DK2741740T3 - Vakuum-understøttet konservering af biologiske produkter, især af vacciner - Google Patents
Vakuum-understøttet konservering af biologiske produkter, især af vacciner Download PDFInfo
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- DK2741740T3 DK2741740T3 DK12726998.3T DK12726998T DK2741740T3 DK 2741740 T3 DK2741740 T3 DK 2741740T3 DK 12726998 T DK12726998 T DK 12726998T DK 2741740 T3 DK2741740 T3 DK 2741740T3
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- 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
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
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- 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
- A61K2035/11—Medicinal preparations comprising living procariotic cells
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- 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
- A61K35/13—Tumour cells, irrespective of tissue of origin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- 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
- C12N2760/18011—Paramyxoviridae
- C12N2760/18051—Methods of production or purification of viral material
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Wood Science & Technology (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
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- Biochemistry (AREA)
- Public Health (AREA)
- Biotechnology (AREA)
- Biomedical Technology (AREA)
- Virology (AREA)
- Immunology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Microbiology (AREA)
- Veterinary Medicine (AREA)
- Molecular Biology (AREA)
- Mechanical Engineering (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (9)
1. Fremgangsmåde til vitrificering af biologisk materiale omfattende trinnene at formulere et flydende biologisk materiale, underkaste materiale for kontrollerede ændringer i tryk og temperatur for at reducere fugtindhold af formuleringen til mindre end ca. 5 vægtprocent, derved vitrificere det biologiske materiale; hvor fremgangsmåden yderligere omfatter trinnene at: (a) tilsætte til det flydende materiale aktive biologiske bestanddele, stabiliseringsmidler, der reducerer eller eliminerer skade induceret af at underkaste biologiske bestanddele til kryogene konserveringsmidler, herunder prilning, vitrificering, og fryse-tørring, og eventuelt tilsætte én eller flere adjuvanser; (b) fylde hætteglas med det biologiske materiale fra trin (a); (c) indsætte hætteglas i en temperatur-styret beholder, hvor temperaturen er mellem -15°C og 10°C, især mellem -10°C og 5°C, og endnu mere specielt ca. 5°C; (d) reducere lufttrykket af den temperatur-styrede beholder indtil et tryk indenfor området på 15-30 mbar opnås; (e) opretholde trykket opnået under trin (d) i mellem 5 og 20 minutter, især mellem 10 og 15 minutter, for at tillade produktets temperatur at stabiliseres og for at tillade flygtige gasser, herunder carbonater, at blive frigivet fra det biologiske materiale, hvor beholdertemperaturen forbliver ved ca. 4°C til ca. 6°C, eller ca. 5°C under dette trin; (f) sænke beholderlufttrykket til ca. 4 til ca. 7 mbar, eller ca. 5 mbar, i mellem ca. 5 til ca. 20 minutter; (g) opretholde trykket fra trin (f) i ca. 30 til ca. 60 minutter, hvilket tillader det biologiske materiale at blive mere koncentreret; (h) øge beholdertemperaturen fra negativ til positiv temperatur (mellem ca. 30°C til ca. 50°C) overforløbet på mellem 45 og 85 minutter, eller ca. 60 minutter, og holde trykket konstant indtil der nåes ca. 10°C til ca. 20°C, eller ca. 15°C; (i) reducere beholderlufttrykket til ca. 1,5 til ca. 4 mbar, eller ca. 3 mbar, for at accelerere koncentrationen, og indtil beholdertemperaturen når og opretholder ca. 30°C i ca. 30 minutter til ca. 90 minutter, eller 60 minutter; (j) yderligere reducere trykket til mellem ca. 0,5 og ca. 4,0 mbar, eller ca. 1 mbar, og opretholde konstant tryk indtil skumning er fuldendt; (k) yderligere reducere trykket til mellem ca. 5 pbar og ca. 100 pbar, eller ca. 25 pbar, mens temperaturen opretholdes ved ca. 30°C i ca. 400 til ca. 2400 minutter eller derover, indtil den ønskede fugtighed på mellem ca. 0,5% til ca. 15%, eller ca. 1% til ca. 4%, opnås; (l) tilproppe hætteglassene mens de er i fryse-tørrebeholderen, derved fuldende vitrificeringsfremgangsmåden.
2. Fremgangsmåden ifølge krav 1, hvor det aktive biologiske materiale er et immunogen, et polypeptid, et nukleotid, et levende virus, levende bakterie, et levende protist, eller en underenhed der stammer fra en sygdom eller forstyrrelses-forårsagende patogen.
3. Fremgangsmåden ifølge krav 2, hvor det aktive biologiske lægemiddel er et levende svækket virus.
4. Fremgangsmåden ifølge krav 3, hvor virusset er hundesyge-virus (CDV), hunde-parainfluenza-virus type 2 (PI2), eller kombinationer deraf.
5. Fremgangsmåden ifølge krav 3, hvor det svækkede virus er canarypox, Marek's sygdomsvirus, infektiøs bursal sygdomsvirus, west nile-virus (WNV) eller katteleukæmivirus (FeLV).
6. Fremgangsmåden ifølge krav 2, hvor bakterien er avibacterium.
7. Fremgangsmåden ifølge et hvilket som helst af de foregående krav, hvor materialet indeholder mindst én adjuvans.
8. Fremgangsmåden ifølge et hvilket som helst af de foregående krav, hvor det j vitrificerede biologiske materiale er stabilt ved 4°C i mindst ét år.
9. Fremgangsmåden ifølge et hvilket som helst af de foregående krav, hvor det vitrificerede biologiske materiale er stabilt ved -20°C og -80°C i mindst ét år. )
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161490987P | 2011-08-12 | 2011-08-12 | |
PCT/US2012/040230 WO2013025274A1 (en) | 2011-08-12 | 2012-05-31 | Vacuum -assisted preservation of biological products, in particular of vaccines |
Publications (1)
Publication Number | Publication Date |
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DK2741740T3 true DK2741740T3 (da) | 2017-06-06 |
Family
ID=46246235
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK12726998.3T DK2741740T3 (da) | 2011-08-12 | 2012-05-31 | Vakuum-understøttet konservering af biologiske produkter, især af vacciner |
Country Status (13)
Country | Link |
---|---|
US (2) | US10166188B2 (da) |
EP (1) | EP2741740B1 (da) |
JP (1) | JP6041361B2 (da) |
CN (1) | CN103841963B (da) |
CA (1) | CA2844927C (da) |
DK (1) | DK2741740T3 (da) |
EA (1) | EA031229B1 (da) |
ES (1) | ES2626297T3 (da) |
HU (1) | HUE035774T2 (da) |
LT (1) | LT2741740T (da) |
MX (1) | MX350096B (da) |
SI (1) | SI2741740T1 (da) |
WO (1) | WO2013025274A1 (da) |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
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ES2894846T3 (es) | 2014-06-09 | 2022-02-16 | Somnio Global Holdings Llc | Procedimientos y dispositivos de vitrificación asistida por capilaridad |
CN110225765B (zh) | 2016-11-30 | 2024-03-12 | 勃林格殷格翰动物保健美国公司 | 减毒猪流感疫苗以及其制备和使用方法 |
CN107043740A (zh) * | 2017-05-10 | 2017-08-15 | 浙江美保龙生物技术有限公司 | 一种mdbk细胞培养液及其制备方法、使用方法 |
CN107217029A (zh) * | 2017-06-08 | 2017-09-29 | 浙江美保龙生物技术有限公司 | 一种pk‑15细胞培养液及其制备方法、使用方法 |
US10973908B1 (en) | 2020-05-14 | 2021-04-13 | David Gordon Bermudes | Expression of SARS-CoV-2 spike protein receptor binding domain in attenuated salmonella as a vaccine |
US11287185B1 (en) | 2020-09-09 | 2022-03-29 | Stay Fresh Technology, LLC | Freeze drying with constant-pressure and constant-temperature phases |
CN113046412B (zh) * | 2021-03-29 | 2021-12-14 | 深圳市麦瑞科林科技有限公司 | 一种高安全性的非灭活型病毒保存液及制备方法 |
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2012
- 2012-05-31 DK DK12726998.3T patent/DK2741740T3/da active
- 2012-05-31 US US13/485,437 patent/US10166188B2/en active Active
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- 2012-05-31 ES ES12726998.3T patent/ES2626297T3/es active Active
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MX350096B (es) | 2017-08-25 |
US20190070117A1 (en) | 2019-03-07 |
EA201400216A1 (ru) | 2014-06-30 |
HUE035774T2 (en) | 2018-05-28 |
CN103841963A (zh) | 2014-06-04 |
US10653627B2 (en) | 2020-05-19 |
SI2741740T1 (sl) | 2017-08-31 |
EP2741740B1 (en) | 2017-05-03 |
LT2741740T (lt) | 2017-08-10 |
JP2014521742A (ja) | 2014-08-28 |
US20130040370A1 (en) | 2013-02-14 |
WO2013025274A1 (en) | 2013-02-21 |
JP6041361B2 (ja) | 2016-12-07 |
US10166188B2 (en) | 2019-01-01 |
CA2844927C (en) | 2017-10-31 |
MX2014001626A (es) | 2015-03-09 |
CN103841963B (zh) | 2018-04-24 |
EP2741740A1 (en) | 2014-06-18 |
EA031229B1 (ru) | 2018-12-28 |
ES2626297T3 (es) | 2017-07-24 |
CA2844927A1 (en) | 2013-02-21 |
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