通過一次性使用和自動化提高設施靈活性.pdf

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1、Advancing Facility Flexibility through Single Use and AutomationMatt Kessler Biologics Manufacturing Innovation,MSD Switzerland2023 BPSA Single-Use SummitWashington DCPublicWe are expanding our network capability in support of the Biologics pipelineBiologics INnovation Xceleration(BioNX)facility for

2、 late-phase Clinical Supply and LaunchDunboyneBioNXBiologics Commercialization and Expedited Launch and Long-Term Supply facilityfor Drug Substance SiteMissionRegistration&Launch+NNext-gen technologies are developed and scaled-up to support pre-clinical toxicologyNext-gen technologies are leveraged

3、at MSD Schachen for early phase clinical supplyRahway Biologics Dev.CenterSchachen BiotechPre-RegistrationDunboyneBioCEL2PublicAge of disruption3Designing,Constructing and Qualifying new facilities can take over 3 years Development and Transfer of Processes is extremely resource intensiveProcess Dev

4、elopmentDevelop Process and CapabilitiesClinical ManufacturingValidate/Innovate StrategyCommercial ManufacturingLeverage Validated StrategyTodays world of un-met medical needs and challenges means that we need to approach Building and transferring products differently Switching to Automated Single U

5、se Systems,with Podular/Modular facilities can enable speed and cost reductionsThousands of Hours are needed to develop and transfer the process between nodesHigh administrative burden in modifying qualified systems and updating documentationPublicBiologics Innovation Xceleration Facility at MSD Dun

6、boyne3 Production Trains at 3K Scale,capable of either Intensified Fed Batch or Continuous Manufacturing Scale-out possibility with Dual Reactor configuration Mixture of Manufacturing methods allow for optimizing COGs,Capacity vs Program Needs.Buffer Stock Blending to manage liquid volume Digital Fi

7、rst facility,with integration between the ERP/MES/DCS layers enabling complete paperless manufacturing,testing,and release.4Fastest Build in MSD Network History From Concept to Construction Complete was 21 months From Construction Complete to Engineering Batch was 9 monthsFacility is based on the mo

8、dular/podular concept over 60%of the facility was manufactured offsiteHiring of staff matched construction pace,with over 135 people hired in one year into the facility.Created uncomfortable but achievable targets leveraging it as unique talent development opportunity to bring key SMEs from the netw

9、ork Cultural Shift in mindset and news ways of working to operate more in parallel on a risk-based approach PublicMSD Dunboyne-BioNX5A Digital Facility going beyond paperless“Lights Out Operations”Imagine setting up all of the process SU equipment,and once the process is started only needing to feed

10、 it more media/buffer and take samples!Advanced PAT Integration:Closed Loop Control.Wireless CTUs for flexibility in qualifying and movement.Sweating our assets to simplify PublicStandardizeAfter 3 times of doing thesame thing-standardize formallySimplicity6The rapid pace of technology development a

11、llows us to constantly simplify in new ways.Imagine enabling new capabilities and flexibility like loading a new App on your phoneSimplicityDigitize with Intent Remove interdependencies with digital business processesPublicISA-88 built for multi-product 7Utilize Early-stage and Late-stage binding to

12、 allow for equipment swap outsAutomation Recipes are built on modules,allowing for adapting to different processes quicklyProcessProcess Stage Protein AProcess Operation EquilibrationProcess ActionBuffer FlushProcedureUnit Procedure Primary CaptureOperation Bind&EluteRecipe Phase EquilibrationProces

13、s CellSuite/BuildingUnit ChromatographyEquipment ModuleControl ModuleProcess ModelProcedural ModelPhysical ModelThe ISA-88 Model when implemented allows us to abstract the process from the automation and the equipment running on it.SimplicityPublicFlexibility builds on simplicity8ParameterizeVariabl

14、es of process that can be in an automated recipeFlexibilityPlug-n-PlaySeamless movement of equipment and devices Ethernet based equipment coupled with parametrization allows for flexibility to rapidly change parameters,but as well the physical layout of equipment.ERP to MES to DCS PublicUtilizing S-

15、88 Principles with lack of Product-specific automation enables Program-to-Program reuseLow customization,minimal qualification efforts,and standard structure enable integration with more systems without complexitySimilarities in how we make a product allows for generic master batch records and SOPS,

16、creating consistent approach which reduces operator errors and increases Right First Time.Allows agile iterative improvements over time,focusing on where flexibility is needed and isnt to maintain sustainability Standardizing flexibilityScale Out vs Scale Up while Standardizing FlexibilityFlexibilit

17、yAutomation freedom Proof of conceptStandardized FlexibilityAutomation support to early phaseLoS for control tools for commercial productionAutomation&Control SMEsTechnical SMEsCommercialLate ClinicalEarly ClinicalDev.&Tox9PublicSimplicity and flexibility enable agility10“Follow Me”Right content,on

18、rightdevice at right timeStandardizing on enterprise systems allows for a uniform approach that operators have with the process.Most companies are very good at collecting data,but not as much at putting it to use.Leveraging those enterprise systems allows for almost real-time visualization of the da

19、ta across digital signage,ensuring tight coordination between areas,and escalationAgilityData Analysis Aggregated data providing insights to trendsPublicAgility from many aspectsBusiness processesAlarm Rationalization Flexibility on whoTechnologyFlexibility in AutomationIntegration of PATBehaviorsPr

20、ocess Understanding Risk Based With Integration of Advanced Analytics and PAT into the process we move to Closed-loop control.Increases process performance,reliability,and quality reducing the amount and effort associated with the lifecycle in offline testing.Business Processes aligned with that tec

21、hnology allow people to flow to the work and focus on what is most important.More focused staff to make better risk-based decisions.Agility11PublicChallenges12Integration with OEM systems required more time due to challenges finding needed information.Native DeltaV systems went smoother.The speed of

22、 the project required implementing new Ways of Working to enable more parallel activities.Risk Based Approach taken regarding COTs system,but COTs while standard are not always error free,challenging the scheduleDesign of Modular SU Assemblies can be challenging balancing flexibility with supply cha

23、in.While we achieved an impressive speed,we were not without our challenges to over-comeNot all Instruments have Industrial Ethernet,and not all support every protocol,putting more effort in integration.Longevity precision data not always available for SU sensors,needing additional controls to manag

24、e.PublicSummary13 18 months faster build 30%COGs reduction 750 hrs savings/transfer -Reduce supply chain risks,by having over 50%of the same components in use at other facilities-Enable Lights-Out-Manufacturing staffing only during normal business week,managing out of hours work by exception/escalat

25、ion via automation-30-50%reduction of overall resources and administration needed to run plant-Industry 4.0 Concepts (AI/ML)can further improve efficiency /COGs 80%Carbon Footprint reductionSingle Use CM vs Stainless Steel BenefitsDigital Strategy&Platform EnabledPublicAcknowledgmentsMSD SwitzerlandMihai Buciu Alexandra DavidAkos FerencziIvan KrizonovicAndreas BergeSteven AltdorferNadja Hoesli14Questions -please defer to Panel Session Merck&Co.,Inc.,Rahway,NJ USAMark BrowerPatricia RowickiDouglas OtteJ.P.DevoeMSD IrelandTimothy Reilly Cathy McFerranTobias Zumbuhel