DK2536829T3 - Fremgangsmåde til produktion af Ad26-adenovirusvektorer - Google Patents

Fremgangsmåde til produktion af Ad26-adenovirusvektorer Download PDF

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DK2536829T3
DK2536829T3 DK11703221.9T DK11703221T DK2536829T3 DK 2536829 T3 DK2536829 T3 DK 2536829T3 DK 11703221 T DK11703221 T DK 11703221T DK 2536829 T3 DK2536829 T3 DK 2536829T3
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cells
cell
rad26
bioreactor
adenovirus
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DK11703221.9T
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Alfred Luitjens
Herk Herman Van
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Crucell Holland Bv
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    • 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
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    • C12N2710/10011—Adenoviridae
    • C12N2710/10311—Mastadenovirus, e.g. human or simian adenoviruses
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    • C12N2710/10011—Adenoviridae
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    • C12N2710/10341—Use of virus, viral particle or viral elements as a vector
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    • C12N2710/00011—Details
    • C12N2710/10011—Adenoviridae
    • C12N2710/10311—Mastadenovirus, e.g. human or simian adenoviruses
    • C12N2710/10351—Methods of production or purification of viral material

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Claims (12)

1. Fremgangsmåde til produktion af rekombinant adenovirus serotype 26 (rAd26), hvilken fremgangsmåde omfatter: a) dyrkning af PER.C6-celler i suspension med et perfusionssystem; b) inficering af cellerne ved en densitet på mellem 10 x 106 levedygtige celler/ml og 16 x 106 levedygtige celler/ml med rAd2 6; c) yderligere dyrkning af de inficerede celler med et perfusionssystem til opformering af rAd26; og d) høst af rAd26.
2. Fremgangsmåde ifølge krav 1, hvor cellerne i trin b) inficeres med rAd26 ved en densitet på mellem ca. 10 x 106 og 14 x 106 levedygtige celler/ml.
3. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, hvor perfusionssystemet i trin c) er et perfusionssystem med alternerende tangentialt flow (ATF).
4. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, der yderligere omfatter: e) oprensning af rAd26 og eventuelt f) fremstilling af en farmaceutisk sammensætning, der indeholder det oprensede rAd26.
5. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, hvor det rekombinante adenovirus mangler mindst en del af El-området og omfatter heterolog nukleinsyre.
6. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, hvor perfusionssystemet i trin a) er et perfusionssystem med alternerende tangentialt flow (ATF).
7. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, hvor trin a) udføres i en første bioreaktor, og trin b) og c) udføres i en anden bioreaktor.
8. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, hvor forholdet mellem fysiske partikler og infektiøse partikler (VP/IU) for det producerede rAd26 er mindre end 30:1, fortrinsvis mindre end 20:1.
9. Anvendelse af en bioreaktor i en fremgangsmåde ifølge et hvilket som helst af kravene 1-8, hvor bioreaktoren har et arbejdsvolumen på mellem 2 og 1000 liter, fortrinsvis mellem 50 og 500 liter og omfatter dyrkningsmedium, PER.C6-celler og mindst 1 x 1012 rAd26-viruspartikler (VP)/ml.
10. Anvendelse ifølge krav 9, hvor bioreaktoren er forbundet til et ATF-perfusionssystem.
11. Anvendelse ifølge krav 9 eller 10, hvor rAd26-viruspartiklerne har et VP/IU-forhold, der er mindre end 30:1, fortrinsvis mindre end 20:1.
12. Fremgangsmåde ifølge krav 1, hvor der produceres mindst 1 x 1012 rAd26-viruspartikler (VP)/ml.
DK11703221.9T 2010-02-15 2011-02-14 Fremgangsmåde til produktion af Ad26-adenovirusvektorer DK2536829T3 (da)

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US30455310P 2010-02-15 2010-02-15
EP10153581 2010-02-15
PCT/EP2011/052109 WO2011098592A1 (en) 2010-02-15 2011-02-14 Method for the production of ad26 adenoviral vectors

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EP (1) EP2536829B1 (da)
JP (1) JP5250155B2 (da)
KR (1) KR101820980B1 (da)
CN (1) CN102762721B (da)
AU (1) AU2011214262B2 (da)
BR (1) BR112012019023B1 (da)
CA (1) CA2786835C (da)
DK (1) DK2536829T3 (da)
EA (1) EA023816B1 (da)
ES (1) ES2578514T3 (da)
MX (1) MX2012007936A (da)
NZ (1) NZ601424A (da)
PL (1) PL2536829T3 (da)
WO (1) WO2011098592A1 (da)

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KR101820980B1 (ko) 2018-01-22
JP5250155B2 (ja) 2013-07-31
EA023816B1 (ru) 2016-07-29
CN102762721B (zh) 2015-03-11
JP2013519366A (ja) 2013-05-30
NZ601424A (en) 2014-07-25
ES2578514T3 (es) 2016-07-27
MX2012007936A (es) 2012-11-22
PL2536829T3 (pl) 2016-09-30
EA201290797A1 (ru) 2013-01-30
CA2786835C (en) 2021-08-31
BR112012019023B1 (pt) 2021-12-21
EP2536829A1 (en) 2012-12-26
AU2011214262B2 (en) 2015-05-21
CA2786835A1 (en) 2011-08-18
AU2011214262A1 (en) 2012-08-30
CN102762721A (zh) 2012-10-31
BR112012019023A2 (pt) 2015-09-15
EP2536829B1 (en) 2016-04-06
KR20130026518A (ko) 2013-03-13

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