生物反應(yīng)器課件 Renowed customer application Applikons BioSep system

RenowneduserapplicationApplikon’sBioSepsystemRenowneduserapplicationAppliContentOverviewPrincipleofoperationBioSepPublicationresultsContentOverviewCustomersinEuropeNovartis,Cell,cGMP DutchVaccineInstitute,Cell,cGMPHPA,UK,Cell,cGMP GlaxoSmithKline,Cell,cGMPBoehringerIngelheim,Cell,cGMP SolvayPharmaceuticals,Cell,cGMPAstraZeneca Bayer,Cell,cGMPEliLilly PfizerFraunhoferInstitute,cGMP Diosynth,Cell,cGMPPharmacia AvantisPasteur,Cell,cGMPMerial,Cell,cGMP AlbaBiosciences,Cell,cGMPSanofiAventis SandozVivalis,Cell,cGMP Avecia,Cell,cGMPL.F.B.,Cell,cGMP CobraBiologicals,Cell,cGMPCentocor,Cell,cGMP Serbio,Cell,cGMPNatl.BioManuf.Centre,Cell,cGMP OctoPlusU.C.B.Celltech,Cell,cGMP CancerResearch,Cell,cGMPSyncoBioPartners,Cell,cGMPCustomersinEuropeNovartis,CCustomersinUSABayer,Cell,cGMP Genentech,Cell,cGMPBristolMyersSquib(BMS) Zymogenetics,Cell,cGMPWyethPharmaceuticals BioMarine,Cell,cGMPInvitrogen Amgen,Cell,cGMPBiogenIDEC,Cell,cGMP AbbottGlaxoSmithKline(GSK),Cell,cGMP Merck,Cell,cGMPCubist,Cgmp SigmaAldrich,Cell,cGMPMedimmune,Cell,cGMP Imclone,Cell,cGMPCambrex,Cell,cGMP CookPhamica.CustomersinUSABayer,Cell,cOverviewManycompaniesworkwithApplikonMicroscaleuptoPilot/ProductionscaleBioSepisuniqueproductforperfusionOverviewManycompaniesworkwiRenoweduserapplicationBioSepintegrationRenoweduserapplicationBioSepPrincipleofoperationPrincipleofoperationHighmovement/LowpressureplaneLowmovement/HighpressureplaneCellsaccumulateinlowpressureplanesHighmovement/LowpressureplaneAcousticstandingwaveHighmovement/Lowmovement/CClarifiedharvestConcentratedcellsuspensionCell“banding”CellsedimentationClarifiedharvestConcentratedCDetailcellbandDetailcellbandBioSep:EconomicalImpact-Perfusionvs.BatchViablecellconcentration: Factor10-20Antibodyconc.inharvest: Factor2-5Antibodyproduction/reactorvolume/day: Factor10-100 =>smallerreactorBioSep:EconomicalImpact-Scalable1L–1000LcGMPScalable1L–1000LcGMPBioSep1000LBioSep1000LBioSepchamber1000LBioSepchamber1000LScalable1L–1000LcGMPBioSep10LScalable1L–1000LcGMPBioSepScalable1L–1000LcGMPBioSep50LScalable1L–1000LcGMPBioSepScalable1L–1000LcGMPBioSep200LScalable1L–1000LcGMPBioSepSetupBioSepAutoclavablechambersPlaceddirectonbioreactor forlabandpilotscale: BioSep10L BioSep50LSetupBioSepSetupBioSep200LSetupBioSep200LBioSeptechnologyproventechnology,>400systemssoldAppliedincGMPconditionCosteffectiveBioSeptechnologyproventechnoPublicationsCNRC,CanadaDSMBiologics,NetherlandsUBC,CND/Zymogenetics,USA*HumanGenomeSciences,USAGenentech,USASerono,SwitserlandPublicationsCNRC,CanadaSetupBioSep200L130LBioreactorwithBioSep200L(inGMPfacility)SetupBioSep200L130LBioreacGorenfloetal,2002Gorenfloetal,2002Gorenfloetal,2002Gorenfloetal,2002Gorenfloetal,2002-ConclusionsScalablefrom10L/dayto200L/dayEfficiency>95%up1*107cell/mlSimpleandreliableGorenfloetal,2002-ConclusQuestions?Questions?RenowneduserapplicationApplikon’sBioSepsystemRenowneduserapplicationAppliContentOverviewPrincipleofoperationBioSepPublicationresultsContentOverviewCustomersinEuropeNovartis,Cell,cGMP DutchVaccineInstitute,Cell,cGMPHPA,UK,Cell,cGMP GlaxoSmithKline,Cell,cGMPBoehringerIngelheim,Cell,cGMP SolvayPharmaceuticals,Cell,cGMPAstraZeneca Bayer,Cell,cGMPEliLilly PfizerFraunhoferInstitute,cGMP Diosynth,Cell,cGMPPharmacia AvantisPasteur,Cell,cGMPMerial,Cell,cGMP AlbaBiosciences,Cell,cGMPSanofiAventis SandozVivalis,Cell,cGMP Avecia,Cell,cGMPL.F.B.,Cell,cGMP CobraBiologicals,Cell,cGMPCentocor,Cell,cGMP Serbio,Cell,cGMPNatl.BioManuf.Centre,Cell,cGMP OctoPlusU.C.B.Celltech,Cell,cGMP CancerResearch,Cell,cGMPSyncoBioPartners,Cell,cGMPCustomersinEuropeNovartis,CCustomersinUSABayer,Cell,cGMP Genentech,Cell,cGMPBristolMyersSquib(BMS) Zymogenetics,Cell,cGMPWyethPharmaceuticals BioMarine,Cell,cGMPInvitrogen Amgen,Cell,cGMPBiogenIDEC,Cell,cGMP AbbottGlaxoSmithKline(GSK),Cell,cGMP Merck,Cell,cGMPCubist,Cgmp SigmaAldrich,Cell,cGMPMedimmune,Cell,cGMP Imclone,Cell,cGMPCambrex,Cell,cGMP CookPhamica.CustomersinUSABayer,Cell,cOverviewManycompaniesworkwithApplikonMicroscaleuptoPilot/ProductionscaleBioSepisuniqueproductforperfusionOverviewManycompaniesworkwiRenoweduserapplicationBioSepintegrationRenoweduserapplicationBioSepPrincipleofoperationPrincipleofoperationHighmovement/LowpressureplaneLowmovement/HighpressureplaneCellsaccumulateinlowpressureplanesHighmovement/LowpressureplaneAcousticstandingwaveHighmovement/Lowmovement/CClarifiedharvestConcentratedcellsuspensionCell“banding”CellsedimentationClarifiedharvestConcentratedCDetailcellbandDetailcellbandBioSep:EconomicalImpact-Perfusionvs.BatchViablecellconcentration: Factor10-20Antibodyconc.inharvest: Factor2-5Antibodyproduction/reactorvolume/day: Factor10-100 =>smallerreactorBioSep:EconomicalImpact-Scalable1L–1000LcGMPScalable1L–1000LcGMPBioSep1000LBioSep1000LBioSepchamber1000LBioSepchamber1000LScalable1L–1000LcGMPBioSep10LScalable1L–1000LcGMPBioSepScalable1L–1000LcGMPBioSep50LScalable1L–1000LcGMPBioSepScalable1L–1000LcGMPBioSep200LScalable1L–1000LcGMPBioSepSetupBioSepAutoclavablechambersPlaceddirectonbioreactor forlabandpilotscale: BioSep10L BioSep50LSetupBioSepSetupBioSep200LSetupBioSep200L