HUE035774T2 - Biológiai anyagok, különösen oltóanyagok, vákuummal elõsegített tartósítása - Google Patents
Biológiai anyagok, különösen oltóanyagok, vákuummal elõsegített tartósítása Download PDFInfo
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- HUE035774T2 HUE035774T2 HUE12726998A HUE12726998A HUE035774T2 HU E035774 T2 HUE035774 T2 HU E035774T2 HU E12726998 A HUE12726998 A HU E12726998A HU E12726998 A HUE12726998 A HU E12726998A HU E035774 T2 HUE035774 T2 HU E035774T2
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- virus
- járás járás
- minutes
- immunogenic
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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
-
- 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)
- Genetics & Genomics (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Engineering & Computer Science (AREA)
- Zoology (AREA)
- Medicinal Chemistry (AREA)
- Wood Science & Technology (AREA)
- Microbiology (AREA)
- Epidemiology (AREA)
- Biomedical Technology (AREA)
- Virology (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Mechanical Engineering (AREA)
- Molecular Biology (AREA)
- Pharmacology & Pharmacy (AREA)
- Biotechnology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (3)
- Szabad atärs & igény po ah :<k I, hljás-ás biológiai anyag varifikálásárts, amely tartalmazza a kővetkező lépéseket; folyékony biológiai készítmény Ibrmalázősa, a készttsnéay alávetése a nyomás és hőmérséklet szabályozott, változásainak, ezáltal a kéSzítíóény öéáveSségtartálmétiák mintegy 5 töm«g% alapkő csökkentése* azáltal S biológiai anyag vlirilskhihytg ahol tsz eljárás tartalmazza a következe lépéseket iá: {a> aktiv biológiai összetevők.. stabilizátorok hozzáadása a folyékony készítményhez, amelyek ,>»'K\,sad s.-js MÍnvAvk s ke.»os,\U{ ?sn, OtolOgs«- ibsek kuegóo % »notas-, o-ndokaok tn-tesso vs\ov\"x< s,dt t., bekem< s.esms.evte'îî, v »noMpsot <s t,up,í,zu,í ^ársava, ',go <' Stetem »dukál os ado» -setk n \\ ',,!$* »Ob ,sonn?t s t » a (b) tartőedények töltése ,»> <*»'» * érinti biológiai készinysésiísyel; ;<·) κ tarsöedéöyak betöltése sznbályözett hön-érsékletö könténerbé, ahol » höniérséklet -:50/ és lob közötti,, különösen · IO':'C ős 5<:C közötti es még inkább különösen mintegy 5':C; td) a szabályozóit hOsíscrsáklctó sççgtéder Icvegöcyo-rsásánok csökkentése 15-30 robzr nyomás-eléréséig; te) a (ill lépés során elért nyoniás sonntsftáss 5-20 petéig. különösen iO-IS petetg. ezáltal lehetővé lévé, hogy a léfteék hoo-térsékieie átabiUdilódjap és ez illékony gázok, kÖZtök a karbonátok fslszahadaijarask a biológiai készlttöéitybók ahol sikoetéher hőnoérsékiOlo ézen lépés aktg mintegy á^o-k) vagy mintegy 5ÖG mamd; (í) a kobideór levogőnyemásáhak mintegy 4«? mfeatm vágy mintegy $ tnbartn csőkkootéso 5-2ö percre; (g) az (t) lépés o.yöÍöásáztak lépbtartdsa mintegy 3Ö-00 petrsg, «ms lehetővé teszi a biológiai készítmény töményebbé válását; (is) a konténer hőmémékiététtek emelése negatív hösoézsék létről. pozitív hőmérsékletté tmintegy 30-átk'G) strategy 45-05 percnyi vagy mintegy óé perçntd iddtártásö alatt, és a nyomás áiláado -értéken tartása mintegy !íi-'2íP€, vggy mintegy t.vk) eléréséig) (1) a kontoner iovegöeyossásáttak snimegy 1,5-4 mbarra vagy mintegy 3 otbarra csökkentése, ezáltal a ’,' íkí>' Ό'·, ','Bsa ·,' un a ", "C"<ets<l cl, o ou ,t",ytO'tps ,s m megs n- t. ot rm tegs Oí 0» percig vagy ÓD percig; φ a nyomás további csökkentése mintegy 1),5-4,0 mbarra vagy mintegy I mbarra és állandó nyomás iénetaríása, amíg a habképződés befejeződik: , > ,í \o u to\if’\ ,--0. u'tose "fi<<'s s ’< o pb.r ? >, sgy ! mum, % t,%Ys \o,txr t hőmérséklet mintegy 3Ö“C-o» tartása rt-iotegy 4Ö0-24ÖÖ vagy főbb percig, amíg a mintegy 0,5--15% vagy mintegy 1 -4%,-o;; kívánt- nedveaaéget. eiétjhk; Φ ,s 'ast>'odcn\d, i,'.-sf,amíg a to·.ns.ma sráutc konténerben vonnak, «. coital a utrpikom élj,sots befejezése, ? Λ,- i soots pont \<Y?nm eh-ra.-, abel a-· akti', bmlögsm ,myag smmonogen, pohpepísd, nckk-okl, cto 't η ok- eoo,'· u « ,'lö ,veös<te s,,gs be«."« -et ' tg' -eotív' es-e^ego; »ko o tesőbe »bei esed» ai?mvg 3. A 2> Igéísypobt szerinti -eljárás, alsói az aktív biológiai anyag éió, legyeogtfest \sn«. í s' ..η , xn t s _ 1 e a» ’ , I \ <t>s \ t t u.r uopor to > as n Ibi , - nos s \ ts c s , so 'k I ' s s t s < ' ' ! s sg' >. V x,>ns γ ' s·, ορι \ o\ j o ! s < ; ! <t ' p ,'s < ' > í e ' t K V ! í \ ' i ï'\ - ä s Mod bet >s \ i s fertőző bursitisbetegség vlnna, nyugat-ahusi vin« (WNVs vagy ntacskaiëlék leokőzisvífosa tkeLV). δ. A 2. Igénypont szerinti eljárás, ahol a baktéri um Ävibaeteznnn. ?. Az előző igénypontok bátmelyike szerinti eljárás, ahol a készítmény tartalmaz legalább egy wíiíováaíií.
- 8. Az előző igénypontok bármelyike szerinti eljárás, ahol a vkrlflkáU biológiai anyag á^C-ort legalább egy évsg \tabtf,
- 9. Az előző igénypontok bármelyike szerinti eljárás, ahol a vimískáh biológiai anyag -200€·οη és •Etre "óh legalább egy évig stobll.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161490987P | 2011-08-12 | 2011-08-12 |
Publications (1)
Publication Number | Publication Date |
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HUE035774T2 true HUE035774T2 (hu) | 2018-05-28 |
Family
ID=46246235
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HUE12726998A HUE035774T2 (hu) | 2011-08-12 | 2012-05-31 | Biológiai anyagok, különösen oltóanyagok, vákuummal elõsegített tartósítása |
Country Status (13)
Country | Link |
---|---|
US (2) | US10166188B2 (hu) |
EP (1) | EP2741740B1 (hu) |
JP (1) | JP6041361B2 (hu) |
CN (1) | CN103841963B (hu) |
CA (1) | CA2844927C (hu) |
DK (1) | DK2741740T3 (hu) |
EA (1) | EA031229B1 (hu) |
ES (1) | ES2626297T3 (hu) |
HU (1) | HUE035774T2 (hu) |
LT (1) | LT2741740T (hu) |
MX (1) | MX350096B (hu) |
SI (1) | SI2741740T1 (hu) |
WO (1) | WO2013025274A1 (hu) |
Families Citing this family (7)
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WO2015191570A1 (en) | 2014-06-09 | 2015-12-17 | Upkara, Inc. | Capillary assisted vitrification processes and devices |
EA201991319A1 (ru) | 2016-11-30 | 2019-11-29 | Вакцины аттенуированного свиного гриппа и способы их изготовления и применения | |
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 HU HUE12726998A patent/HUE035774T2/hu unknown
- 2012-05-31 MX MX2014001626A patent/MX350096B/es active IP Right Grant
- 2012-05-31 EA EA201400216A patent/EA031229B1/ru unknown
- 2012-05-31 LT LTEP12726998.3T patent/LT2741740T/lt unknown
- 2012-05-31 CN CN201280046735.7A patent/CN103841963B/zh active Active
- 2012-05-31 EP EP12726998.3A patent/EP2741740B1/en active Active
- 2012-05-31 JP JP2014525994A patent/JP6041361B2/ja active Active
- 2012-05-31 ES ES12726998.3T patent/ES2626297T3/es active Active
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- 2012-05-31 WO PCT/US2012/040230 patent/WO2013025274A1/en active Application Filing
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- 2012-05-31 US US13/485,437 patent/US10166188B2/en active Active
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WO2013025274A1 (en) | 2013-02-21 |
DK2741740T3 (en) | 2017-06-06 |
JP2014521742A (ja) | 2014-08-28 |
JP6041361B2 (ja) | 2016-12-07 |
EP2741740B1 (en) | 2017-05-03 |
US10166188B2 (en) | 2019-01-01 |
EP2741740A1 (en) | 2014-06-18 |
ES2626297T3 (es) | 2017-07-24 |
US20190070117A1 (en) | 2019-03-07 |
MX2014001626A (es) | 2015-03-09 |
US20130040370A1 (en) | 2013-02-14 |
CN103841963B (zh) | 2018-04-24 |
SI2741740T1 (sl) | 2017-08-31 |
EA201400216A1 (ru) | 2014-06-30 |
US10653627B2 (en) | 2020-05-19 |
CN103841963A (zh) | 2014-06-04 |
CA2844927C (en) | 2017-10-31 |
LT2741740T (lt) | 2017-08-10 |
MX350096B (es) | 2017-08-25 |
CA2844927A1 (en) | 2013-02-21 |
EA031229B1 (ru) | 2018-12-28 |
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