NO322186B1 - Fremgangsmate for fremstilling av kvalitetssikrede sammenslatte plasmamaterialer. - Google Patents
Fremgangsmate for fremstilling av kvalitetssikrede sammenslatte plasmamaterialer. Download PDFInfo
- Publication number
- NO322186B1 NO322186B1 NO19970050A NO970050A NO322186B1 NO 322186 B1 NO322186 B1 NO 322186B1 NO 19970050 A NO19970050 A NO 19970050A NO 970050 A NO970050 A NO 970050A NO 322186 B1 NO322186 B1 NO 322186B1
- Authority
- NO
- Norway
- Prior art keywords
- plasma
- pcr
- virus
- genome
- combined
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims abstract description 108
- 239000000463 material Substances 0.000 title claims abstract description 24
- 230000008569 process Effects 0.000 title claims abstract description 5
- 239000002131 composite material Substances 0.000 title description 3
- 241000700605 Viruses Species 0.000 claims abstract description 129
- 230000003612 virological effect Effects 0.000 claims abstract description 71
- 238000004519 manufacturing process Methods 0.000 claims abstract description 34
- 239000000523 sample Substances 0.000 claims description 72
- 238000001514 detection method Methods 0.000 claims description 53
- 239000007858 starting material Substances 0.000 claims description 45
- 150000007523 nucleic acids Chemical class 0.000 claims description 43
- 108020004707 nucleic acids Proteins 0.000 claims description 39
- 102000039446 nucleic acids Human genes 0.000 claims description 39
- 238000012360 testing method Methods 0.000 claims description 39
- 238000003199 nucleic acid amplification method Methods 0.000 claims description 36
- 230000003321 amplification Effects 0.000 claims description 34
- 208000013210 hematogenous Diseases 0.000 claims description 17
- 238000002360 preparation method Methods 0.000 claims description 12
- 238000012545 processing Methods 0.000 claims description 12
- 229940126601 medicinal product Drugs 0.000 claims description 10
- 108010017384 Blood Proteins Proteins 0.000 claims description 8
- 102000004506 Blood Proteins Human genes 0.000 claims description 8
- 230000036039 immunity Effects 0.000 claims description 8
- 230000001681 protective effect Effects 0.000 claims description 8
- 239000003112 inhibitor Substances 0.000 claims description 7
- 238000005119 centrifugation Methods 0.000 claims description 6
- 238000005194 fractionation Methods 0.000 claims description 2
- 238000004108 freeze drying Methods 0.000 claims description 2
- 238000001179 sorption measurement Methods 0.000 claims description 2
- 230000002401 inhibitory effect Effects 0.000 claims 1
- 241000894007 species Species 0.000 claims 1
- 239000013067 intermediate product Substances 0.000 abstract description 28
- 230000002779 inactivation Effects 0.000 abstract description 24
- 239000003814 drug Substances 0.000 abstract description 18
- 230000000694 effects Effects 0.000 abstract description 5
- 239000013543 active substance Substances 0.000 abstract description 2
- 239000012752 auxiliary agent Substances 0.000 abstract 1
- 210000002381 plasma Anatomy 0.000 description 177
- 238000003752 polymerase chain reaction Methods 0.000 description 68
- 241000711549 Hepacivirus C Species 0.000 description 49
- 241000725303 Human immunodeficiency virus Species 0.000 description 47
- 239000013615 primer Substances 0.000 description 42
- 239000000047 product Substances 0.000 description 32
- 208000015181 infectious disease Diseases 0.000 description 23
- 241000709721 Hepatovirus A Species 0.000 description 18
- 210000004369 blood Anatomy 0.000 description 18
- 239000008280 blood Substances 0.000 description 18
- 238000011109 contamination Methods 0.000 description 18
- 238000006243 chemical reaction Methods 0.000 description 17
- 230000035945 sensitivity Effects 0.000 description 15
- 108020004414 DNA Proteins 0.000 description 14
- 230000002458 infectious effect Effects 0.000 description 14
- 239000000872 buffer Substances 0.000 description 12
- 241000700721 Hepatitis B virus Species 0.000 description 10
- 230000003472 neutralizing effect Effects 0.000 description 10
- 238000003757 reverse transcription PCR Methods 0.000 description 10
- 230000002062 proliferating effect Effects 0.000 description 9
- 238000011002 quantification Methods 0.000 description 9
- 239000000126 substance Substances 0.000 description 9
- 206010058874 Viraemia Diseases 0.000 description 7
- 229940079593 drug Drugs 0.000 description 7
- 238000009396 hybridization Methods 0.000 description 7
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 6
- 241000125945 Protoparvovirus Species 0.000 description 6
- 238000004458 analytical method Methods 0.000 description 6
- 239000000427 antigen Substances 0.000 description 6
- 239000000499 gel Substances 0.000 description 6
- 238000011835 investigation Methods 0.000 description 6
- 239000013612 plasmid Substances 0.000 description 6
- 238000011282 treatment Methods 0.000 description 6
- 102000004190 Enzymes Human genes 0.000 description 5
- 108090000790 Enzymes Proteins 0.000 description 5
- 208000036142 Viral infection Diseases 0.000 description 5
- 239000012678 infectious agent Substances 0.000 description 5
- 239000000543 intermediate Substances 0.000 description 5
- 238000002156 mixing Methods 0.000 description 5
- 239000008188 pellet Substances 0.000 description 5
- 238000000275 quality assurance Methods 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- 230000009385 viral infection Effects 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 description 4
- 238000002105 Southern blotting Methods 0.000 description 4
- 238000000605 extraction Methods 0.000 description 4
- 239000012634 fragment Substances 0.000 description 4
- 208000002672 hepatitis B Diseases 0.000 description 4
- 239000000825 pharmaceutical preparation Substances 0.000 description 4
- 230000009467 reduction Effects 0.000 description 4
- 208000005176 Hepatitis C Diseases 0.000 description 3
- 241000282577 Pan troglodytes Species 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 102000036639 antigens Human genes 0.000 description 3
- 108091007433 antigens Proteins 0.000 description 3
- 230000005540 biological transmission Effects 0.000 description 3
- 239000010836 blood and blood product Substances 0.000 description 3
- 229940125691 blood product Drugs 0.000 description 3
- 239000007795 chemical reaction product Substances 0.000 description 3
- 238000003776 cleavage reaction Methods 0.000 description 3
- 239000002299 complementary DNA Substances 0.000 description 3
- 239000012468 concentrated sample Substances 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 238000001502 gel electrophoresis Methods 0.000 description 3
- 238000010438 heat treatment Methods 0.000 description 3
- 208000006454 hepatitis Diseases 0.000 description 3
- 231100000283 hepatitis Toxicity 0.000 description 3
- 208000005252 hepatitis A Diseases 0.000 description 3
- 238000011534 incubation Methods 0.000 description 3
- 108090000623 proteins and genes Proteins 0.000 description 3
- 230000007017 scission Effects 0.000 description 3
- 238000012216 screening Methods 0.000 description 3
- 210000002966 serum Anatomy 0.000 description 3
- 239000006228 supernatant Substances 0.000 description 3
- 210000001519 tissue Anatomy 0.000 description 3
- 102100027211 Albumin Human genes 0.000 description 2
- 108010088751 Albumins Proteins 0.000 description 2
- 241001227713 Chiron Species 0.000 description 2
- 108010067770 Endopeptidase K Proteins 0.000 description 2
- 108010054218 Factor VIII Proteins 0.000 description 2
- 102000001690 Factor VIII Human genes 0.000 description 2
- 229920002527 Glycogen Polymers 0.000 description 2
- 206010019786 Hepatitis non-A non-B Diseases 0.000 description 2
- 241000713772 Human immunodeficiency virus 1 Species 0.000 description 2
- 108060003951 Immunoglobulin Proteins 0.000 description 2
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 2
- 108091028043 Nucleic acid sequence Proteins 0.000 description 2
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 239000007983 Tris buffer Substances 0.000 description 2
- 108020005202 Viral DNA Proteins 0.000 description 2
- 239000011543 agarose gel Substances 0.000 description 2
- 238000010171 animal model Methods 0.000 description 2
- 238000000429 assembly Methods 0.000 description 2
- 230000000712 assembly Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 238000012790 confirmation Methods 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 238000010790 dilution Methods 0.000 description 2
- 239000012895 dilution Substances 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 230000009977 dual effect Effects 0.000 description 2
- 229960000301 factor viii Drugs 0.000 description 2
- 229940096919 glycogen Drugs 0.000 description 2
- 102000018358 immunoglobulin Human genes 0.000 description 2
- 150000002500 ions Chemical class 0.000 description 2
- 238000001499 laser induced fluorescence spectroscopy Methods 0.000 description 2
- 229910001629 magnesium chloride Inorganic materials 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 239000013642 negative control Substances 0.000 description 2
- JPXMTWWFLBLUCD-UHFFFAOYSA-N nitro blue tetrazolium(2+) Chemical compound COC1=CC(C=2C=C(OC)C(=CC=2)[N+]=2N(N=C(N=2)C=2C=CC=CC=2)C=2C=CC(=CC=2)[N+]([O-])=O)=CC=C1[N+]1=NC(C=2C=CC=CC=2)=NN1C1=CC=C([N+]([O-])=O)C=C1 JPXMTWWFLBLUCD-UHFFFAOYSA-N 0.000 description 2
- 125000003729 nucleotide group Chemical group 0.000 description 2
- 230000001717 pathogenic effect Effects 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 239000013641 positive control Substances 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 238000012800 visualization Methods 0.000 description 2
- 208000030507 AIDS Diseases 0.000 description 1
- 102000002260 Alkaline Phosphatase Human genes 0.000 description 1
- 108020004774 Alkaline Phosphatase Proteins 0.000 description 1
- 108010039209 Blood Coagulation Factors Proteins 0.000 description 1
- 102000015081 Blood Coagulation Factors Human genes 0.000 description 1
- 102100022641 Coagulation factor IX Human genes 0.000 description 1
- 206010010356 Congenital anomaly Diseases 0.000 description 1
- 108020003215 DNA Probes Proteins 0.000 description 1
- 239000003155 DNA primer Substances 0.000 description 1
- 239000003298 DNA probe Substances 0.000 description 1
- 108010014303 DNA-directed DNA polymerase Proteins 0.000 description 1
- 102000016928 DNA-directed DNA polymerase Human genes 0.000 description 1
- 108090000626 DNA-directed RNA polymerases Proteins 0.000 description 1
- 102000004163 DNA-directed RNA polymerases Human genes 0.000 description 1
- 238000002965 ELISA Methods 0.000 description 1
- 102000010911 Enzyme Precursors Human genes 0.000 description 1
- 108010062466 Enzyme Precursors Proteins 0.000 description 1
- 208000007985 Erythema Infectiosum Diseases 0.000 description 1
- 108010076282 Factor IX Proteins 0.000 description 1
- 229920001917 Ficoll Polymers 0.000 description 1
- 241001517118 Goose parvovirus Species 0.000 description 1
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 description 1
- 108010022901 Heparin Lyase Proteins 0.000 description 1
- 241000282412 Homo Species 0.000 description 1
- 102000008100 Human Serum Albumin Human genes 0.000 description 1
- 108091006905 Human Serum Albumin Proteins 0.000 description 1
- 108090000604 Hydrolases Proteins 0.000 description 1
- 102000004157 Hydrolases Human genes 0.000 description 1
- 102100034343 Integrase Human genes 0.000 description 1
- 241000701076 Macacine alphaherpesvirus 1 Species 0.000 description 1
- 108091034117 Oligonucleotide Proteins 0.000 description 1
- 238000009004 PCR Kit Methods 0.000 description 1
- 238000012408 PCR amplification Methods 0.000 description 1
- 241000282579 Pan Species 0.000 description 1
- 241000276498 Pollachius virens Species 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- 108010094028 Prothrombin Proteins 0.000 description 1
- 102100027378 Prothrombin Human genes 0.000 description 1
- 108010092799 RNA-directed DNA polymerase Proteins 0.000 description 1
- 240000004808 Saccharomyces cerevisiae Species 0.000 description 1
- 101000874347 Streptococcus agalactiae IgA FC receptor Proteins 0.000 description 1
- 108010006785 Taq Polymerase Proteins 0.000 description 1
- 206010057040 Temperature intolerance Diseases 0.000 description 1
- 108020000999 Viral RNA Proteins 0.000 description 1
- JLCPHMBAVCMARE-UHFFFAOYSA-N [3-[[3-[[3-[[3-[[3-[[3-[[3-[[3-[[3-[[3-[[3-[[5-(2-amino-6-oxo-1H-purin-9-yl)-3-[[3-[[3-[[3-[[3-[[3-[[5-(2-amino-6-oxo-1H-purin-9-yl)-3-[[5-(2-amino-6-oxo-1H-purin-9-yl)-3-hydroxyoxolan-2-yl]methoxy-hydroxyphosphoryl]oxyoxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(5-methyl-2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxyoxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(5-methyl-2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(4-amino-2-oxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(5-methyl-2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(5-methyl-2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(4-amino-2-oxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(4-amino-2-oxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(4-amino-2-oxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(4-amino-2-oxopyrimidin-1-yl)oxolan-2-yl]methyl [5-(6-aminopurin-9-yl)-2-(hydroxymethyl)oxolan-3-yl] hydrogen phosphate Polymers Cc1cn(C2CC(OP(O)(=O)OCC3OC(CC3OP(O)(=O)OCC3OC(CC3O)n3cnc4c3nc(N)[nH]c4=O)n3cnc4c3nc(N)[nH]c4=O)C(COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3CO)n3cnc4c(N)ncnc34)n3ccc(N)nc3=O)n3cnc4c(N)ncnc34)n3ccc(N)nc3=O)n3ccc(N)nc3=O)n3ccc(N)nc3=O)n3cnc4c(N)ncnc34)n3cnc4c(N)ncnc34)n3cc(C)c(=O)[nH]c3=O)n3cc(C)c(=O)[nH]c3=O)n3ccc(N)nc3=O)n3cc(C)c(=O)[nH]c3=O)n3cnc4c3nc(N)[nH]c4=O)n3cnc4c(N)ncnc34)n3cnc4c(N)ncnc34)n3cnc4c(N)ncnc34)n3cnc4c(N)ncnc34)O2)c(=O)[nH]c1=O JLCPHMBAVCMARE-UHFFFAOYSA-N 0.000 description 1
- 238000000246 agarose gel electrophoresis Methods 0.000 description 1
- 238000005267 amalgamation Methods 0.000 description 1
- 230000002924 anti-infective effect Effects 0.000 description 1
- 239000004599 antimicrobial Substances 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- 229960000074 biopharmaceutical Drugs 0.000 description 1
- 239000003114 blood coagulation factor Substances 0.000 description 1
- UDSAIICHUKSCKT-UHFFFAOYSA-N bromophenol blue Chemical compound C1=C(Br)C(O)=C(Br)C=C1C1(C=2C=C(Br)C(O)=C(Br)C=2)C2=CC=CC=C2S(=O)(=O)O1 UDSAIICHUKSCKT-UHFFFAOYSA-N 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 238000004113 cell culture Methods 0.000 description 1
- 239000013522 chelant Substances 0.000 description 1
- 238000002512 chemotherapy Methods 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 239000012141 concentrate Substances 0.000 description 1
- 239000000356 contaminant Substances 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
- 238000010908 decantation Methods 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000000779 depleting effect Effects 0.000 description 1
- 230000010460 detection of virus Effects 0.000 description 1
- 238000000502 dialysis Methods 0.000 description 1
- 241001493065 dsRNA viruses Species 0.000 description 1
- 239000012147 electrophoresis running buffer Substances 0.000 description 1
- 230000002255 enzymatic effect Effects 0.000 description 1
- 239000002532 enzyme inhibitor Substances 0.000 description 1
- 239000000284 extract Substances 0.000 description 1
- 229960004222 factor ix Drugs 0.000 description 1
- 239000003527 fibrinolytic agent Substances 0.000 description 1
- 230000003480 fibrinolytic effect Effects 0.000 description 1
- 230000008543 heat sensitivity Effects 0.000 description 1
- 229960002897 heparin Drugs 0.000 description 1
- 229920000669 heparin Polymers 0.000 description 1
- 208000010710 hepatitis C virus infection Diseases 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 238000002649 immunization Methods 0.000 description 1
- 230000003053 immunization Effects 0.000 description 1
- 238000003018 immunoassay Methods 0.000 description 1
- 229940072221 immunoglobulins Drugs 0.000 description 1
- 238000012744 immunostaining Methods 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 230000000415 inactivating effect Effects 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 238000010255 intramuscular injection Methods 0.000 description 1
- 239000007927 intramuscular injection Substances 0.000 description 1
- 238000010253 intravenous injection Methods 0.000 description 1
- 150000002540 isothiocyanates Chemical class 0.000 description 1
- 238000002372 labelling Methods 0.000 description 1
- 238000007834 ligase chain reaction Methods 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 108010026228 mRNA guanylyltransferase Proteins 0.000 description 1
- 239000003550 marker Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000013508 migration Methods 0.000 description 1
- 230000005012 migration Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 230000035772 mutation Effects 0.000 description 1
- 238000001728 nano-filtration Methods 0.000 description 1
- 238000007857 nested PCR Methods 0.000 description 1
- 238000006386 neutralization reaction Methods 0.000 description 1
- 239000002773 nucleotide Substances 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- 238000000053 physical method Methods 0.000 description 1
- 238000001470 plasma protein fractionation Methods 0.000 description 1
- 229920002401 polyacrylamide Polymers 0.000 description 1
- 229920000768 polyamine Polymers 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 229940039716 prothrombin Drugs 0.000 description 1
- 238000000746 purification Methods 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 230000010076 replication Effects 0.000 description 1
- 239000012146 running buffer Substances 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 238000011895 specific detection Methods 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 238000010186 staining Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 230000008685 targeting Effects 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 238000013518 transcription Methods 0.000 description 1
- 230000035897 transcription Effects 0.000 description 1
- 238000005199 ultracentrifugation Methods 0.000 description 1
- 241001515965 unidentified phage Species 0.000 description 1
- 238000002255 vaccination Methods 0.000 description 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/70—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
- C12Q1/701—Specific hybridization probes
- C12Q1/706—Specific hybridization probes for hepatitis
- C12Q1/707—Specific hybridization probes for hepatitis non-A, non-B Hepatitis, excluding hepatitis D
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/14—Blood; Artificial blood
- A61K35/16—Blood plasma; Blood serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/70—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
- C12Q1/701—Specific hybridization probes
- C12Q1/702—Specific hybridization probes for retroviruses
- C12Q1/703—Viruses associated with AIDS
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/70—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
- C12Q1/701—Specific hybridization probes
- C12Q1/706—Specific hybridization probes for hepatitis
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/96—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
- C12Q1/6844—Nucleic acid amplification reactions
- C12Q1/6851—Quantitative amplification
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2496/00—Reference solutions for assays of biological material
- G01N2496/05—Reference solutions for assays of biological material containing blood cells or plasma
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Hematology (AREA)
- General Health & Medical Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Wood Science & Technology (AREA)
- Virology (AREA)
- Biotechnology (AREA)
- Molecular Biology (AREA)
- Analytical Chemistry (AREA)
- Microbiology (AREA)
- Physics & Mathematics (AREA)
- Biochemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Cell Biology (AREA)
- Medicinal Chemistry (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Biomedical Technology (AREA)
- Communicable Diseases (AREA)
- General Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Urology & Nephrology (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Epidemiology (AREA)
- AIDS & HIV (AREA)
- Pathology (AREA)
- General Physics & Mathematics (AREA)
- Food Science & Technology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AT0077895A AT406019B (de) | 1995-05-08 | 1995-05-08 | Verfahren zur herstellung eines arzneimittels enthaltend ein oder mehrere plasmaderivate |
| PCT/AT1996/000089 WO1996035437A1 (fr) | 1995-05-08 | 1996-05-06 | Medicament de qualite garantie contenant un ou plusieurs derives plasmatiques |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| NO970050L NO970050L (no) | 1997-01-07 |
| NO970050D0 NO970050D0 (no) | 1997-01-07 |
| NO322186B1 true NO322186B1 (no) | 2006-08-28 |
Family
ID=3499516
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| NO19970050A NO322186B1 (no) | 1995-05-08 | 1997-01-07 | Fremgangsmate for fremstilling av kvalitetssikrede sammenslatte plasmamaterialer. |
Country Status (10)
| Country | Link |
|---|---|
| EP (1) | EP0769954B2 (fr) |
| JP (2) | JPH10502943A (fr) |
| AT (2) | AT406019B (fr) |
| CA (1) | CA2191475C (fr) |
| DE (1) | DE59610626D1 (fr) |
| DK (1) | DK0769954T4 (fr) |
| ES (1) | ES2203688T5 (fr) |
| IL (1) | IL118188A (fr) |
| NO (1) | NO322186B1 (fr) |
| WO (1) | WO1996035437A1 (fr) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5780222A (en) | 1995-04-10 | 1998-07-14 | Alpha Therapeutic Corporation | Method of PCR testing of pooled blood samples |
| AT403477B (de) * | 1996-04-30 | 1998-02-25 | Immuno Ag | Biologisches material frei von viralen und molekularen pathogenen und verfahren zur herstellung |
| AU741141B2 (en) * | 1997-11-04 | 2001-11-22 | Roche Diagnostics Gmbh | Specific and sensitive method for detecting nucleic acids |
| DE19752898A1 (de) * | 1997-11-28 | 1999-08-05 | Centeon Pharma Gmbh | Verfahren zum Nachweis hoher Vierenkonzentrationen im Blutplasma und/oder Blutserum mittels der Polymerasekettenreaktion |
| AT407160B (de) * | 1998-06-04 | 2001-01-25 | Immuno Ag | Verfahren zur bestimmung von antigenen |
| AU774118B2 (en) | 1999-02-12 | 2004-06-17 | Baxter Healthcare Sa | A method for producing a preparation based on fibrinogen and fibronectin as well as protein compositions obtainable according to this method |
| AT410218B (de) | 1999-08-20 | 2003-03-25 | Baxter Ag | Verfahren zur herstellung eines qualitätsgesicherten pools biologischer proben |
| PL1711513T3 (pl) * | 2003-12-01 | 2014-12-31 | Novo Nordisk Healthcare Ag | Nanofiltracja roztworów czynnika vii w celu usunięcia wirusów |
| DE102005054206B4 (de) * | 2005-11-14 | 2010-07-15 | Roth, Willi, Prof. Dr. | Verfahren und Vorrichtung zum automatisierten Bearbeiten von gepoolten Proben |
| AU2016315836A1 (en) * | 2015-09-02 | 2018-02-15 | Ep Minerals, Llc | Regenerated media useful in the treatment of fermented liquids |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0447984A1 (fr) * | 1990-03-20 | 1991-09-25 | Abbott Laboratories | Globuline hyperimmune contre le virus de l'hépatite C et son procédé de préparation |
| WO1992001714A1 (fr) † | 1990-07-24 | 1992-02-06 | Yamanouchi Pharmaceutical Co., Ltd. | Antigene du virus de l'hepatite non a, non b |
| JP3114731B2 (ja) * | 1990-08-14 | 2000-12-04 | 国立感染症研究所長 | Ｃ型肝炎ウイルス抗体検出用ペプチド抗原及びその使用方法 |
| JPH04300000A (ja) * | 1991-03-27 | 1992-10-23 | Teijin Ltd | 核酸の定量方法 |
| AT402891B (de) * | 1991-06-20 | 1997-09-25 | Immuno Ag | Verfahren zur herstellung eines inaktivierten blutproduktes |
| AU4248193A (en) † | 1992-05-15 | 1993-12-13 | New England Deaconess Hospital | Quantitation of viral rna by competitive polymerase chain reaction |
| EP0586112A3 (en) * | 1992-08-14 | 1994-09-14 | Pharma Gen S A | Control of pcr mediated detection of micro-organisms |
| DK0590327T3 (da) * | 1992-09-11 | 2003-07-28 | Hoffmann La Roche | Påvisning af nukleinsyrer i blod |
| CA2159044A1 (fr) * | 1994-09-26 | 1996-03-27 | Falko-Guenter Falkner | Methode de dosage des acides nucleiques |
-
1995
- 1995-05-08 AT AT0077895A patent/AT406019B/de not_active IP Right Cessation
-
1996
- 1996-05-06 JP JP8533598A patent/JPH10502943A/ja active Pending
- 1996-05-06 AT AT96910855T patent/ATE245989T1/de active
- 1996-05-06 DE DE59610626T patent/DE59610626D1/de not_active Expired - Lifetime
- 1996-05-06 CA CA2191475A patent/CA2191475C/fr not_active Expired - Lifetime
- 1996-05-06 ES ES96910855T patent/ES2203688T5/es not_active Expired - Lifetime
- 1996-05-06 EP EP96910855A patent/EP0769954B2/fr not_active Expired - Lifetime
- 1996-05-06 DK DK96910855.4T patent/DK0769954T4/da active
- 1996-05-06 WO PCT/AT1996/000089 patent/WO1996035437A1/fr active IP Right Grant
- 1996-05-08 IL IL11818896A patent/IL118188A/xx not_active IP Right Cessation
-
1997
- 1997-01-07 NO NO19970050A patent/NO322186B1/no not_active IP Right Cessation
-
2008
- 2008-04-22 JP JP2008111565A patent/JP2008247913A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| DE59610626D1 (de) | 2003-09-04 |
| ES2203688T5 (es) | 2011-07-01 |
| DK0769954T4 (da) | 2011-04-04 |
| CA2191475C (fr) | 2010-09-14 |
| EP0769954A1 (fr) | 1997-05-02 |
| JP2008247913A (ja) | 2008-10-16 |
| EP0769954B2 (fr) | 2011-03-09 |
| ES2203688T3 (es) | 2004-04-16 |
| CA2191475A1 (fr) | 1996-11-14 |
| ATE245989T1 (de) | 2003-08-15 |
| ATA77895A (de) | 1999-06-15 |
| NO970050L (no) | 1997-01-07 |
| JPH10502943A (ja) | 1998-03-17 |
| DK0769954T3 (da) | 2003-11-17 |
| NO970050D0 (no) | 1997-01-07 |
| IL118188A (en) | 2000-07-16 |
| IL118188A0 (en) | 1996-09-12 |
| EP0769954B1 (fr) | 2003-07-30 |
| WO1996035437A1 (fr) | 1996-11-14 |
| AT406019B (de) | 2000-01-25 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP2008247913A (ja) | １以上の血漿誘導体を含む、品質保証された薬物 | |
| US5789153A (en) | Method of quantitating nucleic acid | |
| Maggi et al. | Human gyrovirus DNA in human blood, Italy | |
| Rotbart et al. | Persistent enterovirus infection in culture-negative meningoencephalitis: demonstration by enzymatic RNA amplification | |
| Kleim et al. | Acute HIV-1 Infection in Patients with Hemophilia B Treated with β-Propiolactone-UV-lnactivated Clotting Factor | |
| CN114080456A (zh) | Rna病毒检测方法 | |
| CN101487064B (zh) | 检测五种人兽共患病病毒的方法及专用试剂盒 | |
| JP2017023144A (ja) | インビトロにおいて生成したウイルスの精製方法及びウイルスのクリアランスアッセイ | |
| Ozoemena et al. | Comparative evaluation of measles virus specific TaqMan PCR and conventional PCR using synthetic and natural RNA templates | |
| JP2006087442A (ja) | 質の保証された生物学的サンプルおよびこのサンプルを含む組成物を生成するための方法 | |
| CN111254217A (zh) | 诺如病毒的检测方法 | |
| Lin et al. | Occurrence of identical hypervariable region 1 sequences of hepatitis C virus in transfusion recipients and their respective blood donors: divergence over time | |
| US20210025012A1 (en) | Method for detecting nucleic acid | |
| CN111254218A (zh) | Rna病毒检测方法 | |
| CN106868211B (zh) | 一种检测巨细胞病毒巢式pcr产物的可视化方法 | |
| JP3351773B2 (ja) | Ｈｉｖ−１のサブタイプ決定法 | |
| Hsu et al. | Development of a quantitative real-time RT-PCR assay for detecting Taiwan ferret badger rabies virus in ear tissue of ferret badgers and mice | |
| JP2010110327A (ja) | 質の保証された生物学的サンプルおよびこのサンプルを含む組成物を生成するための方法 | |
| KR100481357B1 (ko) | 바이러스 핵산 추출용 조성물 | |
| Schlabe et al. | Acute Hepatitis E Virus infection in a hemophilic patient with acquired inhibitor during immune tolerance therapy according to modified Bonn‐Malmö protocol. | |
| Rabenau et al. | Viral Contamination of Plasma Preparations: Determination of the Prevalence of Transfusion-Transmissible Viruses (HAV, HBV, HCV, GB Virus C and HIV) in Plasma Pools and Products | |
| AT940U1 (de) | Qualitätsgesichertes arzneimittel, enthaltend ein oder mehrere plasmaderivate | |
| JPH04200400A (ja) | ヒト生体由来の試料からのウイルスゲノムの抽出法及び該ウイルスゲノムの検出法 |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| CHAD | Change of the owner's name or address (par. 44 patent law, par. patentforskriften) |
Owner name: BAXALTA INCORPORATED, CH |
|
| MK1K | Patent expired |