1、Foundations of Pharma 4.0:The Missing PiecesSam SvitenkoCOO,ConSynSys TechnologiesCraig Vincze,PhDVP,Alphinity USAWhy Pharma 4.0?The Promise of Pharma 4.0The fourth Industrial RevolutionMass CustomizationUpskill workersConnected EcosystemsThe Missing Pieces of Pharma 4.0ProCaaSPYTHONDE-CENTRALIZATIO

2、NCLOUDFLEXIBLE HARDWAREThe Missing Pieces of Pharma 4.0ProCaaSPYTHONDE-CENTRALIZATIONCLOUDFLEXIBLE HARDWAREGetting to Abundance in MedicineRemove limitations of PLCs and Ladder LogicExpand the available labor poolDe-centralize manufacturing with centralized controlOffload repetitive tasks to AILever

3、age flexible,configurable hardware with flexible softwareBest PracticesSecurity-focused architectureProgram in the Cloud-Execute at the edgeCapture data differentlyDecouple hardware from recipesBest PracticesSecurity-focused architectureProgram in the Cloud-Execute at the edgeCapture data differentl

4、yDecouple hardware from recipesBest PracticesSecurity-focused architectureProgram in the Cloud-Execute at the edgeCapture data differentlyDecouple hardware from recipesBest PracticesSecurity-focused architectureProgram in the Cloud-Execute at the edgeCapture data differentlyDecouple hardware from re

5、cipesDelivering:The ProCaaSo Platform“The Art of Process Control”The Promise of Pharma 4.0The fourth Industrial RevolutionMass CustomizationUpskill workersConnected EcosystemsSUBJECTS&THEMES BPSA 2023ConnectivityUpcoming SUTComponent ScalabilityModular ApproachFacility FlexibilityBottlenecksThe Chal

6、lengePivot to Adapt to New Modalities&Market Demands2,408 Gene Therapy Clinical Trials(July 4,2023,clinicaltrials.gov)457,560 Total Clinical Trails(July 4,2023,clinicaltrials.gov)The Goal“ability to create tailored products at high speed and on a scale never before possible.”-Henrik von Scheel The f

7、ourth Industrial RevolutionMass CustomizationUpskill workersConnected EcosystemsKey Issues and Challenges Facing the Single-Use EcosystemMass ProductionThe fourth Industrial RevolutionMass CustomizationUpskill workersConnected EcosystemsMass CustomizationFast and AdaptiveProduce Diverse Products wit

8、h Efficiency of Mass ProductionHighly flexible,agile,and smart production linesHighly flexible,agile,and smart production linesBUFFERSTOCKCONCMWIT003WE003BUFFERSTOCKCONCMWIT002WE002BUFFERSTOCKCONCMWIT001WE001BUFFERSTOCKCONCMWIT004WE004BUFFERSTOCKCONCMWIT005WE005BUFFERSTOCKCONCMWIT006WE006WFIMWIT007W

9、E007TOTEMWIT000WE000YWASTE(DRAIN)MBioreactorInletsOutletsFEEDRETURNUF/DF TFFTulip TankSingle Use MixerPivot to Adapt to New Modalities&Market DemandsPolymorphic Pump TechnologyPIXERParaFlowParaFlow MixerParaFlow MultiThe Promise of Pharma 4.0The fourth Industrial RevolutionMass CustomizationUpskill workersConnected EcosystemsEnabling Abundance in Medicine