HRP20161435T1 - Filtracija virusa iz medija stanične kulture - Google Patents
Filtracija virusa iz medija stanične kulture Download PDFInfo
- Publication number
- HRP20161435T1 HRP20161435T1 HRP20161435TT HRP20161435T HRP20161435T1 HR P20161435 T1 HRP20161435 T1 HR P20161435T1 HR P20161435T T HRP20161435T T HR P20161435TT HR P20161435 T HRP20161435 T HR P20161435T HR P20161435 T1 HRP20161435 T1 HR P20161435T1
- Authority
- HR
- Croatia
- Prior art keywords
- filtration
- cell culture
- mbar
- use according
- culture medium
- Prior art date
Links
- 239000006143 cell culture medium Substances 0.000 title claims 7
- 238000011100 viral filtration Methods 0.000 title 1
- 238000000034 method Methods 0.000 claims 12
- 238000001914 filtration Methods 0.000 claims 10
- 230000003612 virological effect Effects 0.000 claims 8
- 238000011109 contamination Methods 0.000 claims 5
- 238000002360 preparation method Methods 0.000 claims 5
- 239000011148 porous material Substances 0.000 claims 2
- 235000010469 Glycine max Nutrition 0.000 claims 1
- 244000068988 Glycine max Species 0.000 claims 1
- 241000700605 Viruses Species 0.000 claims 1
- 238000004113 cell culture Methods 0.000 claims 1
- 239000000706 filtrate Substances 0.000 claims 1
Classifications
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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
- C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
- C12N5/06—Animal cells or tissues; Human cells or tissues
- C12N5/0602—Vertebrate cells
-
- 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
- A61L2/0017—Filtration
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M29/00—Means for introduction, extraction or recirculation of materials, e.g. pumps
- C12M29/26—Conditioning fluids entering or exiting the reaction vessel
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M37/00—Means for sterilizing, maintaining sterile conditions or avoiding chemical or biological contamination
- C12M37/02—Filters
-
- 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
- C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
- C12N5/0018—Culture media for cell or tissue culture
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Biomedical Technology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Biotechnology (AREA)
- Genetics & Genomics (AREA)
- General Health & Medical Sciences (AREA)
- Microbiology (AREA)
- Biochemistry (AREA)
- General Engineering & Computer Science (AREA)
- Sustainable Development (AREA)
- Molecular Biology (AREA)
- Cell Biology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Cosmetics (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
- Filtering Materials (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
Claims (13)
1. Postupak uklanjanja virusnog onečišćenja iz pripravka koji je medij stanične kulture ili barem komponenta medija stanične kulture, a koji obuhvaća korak:
a) podvrgavanje tog pripravka filtraciji kroz najmanje 24 sata kroz virusni filter s učinkovitom veličinom pora od najviše 75 nm i volumetrijskim kapacitetom od najmanje oko 2000 L/m2.
2. Uporaba virusnog filtra s učinkovitom veličinom pora od najviše 75 nm i volumetrijskim kapacitetom od najmanje oko 2000 L/m2 u filtraciji kroz najmanje 24 sata radi uklanjanja virusnog onečišćenja iz pripravka koji je medij stanične kulture ili barem komponenta medija stanične kulture.
3. Postupak ili uporaba prema zahtjevu 1 ili 2, gdje se filtracija provodi uz volumetrijski kapacitet od najmanje oko 3000 L/m2, poželjno od najmanje oko 5000 L/m2.
4. Postupak ili uporaba prema bilo kojem od zahtjeva 1 do 3, gdje se pripravak podvrgava filtraciji ili se filtracija provodi kroz najmanje 48 sati do oko 7 mjeseci i poželjno oko 72 sata do oko 3 mjeseca.
5. Postupak prema bilo kojem od zahtjeva 1, 3 ili 4, koji dalje obuhvaća korak:
b) punjenje filtrata u staničnu kulturu ili u druge komponente koje su također komponente medija stanične kulture.
6. Postupak ili uporaba prema bilo kojem od zahtjeva 1 do 5, gdje je filtracija kontinuirana.
7. Postupak ili uporaba prema bilo kojem od zahtjeva 1 do 6, gdje se filtracija provodi na temperaturi od oko 2°C do oko 60°C, poželjno oko 10°C do oko 40°C, najpoželjnije oko 15°C do oko 37°C.
8. Postupak ili uporaba prema bilo kojem od zahtjeva 1 do 7, gdje taj virusni filter daje vrijednost smanjenja od najmanje 1 Log10 (engl. Log10 reduction value, LRV) za virusno onečišćenje, poželjno vrijednost smanjenja od najmanje 4 Log10 (LRV) za virusno onečišćenje i najpoželjnije vrijednost smanjenja od najmanje 6 Log10 (LRV) za virusno onečišćenje.
9. Postupak ili uporaba prema bilo kojem od zahtjeva 1 do 8 gdje se filtracija provodi uz uporabu dva ili više filtra raspoređena u seriju, u paralelu ili u kombinaciju obojeg.
10. Postupak ili uporaba prema zahtjevu 9, gdje se filtracija provodi uz uporabu dva filtra raspoređena u paralelu u sustavu cijevi koji ima spoj Y-oblika i gdje je svaki filter u protočnoj vezi s granom spoja Y-oblika i izvorom dopreme pripravka.
11. Postupak prema bilo kojem od zahtjeva 1 do 10, gdje se filtracija provodi pri tlaku u rasponu od oko 100 mbar do oko 4000 mbar, poželjno od oko 100 mbar do oko 3500 mbar, najpoželjnije od oko 1000 mbar do oko 3000 mbar.
12. Postupak prema bilo kojem od zahtjeva 1 do 11, gdje se virusni filter može sterilizirati u autoklavu.
13. Postupak prema bilo kojem od zahtjeva 1 do 12, gdje medij stanične kulture sadrži hidrolizat soje.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261662814P | 2012-06-21 | 2012-06-21 | |
| PCT/US2013/045663 WO2013192009A1 (en) | 2012-06-21 | 2013-06-13 | Virus filtration of cell culture media |
| EP13731015.7A EP2732020B1 (en) | 2012-06-21 | 2013-06-13 | Virus filtration of cell culture media |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20161435T1 true HRP20161435T1 (hr) | 2017-02-24 |
Family
ID=48672845
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20161435TT HRP20161435T1 (hr) | 2012-06-21 | 2016-11-02 | Filtracija virusa iz medija stanične kulture |
Country Status (28)
| Country | Link |
|---|---|
| US (3) | US9670456B2 (hr) |
| EP (2) | EP3103861B1 (hr) |
| JP (3) | JP6220392B2 (hr) |
| KR (2) | KR102008048B1 (hr) |
| CN (2) | CN104640969A (hr) |
| AR (1) | AR092847A1 (hr) |
| AU (2) | AU2013277532B2 (hr) |
| BR (1) | BR112014031842B1 (hr) |
| CA (1) | CA2876473C (hr) |
| CO (1) | CO7151484A2 (hr) |
| DK (2) | DK2732020T3 (hr) |
| EA (2) | EA201990887A1 (hr) |
| ES (2) | ES2829968T3 (hr) |
| HK (2) | HK1198335A1 (hr) |
| HR (1) | HRP20161435T1 (hr) |
| HU (1) | HUE031601T2 (hr) |
| IL (2) | IL236073B (hr) |
| IN (1) | IN2014DN10441A (hr) |
| MX (1) | MX347319B (hr) |
| MY (2) | MY195362A (hr) |
| NZ (1) | NZ629083A (hr) |
| PL (2) | PL3103861T3 (hr) |
| PT (2) | PT2732020T (hr) |
| SG (2) | SG11201408490PA (hr) |
| SI (1) | SI2732020T1 (hr) |
| TW (2) | TWI609962B (hr) |
| WO (1) | WO2013192009A1 (hr) |
| ZA (1) | ZA201409253B (hr) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MY195362A (en) * | 2012-06-21 | 2023-01-16 | Baxalta Inc | Virus Filtration of Cell Culture Media |
| AR095196A1 (es) | 2013-03-15 | 2015-09-30 | Regeneron Pharma | Medio de cultivo celular libre de suero |
| SG10201507931QA (en) * | 2014-12-22 | 2016-07-28 | Emd Millipore Corp | Removal of microorganisms from cell culture media |
| WO2016154290A1 (en) | 2015-03-23 | 2016-09-29 | Alexion Pharmaceuticals, Inc. | Virus filtration |
| EP3015542A1 (de) * | 2015-05-07 | 2016-05-04 | Bayer Technology Services GmbH | Modulare anlage und verfahren zur kontinuierlichen, keimreduzierten produktion und/oder aufbereitung eines produktes |
| TWI797060B (zh) | 2015-08-04 | 2023-04-01 | 美商再生元醫藥公司 | 補充牛磺酸之細胞培養基及用法 |
| KR102414290B1 (ko) * | 2016-04-15 | 2022-06-29 | 베링거 인겔하임 인터내셔날 게엠베하 | 세포 보유 장치 및 방법 |
| WO2018107099A1 (en) * | 2016-12-09 | 2018-06-14 | Lonza Ltd | Method for the reduction of viral titer in pharmaceuticals |
| JP7265494B2 (ja) * | 2017-07-06 | 2023-04-26 | リジェネロン・ファーマシューティカルズ・インコーポレイテッド | 糖タンパク質を作製するための細胞培養方法 |
| KR20210005237A (ko) * | 2018-05-04 | 2021-01-13 | 젠자임 코포레이션 | 여과 시스템을 구비한 관류식 생물반응기 |
| KR20210134973A (ko) * | 2019-03-11 | 2021-11-11 | 젠자임 코포레이션 | 접선 흐름 바이러스 여과장치 |
| US20230181796A1 (en) * | 2020-05-14 | 2023-06-15 | North Carolina State University | Fast automated approach for the derivation of acellular extracellular matrix scaffolds from tissues |
| IL301774A (en) * | 2020-10-02 | 2023-05-01 | Regeneron Pharma | Continuous retentive filtering of viruses |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH0422874A (ja) * | 1990-05-16 | 1992-01-27 | Matsushita Electric Ind Co Ltd | 波形表示装置 |
| GB2352652A (en) | 1999-08-06 | 2001-02-07 | Fsm Technologies Ltd | Pre-treating hollow fibre membranes for micro-organism detection |
| US6485686B1 (en) * | 1999-09-17 | 2002-11-26 | The United States Of America As Represented By The Secretary Of The Army | Method and apparatus for counting submicron sized particles |
| US6861001B2 (en) | 1999-12-02 | 2005-03-01 | The General Hospital Corporation | Methods for removal, purification, and concentration of viruses, and methods of therapy based thereupon |
| US6485688B1 (en) | 2000-04-24 | 2002-11-26 | General Electric Company | On-line sparging sampling and monitoring systems and methods |
| US6630016B2 (en) * | 2002-01-31 | 2003-10-07 | Koslow Technologies Corp. | Microporous filter media, filtration systems containing same, and methods of making and using |
| US6835311B2 (en) | 2002-01-31 | 2004-12-28 | Koslow Technologies Corporation | Microporous filter media, filtration systems containing same, and methods of making and using |
| ES2214967B1 (es) * | 2003-03-06 | 2005-06-16 | Probitas Pharma, S.A | Procedimiento para la eliminacion de virus en soluciones de fibrinogeno y fibrinogeno obtenido por dicho procedimiento. |
| JP4874806B2 (ja) * | 2003-12-01 | 2012-02-15 | ノボ ノルディスク ヘルス ケア アクチェンゲゼルシャフト | 液体因子ｖｉｉ組成物のウイルス濾過 |
| DE102005047301B4 (de) * | 2005-09-30 | 2009-04-16 | Sartorius Stedim Biotech Gmbh | Verfahren zum Nachweis der Virenabreicherung für die Validierung von Filtern und Filtrationsprozessen |
| US20070084788A1 (en) * | 2005-10-14 | 2007-04-19 | Millipore Corporation | Ultrafiltration membranes and methods of making and use of ultrafiltration membranes |
| US8309029B1 (en) * | 2009-03-26 | 2012-11-13 | The United States Of America As Represented By The Secretary Of The Army | Virus and particulate separation from solution |
| US8945895B2 (en) * | 2009-07-31 | 2015-02-03 | Baxter International Inc. | Methods of purifying recombinant ADAMTS13 and other proteins and compositions thereof |
| CN106008697B (zh) * | 2009-08-20 | 2020-08-04 | 百深公司 | 纯化vwf以增加非-脂质包封的病毒的去除 |
| MY195362A (en) * | 2012-06-21 | 2023-01-16 | Baxalta Inc | Virus Filtration of Cell Culture Media |
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2013
- 2013-06-13 MY MYPI2018000283A patent/MY195362A/en unknown
- 2013-06-13 SG SG11201408490PA patent/SG11201408490PA/en unknown
- 2013-06-13 AU AU2013277532A patent/AU2013277532B2/en active Active
- 2013-06-13 IN IN10441DEN2014 patent/IN2014DN10441A/en unknown
- 2013-06-13 SI SI201330369A patent/SI2732020T1/sl unknown
- 2013-06-13 DK DK13731015.7T patent/DK2732020T3/en active
- 2013-06-13 PT PT137310157T patent/PT2732020T/pt unknown
- 2013-06-13 CN CN201380032998.7A patent/CN104640969A/zh active Pending
- 2013-06-13 MY MYPI2014003498A patent/MY173835A/en unknown
- 2013-06-13 BR BR112014031842-5A patent/BR112014031842B1/pt active IP Right Grant
- 2013-06-13 CN CN201810569534.4A patent/CN108795724A/zh active Pending
- 2013-06-13 EP EP16181886.9A patent/EP3103861B1/en active Active
- 2013-06-13 MX MX2014015950A patent/MX347319B/es active IP Right Grant
- 2013-06-13 CA CA2876473A patent/CA2876473C/en active Active
- 2013-06-13 HU HUE13731015A patent/HUE031601T2/hu unknown
- 2013-06-13 PT PT161818869T patent/PT3103861T/pt unknown
- 2013-06-13 EA EA201990887A patent/EA201990887A1/ru unknown
- 2013-06-13 NZ NZ629083A patent/NZ629083A/en unknown
- 2013-06-13 KR KR1020157001269A patent/KR102008048B1/ko active IP Right Grant
- 2013-06-13 KR KR1020197022413A patent/KR20190092618A/ko not_active Application Discontinuation
- 2013-06-13 ES ES16181886T patent/ES2829968T3/es active Active
- 2013-06-13 ES ES13731015.7T patent/ES2601429T3/es active Active
- 2013-06-13 EA EA201590059A patent/EA033006B1/ru not_active IP Right Cessation
- 2013-06-13 EP EP13731015.7A patent/EP2732020B1/en active Active
- 2013-06-13 DK DK16181886.9T patent/DK3103861T3/da active
- 2013-06-13 PL PL16181886.9T patent/PL3103861T3/pl unknown
- 2013-06-13 JP JP2015518459A patent/JP6220392B2/ja active Active
- 2013-06-13 SG SG10201701721TA patent/SG10201701721TA/en unknown
- 2013-06-13 WO PCT/US2013/045663 patent/WO2013192009A1/en active Application Filing
- 2013-06-13 PL PL13731015T patent/PL2732020T3/pl unknown
- 2013-06-19 TW TW102121710A patent/TWI609962B/zh active
- 2013-06-19 AR ARP130102198A patent/AR092847A1/es active IP Right Grant
- 2013-06-19 TW TW106136343A patent/TWI698522B/zh active
- 2013-06-19 US US13/921,417 patent/US9670456B2/en active Active
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2014
- 2014-11-19 HK HK14111690.4A patent/HK1198335A1/zh unknown
- 2014-12-04 IL IL236073A patent/IL236073B/en active IP Right Grant
- 2014-12-15 ZA ZA2014/09253A patent/ZA201409253B/en unknown
- 2014-12-17 CO CO14277524A patent/CO7151484A2/es unknown
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2016
- 2016-11-02 HR HRP20161435TT patent/HRP20161435T1/hr unknown
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2017
- 2017-03-27 US US15/470,064 patent/US20170260498A1/en not_active Abandoned
- 2017-05-23 HK HK17105198.0A patent/HK1231502A1/zh unknown
- 2017-07-13 JP JP2017137031A patent/JP6557706B2/ja not_active Expired - Fee Related
- 2017-09-12 AU AU2017228547A patent/AU2017228547B2/en active Active
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2018
- 2018-11-14 JP JP2018213613A patent/JP2019022526A/ja not_active Withdrawn
- 2018-12-04 IL IL263479A patent/IL263479B/en active IP Right Grant
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2020
- 2020-03-12 US US16/816,641 patent/US11421202B2/en active Active
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