ES2653197T3 - Procedimiento para producir antígeno ortomixoviral y vacunas - Google Patents
Procedimiento para producir antígeno ortomixoviral y vacunas Download PDFInfo
- Publication number
- ES2653197T3 ES2653197T3 ES12734892.8T ES12734892T ES2653197T3 ES 2653197 T3 ES2653197 T3 ES 2653197T3 ES 12734892 T ES12734892 T ES 12734892T ES 2653197 T3 ES2653197 T3 ES 2653197T3
- Authority
- ES
- Spain
- Prior art keywords
- stage
- orthomyxovirus
- carried out
- equal
- virus
- 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.)
- Active
Links
- 238000000034 method Methods 0.000 title claims abstract description 139
- 239000000427 antigen Substances 0.000 title claims description 72
- 102000036639 antigens Human genes 0.000 title claims description 72
- 108091007433 antigens Proteins 0.000 title claims description 72
- 229960005486 vaccine Drugs 0.000 title claims description 48
- 241000700605 Viruses Species 0.000 claims abstract description 85
- 239000003599 detergent Substances 0.000 claims abstract description 81
- 101710154606 Hemagglutinin Proteins 0.000 claims abstract description 79
- 101710093908 Outer capsid protein VP4 Proteins 0.000 claims abstract description 79
- 101710135467 Outer capsid protein sigma-1 Proteins 0.000 claims abstract description 79
- 101710176177 Protein A56 Proteins 0.000 claims abstract description 79
- 239000000185 hemagglutinin Substances 0.000 claims abstract description 79
- 230000003612 virological effect Effects 0.000 claims abstract description 72
- 238000000746 purification Methods 0.000 claims abstract description 52
- 108010006232 Neuraminidase Proteins 0.000 claims abstract description 45
- 102000005348 Neuraminidase Human genes 0.000 claims abstract description 45
- 239000007788 liquid Substances 0.000 claims abstract description 45
- 239000000203 mixture Substances 0.000 claims abstract description 38
- 238000009295 crossflow filtration Methods 0.000 claims abstract description 37
- 125000002091 cationic group Chemical group 0.000 claims abstract description 30
- 239000012530 fluid Substances 0.000 claims abstract description 28
- 238000004519 manufacturing process Methods 0.000 claims abstract description 28
- 238000004587 chromatography analysis Methods 0.000 claims abstract description 22
- 238000005119 centrifugation Methods 0.000 claims abstract description 20
- 238000011038 discontinuous diafiltration by volume reduction Methods 0.000 claims abstract description 20
- 238000001914 filtration Methods 0.000 claims abstract description 10
- 238000002360 preparation method Methods 0.000 claims description 38
- 230000002779 inactivation Effects 0.000 claims description 28
- 238000005199 ultracentrifugation Methods 0.000 claims description 25
- 239000008194 pharmaceutical composition Substances 0.000 claims description 20
- 230000008569 process Effects 0.000 claims description 15
- 238000004191 hydrophobic interaction chromatography Methods 0.000 claims description 12
- GNFTZDOKVXKIBK-UHFFFAOYSA-N 3-(2-methoxyethoxy)benzohydrazide Chemical compound COCCOC1=CC=CC(C(=O)NN)=C1 GNFTZDOKVXKIBK-UHFFFAOYSA-N 0.000 claims description 11
- 238000001042 affinity chromatography Methods 0.000 claims description 11
- 238000004255 ion exchange chromatography Methods 0.000 claims description 9
- 238000001556 precipitation Methods 0.000 claims description 9
- -1 quaternary ammonium cations Chemical class 0.000 claims description 8
- 101710163270 Nuclease Proteins 0.000 claims description 7
- 238000011210 chromatographic step Methods 0.000 claims description 6
- 238000001542 size-exclusion chromatography Methods 0.000 claims description 4
- 102000004190 Enzymes Human genes 0.000 claims description 3
- 108090000790 Enzymes Proteins 0.000 claims description 3
- 241000371980 Influenza B virus (B/Shanghai/361/2002) Species 0.000 claims description 3
- 230000029087 digestion Effects 0.000 claims description 3
- 208000037797 influenza A Diseases 0.000 claims description 3
- 208000037798 influenza B Diseases 0.000 claims description 3
- 208000037799 influenza C Diseases 0.000 claims description 3
- 235000013601 eggs Nutrition 0.000 abstract description 27
- 210000004027 cell Anatomy 0.000 description 88
- 238000011084 recovery Methods 0.000 description 43
- LZZYPRNAOMGNLH-UHFFFAOYSA-M Cetrimonium bromide Chemical compound [Br-].CCCCCCCCCCCCCCCC[N+](C)(C)C LZZYPRNAOMGNLH-UHFFFAOYSA-M 0.000 description 31
- 230000009467 reduction Effects 0.000 description 31
- 229920001429 chelating resin Polymers 0.000 description 30
- 239000000047 product Substances 0.000 description 23
- 238000005063 solubilization Methods 0.000 description 22
- 230000007928 solubilization Effects 0.000 description 22
- 238000003306 harvesting Methods 0.000 description 19
- 239000002245 particle Substances 0.000 description 19
- 102000004169 proteins and genes Human genes 0.000 description 18
- 108090000623 proteins and genes Proteins 0.000 description 18
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 17
- 229920000053 polysorbate 80 Polymers 0.000 description 17
- 239000012535 impurity Substances 0.000 description 15
- 238000005352 clarification Methods 0.000 description 14
- 206010022000 influenza Diseases 0.000 description 13
- 238000000926 separation method Methods 0.000 description 13
- 239000000126 substance Substances 0.000 description 13
- 230000009286 beneficial effect Effects 0.000 description 12
- 238000000108 ultra-filtration Methods 0.000 description 12
- 239000000872 buffer Substances 0.000 description 9
- 230000000694 effects Effects 0.000 description 9
- 239000000706 filtrate Substances 0.000 description 9
- 239000006228 supernatant Substances 0.000 description 9
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 8
- 238000011109 contamination Methods 0.000 description 8
- 238000011068 loading method Methods 0.000 description 7
- 241000712461 unidentified influenza virus Species 0.000 description 7
- 238000011026 diafiltration Methods 0.000 description 6
- 239000000543 intermediate Substances 0.000 description 6
- 239000012528 membrane Substances 0.000 description 6
- 229920000136 polysorbate Polymers 0.000 description 6
- 238000011027 product recovery Methods 0.000 description 6
- 230000000644 propagated effect Effects 0.000 description 6
- 238000010828 elution Methods 0.000 description 5
- 239000012467 final product Substances 0.000 description 5
- 230000006872 improvement Effects 0.000 description 5
- 210000004962 mammalian cell Anatomy 0.000 description 5
- 238000012545 processing Methods 0.000 description 5
- 150000003839 salts Chemical class 0.000 description 5
- 239000000725 suspension Substances 0.000 description 5
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 4
- 108010058846 Ovalbumin Proteins 0.000 description 4
- 238000002298 density-gradient ultracentrifugation Methods 0.000 description 4
- 238000011118 depth filtration Methods 0.000 description 4
- 239000013067 intermediate product Substances 0.000 description 4
- 239000012160 loading buffer Substances 0.000 description 4
- 239000002609 medium Substances 0.000 description 4
- 229960000380 propiolactone Drugs 0.000 description 4
- 230000001932 seasonal effect Effects 0.000 description 4
- 239000013049 sediment Substances 0.000 description 4
- 238000005406 washing Methods 0.000 description 4
- 108010000912 Egg Proteins Proteins 0.000 description 3
- 102000002322 Egg Proteins Human genes 0.000 description 3
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 description 3
- 241000287828 Gallus gallus Species 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
- 238000004458 analytical method Methods 0.000 description 3
- 210000004102 animal cell Anatomy 0.000 description 3
- 230000008901 benefit Effects 0.000 description 3
- 238000007796 conventional method Methods 0.000 description 3
- 238000012937 correction Methods 0.000 description 3
- 238000010790 dilution Methods 0.000 description 3
- 239000012895 dilution Substances 0.000 description 3
- 230000000415 inactivating effect Effects 0.000 description 3
- 238000011534 incubation Methods 0.000 description 3
- 238000004460 liquid liquid chromatography Methods 0.000 description 3
- 229940092253 ovalbumin Drugs 0.000 description 3
- 229920000151 polyglycol Polymers 0.000 description 3
- 239000010695 polyglycol Substances 0.000 description 3
- 238000004062 sedimentation Methods 0.000 description 3
- 229940031626 subunit vaccine Drugs 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
- 244000060011 Cocos nucifera Species 0.000 description 2
- 235000013162 Cocos nucifera Nutrition 0.000 description 2
- QUSNBJAOOMFDIB-UHFFFAOYSA-N Ethylamine Chemical compound CCN QUSNBJAOOMFDIB-UHFFFAOYSA-N 0.000 description 2
- 239000002202 Polyethylene glycol Substances 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 108010093857 Viral Hemagglutinins 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
- 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 class [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 description 2
- 150000003842 bromide salts Chemical class 0.000 description 2
- 238000004113 cell culture Methods 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 230000001143 conditioned effect Effects 0.000 description 2
- 239000000356 contaminant Substances 0.000 description 2
- 230000003247 decreasing effect Effects 0.000 description 2
- 238000000432 density-gradient centrifugation Methods 0.000 description 2
- 235000019441 ethanol Nutrition 0.000 description 2
- 230000000951 immunodiffusion Effects 0.000 description 2
- 230000005847 immunogenicity Effects 0.000 description 2
- 229960003971 influenza vaccine Drugs 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 238000005374 membrane filtration Methods 0.000 description 2
- OKKJLVBELUTLKV-UHFFFAOYSA-N methanol Natural products OC OKKJLVBELUTLKV-UHFFFAOYSA-N 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
- 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
- 229950008882 polysorbate Drugs 0.000 description 2
- 239000002244 precipitate Substances 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
- 238000003753 real-time PCR Methods 0.000 description 2
- 239000011780 sodium chloride Substances 0.000 description 2
- HXYCHJFUBNTKQR-RNFRBKRXSA-N (2R,3R)-heptane-1,2,3-triol Chemical compound CCCC[C@@H](O)[C@H](O)CO HXYCHJFUBNTKQR-RNFRBKRXSA-N 0.000 description 1
- 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
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 description 1
- 108010088751 Albumins Proteins 0.000 description 1
- 102000009027 Albumins Human genes 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
- 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 1
- 241000282693 Cercopithecidae Species 0.000 description 1
- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 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
- 241000282414 Homo sapiens Species 0.000 description 1
- 208000002979 Influenza in Birds Diseases 0.000 description 1
- 101710085938 Matrix protein Proteins 0.000 description 1
- 108010052285 Membrane Proteins Proteins 0.000 description 1
- 102000018697 Membrane Proteins Human genes 0.000 description 1
- 101710127721 Membrane protein Proteins 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 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 1
- REYJJPSVUYRZGE-UHFFFAOYSA-N Octadecylamine Chemical compound CCCCCCCCCCCCCCCCCCN REYJJPSVUYRZGE-UHFFFAOYSA-N 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
- 108010065667 Viral Matrix Proteins Proteins 0.000 description 1
- 108010067390 Viral Proteins Proteins 0.000 description 1
- 230000001133 acceleration 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
- 125000005210 alkyl ammonium group Chemical group 0.000 description 1
- 125000000217 alkyl group Chemical group 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
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 206010064097 avian influenza Diseases 0.000 description 1
- 229910001423 beryllium ion Inorganic materials 0.000 description 1
- 229960000074 biopharmaceutical Drugs 0.000 description 1
- 230000003139 buffering effect Effects 0.000 description 1
- OXJUJQDEISSCTB-UHFFFAOYSA-N but-3-en-2-imine Chemical compound CC(=N)C=C OXJUJQDEISSCTB-UHFFFAOYSA-N 0.000 description 1
- ABDBNWQRPYOPDF-UHFFFAOYSA-N carbonofluoridic acid Chemical compound OC(F)=O ABDBNWQRPYOPDF-UHFFFAOYSA-N 0.000 description 1
- 230000001413 cellular effect Effects 0.000 description 1
- 238000007385 chemical modification Methods 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 229920001436 collagen Polymers 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- WOQQAWHSKSSAGF-WXFJLFHKSA-N decyl beta-D-maltopyranoside Chemical compound O[C@@H]1[C@@H](O)[C@H](OCCCCCCCCCC)O[C@H](CO)[C@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 WOQQAWHSKSSAGF-WXFJLFHKSA-N 0.000 description 1
- 102000038379 digestive enzymes Human genes 0.000 description 1
- 108091007734 digestive enzymes Proteins 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 235000014103 egg white Nutrition 0.000 description 1
- 210000000969 egg white Anatomy 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000006167 equilibration buffer Substances 0.000 description 1
- SFNALCNOMXIBKG-UHFFFAOYSA-N ethylene glycol monododecyl ether Chemical compound CCCCCCCCCCCCOCCO SFNALCNOMXIBKG-UHFFFAOYSA-N 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
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 239000001963 growth medium Substances 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 229940102728 methylbenzethonium Drugs 0.000 description 1
- 229960002285 methylbenzethonium chloride Drugs 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
- 238000012544 monitoring process Methods 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
- 102000039446 nucleic acids Human genes 0.000 description 1
- 108020004707 nucleic acids Proteins 0.000 description 1
- 150000007523 nucleic acids Chemical class 0.000 description 1
- 229920002113 octoxynol Polymers 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 244000052769 pathogen Species 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 238000005453 pelletization Methods 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
- 229940068968 polysorbate 80 Drugs 0.000 description 1
- 229940068965 polysorbates 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
- 238000012776 robust process Methods 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 238000004904 shortening Methods 0.000 description 1
- NRHMKIHPTBHXPF-TUJRSCDTSA-M sodium cholate Chemical compound [Na+].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 NRHMKIHPTBHXPF-TUJRSCDTSA-M 0.000 description 1
- 238000003892 spreading Methods 0.000 description 1
- 230000007480 spreading Effects 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 201000010740 swine influenza Diseases 0.000 description 1
- 230000008685 targeting Effects 0.000 description 1
- 229960004854 viral vaccine Drugs 0.000 description 1
Classifications
-
- 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
- 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
- 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 | ||
| US201161509630P | 2011-07-20 | ||
| EP11174660 | 2011-07-20 | ||
| PCT/EP2012/063045 WO2013010797A1 (en) | 2011-07-20 | 2012-07-04 | Process for producing viral antigen and vaccines |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2653197T3 true ES2653197T3 (es) | 2018-02-06 |
Family
ID=45094875
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES12734892.8T Active ES2653197T3 (es) | 2011-07-20 | 2012-07-04 | Procedimiento para producir antígeno ortomixoviral y vacunas |
Country Status (12)
| Country | Link |
|---|---|
| EP (1) | EP2734619B1 (cg-RX-API-DMAC7.html) |
| JP (1) | JP6275641B2 (cg-RX-API-DMAC7.html) |
| KR (2) | KR20140038530A (cg-RX-API-DMAC7.html) |
| CN (1) | CN103827296B (cg-RX-API-DMAC7.html) |
| AU (1) | AU2012286098C1 (cg-RX-API-DMAC7.html) |
| BR (1) | BR112014001049A2 (cg-RX-API-DMAC7.html) |
| CA (1) | CA2841604C (cg-RX-API-DMAC7.html) |
| ES (1) | ES2653197T3 (cg-RX-API-DMAC7.html) |
| MX (1) | MX2014000753A (cg-RX-API-DMAC7.html) |
| RU (1) | RU2565827C2 (cg-RX-API-DMAC7.html) |
| TW (1) | TW201311896A (cg-RX-API-DMAC7.html) |
| WO (1) | WO2013010797A1 (cg-RX-API-DMAC7.html) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109568573A (zh) * | 2014-12-12 | 2019-04-05 | 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 |
| US11690907B2 (en) | 2018-06-12 | 2023-07-04 | Kbio Holdings Limited | Vaccines formed by virus and antigen conjugation |
| 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 |
| BR112020025250A2 (pt) | 2018-06-12 | 2021-03-09 | Kentucky Bioprocessing, Inc. | Purificação e conjugação de vírus e antígeno |
| CN112384615A (zh) * | 2018-07-04 | 2021-02-19 | 普罗拜奥根股份公司 | 用于纯化包膜病毒的方法 |
| 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 |
| KR20220098370A (ko) * | 2019-11-07 | 2022-07-12 | 세퀴러스 유케이 리미티드 | 감소된 입자 크기를 가지는 바이러스 백신을 제조하기 위한 조성물 및 방법 |
| KR102546626B1 (ko) * | 2020-04-29 | 2023-06-21 | 에스케이바이오사이언스(주) | 인플루엔자 바이러스 항원 정제 조건 신속 확인 시험 |
| US20230212230A1 (en) * | 2020-04-29 | 2023-07-06 | Sk Bioscience Co., Ltd. | Influenza virus production method using single-use culture process system and rapid confirmation test of influenza virus antigen purification condition |
| 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 |
| KR101190932B1 (ko) * | 2003-02-25 | 2012-10-16 | 메디뮨 엘엘씨 | 인플루엔자 백신 조성물의 제조 방법 |
| 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 |
| SI2192917T1 (sl) * | 2007-08-28 | 2014-05-30 | Baxter International Inc. | Postopek za proizvodnjo virusnih cepiv |
| AU2009227674C1 (en) * | 2008-03-18 | 2015-01-29 | Seqirus UK Limited | Improvements in preparation of influenza virus vaccine antigens |
| KR20110074563A (ko) * | 2008-09-24 | 2011-06-30 | 메디뮨 엘엘씨 | 바이러스의 정제 방법 |
| US8202726B2 (en) * | 2008-09-24 | 2012-06-19 | Medimmune, Llc | Methods for cultivating cells, propagating and purifying viruses |
| GB0918830D0 (en) * | 2009-10-27 | 2009-12-09 | Glaxosmithkline Biolog Niederl | Process |
-
2012
- 2012-07-04 ES ES12734892.8T patent/ES2653197T3/es active Active
- 2012-07-04 BR BR112014001049A patent/BR112014001049A2/pt not_active IP Right Cessation
- 2012-07-04 MX MX2014000753A patent/MX2014000753A/es not_active Application Discontinuation
- 2012-07-04 KR KR1020147001348A patent/KR20140038530A/ko not_active Ceased
- 2012-07-04 CA CA2841604A patent/CA2841604C/en not_active Expired - Fee Related
- 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 JP JP2014520591A patent/JP6275641B2/ja not_active Expired - Fee Related
- 2012-07-04 WO PCT/EP2012/063045 patent/WO2013010797A1/en not_active Ceased
- 2012-07-04 AU AU2012286098A patent/AU2012286098C1/en not_active Ceased
- 2012-07-04 RU RU2014101484/10A patent/RU2565827C2/ru not_active IP Right Cessation
- 2012-07-04 CN CN201280035724.9A patent/CN103827296B/zh not_active Expired - Fee Related
- 2012-07-19 TW TW101126141A patent/TW201311896A/zh unknown
Also Published As
| Publication number | Publication date |
|---|---|
| TW201311896A (zh) | 2013-03-16 |
| KR20160096215A (ko) | 2016-08-12 |
| JP2014524747A (ja) | 2014-09-25 |
| RU2565827C2 (ru) | 2015-10-20 |
| EP2734619A1 (en) | 2014-05-28 |
| CN103827296B (zh) | 2016-11-16 |
| RU2014101484A (ru) | 2015-07-27 |
| CA2841604A1 (en) | 2013-01-24 |
| EP2734619B1 (en) | 2017-09-06 |
| MX2014000753A (es) | 2014-05-07 |
| BR112014001049A2 (pt) | 2017-02-21 |
| CA2841604C (en) | 2020-01-21 |
| CN103827296A (zh) | 2014-05-28 |
| KR20140038530A (ko) | 2014-03-28 |
| AU2012286098C1 (en) | 2016-09-15 |
| JP6275641B2 (ja) | 2018-02-07 |
| WO2013010797A1 (en) | 2013-01-24 |
| AU2012286098A1 (en) | 2014-01-23 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| ES2653197T3 (es) | Procedimiento para producir antígeno ortomixoviral y vacunas | |
| AU2012286098B2 (en) | Process for producing viral antigen and vaccines | |
| ES2352638T3 (es) | Células animales y procedimientos de replicación del virus de la gripe. | |
| ES2345606T3 (es) | Multiplicacion de virus en un cultivo celular. | |
| ES2367081T3 (es) | Procedimiento para la replicación de virus de la gripe en cultivo celular y los virus de la gripe que pueden obtenerse por el procedimiento. | |
| US20050118140A1 (en) | Methods for producing an active constituent of a pharmaceutical or a diagnostic agent in an mdck cell suspension culture | |
| US6048537A (en) | Method for preparing an influenza virus, antigens obtained and applications thereof | |
| PL187982B1 (pl) | Szczepionka przeciw grypie | |
| Makovitzki et al. | Evaluation of a downstream process for the recovery and concentration of a Cell-Culture-Derived rVSV-Spike COVID-19 vaccine candidate | |
| CN104888212A (zh) | 一种流感病毒亚单位疫苗及其制备方法 | |
| ES2778928T3 (es) | Producción a gran escala de virus en cultivos celulares | |
| 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 | |
| CN107475204A (zh) | 一种囊膜病毒保护剂及其制备方法 | |
| KR101862332B1 (ko) | 인플루엔자 전바이러스 백신 제조 방법 | |
| Weigel | Development of chromatography-based purification processes for cell culture-derived influenza virus particles | |
| KR102444684B1 (ko) | 일회용 배양 공정 시스템을 이용한 인플루엔자 바이러스 생산 방법 | |
| KR20100017593A (ko) | 바이러스의 증식을 위한 ２-단계 온도 프로파일 | |
| HK1194763A (en) | Process for producing viral antigen and vaccines | |
| US20230220356A1 (en) | Compositions and methods for producing a viral vaccine with reduced particle size | |
| RU2604414C2 (ru) | Живая вакцина для профилактики гриппа и способ ее получения | |
| KR20210133732A (ko) | 인플루엔자 바이러스 항원 정제 조건 신속 확인 시험 |