DK2307551T3 - Oprensning af retrovirale vektorer - Google Patents
Oprensning af retrovirale vektorer Download PDFInfo
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- DK2307551T3 DK2307551T3 DK09766124.3T DK09766124T DK2307551T3 DK 2307551 T3 DK2307551 T3 DK 2307551T3 DK 09766124 T DK09766124 T DK 09766124T DK 2307551 T3 DK2307551 T3 DK 2307551T3
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- retroviral vector
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (12)
1. Fremgangsmåde til fremstilling af en retrovirusvektorformulering, som er egnet til administration til en patient, hvilken fremgangsmåde omfatter et filtersterilisationstrin og et koncentrationstrin, hvor koncentrationstrinet er fremgangsmådens sidste trin, og filter-sterilisationstrinet er fremgangsmådens næstsidste trin, og hvor koncentrationstrinet udføres under aseptiske betingelser, og, endvidere, hvor filter-sterilisationstrinet udføres ved anvendelse af et sterilisationsfilter med en maksimal porestørrelse på op til, eller som er lig med, 0,22 pm.
2. Fremgangsmåde ifølge krav 1, som omfatter følgende trin (i) til (vi) i kronologisk rækkefølge: (i) dyrkning af celler, som fremstiller retrovirusvektor; (ii) høst af supernatanten, som indeholder retrovirusvektor; (iii) eventuelt klaring af supernatanten; (iv) oprensning af retrovirusvektoren for at opnå et retrovirusvektorpræparat; (v) filter-sterilisation af retrovirusvektorpræparatet og (vi) koncentration af retrovirusvektorpræparatet for at frembringe det endelige bulkprodukt.
3. Fremgangsmåde ifølge krav 2, hvor trin (iv) udføres ved anvendelse af en fremgangsmåde eller en kombination af fremgangsmåder valgt blandt kromatografi, ultrafiltrering/diafiltrering og centrifugering.
4. Fremgangsmåde ifølge krav 2 eller 3, hvor der er indbefattet mindst ét trin til nedbrydning af nukleinsyre for at forbedre oprensningen.
5. Fremgangsmåde ifølge krav 4, hvor trinet er nukleasebehandling.
6. Fremgangsmåde ifølge et hvilket som helst af kravene 4 og 5, hvor der udføres et nukleinsyrenedbrydningstrin på et hvilket som helst tidspunkt til og med trin (iv).
7. Fremgangsmåde ifølge et hvilket som helst af kravene 4 og 5, hvor oprensningstrinet (iv) indbefatter et eller flere bufferudskiftningstrin.
8. Fremgangsmåde ifølge et hvilket som helst af kravene 2-7, hvor trin (iii) udføres ved klaring ved filtrering.
9. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor koncentrationstrinet udføres ved anvendelse af ultrafiltrering.
10. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor et retrovirusvektorpræparat fortyndes inden filter-sterilisation.
11. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor retrovirusvektoren stammer fra et lentivirus.
12. Fremgangsmåde ifølge krav 11, hvor retrovirusvektoren stammer fra equin infektiøs anæmi-virus (Equine Infectious Anaemia Virus [EIAV]), og koncentrationen af retrovirusvektoren inden filter-sterilisation er mindre end eller lig med 4,6x1ο11 RNA-genomkopier pr. ml retrovirusvektorpræparat.
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| US7368508P | 2008-06-18 | 2008-06-18 | |
| PCT/GB2009/001527 WO2009153563A1 (en) | 2008-06-18 | 2009-06-18 | Virus purification |
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| DK2307551T3 true DK2307551T3 (da) | 2017-03-20 |
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| DK16002644.9T DK3192874T3 (da) | 2008-06-18 | 2009-06-18 | Virusoprensning |
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| EP (2) | EP2307551B1 (da) |
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| ES (2) | ES2762864T3 (da) |
| PL (2) | PL3192874T3 (da) |
| WO (1) | WO2009153563A1 (da) |
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| Publication number | Publication date |
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| EP2307551A1 (en) | 2011-04-13 |
| JP2014237661A (ja) | 2014-12-18 |
| CN102124115A (zh) | 2011-07-13 |
| PL2307551T3 (pl) | 2017-07-31 |
| CN103993040A (zh) | 2014-08-20 |
| EP2307551B1 (en) | 2016-12-14 |
| DK3192874T3 (da) | 2019-12-16 |
| JP2011524887A (ja) | 2011-09-08 |
| WO2009153563A1 (en) | 2009-12-23 |
| PL3192874T3 (pl) | 2020-06-29 |
| US9169491B2 (en) | 2015-10-27 |
| JP6002720B2 (ja) | 2016-10-05 |
| JP5615271B2 (ja) | 2014-10-29 |
| EP3192874A1 (en) | 2017-07-19 |
| US20090325284A1 (en) | 2009-12-31 |
| ES2762864T3 (es) | 2020-05-26 |
| ES2618851T3 (es) | 2017-06-22 |
| CN103993040B (zh) | 2018-02-13 |
| EP3192874B1 (en) | 2019-10-16 |
| CN102124115B (zh) | 2020-03-03 |
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