通过一次性使用和自动化提高设施灵活性.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