KR20160096215A - 바이러스 항원 및 백신의 제조 방법 - Google Patents
바이러스 항원 및 백신의 제조 방법 Download PDFInfo
- Publication number
- KR20160096215A KR20160096215A KR1020167020663A KR20167020663A KR20160096215A KR 20160096215 A KR20160096215 A KR 20160096215A KR 1020167020663 A KR1020167020663 A KR 1020167020663A KR 20167020663 A KR20167020663 A KR 20167020663A KR 20160096215 A KR20160096215 A KR 20160096215A
- Authority
- KR
- South Korea
- Prior art keywords
- virus
- viral
- envelope
- cell
- detergent
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
- 239000000427 antigen Substances 0.000 title claims abstract description 84
- 102000036639 antigens Human genes 0.000 title claims abstract description 84
- 108091007433 antigens Proteins 0.000 title claims abstract description 84
- 230000003612 virological effect Effects 0.000 title claims abstract description 66
- 238000000034 method Methods 0.000 title abstract description 123
- 229960005486 vaccine Drugs 0.000 title abstract description 38
- 230000008569 process Effects 0.000 title description 27
- 241000700605 Viruses Species 0.000 claims abstract description 170
- 239000012530 fluid Substances 0.000 claims abstract description 27
- 238000004519 manufacturing process Methods 0.000 claims abstract description 24
- 230000003381 solubilizing effect Effects 0.000 claims abstract description 7
- 239000003599 detergent Substances 0.000 claims description 71
- 238000003306 harvesting Methods 0.000 claims description 44
- 239000007788 liquid Substances 0.000 claims description 38
- 239000000203 mixture Substances 0.000 claims description 34
- 125000002091 cationic group Chemical group 0.000 claims description 25
- 238000002360 preparation method Methods 0.000 abstract description 33
- 108010003533 Viral Envelope Proteins Proteins 0.000 abstract 1
- 210000004779 membrane envelope Anatomy 0.000 abstract 1
- 210000004027 cell Anatomy 0.000 description 59
- 238000000746 purification Methods 0.000 description 47
- 108020004414 DNA Proteins 0.000 description 45
- 101710154606 Hemagglutinin Proteins 0.000 description 45
- 101710093908 Outer capsid protein VP4 Proteins 0.000 description 45
- 101710135467 Outer capsid protein sigma-1 Proteins 0.000 description 45
- 101710176177 Protein A56 Proteins 0.000 description 45
- 239000000185 hemagglutinin Substances 0.000 description 45
- 238000011084 recovery Methods 0.000 description 29
- 238000009295 crossflow filtration Methods 0.000 description 28
- 238000005063 solubilization Methods 0.000 description 27
- 230000007928 solubilization Effects 0.000 description 27
- LZZYPRNAOMGNLH-UHFFFAOYSA-M Cetrimonium bromide Chemical compound [Br-].CCCCCCCCCCCCCCCC[N+](C)(C)C LZZYPRNAOMGNLH-UHFFFAOYSA-M 0.000 description 26
- 230000009467 reduction Effects 0.000 description 25
- 238000005199 ultracentrifugation Methods 0.000 description 23
- 108010006232 Neuraminidase Proteins 0.000 description 22
- 102000005348 Neuraminidase Human genes 0.000 description 22
- 239000008194 pharmaceutical composition Substances 0.000 description 19
- 238000005119 centrifugation Methods 0.000 description 18
- 238000005352 clarification Methods 0.000 description 18
- 230000002779 inactivation Effects 0.000 description 18
- 102000004169 proteins and genes Human genes 0.000 description 18
- 108090000623 proteins and genes Proteins 0.000 description 18
- 238000011038 discontinuous diafiltration by volume reduction Methods 0.000 description 17
- 238000001914 filtration Methods 0.000 description 17
- 239000000047 product Substances 0.000 description 17
- 229920001429 chelating resin Polymers 0.000 description 16
- 239000012535 impurity Substances 0.000 description 16
- 239000002245 particle Substances 0.000 description 16
- 238000004587 chromatography analysis Methods 0.000 description 15
- 230000001976 improved effect Effects 0.000 description 14
- 239000000126 substance Substances 0.000 description 13
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 12
- 229920000053 polysorbate 80 Polymers 0.000 description 12
- 230000000644 propagated effect Effects 0.000 description 12
- 238000000108 ultra-filtration Methods 0.000 description 12
- 241000712461 unidentified influenza virus Species 0.000 description 11
- 206010057190 Respiratory tract infections Diseases 0.000 description 10
- VEZXCJBBBCKRPI-UHFFFAOYSA-N beta-propiolactone Chemical compound O=C1CCO1 VEZXCJBBBCKRPI-UHFFFAOYSA-N 0.000 description 10
- 238000004191 hydrophobic interaction chromatography Methods 0.000 description 10
- 238000011027 product recovery Methods 0.000 description 10
- GNFTZDOKVXKIBK-UHFFFAOYSA-N 3-(2-methoxyethoxy)benzohydrazide Chemical compound COCCOC1=CC=CC(C(=O)NN)=C1 GNFTZDOKVXKIBK-UHFFFAOYSA-N 0.000 description 9
- 230000009286 beneficial effect Effects 0.000 description 9
- 239000000356 contaminant Substances 0.000 description 9
- 239000012528 membrane Substances 0.000 description 9
- 239000006228 supernatant Substances 0.000 description 9
- 238000001042 affinity chromatography Methods 0.000 description 8
- 238000011210 chromatographic step Methods 0.000 description 8
- 230000000694 effects Effects 0.000 description 8
- 239000000543 intermediate Substances 0.000 description 8
- 238000000926 separation method Methods 0.000 description 8
- 241001493065 dsRNA viruses Species 0.000 description 7
- 238000004255 ion exchange chromatography Methods 0.000 description 7
- 238000000502 dialysis Methods 0.000 description 6
- 239000000706 filtrate Substances 0.000 description 6
- 230000006872 improvement Effects 0.000 description 6
- 230000000415 inactivating effect Effects 0.000 description 6
- 206010022000 influenza Diseases 0.000 description 6
- 238000011068 loading method Methods 0.000 description 6
- 238000001556 precipitation Methods 0.000 description 6
- 229960000380 propiolactone Drugs 0.000 description 6
- 150000003839 salts Chemical class 0.000 description 6
- 229940124873 Influenza virus vaccine Drugs 0.000 description 5
- 101710163270 Nuclease Proteins 0.000 description 5
- -1 alkylamine acetate Chemical class 0.000 description 5
- 239000000872 buffer Substances 0.000 description 5
- 239000012263 liquid product Substances 0.000 description 5
- 210000004962 mammalian cell Anatomy 0.000 description 5
- 229920000136 polysorbate Polymers 0.000 description 5
- 230000001932 seasonal effect Effects 0.000 description 5
- 239000000725 suspension Substances 0.000 description 5
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 4
- 108010052285 Membrane Proteins Proteins 0.000 description 4
- 102000018697 Membrane Proteins Human genes 0.000 description 4
- 230000009849 deactivation Effects 0.000 description 4
- 230000004720 fertilization Effects 0.000 description 4
- 238000011534 incubation Methods 0.000 description 4
- 229960003971 influenza vaccine Drugs 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 239000002609 medium Substances 0.000 description 4
- 229920000151 polyglycol Polymers 0.000 description 4
- 239000010695 polyglycol Substances 0.000 description 4
- 239000000243 solution Substances 0.000 description 4
- 229940031626 subunit vaccine Drugs 0.000 description 4
- 238000005406 washing Methods 0.000 description 4
- FGUUSXIOTUKUDN-IBGZPJMESA-N C1(=CC=CC=C1)N1C2=C(NC([C@H](C1)NC=1OC(=NN=1)C1=CC=CC=C1)=O)C=CC=C2 Chemical compound C1(=CC=CC=C1)N1C2=C(NC([C@H](C1)NC=1OC(=NN=1)C1=CC=CC=C1)=O)C=CC=C2 FGUUSXIOTUKUDN-IBGZPJMESA-N 0.000 description 3
- 241000450599 DNA viruses Species 0.000 description 3
- 102000004190 Enzymes Human genes 0.000 description 3
- 108090000790 Enzymes Proteins 0.000 description 3
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 description 3
- 208000037262 Hepatitis delta Diseases 0.000 description 3
- 241000724709 Hepatitis delta virus Species 0.000 description 3
- 101710085938 Matrix protein Proteins 0.000 description 3
- 101710127721 Membrane protein Proteins 0.000 description 3
- 108010058846 Ovalbumin Proteins 0.000 description 3
- 108010034546 Serratia marcescens nuclease Proteins 0.000 description 3
- 229930006000 Sucrose Natural products 0.000 description 3
- 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 description 3
- 108010067390 Viral Proteins Proteins 0.000 description 3
- 210000004102 animal cell Anatomy 0.000 description 3
- 239000007795 chemical reaction product Substances 0.000 description 3
- 239000003795 chemical substances by application Substances 0.000 description 3
- 238000002298 density-gradient ultracentrifugation Methods 0.000 description 3
- 238000010790 dilution Methods 0.000 description 3
- 239000012895 dilution Substances 0.000 description 3
- 238000003379 elimination reaction Methods 0.000 description 3
- 239000012467 final product Substances 0.000 description 3
- 239000001963 growth medium Substances 0.000 description 3
- 238000004460 liquid liquid chromatography Methods 0.000 description 3
- 239000008267 milk Substances 0.000 description 3
- 235000013336 milk Nutrition 0.000 description 3
- 210000004080 milk Anatomy 0.000 description 3
- 229940092253 ovalbumin Drugs 0.000 description 3
- 238000005453 pelletization Methods 0.000 description 3
- 239000002244 precipitate Substances 0.000 description 3
- 238000001542 size-exclusion chromatography Methods 0.000 description 3
- 239000005720 sucrose Substances 0.000 description 3
- 210000002845 virion Anatomy 0.000 description 3
- QGLWBTPVKHMVHM-KTKRTIGZSA-N (z)-octadec-9-en-1-amine Chemical compound CCCCCCCC\C=C/CCCCCCCCN QGLWBTPVKHMVHM-KTKRTIGZSA-N 0.000 description 2
- 108010088751 Albumins Proteins 0.000 description 2
- 102000009027 Albumins Human genes 0.000 description 2
- 241000712891 Arenavirus Species 0.000 description 2
- 244000060011 Cocos nucifera Species 0.000 description 2
- 235000013162 Cocos nucifera Nutrition 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- QUSNBJAOOMFDIB-UHFFFAOYSA-N Ethylamine Chemical group CCN QUSNBJAOOMFDIB-UHFFFAOYSA-N 0.000 description 2
- 241000282414 Homo sapiens Species 0.000 description 2
- 101710084021 Large envelope protein Proteins 0.000 description 2
- QWZLBLDNRUUYQI-UHFFFAOYSA-M Methylbenzethonium chloride Chemical compound [Cl-].CC1=CC(C(C)(C)CC(C)(C)C)=CC=C1OCCOCC[N+](C)(C)CC1=CC=CC=C1 QWZLBLDNRUUYQI-UHFFFAOYSA-M 0.000 description 2
- REYJJPSVUYRZGE-UHFFFAOYSA-N Octadecylamine Chemical compound CCCCCCCCCCCCCCCCCCN REYJJPSVUYRZGE-UHFFFAOYSA-N 0.000 description 2
- 238000011529 RT qPCR Methods 0.000 description 2
- 108010065667 Viral Matrix Proteins Proteins 0.000 description 2
- 125000005211 alkyl trimethyl ammonium group Chemical group 0.000 description 2
- POJWUDADGALRAB-UHFFFAOYSA-N allantoin Chemical compound NC(=O)NC1NC(=O)NC1=O POJWUDADGALRAB-UHFFFAOYSA-N 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- UREZNYTWGJKWBI-UHFFFAOYSA-M benzethonium chloride Chemical compound [Cl-].C1=CC(C(C)(C)CC(C)(C)C)=CC=C1OCCOCC[N+](C)(C)CC1=CC=CC=C1 UREZNYTWGJKWBI-UHFFFAOYSA-M 0.000 description 2
- 229960001950 benzethonium chloride Drugs 0.000 description 2
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 description 2
- 108091092356 cellular DNA Proteins 0.000 description 2
- 230000001143 conditioned effect Effects 0.000 description 2
- 238000011109 contamination Methods 0.000 description 2
- 238000000432 density-gradient centrifugation Methods 0.000 description 2
- 230000008030 elimination Effects 0.000 description 2
- 239000006167 equilibration buffer Substances 0.000 description 2
- 235000019441 ethanol Nutrition 0.000 description 2
- 150000002170 ethers Chemical class 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 230000000951 immunodiffusion Effects 0.000 description 2
- 230000005847 immunogenicity Effects 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 230000002458 infectious effect Effects 0.000 description 2
- 239000012160 loading buffer Substances 0.000 description 2
- 210000002540 macrophage Anatomy 0.000 description 2
- 238000005374 membrane filtration Methods 0.000 description 2
- WSFSSNUMVMOOMR-NJFSPNSNSA-N methanone Chemical compound O=[14CH2] WSFSSNUMVMOOMR-NJFSPNSNSA-N 0.000 description 2
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 2
- 229960002285 methylbenzethonium chloride Drugs 0.000 description 2
- 238000012434 mixed-mode chromatography Methods 0.000 description 2
- UPHWVVKYDQHTCF-UHFFFAOYSA-N octadecylazanium;acetate Chemical compound CC(O)=O.CCCCCCCCCCCCCCCCCCN UPHWVVKYDQHTCF-UHFFFAOYSA-N 0.000 description 2
- 239000013618 particulate matter Substances 0.000 description 2
- 229920001223 polyethylene glycol Polymers 0.000 description 2
- 229940068965 polysorbates Drugs 0.000 description 2
- ZCCUUQDIBDJBTK-UHFFFAOYSA-N psoralen Chemical compound C1=C2OC(=O)C=CC2=CC2=C1OC=C2 ZCCUUQDIBDJBTK-UHFFFAOYSA-N 0.000 description 2
- 239000013049 sediment Substances 0.000 description 2
- 241001529453 unidentified herpesvirus Species 0.000 description 2
- 241001430294 unidentified retrovirus Species 0.000 description 2
- SIDULKZCBGMXJL-UHFFFAOYSA-N 1-dimethylphosphoryldodecane Chemical compound CCCCCCCCCCCCP(C)(C)=O SIDULKZCBGMXJL-UHFFFAOYSA-N 0.000 description 1
- BHNQPLPANNDEGL-UHFFFAOYSA-N 2-(4-octylphenoxy)ethanol Chemical compound CCCCCCCCC1=CC=C(OCCO)C=C1 BHNQPLPANNDEGL-UHFFFAOYSA-N 0.000 description 1
- VXGRJERITKFWPL-UHFFFAOYSA-N 4',5'-Dihydropsoralen Natural products C1=C2OC(=O)C=CC2=CC2=C1OCC2 VXGRJERITKFWPL-UHFFFAOYSA-N 0.000 description 1
- QCVGEOXPDFCNHA-UHFFFAOYSA-N 5,5-dimethyl-2,4-dioxo-1,3-oxazolidine-3-carboxamide Chemical compound CC1(C)OC(=O)N(C(N)=O)C1=O QCVGEOXPDFCNHA-UHFFFAOYSA-N 0.000 description 1
- POJWUDADGALRAB-PVQJCKRUSA-N Allantoin Natural products NC(=O)N[C@@H]1NC(=O)NC1=O POJWUDADGALRAB-PVQJCKRUSA-N 0.000 description 1
- 241000271566 Aves Species 0.000 description 1
- 241000283690 Bos taurus Species 0.000 description 1
- CPELXLSAUQHCOX-UHFFFAOYSA-M Bromide Chemical compound [Br-] CPELXLSAUQHCOX-UHFFFAOYSA-M 0.000 description 1
- 241001260012 Bursa Species 0.000 description 1
- 241000282472 Canis lupus familiaris Species 0.000 description 1
- 241000282693 Cercopithecidae Species 0.000 description 1
- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 0.000 description 1
- 241000711573 Coronaviridae Species 0.000 description 1
- 241000699800 Cricetinae Species 0.000 description 1
- 108010053770 Deoxyribonucleases Proteins 0.000 description 1
- 102000016911 Deoxyribonucleases Human genes 0.000 description 1
- 108010000912 Egg Proteins Proteins 0.000 description 1
- 102000002322 Egg Proteins Human genes 0.000 description 1
- 241000711950 Filoviridae Species 0.000 description 1
- 241000710831 Flavivirus Species 0.000 description 1
- 241000282412 Homo Species 0.000 description 1
- 208000002979 Influenza in Birds Diseases 0.000 description 1
- 241001500351 Influenzavirus A Species 0.000 description 1
- 241001500350 Influenzavirus B Species 0.000 description 1
- 241001500343 Influenzavirus C Species 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- 229920001213 Polysorbate 20 Polymers 0.000 description 1
- 229920001214 Polysorbate 60 Polymers 0.000 description 1
- 241000288906 Primates Species 0.000 description 1
- 241000725681 Swine influenza virus Species 0.000 description 1
- 208000036142 Viral infection Diseases 0.000 description 1
- 240000008042 Zea mays Species 0.000 description 1
- 235000005824 Zea mays ssp. parviglumis Nutrition 0.000 description 1
- 235000002017 Zea mays subsp mays Nutrition 0.000 description 1
- 230000001133 acceleration Effects 0.000 description 1
- 229940022663 acetate Drugs 0.000 description 1
- 230000003213 activating effect Effects 0.000 description 1
- 238000004115 adherent culture Methods 0.000 description 1
- 230000001464 adherent effect Effects 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 239000002168 alkylating agent Substances 0.000 description 1
- 229940100198 alkylating agent Drugs 0.000 description 1
- 229960000458 allantoin Drugs 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 230000000692 anti-sense effect Effects 0.000 description 1
- 230000000840 anti-viral effect Effects 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 239000003443 antiviral agent Substances 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 206010064097 avian influenza Diseases 0.000 description 1
- 229960002233 benzalkonium bromide Drugs 0.000 description 1
- 229960000686 benzalkonium chloride Drugs 0.000 description 1
- 229910001423 beryllium ion Inorganic materials 0.000 description 1
- 229960000074 biopharmaceutical Drugs 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 150000001649 bromium compounds Chemical class 0.000 description 1
- OXJUJQDEISSCTB-UHFFFAOYSA-N but-3-en-2-imine Chemical group CC(=N)C=C OXJUJQDEISSCTB-UHFFFAOYSA-N 0.000 description 1
- 239000013622 capto Q Substances 0.000 description 1
- 238000004113 cell culture Methods 0.000 description 1
- 239000006143 cell culture medium Substances 0.000 description 1
- 230000001413 cellular effect Effects 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 229920001436 collagen Polymers 0.000 description 1
- 238000009833 condensation Methods 0.000 description 1
- 230000005494 condensation Effects 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 235000005822 corn Nutrition 0.000 description 1
- 239000012531 culture fluid Substances 0.000 description 1
- 125000002704 decyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])* 0.000 description 1
- GSVLCKASFMVUSW-UHFFFAOYSA-N decyl(dimethyl)phosphine oxide Chemical compound CCCCCCCCCCP(C)(C)=O GSVLCKASFMVUSW-UHFFFAOYSA-N 0.000 description 1
- 230000000593 degrading effect Effects 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 235000014103 egg white Nutrition 0.000 description 1
- 210000000969 egg white Anatomy 0.000 description 1
- 235000013601 eggs Nutrition 0.000 description 1
- 238000010828 elution Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 125000005909 ethyl alcohol group Chemical group 0.000 description 1
- 239000012634 fragment Substances 0.000 description 1
- 238000013467 fragmentation Methods 0.000 description 1
- 238000006062 fragmentation reaction Methods 0.000 description 1
- 238000005227 gel permeation chromatography Methods 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 230000028993 immune response Effects 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 208000037797 influenza A Diseases 0.000 description 1
- 208000037798 influenza B Diseases 0.000 description 1
- 208000037799 influenza C Diseases 0.000 description 1
- 239000013067 intermediate product Substances 0.000 description 1
- 235000015073 liquid stocks Nutrition 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 239000012533 medium component Substances 0.000 description 1
- OKKJLVBELUTLKV-UHFFFAOYSA-N methanol Natural products OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 1
- CXKWCBBOMKCUKX-UHFFFAOYSA-M methylene blue Chemical compound [Cl-].C1=CC(N(C)C)=CC2=[S+]C3=CC(N(C)C)=CC=C3N=C21 CXKWCBBOMKCUKX-UHFFFAOYSA-M 0.000 description 1
- 229960000907 methylthioninium chloride Drugs 0.000 description 1
- 238000001471 micro-filtration Methods 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 239000003094 microcapsule Substances 0.000 description 1
- UMWKZHPREXJQGR-UHFFFAOYSA-N n-methyl-n-(2,3,4,5,6-pentahydroxyhexyl)decanamide Chemical compound CCCCCCCCCC(=O)N(C)CC(O)C(O)C(O)C(O)CO UMWKZHPREXJQGR-UHFFFAOYSA-N 0.000 description 1
- GCRLIVCNZWDCDE-SJXGUFTOSA-N n-methyl-n-[(2s,3r,4r,5r)-2,3,4,5,6-pentahydroxyhexyl]nonanamide Chemical compound CCCCCCCCC(=O)N(C)C[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO GCRLIVCNZWDCDE-SJXGUFTOSA-N 0.000 description 1
- SBWGZAXBCCNRTM-CTHBEMJXSA-N n-methyl-n-[(2s,3r,4r,5r)-2,3,4,5,6-pentahydroxyhexyl]octanamide Chemical compound CCCCCCCC(=O)N(C)C[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO SBWGZAXBCCNRTM-CTHBEMJXSA-N 0.000 description 1
- 108020004707 nucleic acids Proteins 0.000 description 1
- 102000039446 nucleic acids Human genes 0.000 description 1
- 150000007523 nucleic acids Chemical class 0.000 description 1
- 229920002113 octoxynol Polymers 0.000 description 1
- 244000052769 pathogen Species 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 230000010412 perfusion Effects 0.000 description 1
- 229920001983 poloxamer Polymers 0.000 description 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 description 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 1
- 229950008882 polysorbate Drugs 0.000 description 1
- 229940068968 polysorbate 80 Drugs 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 238000011045 prefiltration Methods 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000002335 preservative effect Effects 0.000 description 1
- 230000035755 proliferation Effects 0.000 description 1
- 230000001902 propagating effect Effects 0.000 description 1
- 125000001453 quaternary ammonium group Chemical group 0.000 description 1
- 238000007670 refining Methods 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 238000012776 robust process Methods 0.000 description 1
- 238000004062 sedimentation Methods 0.000 description 1
- 238000004904 shortening Methods 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 238000011146 sterile filtration Methods 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 230000002485 urinary effect Effects 0.000 description 1
- 230000009385 viral infection Effects 0.000 description 1
- 229960004854 viral vaccine Drugs 0.000 description 1
- 230000005727 virus proliferation Effects 0.000 description 1
- 239000002351 wastewater Substances 0.000 description 1
Images
Classifications
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/005—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from viruses
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
- C12N7/02—Recovery or purification
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
- C12N2760/00011—Details
- C12N2760/16011—Orthomyxoviridae
- C12N2760/16111—Influenzavirus A, i.e. influenza A virus
- C12N2760/16151—Methods of production or purification of viral material
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Wood Science & Technology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Zoology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Virology (AREA)
- Analytical Chemistry (AREA)
- Immunology (AREA)
- Microbiology (AREA)
- Biotechnology (AREA)
- Biomedical Technology (AREA)
- General Engineering & Computer Science (AREA)
- Gastroenterology & Hepatology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161509630P | 2011-07-20 | 2011-07-20 | |
| EP11174660 | 2011-07-20 | ||
| EP11174660.8 | 2011-07-20 | ||
| US61/509,630 | 2011-07-20 | ||
| PCT/EP2012/063045 WO2013010797A1 (en) | 2011-07-20 | 2012-07-04 | Process for producing viral antigen and vaccines |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1020147001348A Division KR20140038530A (ko) | 2011-07-20 | 2012-07-04 | 바이러스 항원 및 백신의 제조 방법 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| KR20160096215A true KR20160096215A (ko) | 2016-08-12 |
Family
ID=45094875
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1020167020663A Withdrawn KR20160096215A (ko) | 2011-07-20 | 2012-07-04 | 바이러스 항원 및 백신의 제조 방법 |
| KR1020147001348A Ceased KR20140038530A (ko) | 2011-07-20 | 2012-07-04 | 바이러스 항원 및 백신의 제조 방법 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1020147001348A Ceased KR20140038530A (ko) | 2011-07-20 | 2012-07-04 | 바이러스 항원 및 백신의 제조 방법 |
Country Status (12)
| Country | Link |
|---|---|
| EP (1) | EP2734619B1 (https=) |
| JP (1) | JP6275641B2 (https=) |
| KR (2) | KR20160096215A (https=) |
| CN (1) | CN103827296B (https=) |
| AU (1) | AU2012286098C1 (https=) |
| BR (1) | BR112014001049A2 (https=) |
| CA (1) | CA2841604C (https=) |
| ES (1) | ES2653197T3 (https=) |
| MX (1) | MX2014000753A (https=) |
| RU (1) | RU2565827C2 (https=) |
| TW (1) | TW201311896A (https=) |
| WO (1) | WO2013010797A1 (https=) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021221338A1 (ko) * | 2020-04-29 | 2021-11-04 | 에스케이바이오사이언스(주) | 일회용 배양 공정 시스템을 이용한 인플루엔자 바이러스 생산 방법 및 인플루엔자 바이러스 항원 정제 조건 신속 확인 시험 |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104524563A (zh) * | 2014-12-12 | 2015-04-22 | 普莱柯生物工程股份有限公司 | 疫苗组合物及其制备方法和应用 |
| WO2019121846A1 (en) | 2017-12-19 | 2019-06-27 | CSL Behring Lengnau AG | Protein purification and virus inactivation with alkyl glycosides |
| JP7360594B2 (ja) * | 2017-12-28 | 2023-10-13 | 共立製薬株式会社 | ワクチン製剤、並びに魚類のイリドウイルス感染症予防方法 |
| US11529413B2 (en) | 2018-06-12 | 2022-12-20 | Kbio Holdings Limited | Virus and antigen purification and conjugation |
| US11696948B2 (en) | 2018-06-12 | 2023-07-11 | Kbio Holdings Limited | Vaccines formed by virus and antigen conjugation |
| US11690907B2 (en) | 2018-06-12 | 2023-07-04 | Kbio Holdings Limited | Vaccines formed by virus and antigen conjugation |
| IL279295B2 (en) | 2018-06-12 | 2026-03-01 | Kentucky Bioprocessing Inc | Purification and cross-linking of virus and antigen |
| US11999975B2 (en) * | 2018-07-04 | 2024-06-04 | Probiogen Ag | Method for purifying an enveloped virus |
| US12123028B2 (en) | 2018-11-15 | 2024-10-22 | Bayer Healthcare Llc | Viral inactivation methods for continuous manufacturing of antibodies |
| RU2710239C1 (ru) * | 2019-06-14 | 2019-12-25 | Федеральное государственное унитарное предприятие "Санкт-Петербургский научно-исследовательский институт вакцин и сывороток и предприятие по производству бактерийных препаратов" Федерального медико-биологического агентства | Способ получения антигена или антигенов для производства противогриппозной вакцины и вакцина на его основе |
| MX2022005513A (es) * | 2019-11-07 | 2022-06-08 | Seqirus Uk Ltd | Composiciones y metodos para producir una vacuna viral con tama?o de particula reducido. |
| KR102546626B1 (ko) * | 2020-04-29 | 2023-06-21 | 에스케이바이오사이언스(주) | 인플루엔자 바이러스 항원 정제 조건 신속 확인 시험 |
| CN112309502B (zh) * | 2020-10-14 | 2024-09-20 | 深圳市新合生物医疗科技有限公司 | 一种计算肿瘤新抗原负荷的方法及系统 |
| JP2023141423A (ja) * | 2022-03-24 | 2023-10-05 | 国立大学法人 東京大学 | ウイルスの精製方法 |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4140762A (en) * | 1974-01-14 | 1979-02-20 | Sandoz Ltd. | Influenza sub-unit vaccine |
| US4240762A (en) * | 1979-03-12 | 1980-12-23 | Johnston Pump Company | Seal-aligning rigid coupling assembly |
| SE8405493D0 (sv) * | 1984-11-01 | 1984-11-01 | Bror Morein | Immunogent komplex samt sett for framstellning derav och anvendning derav som immunstimulerande medel |
| US7262045B2 (en) * | 2003-02-25 | 2007-08-28 | Medimmune Vaccines, Inc. | Methods of producing influenza vaccine compositions |
| RU2283139C1 (ru) * | 2005-03-21 | 2006-09-10 | Федеральное государственное унитарное предприятие "Научно-производственное объединение по медицинским иммунобиологическим препаратам "Микроген" Министерства здравоохранения Российской Федерации | Способ получения антигенов для вакцины против вирусов гриппа |
| EP1982727A1 (en) * | 2007-04-17 | 2008-10-22 | Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V. | Method for purification of viral proteins |
| AU2008293513B2 (en) * | 2007-08-28 | 2013-11-21 | Alachua Government Services, Inc. | Method for producing viral vaccines |
| WO2009115917A2 (en) * | 2008-03-18 | 2009-09-24 | Novartis Ag | Improvements in preparation of influenza virus vaccine antigens |
| CN102215865B (zh) * | 2008-09-24 | 2013-10-30 | 米迪缪尼有限公司 | 病毒纯化方法 |
| RU2547587C2 (ru) * | 2008-09-24 | 2015-04-10 | Медиммун, Ллк | Способы культивирования клеток, размножения и очистки вирусов |
| GB0918830D0 (en) * | 2009-10-27 | 2009-12-09 | Glaxosmithkline Biolog Niederl | Process |
-
2012
- 2012-07-04 CA CA2841604A patent/CA2841604C/en not_active Expired - Fee Related
- 2012-07-04 MX MX2014000753A patent/MX2014000753A/es not_active Application Discontinuation
- 2012-07-04 ES ES12734892.8T patent/ES2653197T3/es active Active
- 2012-07-04 KR KR1020167020663A patent/KR20160096215A/ko not_active Withdrawn
- 2012-07-04 EP EP12734892.8A patent/EP2734619B1/en active Active
- 2012-07-04 BR BR112014001049A patent/BR112014001049A2/pt not_active IP Right Cessation
- 2012-07-04 JP JP2014520591A patent/JP6275641B2/ja not_active Expired - Fee Related
- 2012-07-04 AU AU2012286098A patent/AU2012286098C1/en not_active Ceased
- 2012-07-04 KR KR1020147001348A patent/KR20140038530A/ko not_active Ceased
- 2012-07-04 RU RU2014101484/10A patent/RU2565827C2/ru not_active IP Right Cessation
- 2012-07-04 WO PCT/EP2012/063045 patent/WO2013010797A1/en not_active Ceased
- 2012-07-04 CN CN201280035724.9A patent/CN103827296B/zh not_active Expired - Fee Related
- 2012-07-19 TW TW101126141A patent/TW201311896A/zh unknown
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021221338A1 (ko) * | 2020-04-29 | 2021-11-04 | 에스케이바이오사이언스(주) | 일회용 배양 공정 시스템을 이용한 인플루엔자 바이러스 생산 방법 및 인플루엔자 바이러스 항원 정제 조건 신속 확인 시험 |
Also Published As
| Publication number | Publication date |
|---|---|
| AU2012286098A1 (en) | 2014-01-23 |
| MX2014000753A (es) | 2014-05-07 |
| JP6275641B2 (ja) | 2018-02-07 |
| CN103827296B (zh) | 2016-11-16 |
| EP2734619B1 (en) | 2017-09-06 |
| AU2012286098C1 (en) | 2016-09-15 |
| JP2014524747A (ja) | 2014-09-25 |
| WO2013010797A1 (en) | 2013-01-24 |
| CN103827296A (zh) | 2014-05-28 |
| TW201311896A (zh) | 2013-03-16 |
| RU2014101484A (ru) | 2015-07-27 |
| CA2841604C (en) | 2020-01-21 |
| RU2565827C2 (ru) | 2015-10-20 |
| CA2841604A1 (en) | 2013-01-24 |
| EP2734619A1 (en) | 2014-05-28 |
| ES2653197T3 (es) | 2018-02-06 |
| KR20140038530A (ko) | 2014-03-28 |
| BR112014001049A2 (pt) | 2017-02-21 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| KR20160096215A (ko) | 바이러스 항원 및 백신의 제조 방법 | |
| AU2012286098B2 (en) | Process for producing viral antigen and vaccines | |
| US11629339B2 (en) | Aseptic purification process for viruses | |
| EP0870508B1 (en) | Influenza vaccine | |
| HK1248763A1 (en) | Aseptic purification process for viruses | |
| JP2012507272A (ja) | 新規な方法 | |
| CN105473712B (zh) | 在细胞培养物中大规模生产病毒 | |
| JP7779858B2 (ja) | 使い捨て培養工程システムを用いたインフルエンザウイルス生産方法及びインフルエンザウイルス抗原精製条件の迅速確認試験 | |
| HK1194763A (en) | Process for producing viral antigen and vaccines | |
| KR101862332B1 (ko) | 인플루엔자 전바이러스 백신 제조 방법 | |
| KR20100017593A (ko) | 바이러스의 증식을 위한 ２-단계 온도 프로파일 | |
| Weigel | Development of chromatography-based purification processes for cell culture-derived influenza virus particles | |
| HK1010833B (en) | Influenza vaccine |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| A107 | Divisional application of patent | ||
| PA0104 | Divisional application for international application |
Comment text: Divisional Application for International Patent Patent event code: PA01041R01D Patent event date: 20160727 Application number text: 1020147001348 Filing date: 20140117 |
|
| PG1501 | Laying open of application | ||
| PC1203 | Withdrawal of no request for examination | ||
| WITN | Application deemed withdrawn, e.g. because no request for examination was filed or no examination fee was paid |