CA2633338C - The invention relates to a method of viral inactivation by dry heating - Google Patents
The invention relates to a method of viral inactivation by dry heating Download PDFInfo
- Publication number
- CA2633338C CA2633338C CA2633338A CA2633338A CA2633338C CA 2633338 C CA2633338 C CA 2633338C CA 2633338 A CA2633338 A CA 2633338A CA 2633338 A CA2633338 A CA 2633338A CA 2633338 C CA2633338 C CA 2633338C
- Authority
- CA
- Canada
- Prior art keywords
- biological product
- heating
- glass transition
- viral
- dry
- 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
- 238000010438 heat treatment Methods 0.000 title claims abstract description 73
- 230000002779 inactivation Effects 0.000 title claims abstract description 61
- 230000003612 virological effect Effects 0.000 title claims abstract description 59
- 238000000034 method Methods 0.000 title claims abstract description 37
- 230000009477 glass transition Effects 0.000 claims abstract description 35
- 241000700605 Viruses Species 0.000 claims abstract description 20
- 230000009467 reduction Effects 0.000 claims description 37
- 239000000203 mixture Substances 0.000 claims description 9
- 244000309711 non-enveloped viruses Species 0.000 claims description 7
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 7
- 210000002381 plasma Anatomy 0.000 claims description 6
- 102000004169 proteins and genes Human genes 0.000 claims description 6
- 108090000623 proteins and genes Proteins 0.000 claims description 6
- 150000003839 salts Chemical class 0.000 claims description 3
- 230000008685 targeting Effects 0.000 claims 1
- 241000709721 Hepatovirus A Species 0.000 description 15
- 241000702619 Porcine parvovirus Species 0.000 description 15
- 241000272878 Apodiformes Species 0.000 description 10
- 241000035705 Enterobacteria phage PR772 Species 0.000 description 9
- 108010054218 Factor VIII Proteins 0.000 description 8
- 102000001690 Factor VIII Human genes 0.000 description 8
- 230000008569 process Effects 0.000 description 8
- 241000725303 Human immunodeficiency virus Species 0.000 description 7
- 229960000301 factor viii Drugs 0.000 description 7
- 108010047303 von Willebrand Factor Proteins 0.000 description 7
- 102100036537 von Willebrand factor Human genes 0.000 description 7
- 229960001134 von willebrand factor Drugs 0.000 description 7
- 239000013543 active substance Substances 0.000 description 6
- 239000012141 concentrate Substances 0.000 description 6
- 238000009472 formulation Methods 0.000 description 6
- 210000004369 blood Anatomy 0.000 description 5
- 239000008280 blood Substances 0.000 description 5
- 230000008859 change Effects 0.000 description 5
- 229920000642 polymer Polymers 0.000 description 5
- 239000003795 chemical substances by application Substances 0.000 description 4
- 230000003247 decreasing effect Effects 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- 102000015081 Blood Coagulation Factors Human genes 0.000 description 3
- 108010039209 Blood Coagulation Factors Proteins 0.000 description 3
- 241000283690 Bos taurus Species 0.000 description 3
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Natural products NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 3
- 239000004471 Glycine Substances 0.000 description 3
- 230000005540 biological transmission Effects 0.000 description 3
- 239000003114 blood coagulation factor Substances 0.000 description 3
- 238000011109 contamination Methods 0.000 description 3
- 239000003599 detergent Substances 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 239000002904 solvent Substances 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 230000001225 therapeutic effect Effects 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 241000701022 Cytomegalovirus Species 0.000 description 2
- 241000125945 Protoparvovirus Species 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 206010051511 Viral diarrhoea Diseases 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 238000004108 freeze drying Methods 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 229940106780 human fibrinogen Drugs 0.000 description 2
- 230000000415 inactivating effect Effects 0.000 description 2
- RZJRJXONCZWCBN-UHFFFAOYSA-N octadecane Chemical compound CCCCCCCCCCCCCCCCCC RZJRJXONCZWCBN-UHFFFAOYSA-N 0.000 description 2
- 102000004196 processed proteins & peptides Human genes 0.000 description 2
- 108090000765 processed proteins & peptides Proteins 0.000 description 2
- 230000000069 prophylactic effect Effects 0.000 description 2
- 239000001509 sodium citrate Substances 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 229940038773 trisodium citrate Drugs 0.000 description 2
- ZCYVEMRRCGMTRW-UHFFFAOYSA-N 7553-56-2 Chemical compound [I] ZCYVEMRRCGMTRW-UHFFFAOYSA-N 0.000 description 1
- 102000009027 Albumins Human genes 0.000 description 1
- 108010088751 Albumins Proteins 0.000 description 1
- 239000004475 Arginine Substances 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 241000701922 Bovine parvovirus Species 0.000 description 1
- 241000701931 Canine parvovirus Species 0.000 description 1
- 241000282465 Canis Species 0.000 description 1
- 206010061041 Chlamydial infection Diseases 0.000 description 1
- 102100023804 Coagulation factor VII Human genes 0.000 description 1
- 102100026735 Coagulation factor VIII Human genes 0.000 description 1
- 241000991587 Enterovirus C Species 0.000 description 1
- 108010023321 Factor VII Proteins 0.000 description 1
- 108010054265 Factor VIIa Proteins 0.000 description 1
- 108010049003 Fibrinogen Proteins 0.000 description 1
- 102000008946 Fibrinogen Human genes 0.000 description 1
- 238000001159 Fisher's combined probability test Methods 0.000 description 1
- 208000031886 HIV Infections Diseases 0.000 description 1
- 208000037357 HIV infectious disease Diseases 0.000 description 1
- 101000911390 Homo sapiens Coagulation factor VIII Proteins 0.000 description 1
- AGPKZVBTJJNPAG-WHFBIAKZSA-N L-isoleucine Chemical compound CC[C@H](C)[C@H](N)C(O)=O AGPKZVBTJJNPAG-WHFBIAKZSA-N 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 229920002367 Polyisobutene Polymers 0.000 description 1
- 241000606651 Rickettsiales Species 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 241000701093 Suid alphaherpesvirus 1 Species 0.000 description 1
- 229920006125 amorphous polymer Polymers 0.000 description 1
- 229960003121 arginine Drugs 0.000 description 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 description 1
- 229960003589 arginine hydrochloride Drugs 0.000 description 1
- 238000000889 atomisation Methods 0.000 description 1
- 239000012620 biological material Substances 0.000 description 1
- 229960000074 biopharmaceutical Drugs 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 125000000837 carbohydrate group Chemical group 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 201000000902 chlamydia Diseases 0.000 description 1
- 208000012538 chlamydia trachomatis infectious disease Diseases 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000002425 crystallisation Methods 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 238000002405 diagnostic procedure Methods 0.000 description 1
- 229920001971 elastomer Polymers 0.000 description 1
- 244000309457 enveloped RNA virus Species 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 229940012413 factor vii Drugs 0.000 description 1
- 229940012952 fibrinogen Drugs 0.000 description 1
- 150000004676 glycans Chemical group 0.000 description 1
- 239000001963 growth medium Substances 0.000 description 1
- 208000033519 human immunodeficiency virus infectious disease Diseases 0.000 description 1
- 229910052738 indium Inorganic materials 0.000 description 1
- APFVFJFRJDLVQX-UHFFFAOYSA-N indium atom Chemical compound [In] APFVFJFRJDLVQX-UHFFFAOYSA-N 0.000 description 1
- 239000011630 iodine Substances 0.000 description 1
- 229910052740 iodine Inorganic materials 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 238000011031 large-scale manufacturing process Methods 0.000 description 1
- 150000002632 lipids Chemical group 0.000 description 1
- 229960003646 lysine Drugs 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 210000004779 membrane envelope Anatomy 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 150000007523 nucleic acids Chemical group 0.000 description 1
- 108020004707 nucleic acids Chemical group 0.000 description 1
- 102000039446 nucleic acids Human genes 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 238000005373 pervaporation Methods 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 229920001195 polyisoprene Polymers 0.000 description 1
- 229920001184 polypeptide Polymers 0.000 description 1
- 229920001282 polysaccharide Chemical group 0.000 description 1
- 239000005017 polysaccharide Chemical group 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 230000000750 progressive effect Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 239000005060 rubber Substances 0.000 description 1
- -1 salts Chemical class 0.000 description 1
- 150000003384 small molecules Chemical class 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000011343 solid material Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 230000010512 thermal transition Effects 0.000 description 1
- 238000001757 thermogravimetry curve Methods 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
- 241001515965 unidentified phage Species 0.000 description 1
- 238000001291 vacuum drying Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/04—Heat
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0023—Heat
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
-
- 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
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Hematology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Diabetes (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Plant Substances (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Immobilizing And Processing Of Enzymes And Microorganisms (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR0512875A FR2894830B1 (fr) | 2005-12-19 | 2005-12-19 | Procede d'inactivation virale par chauffage a sec selon la temperature de transition vitreuse |
| FR0512875 | 2005-12-19 | ||
| PCT/FR2006/002817 WO2007071845A2 (fr) | 2005-12-19 | 2006-12-19 | Procede d'inactivation virale par chauffage a sec selon la temperature de transition vitreuse |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2633338A1 CA2633338A1 (en) | 2007-06-28 |
| CA2633338C true CA2633338C (en) | 2012-02-28 |
Family
ID=36698885
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2633338A Active CA2633338C (en) | 2005-12-19 | 2006-12-19 | The invention relates to a method of viral inactivation by dry heating |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US8252227B2 (enExample) |
| EP (1) | EP1981549B1 (enExample) |
| JP (1) | JP5085558B2 (enExample) |
| KR (1) | KR101162060B1 (enExample) |
| CN (1) | CN101355972B (enExample) |
| AT (1) | ATE431162T1 (enExample) |
| AU (1) | AU2006328804B2 (enExample) |
| BR (1) | BRPI0621074B1 (enExample) |
| CA (1) | CA2633338C (enExample) |
| DE (1) | DE602006006875D1 (enExample) |
| DK (1) | DK1981549T3 (enExample) |
| ES (1) | ES2327279T3 (enExample) |
| FR (1) | FR2894830B1 (enExample) |
| IL (1) | IL192194A (enExample) |
| PL (1) | PL1981549T3 (enExample) |
| WO (1) | WO2007071845A2 (enExample) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PH12013501365A1 (en) | 2010-12-30 | 2013-09-16 | Laboratoire Francais Du Fractionnment Et Des Biotechnologies | Glycols as pathogen inactivating agents |
| USD689039S1 (en) * | 2012-07-12 | 2013-09-03 | Alljack Co., Ltd. | Stereo set |
| CN109444209A (zh) * | 2018-10-26 | 2019-03-08 | 北京食品科学研究院 | 一种测量蛋清粉玻璃化转变温度的方法 |
| CN116059410A (zh) * | 2021-08-19 | 2023-05-05 | 南京金斯瑞生物科技有限公司 | 一种去除生物样本中噬菌体的方法 |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2248817C2 (de) * | 1972-10-05 | 1981-09-24 | Bayer Ag, 5090 Leverkusen | Polycarbonatmischungen |
| US4456590B2 (en) * | 1981-11-02 | 1989-05-30 | Heat treatment of lyphilized blood clotting factor viii concentrate | |
| GB9424732D0 (en) * | 1994-12-08 | 1995-02-08 | Common Services Agency | Heat treated blood plasma proteins |
| US5837519A (en) * | 1996-11-21 | 1998-11-17 | Bayer Corporation | Dry-heat viral inactivation under controlled moisture conditions |
| ATE429491T1 (de) * | 1997-09-23 | 2009-05-15 | Ib2 L L C | Verfahren und vorrichtung für schnelle thermozyklen |
| CN1286725A (zh) * | 1997-11-26 | 2001-03-07 | 环球保藏技术股份有限公司 | 敏感性生物样品的玻化保质法 |
| DK1121015T4 (da) * | 1998-10-14 | 2012-05-21 | Katrina T Forest | Fremgangsmåde til forglasning af et biologisk materiale |
| WO2001049112A2 (en) * | 2000-01-04 | 2001-07-12 | University Of Connecticut | Oocyte vitrification technique |
| JP2007501224A (ja) * | 2003-08-05 | 2007-01-25 | フジ フォト フィルム ビー．ブイ． | 安定剤としての組換え又は合成ゼラチン様タンパク質の、凍結乾燥医薬組成物中の使用 |
-
2005
- 2005-12-19 FR FR0512875A patent/FR2894830B1/fr not_active Expired - Lifetime
-
2006
- 2006-12-19 WO PCT/FR2006/002817 patent/WO2007071845A2/fr not_active Ceased
- 2006-12-19 CN CN2006800479202A patent/CN101355972B/zh active Active
- 2006-12-19 DK DK06847095T patent/DK1981549T3/da active
- 2006-12-19 CA CA2633338A patent/CA2633338C/en active Active
- 2006-12-19 BR BRPI0621074A patent/BRPI0621074B1/pt not_active IP Right Cessation
- 2006-12-19 ES ES06847095T patent/ES2327279T3/es active Active
- 2006-12-19 US US12/097,860 patent/US8252227B2/en active Active
- 2006-12-19 AT AT06847095T patent/ATE431162T1/de active
- 2006-12-19 JP JP2008545048A patent/JP5085558B2/ja not_active Expired - Fee Related
- 2006-12-19 AU AU2006328804A patent/AU2006328804B2/en not_active Ceased
- 2006-12-19 DE DE602006006875T patent/DE602006006875D1/de active Active
- 2006-12-19 PL PL06847095T patent/PL1981549T3/pl unknown
- 2006-12-19 KR KR1020087016839A patent/KR101162060B1/ko not_active Expired - Fee Related
- 2006-12-19 EP EP06847095A patent/EP1981549B1/fr active Active
-
2008
- 2008-06-15 IL IL192194A patent/IL192194A/en not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| IL192194A0 (en) | 2009-02-11 |
| ES2327279T3 (es) | 2009-10-27 |
| WO2007071845A3 (fr) | 2007-08-16 |
| KR101162060B1 (ko) | 2012-07-03 |
| CN101355972A (zh) | 2009-01-28 |
| PL1981549T3 (pl) | 2009-10-30 |
| KR20080093098A (ko) | 2008-10-20 |
| WO2007071845A2 (fr) | 2007-06-28 |
| IL192194A (en) | 2010-12-30 |
| US8252227B2 (en) | 2012-08-28 |
| CA2633338A1 (en) | 2007-06-28 |
| FR2894830A1 (fr) | 2007-06-22 |
| EP1981549A2 (fr) | 2008-10-22 |
| ATE431162T1 (de) | 2009-05-15 |
| FR2894830B1 (fr) | 2008-04-04 |
| AU2006328804B2 (en) | 2012-08-02 |
| US20090297398A1 (en) | 2009-12-03 |
| BRPI0621074B1 (pt) | 2016-07-26 |
| JP2009519920A (ja) | 2009-05-21 |
| CN101355972B (zh) | 2012-07-04 |
| DE602006006875D1 (de) | 2009-06-25 |
| EP1981549B1 (fr) | 2009-05-13 |
| BRPI0621074A2 (pt) | 2011-11-29 |
| DK1981549T3 (da) | 2009-08-17 |
| JP5085558B2 (ja) | 2012-11-28 |
| AU2006328804A1 (en) | 2007-06-28 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |