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CHAPTER1NewProductDevelopmentandSupplyChains inthePharmaceuticalIndustry ............................................ 1 CatherineAzzaro-Pantel
1. Introduction.....................................................................................1
2. TypicalFeaturesofPharmaceuticalIndustry.................................2
2.1.AnalysisoftheProductDevelopmentProcess......................2
2.2.LifeCycleofaDrug..............................................................3
2.3.DrugMarketFeatures.............................................................5
2.4.SupplyChainManagement....................................................5
3. ManagementofProductDevelopmentPipeline............................8
3.1.MethodologicalApproaches...................................................8
3.2.RelatedOptimizationWorks................................................11
4. CapacityPlanning.........................................................................18
5. ManagementoftheWholePharmaceutical SupplyChain.................................................................................19
6. Conclusions...................................................................................22 References..........................................................................................23
CHAPTER2Thedevelopmentofapharmaceuticaloral soliddosageforms ................................................................. 27 RahamatullahShaikh,Do ´ nalP.O’Brien,DeniseM.Croker, GavinM.Walker
1. Introduction...................................................................................27
2. PharmaceuticalPreformulationandItsSignificanceinthe DevelopmentofSolidDosageForms..........................................28
2.1.Solid-StateProperties...........................................................28
2.2.Solubility...............................................................................29
2.3.DissolutionStudies...............................................................32
2.4.StabilityStudies....................................................................33
2.5.Drug-ExcipientCompatibilityStudies.................................34
2.6.PhysicalPropertiesofPharmaceuticalSolids......................34
3. DrugProductManufacturing........................................................35
3.1.Diluents.................................................................................38
3.2.Binders..................................................................................38 v
3. Plant-WideModel.......................................................................144
4. ResultsandDiscussions..............................................................146
4.1.ImpactofWashFactors.....................................................149
4.2.ImpactofPurgeRatio........................................................151
5. Conclusions.................................................................................155 References........................................................................................156
CHAPTER7Advancedmultiphasehybridmodeldevelopment offluidizedbedwetgranulationprocesses ................ 159 AshutoshTamrakar,DheerajR.Devarampally, RohitRamachandran
1. IntroductiontoGranulationModeling.......................................159
1.1.FluidBedModelDevelopment:MultiphaseFlow andGranulation..................................................................161
1.2.DifferentModelingTechniques.........................................164
2. MultiphaseModelDevelopmentandImplementation: FluidizedBedWetGranulation..................................................169
2.1.CFD-DEM:ModelDevelopment.......................................169
2.2.PBM:CompartmentalModelDevelopment......................172
2.3.CFD-DEM-PBM:ModelImplementation.........................175
3. ResultsandDiscussion...............................................................177
3.1.CFD-DEMSimulationResults...........................................177
3.2.PBMResultsandValidationofHybridModel.................182
4. Summary.....................................................................................184 References........................................................................................184
CHAPTER8Globalsensitivity,feasibility,andflexibility analysisofcontinuouspharmaceutical manufacturingprocesses ................................................... 189 ZilongWang,MarianthiIerapetritou
1. Introduction.................................................................................189
2. GlobalSensitivityAnalysis........................................................191
2.1.Methods...............................................................................192
2.2.VisualizationofSensitivityResults...................................200
3. FeasibilityandFlexibilityAnalysis............................................201
3.1.Methods...............................................................................202
3.2.VisualizationofResults......................................................208
3.3.Extensions...........................................................................209
4. Software......................................................................................209
5. ConclusionandFuturePerspectives...........................................209 Acknowledgments...........................................................................210 References........................................................................................211
CHAPTER9Crystallizationprocessmonitoringandcontrol usingprocessanalyticaltechnology 215 LeventeL.Simon,ElenaSimone,KaoutarAbbouOucherif
1. Introduction.................................................................................216
2. QbDandPAT.............................................................................216
3. Liquid-andSolid-PhaseMonitoring..........................................218
3.1.ATR-FTIRandUltraviolet-VisibleSpectroscopy.............218
3.2.ConductivityMeasurements...............................................219
3.3.RefractiveIndexMeasurement..........................................219
3.4.TurbidityMeasurement......................................................219
3.5.FBRM.................................................................................220
3.6.PVMandEndoscopy..........................................................220
3.7.RamanSpectroscopy..........................................................221
3.8.AcousticSpectroscopy(Ultrasound)..................................221
4. MonitoringandControlofBatchCrystallizationProcesses.....221
4.1.OptimalSwitchingBetweenNucleationand SeedRipeningUsingControlCharts.................................221
4.2.ConcentrationFeedbackControl........................................222
4.3.ADNC.................................................................................224
4.4.PolymorphicFeedbackControl..........................................226
4.5.PolymorphicControlbyOptimalSolventSelection.........229
5. MonitoringandControlofContinuousCrystallization Processes.....................................................................................231
5.1.ADNCofContinuousCrystallizationProcesses...............231
5.2.PolymorphicControlinContinuousCrystallization..........234
5.3.EncrustationMonitoringinContinuousCrystallization....235 References........................................................................................237 FurtherReading...............................................................................242
CHAPTER10BioProcessperformancemonitoringusing multiwayintervalpartialleastsquares ........................ 243 ShallonStubbs,JieZhang,JulianMorris
1. MotivationandBackground.......................................................243
2. CombiningdataUnfoldingandIntervalSplicingTechniques..244
2.1.Three-DimensionalDataUnfolding...................................244
2.2.CombiningDataUnfoldingandIntervalSplicing.............245
3. Fed-BatchPenicillinSimulatorPredictionandFault Monitoring...................................................................................248
3.1.Fed-BatchPenicillinProductionProcessSimulator Overview.............................................................................248
3.2.PredictionandProcessMonitoring....................................250
4. PredictionandMonitoringResults.............................................252
4.1.PredictiveModelPerformance...........................................252 4.2.ProcessPerformanceMonitoring.......................................254
5. Conclusions.................................................................................257
CHAPTER11ProcessdynamicsandcontrolofAPI
1. Introduction,Objectives,andBackground.................................261
2. IntegratedProcess.......................................................................264
3. ModelDevelopment...................................................................266
3.1.PopulationBalanceModel.................................................266
3.2.Crystallizer..........................................................................266
3.3.Filter....................................................................................268
3.4.Dryer...................................................................................269
3.5.Mixer...................................................................................270
3.6.PrincipalComponentAnalysis-BasedROM.....................273
3.7.NumericalTechnique.........................................................276
4. DesignStrategyoftheHybridMPC-PIDandPIDOnly ControlSystem............................................................................276
4.1.HybridMPC-PIDDesign...................................................276
4.2.PIDOnlyDesign................................................................278
4.3.DesignofController...........................................................280
4.4.MPC-PIDControllerEquations.........................................281
5. PerformanceoftheHybridControlSystem...............................282
5.1.ComparisonofHybridMPC-PIDSchemeWith PIDOnlyScheme...............................................................284 6. Conclusions.................................................................................289
CHAPTER12PATforpharmaceuticalmanufacturingprocess
1. Introduction.................................................................................293
2. BasicsonNear-InfraredSpectroscopyandScatteringEffects..293
2.1.SpectralDataPretreatment.................................................295
CHAPTER15Advancedcontrolforthecontinuousdropwise additivemanufacturingofpharmaceutical products .................................................................................... 379 Elc ¸ inIc ¸ ten,GintarasV.Reklaitis,ZoltanK.Nagy
1. Introduction.................................................................................379
2. ProcessControlStrategy.............................................................380
2.1.Low-LevelControlSystem................................................382
2.2.Surrogate-Model-BasedSupervisoryControl System.................................................................................384
2.3.EffectofCriticalProcessParameterson ProductQuality...................................................................384
3. PolynomialChaosExpansion-BasedSurrogateModel Development...............................................................................388
4. Surrogate-Model-BasedOptimizationofTemperature Profiles........................................................................................395
5. Conclusions.................................................................................399 Acknowledgments...........................................................................399 References........................................................................................399
CHAPTER16Controlsystemimplementationandplant-wide controlofcontinuouspharmaceutical manufacturingpilotplant(end-to-end manufacturingprocess) 403 RichardLakerveld
1. Introduction.................................................................................403
2. ActiveandPassiveControlofContinuousPharmaceutical Processes.....................................................................................404
3. Plant-WideProcessControl........................................................408
4. ImplementationofPlant-WideControlforaCaseStudy ofanEnd-to-EndContinuousPharmaceuticalProcess.............410
4.1.ProcessDescription............................................................411
4.2.SynthesisofaPlant-WideControlStructure.....................412
4.3.ValidationofPlant-WideControlStrategyUsing DynamicSimulations.........................................................415
4.4.ExperimentalValidationofBasicControlStructure.........417
4.5.PerformanceOptimizationUsingAdvanced Controllers..........................................................................422
5. ConclusionsandOutlook............................................................425 References........................................................................................427
2.3.FixedContinuousProcessDrawbacks...............................491
2.4.FDASupportsCM..............................................................492
2.5.OtherGovernmentAgency—BARDA, NSFSupportsCM..............................................................492
3. Object-OrientedPlantDesign.....................................................493
3.1.Flexibility/ModularDesign/AgileManufacturing.............493
3.2.Object-OrientedPlantDesignDefined..............................494
3.3.Object-OrientedDesignSoftware—History......................494
3.4.Object-OrientedDesign—ClassBased..............................494
3.5.Object-OrientedDesignSoftware—Benefits.....................495
4. Object-OrientedPlantDesign—BasedonS88Batch................495
4.1.Class-BasedApproach........................................................495
4.2.BatchistheCurrentStateoftheArt.................................496
5. S88FixedUnits—ALIASES......................................................502
5.1.FlexBatch—DynamicLinks..............................................503
5.2.FlexPlant—RecipeControl...............................................504
5.3.CMFunctionality................................................................505
1. Introduction.................................................................................519
2. AMathematicalProgrammingModelforClinical TrialPlanningUnderPerfectInformation.................................523
2.1.DefinitionofDecisionVariables.......................................523
2.2.TheObjectiveFunction......................................................524
2.3.Constraints..........................................................................525
3. AStochasticProgrammingApproachtoAccountfor ClinicalTrialOutcomeUncertainty...........................................526
4. ComplexityoftheDeterministicEquivalentoftheMSSP.......530
5. AHeuristicDecompositionAlgorithmBasedonSolving aSeriesofTwo-StageStochasticPrograms..............................531
6. AKnapsackProblem-BasedDecompositionApproachfor SolvingClinicalTrialPlanningProblem...................................533
7. ClinicalTrialPlanningCaseStudies..........................................536
8. ImprovementstotheKnapsackProblem-Based DecompositionApproach...........................................................540
9. AParallelBranch-and-BoundAlgorithmforSolving theClinicalTrialPlanningMSSP..............................................543
9.1.BoundGeneration...............................................................545
9.2.Results.................................................................................545
10. ConclusionsandFutureDirections............................................547
Acknowledgments...........................................................................548 References........................................................................................548
CHAPTER22Integratedproductionplanningandinventory managementinamultinationalpharmaceutical supplychain 551
NareshSusarla,IftekharA.Karimi
1. Introduction.................................................................................552
2. ProblemStatement......................................................................558
3. MathematicalFormulation..........................................................559
4. NumericalEvaluation.................................................................563
5. Conclusions.................................................................................565 Acknowledgments...........................................................................565 References........................................................................................565
CHAPTER23Optimalproductionofbiopharmaceutical manufacturing 569
SongsongLiu,LazarosG.Papageorgiou
1. Introduction.................................................................................572
2. LiteratureModelsOverview.......................................................574
2.1.DeterministicModels.........................................................575
2.2.StochasticModel................................................................580
2.3.Summary.............................................................................581
3. ModelExtensions........................................................................582
3.1.OptimizationwithPurityRestriction.................................582
3.2.BiobjectiveOptimization....................................................585
4. Conclusions.................................................................................586
Acknowledgments...........................................................................587 Appendix..........................................................................................587
A.1.IntegerVariableDiscretization.........................................587
A.2.ChromatographySequence................................................588
A.3.ProteinMass......................................................................588
A.4.ResinVolume....................................................................588
A.5.FlowRate...........................................................................589
A.6.ProductandBufferVolume..............................................589
A.7.ProcessingTime.................................................................590
MarianthiIerapetritou
Rutgers,TheStateUniversityofNewJersey,Piscataway,NJ,UnitedStates
HikaruG.Jolliffe
UniversityofEdinburgh,Edinburgh,UnitedKingdom
IftekharA.Karimi
NationalUniversityofSingapore,Singapore,Singapore
RichardLakerveld
TheHongKongUniversityofScienceandTechnology,ClearWaterBay,Hong Kong
HuolongLiu
TheUniversityofMassachusettsLowel,Lowell,MA,UnitedStates
SongsongLiu
SwanseaUniversity,Swansea,UnitedKingdom
AliMesbah
UniversityofCalifornia,Berkeley,CA,UnitedStates
JulianMorris
NewcastleUniversity,NewcastleUponTyne,UnitedKingdom
ZoltanK.Nagy
PurdueUniversity,WestLafayette,IN,UnitedStates
Do ´ nalP.O’Brien
UniversityofLimerick,Limerick,Ireland
CarlosOrtega-Zun ˜ iga
UniversityofPuertoRico,Mayaguez,PR,UnitedStates
EmmanouilPapadakis
TechnicalUniversityofDenmark,Kgs.Lyngby,Denmark
LazarosG.Papageorgiou
UCL(UniversityCollegeLondon),London,UnitedKingdom
JoelA.Paulson
UniversityofCalifornia,Berkeley,CA,UnitedStates
LeonelQuin ˜ ones
UniversityofPuertoRico,Mayaguez,PR,UnitedStates
RohitRamachandran
Rutgers,TheStateUniversityofNewJersey,Piscataway,NJ,UnitedStates
GintarasV.Reklaitis
PurdueUniversity,WestLafayette,IN,UnitedStates
AndresD.Roma ´ n-Ospino
Rutgers,TheStateUniversityofNewJersey,Piscataway,NJ,UnitedStates
Chapter5 describestheflowsheetmodelingofacontinuousdirect-compression pharmaceuticaltablet-manufacturingprocess.Aplant-widedynamicmodelforthe integratedcontinuouspharmaceuticalmanufacturingprocessincludingrecyclehas beendescribedin Chapter6.Anadvancedmultiphasehybridmodeloffluidizedbed wetgranulationprocesseshasbeengivenin Chapter7.Globalsensitivity,feasibility, andflexibilityanalysisofcontinuouspharmaceuticalmanufacturingprocesseshas beenperformedin Chapter8
Crystallizationprocessmonitoringandcontrolusingprocessanalyticaltechnologyhasbeendescribedin Chapter9.Bioprocessperformancemonitoringusing multiwayintervalpartialleastsquaresisgivenin Chapter10 Chapter11 reviewsthe processdynamicsandcontrolofAPImanufacturingandpurificationprocesses.
PATforpharmaceuticalmanufacturingprocessinvolvingsoliddosagesforms isdescribedin Chapter12.Model-basedcontrolsystemdesignandevaluationfor continuouspharmaceuticaltabletmanufacturingviadirectcompaction,rollercompaction,andwetgranulationroutesisgivenin Chapter13.Faststochasticmodelpredictivecontrolofend-to-endcontinuouspharmaceuticalmanufacturingisdescribed inChapter14.Advancedcontrolforthecontinuousdropwiseadditivemanufacturing ofpharmaceuticalproductsisgivenin Chapter15.Controlsystemimplementation andplant-widecontrolofcontinuouspharmaceuticalmanufacturingpilotplant(endto-endmanufacturingprocess)isillustratedin Chapter16.Automationofcontinuous pharmaceuticalmanufacturingprocessisdescribedin Chapter17.Implementationof controlsystemintocontinuouspharmaceuticalmanufacturingpilotplant(powderto tablet)isdemonstratedin Chapter18.Monitoringandcontrolofacontinuoustumble mixerisdescribedin Chapter19.TheapplicationsofS88batchstandardsandobjectorienteddesignforcontinuouspharmaceuticaltabletmanufacturingisgivenin Chapter20.
Chapter21 introducestheoptimalplanningandschedulingofpharmaceutical clinicaltrials.Integratedproductionplanningandinventorymanagementinamultinationalpharmaceuticalsupplychainisgivenin Chapter22.Optimalproductionof biopharmaceuticalmanufacturingisdescribedin Chapter23.Finally,theperspective onPSEinpharmaceuticalprocessdevelopmentandinnovationisgivenin Chapter24
ThesechapterssystematicallyintroducetheuseofPSEmethodsandtoolsfor discovering,developing,deployinggreener,safer,cost-effective,andefficientpharmaceuticalproductionprocesses.Awidespectrumofcasestudieshasbeendescribed wheredifferentPSEtoolsandmethodshavebeenusedtoimprovevariouspharmaceuticalproductionprocesseswithdistinctfinalproducts.Thisbookwillpromotethe applicationsofprocesssystemengineeringforpharmaceuticalmanufacturingand willserveasafoundationforfutureresearchanddevelopmentofthisarea.
RavendraSingh
Rutgers,TheStateUniversityofNewJersey,Piscataway,NJ,UnitedStatesofAmerica