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生物反应器PATIntroduction的学习课件第1页/共22页PATProcessAnalyticalTechnology第2页/共22页WhatisPAT?WhatisPAT(andwhatisn’t)?PATEnabledSCADASomeKeyElementsofaPATincombinationwithSCADASpectrometryMetadata&ExperimentalcontextGettingmorefromyourdata第3页/共22页IsPAT?Installingsomeshinynewequipment?Connectinganewprobe/cellcounter
toabioreactor?AlreadystandardpracticeinBioprocess
development?Littlebusinessbenefittoearlybioprocess
development?AnimportanttoolforQualitybyDesign?第4页/共22页WhatisPATProcessanalyticaltechnology(PAT)hasbeendefinedbytheFDAasamechanismtodesign,analyze,andcontrolpharmaceuticalmanufacturingprocessesthroughthemeasurementofCriticalProcessParameters(CPP)whichaffectCriticalQualityAttributes(CQA).PATshouldaddressuncontrolledprocessvariationtomitigateriskofuncontrolledproductvariabilityPATSolutionsshouldbeanintegralpartofaQualitybyDesign(QbD)strategy第5页/共22页Longtermgoalsreduceproductioncyclingtimepreventrejectionofbatchesenablerealtimereleaseincreaseautomationimproveenergyandmaterialusefacilitatecontinuousprocessing第6页/共22页Howdowegetthere?DefineprocessandproductqualityWhatcausesvariance?Whatiscritical?UnderstandtheprocessHowcanwecontroltheprocesstothedesiredendproductquality?Onlinemonitoring(nearinfrared)第7页/共22页Howdowegetthere?EliminateprimarysourcesofvarianceMediumcomposition:fromundefinedmedium(containingproteinextracts),tochemicallydefinedmediumwithbalancedC/NratioInoculum:reproducibleseedlotpreparation,freezeatfixedOD,duringmid-loggrowthphase.DefineQuality第8页/共22页Whereshouldwefinish?ExperimentaldesignDesignspaceControlspaceFrom:D.Low,AmgenBioProduction2006,Dublin第9页/共22页Tools:SCADAIsthetechnologyfitforpurpose?Howmuchdata?Howwillyoustoreit?Howwillyouannotatedata?IsthePATapplicationgoingtobeon-line?IssoftwareOPCcompliant?Ifnot,haveyouassessedinterfacingcosts?第10页/共22页Tools:NIRFullSpectrumNearInfraredVibrationalspectroscopy(800–2500nm)Non-invasiveopticalsensingNIRhaswidespreadacceptanceinpharmaceuticalmanufacturingOperational&TechnicalFlexibilityCostEffective,Robust&Scalable第11页/共22页Tools:NIRHowever,Chemometricmodelsarerequiredtoextractbiomass,metabolite&catabolitedata(othermethodsarealsopossible)Inaddition,largedatasetsmakemodelbuildingdifficult第12页/共22页Results:CalibrationsensorOneCHOrun(10days)@NewCastleUniverity(UK)1Spectraevery2min5500Spectra2000Absreadingperspectra10-15runsforeachcalibrationsEachBioreactorrunRawExportfile55MbOpusfiles75Mb第13页/共22页CalibrationtofullscaleNIRprobecalibrationdatacollectedinmultiplesmallscalevesselruninparallelBetterintegrationofNIRcalibrationintoDevelopmentlifecycleAugmentcalibrationsoverthedevelopmentlifecycleRun1Run2Run3Run4Run5SmallscaleBenchtopBioreactorsCalibrationsetValidationsetCalibrationModelTransferredtoFullscaleProductionbioreactorTemppHDOTFT-NIRFullScaleProductionBioreactorTime第14页/共22页PharmaManufacturingBenchmarkingStudyData(2005)Broadsurveyof104Pharmacompanies.LimitedITsupportfortransitionfrombenchthroughprocessdevtocommercialisationUnstructuredinformationcollection,storage&retrievalresultsinmoretimesearchingfordataLimitedcoordinationacrossgroupsandsitesaffectstheabilitytomeetdevelopmentcycletimes(timetohuman,timetoclinic,etc)andproductcosttargetsLackofinformationvisibility&contextlimittheeffectivenessofportfolioandprojectmanagementprocesses第15页/共22页5hrperweekonaveragelookingfordataCan’tfinddata25%oftimeleadingtorepeating8%ofexperimentsandincreasedR&DcostsLimitedandinefficienttraceability(paperbased)FewITsystemsfacilitatedatareuse&abilityto“drillacross”GenerallackofsatisfactionwithallPharmaITsystemsPharmaManufacturingBenchmarkingStudyData(2005)第16页/共22页FuturerequirementsDevelopmentofconsistentannotationstandardstomakebioprocessdatameaningfulMetadatashouldenabledrillingdownandacrossdatasets,filterandsift&batchgenealogycreationFreetextwillnotbeappropriateforallfieldsReportingsoftwareformatsdatatoeasetransferintoanalysissoftware第17页/共22页WhatshouldSCADAdo?RecipedrivenbatchexecutionRecipetransferbetweenunitsSecureacquisition&storageofBioreactordataOfflinedatastorageEasyintegrationofnewsensorsthroughOPCRealtimeProcessview第18页/共22页WhatshouldBioreactorControllerdo?Metadata&AnnotationsentryBlankTagsforanalyservaluesviaOPCGenericPIDcontrollerwithOPCInputandconfigurableoutputs第19页/共22页SCADALevelreporting60-70%ofanalysistimeisreformattingdataforimportingintoanalysistoolMostusershavesimplereportingrequirementsProcessmapofthedataflowSearch,Sift,Filter&ExportUserdefinableexp
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