生物反应器课件PATIntrodu

《生物反应器课件PATIntrodu》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。

1、PATIntroductionPATProcessAnalyticalTechnologyWhatisPAT?WhatisPAT(andwhatisn’t)?PATEnabledSCADASomeKeyElementsofaPATincombinationwithSCADASpectrometryMetadata&ExperimentalcontextGettingmorefromyourdataIsPAT?Installingsomeshinynewequipment?Connectingane

2、wprobe/cellcountertoabioreactor?AlreadystandardpracticeinBioprocessdevelopment?Littlebusinessbenefittoearlybioprocessdevelopment?AnimportanttoolforQualitybyDesign?WhatisPATProcessanalyticaltechnology(PAT)hasbeendefinedbytheFDAasamechanismtodes

3、ign,analyze,andcontrolpharmaceuticalmanufacturingprocessesthroughthemeasurementofCriticalProcessParameters(CPP)whichaffectCriticalQualityAttributes(CQA).PATshouldaddressuncontrolledprocessvariationtomitigateriskofuncontrolledproductvariabilityPATSolut

4、ionsshouldbeanintegralpartofaQualitybyDesign(QbD)strategyLongtermgoalsreduceproductioncyclingtimepreventrejectionofbatchesenablerealtimereleaseincreaseautomationimproveenergyandmaterialusefacilitatecontinuousprocessingHowdowegetthere?Defineprocessandp

5、roductqualityWhatcausesvariance?Whatiscritical?UnderstandtheprocessHowcanwecontroltheprocesstothedesiredendproductquality?Onlinemonitoring(nearinfrared)Howdowegetthere?EliminateprimarysourcesofvarianceMediumcomposition:fromundefinedmedium(containingpr

6、oteinextracts),tochemicallydefinedmediumwithbalancedC/NratioInoculum:reproducibleseedlotpreparation,freezeatfixedOD,duringmid-loggrowthphase.DefineQualityWhereshouldwefinish?ExperimentaldesignDesignspaceControlspaceFrom:D.Low,AmgenBioProduction2006,Du

7、blinTools:SCADAIsthetechnologyfitforpurpose?Howmuchdata?Howwillyoustoreit?Howwillyouannotatedata?IsthePATapplicationgoingtobeon-line?IssoftwareOPCcompliant?Ifnot,haveyouassessedinterfacingcosts?Tools:NIRFullSpectrumNearInfraredVibrationalspectroscopy(

8、800–2500nm)Non-invasiveopticalsensingNIRhaswidespreadacceptanceinpharmaceuticalmanufacturingOperational&TechnicalFlexibilityCostEffective,Robust&ScalableTools:NIRHowever,Chemometricmodelsarerequiredtoextractbiomass,metabolite&catabolitedata(ot