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PATIntroductionPATProcessAnalyticalTechnologyWhatisPAT?WhatisPAT(andwhatisn’t)?PATEnabledSCADASomeKeyElementsofaPATincombinationwithSCADASpectrometryMetadata&ExperimentalcontextGettingmorefromyourdataWhatisPATProcessanalyticaltechnology(PAT)hasbeendefinedbytheFDAasamechanismtodesign,analyze,andcontrolpharmaceuticalmanufacturingprocessesthroughthemeasurementofCriticalProcessParameters(CPP)whichaffectCriticalQualityAttributes(CQA).PATshouldaddressuncontrolledprocessvariationtomitigateriskofuncontrolledproductvariabilityPATSolutionsshouldbeanintegralpartofaQualitybyDesign(QbD)strategyLongtermgoalsreduceproductioncyclingtimepreventrejectionofbatchesenablerealtimereleaseincreaseautomationimproveenergyandmaterialusefacilitatecontinuousprocessingHowdowegetthere?DefineprocessandproductqualityWhatcausesvariance?Whatiscritical?UnderstandtheprocessHowcanwecontroltheprocesstothedesiredendproductquality?Onlinemonitoring(nearinfrared)Whereshouldwefinish?ExperimentaldesignDesignspaceControlspaceFrom:D.Low,AmgenBioProduction2006,DublinTools:SCADAIsthetechnologyfitforpurpose?Howmuchdata?Howwillyoustoreit?Howwillyouannotatedata?IsthePATapplicationgoingtobeon-line?IssoftwareOPCcompliant?Ifnot,haveyouassessedinterfacingcosts?Tools:NIRFullSpectrumNearInfraredVibrationalspectroscopy(800–2500nm)Non-invasiveopticalsensingNIRhaswidespreadacceptanceinpharmaceuticalmanufacturingOperational&TechnicalFlexibilityCostEffective,Robust&ScalableResults:CalibrationsensorOneCHOrun(10days)@NewCastleUniverity(UK)1Spectraevery2min5500Spectra2000Absreadingperspectra10-15runsforeachcalibrationsEachBioreactorrunRawExportMbOpusfiles75MbCalibrationtofullscaleNIRprobecalibrationdatacollectedinmultiplesmallscalevesselruninparallelBetterintegrationofNIRcalibrationintoDevelopmentlifecycleAugmentcalibrationsoverthedevelopmentlifecycleRun1Run2Run3Run4Run5SmallscaleBenchtopBioreactorsCalibrationsetValidationsetCalibrationModelTransferredtoFullscaleProductionbioreactorTemppHDOTFT-NIRFullScaleProductionBioreactorTimePharmaManufacturingBenchmarkingStudyData(2005)Broadsurveyof104Pharmacompanies.LimitedITsupportfortransitionfrombenchthroughprocessdevtocommercialisationUnstructuredinformationcollection,storage&retrievalresultsinmoretimesearchingfordataLimitedcoordinationacrossgroupsandsitesaffectstheabilitytomeetdevelopmentcycletimes(timetohuman,timetoclinic,etc)andproductcosttargetsLackofinformationvisibility&contextlimittheeffectivenessofportfolioandprojectmanagementprocessesFuturerequirementsDevelopmentofconsistentannotationstandardstomakebioprocessdatameaningfulMetadatashouldenabledrillingdownandacrossdatasets,filterandsift&batchgenealogycreationFreetextwillnotbeappropriateforallfieldsReportingsoftwareformatsdatatoeasetransferintoanalysissoftwareWhatshouldSCADAdo?RecipedrivenbatchexecutionRecipetransferbetweenunitsSecureacquisition&storageofBioreactordataOfflinedatastorageEasyintegrationofnewsensorsthroughOPCRealtimeProcessviewWhatshouldBioreactorControllerdo?Metadata&AnnotationsentryBlankTagsforanalyservaluesviaOPCGenericPIDcontrollerwi

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