DK2744895T3 - Fjernelse af smittende vira fra aav-præparater - Google Patents
Fjernelse af smittende vira fra aav-præparater Download PDFInfo
- Publication number
- DK2744895T3 DK2744895T3 DK12758663.4T DK12758663T DK2744895T3 DK 2744895 T3 DK2744895 T3 DK 2744895T3 DK 12758663 T DK12758663 T DK 12758663T DK 2744895 T3 DK2744895 T3 DK 2744895T3
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- DK
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- Prior art keywords
- filter
- virus
- sample
- virions
- baculovirus
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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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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/14—Ultrafiltration; Microfiltration
- B01D61/145—Ultrafiltration
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/14—Ultrafiltration; Microfiltration
- B01D61/16—Feed pretreatment
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
- B01D71/06—Organic material
- B01D71/08—Polysaccharides
- B01D71/10—Cellulose; Modified cellulose
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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
- C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
- C12N15/09—Recombinant DNA-technology
- C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
- C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
- C12N15/85—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
- C12N15/86—Viral vectors
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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
- C12N7/02—Recovery or purification
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2311/00—Details relating to membrane separation process operations and control
- B01D2311/04—Specific process operations in the feed stream; Feed pretreatment
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2311/00—Details relating to membrane separation process operations and control
- B01D2311/26—Further operations combined with membrane separation processes
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2311/00—Details relating to membrane separation process operations and control
- B01D2311/26—Further operations combined with membrane separation processes
- B01D2311/2623—Ion-Exchange
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2311/00—Details relating to membrane separation process operations and control
- B01D2311/26—Further operations combined with membrane separation processes
- B01D2311/2649—Filtration
-
- 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
- C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
- C12N2710/00011—Details
- C12N2710/14011—Baculoviridae
- C12N2710/14041—Use of virus, viral particle or viral elements as a vector
- C12N2710/14043—Use of virus, viral particle or viral elements as a vector viral genome or elements thereof as genetic vectore
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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
- C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
- C12N2710/00011—Details
- C12N2710/14011—Baculoviridae
- C12N2710/14051—Methods of production or purification of viral material
-
- 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
- C12N2750/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
- C12N2750/00011—Details
- C12N2750/14011—Parvoviridae
- C12N2750/14051—Methods of production or purification of viral material
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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
- C12N2750/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
- C12N2750/00011—Details
- C12N2750/14011—Parvoviridae
- C12N2750/14311—Parvovirus, e.g. minute virus of mice
- C12N2750/14332—Use of virus as therapeutic agent, other than vaccine, e.g. as cytolytic agent
-
- 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
- C12N2750/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
- C12N2750/00011—Details
- C12N2750/14011—Parvoviridae
- C12N2750/14311—Parvovirus, e.g. minute virus of mice
- C12N2750/14351—Methods of production or purification of viral material
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- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Genetics & Genomics (AREA)
- Zoology (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Wood Science & Technology (AREA)
- Water Supply & Treatment (AREA)
- Biomedical Technology (AREA)
- Biotechnology (AREA)
- General Engineering & Computer Science (AREA)
- Virology (AREA)
- Microbiology (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Immunology (AREA)
- Medicinal Chemistry (AREA)
- Physics & Mathematics (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Plant Pathology (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Solid-Sorbent Or Filter-Aiding Compositions (AREA)
Claims (13)
1. Fremgangsmåde til udskillelse af en population af parvovirus-virioner fra en population af baculovirus-virioner, hvor fremgangsmåden omfatter trinnet at filtrere en prøve omfattende populationerne af parvovirus- og baculovirus-virioner over et filter, hvor filteret har en nominel porestørrelse på 30 - 40 nm.
2. Fremgangsmåde ifølge krav 1, hvor parvovirussen er en adeno-associeret virus.
3. Fremgangsmåde ifølge krav 1 eller krav 2, hvor baculovirus er Autographa californica multicapsid nucleopolyhedrovirus (AcmNPV).
4. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor filteret er et virusfilter eller et ultrafilter.
5. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor filteret er et overflade- og/eller dybdefilter.
6. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor filteret omfatter et materiale udvalgt fra gruppen bestående af: kobberammo-nium-regenereret cellulose, polyvinylidenfluorid, polysulfon, polytetra-fluorethylen, polypropylen, modificeret eller umodificeret polyethersulfon, celluloseacetat, cellulosenitrat, polyamid eller regenereret cellulose.
7. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor filteret har en nominel porestørrelse på 32 - 38 nm.
8. Fremgangsmåde ifølge krav 6 eller krav 7, hvor filteret omfatter kobber-ammonium-regenereret cellulose, fortrinsvis hule kobberammonium-regenerede cellulosefibre, mere fortrinsvis hvor filteret er en Planova 35-membran eller et Ultipor DV50-filter.
9. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvorved prøven udsættes for filtrering under anvendelse af to eller flere filtre.
10. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvorved prøven inden trinnet med filtrering forrenses under anvendelse af en fremgangsmåde udvalgt fra gruppen bestående af en densitetsgradient, en forfiltrering, et kromatografitrin, fortrinsvis affinitetskromatografi og/eller ionbytningskromatografi, og kombinationer af disse fremgangsmåder.
11. Fremgangsmåde ifølge krav 10, hvorved forfiltrering udføres ved hjælp af et filter med en porestørrelse på 70 - 200 nm.
12. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor pFI-værdien af prøven er 6 til 10, fortrinsvis 7 til 9, mere fortrinsvis 7,5 til 8,5, mest fortrinsvis 8.
13. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvorved 1 til 200 ml af prøven filtreres pr. 1 cm2 virusfilteroverflade, fortrinsvis 80 til 120 ml pr. 1 cm2.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161532176P | 2011-09-08 | 2011-09-08 | |
| EP11180594 | 2011-09-08 | ||
| PCT/NL2012/050619 WO2013036118A1 (en) | 2011-09-08 | 2012-09-07 | Removal of contaminating viruses from aav preparations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2744895T3 true DK2744895T3 (da) | 2016-01-04 |
Family
ID=47832422
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK12758663.4T DK2744895T3 (da) | 2011-09-08 | 2012-09-07 | Fjernelse af smittende vira fra aav-præparater |
Country Status (20)
| Country | Link |
|---|---|
| US (3) | US9840694B2 (da) |
| EP (3) | EP3425044A1 (da) |
| JP (2) | JP6198278B2 (da) |
| KR (1) | KR101961347B1 (da) |
| CN (2) | CN107502597A (da) |
| AU (1) | AU2012304993B2 (da) |
| BR (1) | BR112014005255A2 (da) |
| CA (1) | CA2847604A1 (da) |
| DK (1) | DK2744895T3 (da) |
| EA (1) | EA027511B1 (da) |
| ES (1) | ES2558168T3 (da) |
| HK (1) | HK1220229A1 (da) |
| HU (1) | HUE026579T2 (da) |
| IL (1) | IL231398A (da) |
| MX (1) | MX349601B (da) |
| PL (1) | PL2744895T3 (da) |
| PT (1) | PT2744895E (da) |
| SI (1) | SI2744895T1 (da) |
| WO (1) | WO2013036118A1 (da) |
| ZA (1) | ZA201401714B (da) |
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| JP6198278B2 (ja) * | 2011-09-08 | 2017-09-20 | ユニキュアー アイピー ビー．ブイ． | Ａａｖ調製物からの混入ウイルスの除去 |
| WO2015060722A1 (en) | 2013-10-24 | 2015-04-30 | Uniqure Ip B.V. | Aav-5 pseudotyped vector for gene therapy for neurological diseases |
| WO2015191508A1 (en) | 2014-06-09 | 2015-12-17 | Voyager Therapeutics, Inc. | Chimeric capsids |
| MX2017005834A (es) | 2014-11-05 | 2017-11-17 | Voyager Therapeutics Inc | Polinucleotidos aad para el tratamiento de la enfermedad de parkinson. |
| AU2015346162B2 (en) | 2014-11-14 | 2022-02-10 | Voyager Therapeutics, Inc. | Compositions and methods of treating amyotrophic lateral sclerosis (ALS) |
| CN112375760A (zh) | 2014-11-14 | 2021-02-19 | 沃雅戈治疗公司 | 调节性多核苷酸 |
| WO2016094783A1 (en) | 2014-12-12 | 2016-06-16 | Voyager Therapeutics, Inc. | Compositions and methods for the production of scaav |
| LT3237618T (lt) | 2014-12-24 | 2019-07-10 | Uniqure Ip B.V. | Rnri sukeltas hantingtino geno slopinimas |
| EP3054007A1 (en) | 2015-02-09 | 2016-08-10 | Institut National De La Sante Et De La Recherche Medicale (Inserm) | Recombinant adeno-associated virus particle purification comprising an immuno-affinity purification step |
| EP3448987A4 (en) | 2016-04-29 | 2020-05-27 | Voyager Therapeutics, Inc. | COMPOSITIONS FOR THE TREATMENT OF DISEASES |
| WO2017189959A1 (en) | 2016-04-29 | 2017-11-02 | Voyager Therapeutics, Inc. | Compositions for the treatment of disease |
| SG11201809699XA (en) | 2016-05-18 | 2018-12-28 | Voyager Therapeutics Inc | Modulatory polynucleotides |
| RU2764587C2 (ru) | 2016-05-18 | 2022-01-18 | Вояджер Терапьютикс, Инк. | Способы и композиции для лечения хореи гентингтона |
| US11298041B2 (en) | 2016-08-30 | 2022-04-12 | The Regents Of The University Of California | Methods for biomedical targeting and delivery and devices and systems for practicing the same |
| SG11201909868YA (en) | 2017-05-05 | 2019-11-28 | Voyager Therapeutics Inc | Compositions and methods of treating huntington's disease |
| JP2020518258A (ja) | 2017-05-05 | 2020-06-25 | ボイジャー セラピューティクス インコーポレイテッドＶｏｙａｇｅｒ Ｔｈｅｒａｐｅｕｔｉｃｓ，Ｉｎｃ． | 筋萎縮性側索硬化症（ａｌｓ）治療組成物および方法 |
| JOP20190269A1 (ar) | 2017-06-15 | 2019-11-20 | Voyager Therapeutics Inc | بولي نوكليوتيدات aadc لعلاج مرض باركنسون |
| CN111132626B (zh) | 2017-07-17 | 2024-01-30 | 沃雅戈治疗公司 | 轨迹阵列引导系统 |
| JP2021502060A (ja) | 2017-10-16 | 2021-01-28 | ボイジャー セラピューティクス インコーポレイテッドＶｏｙａｇｅｒ Ｔｈｅｒａｐｅｕｔｉｃｓ，Ｉｎｃ． | 筋萎縮性側索硬化症（ａｌｓ）の治療 |
| WO2019079242A1 (en) | 2017-10-16 | 2019-04-25 | Voyager Therapeutics, Inc. | TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) |
| ES2957622T3 (es) | 2018-01-17 | 2024-01-23 | Meiragtx Uk Ii Ltd | Proteína de cápside de rAAV modificada para terapia génica |
| WO2020053258A1 (en) | 2018-09-12 | 2020-03-19 | Uniqure Ip B.V. | Rnai induced c9orf72 suppression for the treatment of als/ftd |
| AU2019382824A1 (en) | 2018-11-19 | 2021-06-03 | Uniqure Ip B.V. | Method and means to deliver miRNA to target cells |
| WO2020104435A1 (en) | 2018-11-19 | 2020-05-28 | Uniqure Ip B.V. | A companion diagnostic to monitor the effects of gene therapy |
| WO2020104480A1 (en) | 2018-11-19 | 2020-05-28 | Uniqure Biopharma B.V. | Adeno-associated virus vectors for expressing fviii mimetics and uses thereof |
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| HUE028341T2 (en) * | 2009-06-16 | 2016-12-28 | Genzyme Corp | Improved methods for purifying recombinant AAV vectors |
| CN105838737A (zh) * | 2010-01-28 | 2016-08-10 | 费城儿童医院 | 用于病毒载体纯化的可扩缩生产平台和用于基因治疗中的如此纯化的病毒载体 |
| JP6198278B2 (ja) * | 2011-09-08 | 2017-09-20 | ユニキュアー アイピー ビー．ブイ． | Ａａｖ調製物からの混入ウイルスの除去 |
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