와 DNAse로 불활성화시키는 단계; g)보강 및 추가 바이러스 분쇄 및 불활성화 이후, 디지토닌으로 재응집시키는 단계; h) 재응집된 비리온을 적당한 포름 알데히드 또는 글루타르 알데히드로 안정화시키는 단계; i) 함께 배양함으로써 남아있는 불활성화되지 않은 바이러스의 백신 제제를 인체의 말초 혈액 단핵 세포로 6주간 시험하는 단계; j) 바이러스의 역전사효소 및 인테그라제(integrase)에 특이성이 있는 프라이머를 사용하여 잔류한 프로바이러스의 DNA및 바이러스의 RNA에 대한 폴리머라제 쇄반응으로 분석하는 단계; k) 항원성 생존을 확인하기 위하여, 감염후, 항혈청을 이용한 ELISA 및 면역블롯팅으로 백신을 표준화하는 단계; 및 l) 소수 또는 다수으이 실험 동물에 백신 접종 시험을 함으로써 면역원성을 표준화하는 단계가 순차적으로 수행되는 것을 특징으로 하는 백신용 HIV입자의 제조방법.
- 제16항 내지 제18항중 어느 한 항에 따른 백신을 면역 유효량으로 투여하는 것을 특징으로 하는 상기 백신이 필요한 포유류의 바이러스 감염을 치료 또는 예방하기 위한 방법.※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB9110808.4 | 1991-05-17 | ||
| GB919110808A GB9110808D0 (en) | 1991-05-17 | 1991-05-17 | Aids vaccine and method for its production |
Publications (2)
| Publication Number | Publication Date |
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| KR920021162A true KR920021162A (ko) | 1992-12-18 |
| KR0149182B1 KR0149182B1 (ko) | 1998-10-15 |
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| KR1019920008346A KR0149182B1 (ko) | 1991-05-17 | 1992-05-18 | 백신 및 그의 제조방법 |
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| US (1) | US5698432A (ko) |
| EP (1) | EP0514199B1 (ko) |
| JP (1) | JPH05328967A (ko) |
| KR (1) | KR0149182B1 (ko) |
| AT (1) | ATE172642T1 (ko) |
| AU (1) | AU652447B2 (ko) |
| BR (1) | BR9201848A (ko) |
| CA (1) | CA2068817A1 (ko) |
| DE (1) | DE69227400T2 (ko) |
| ES (1) | ES2127203T3 (ko) |
| GB (1) | GB9110808D0 (ko) |
| IE (1) | IE921556A1 (ko) |
| IN (1) | IN174080B (ko) |
| NZ (1) | NZ242780A (ko) |
| SG (1) | SG49763A1 (ko) |
| ZA (1) | ZA923607B (ko) |
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| CN105008381B (zh) | 2012-12-13 | 2018-08-07 | 艾杜罗生物科技公司 | 包含具有确定立体化学的环嘌呤二核苷酸的组合物及其制备和使用方法 |
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| US4086134A (en) * | 1973-09-18 | 1978-04-25 | University Of Glasgow | Method for preparation of vaccine against feline leukemia |
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| GB8906794D0 (en) * | 1989-03-23 | 1989-05-10 | Carroll Noel | Preparation of vaccines |
-
1991
- 1991-05-17 GB GB919110808A patent/GB9110808D0/en active Pending
-
1992
- 1992-05-15 BR BR929201848A patent/BR9201848A/pt not_active Application Discontinuation
- 1992-05-15 EP EP92304422A patent/EP0514199B1/en not_active Expired - Lifetime
- 1992-05-15 CA CA002068817A patent/CA2068817A1/en not_active Abandoned
- 1992-05-15 AT AT92304422T patent/ATE172642T1/de not_active IP Right Cessation
- 1992-05-15 IN IN294MA1992 patent/IN174080B/en unknown
- 1992-05-15 SG SG1996004956A patent/SG49763A1/en unknown
- 1992-05-15 ES ES92304422T patent/ES2127203T3/es not_active Expired - Lifetime
- 1992-05-15 AU AU16340/92A patent/AU652447B2/en not_active Ceased
- 1992-05-15 DE DE69227400T patent/DE69227400T2/de not_active Expired - Fee Related
- 1992-05-18 KR KR1019920008346A patent/KR0149182B1/ko not_active IP Right Cessation
- 1992-05-18 NZ NZ24278092A patent/NZ242780A/en not_active IP Right Cessation
- 1992-05-18 JP JP4168187A patent/JPH05328967A/ja active Pending
- 1992-05-18 ZA ZA923607A patent/ZA923607B/xx unknown
- 1992-07-01 IE IE155692A patent/IE921556A1/en not_active IP Right Cessation
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1996
- 1996-10-11 US US08/729,135 patent/US5698432A/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| GB9110808D0 (en) | 1991-07-10 |
| AU1634092A (en) | 1992-12-17 |
| EP0514199A2 (en) | 1992-11-19 |
| JPH05328967A (ja) | 1993-12-14 |
| ES2127203T3 (es) | 1999-04-16 |
| SG49763A1 (en) | 1998-06-15 |
| IN174080B (ko) | 1994-09-10 |
| AU652447B2 (en) | 1994-08-25 |
| ZA923607B (en) | 1993-02-24 |
| BR9201848A (pt) | 1993-01-05 |
| ATE172642T1 (de) | 1998-11-15 |
| US5698432A (en) | 1997-12-16 |
| EP0514199B1 (en) | 1998-10-28 |
| NZ242780A (en) | 1994-07-26 |
| DE69227400T2 (de) | 1999-07-01 |
| IE921556A1 (en) | 1992-11-18 |
| EP0514199A3 (en) | 1993-11-10 |
| KR0149182B1 (ko) | 1998-10-15 |
| CA2068817A1 (en) | 1992-11-18 |
| DE69227400D1 (de) | 1998-12-03 |
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