Single-use Technology

Single-useTechnology–EvaluationandSuitabilityandProcessEconomyinBiopharmaceuticalManufacturingSincetheintroductionofdisposablesandgainingpopularityofSingle-useTechnology(SUT)forbiopharmaceuticalmanufacturingthereisneverthelessanongoingcontroversialdiscussionontheadvantagesanddisadvantagesversusaconventionalstainlesssteelenvironment.Oncetheconceptforthegeneraloperationofthefacilityinquestionhasbeenestablished,theselectionandchoiceofequipmenthastobemade,theirfootprintwilldefinetherequiredspace,andmostlikelyandpreferablytheyarebasedontheintendedmanufacturingprocess(es):Howmuchandtowhatdetailistheintendedprocessdefined?Whichvolumesneedtobehandled?Howmanytanks/containersofwhichvolumearerequired?Whatscaleofequipmenttochoose?Thismayillustratethatinspiteofprocesseconomyandcommercialprofitasuitabledevelopmentanddesignofamanufacturingprocesscanonlybeasgoodasthemanagementforecastfortheproduct’smarket.Afterall,atailoredprocessdesignisfinallydecisivefortheoverallcommercialproductioneconomy.The“flexible”approachusingdisposablesandsingle-useequipmentcanoffersignificantadvantagesregardingchangeoverworkandtimethusahighthroughputofdifferentprocesseswilldefinitelytakeprofitasanycleaningandrelatedvalidationandcostlyanalyticsdoesn’tapplytoalargerextent.Despitethepotentialbenefitsloudlyadvertisedbytherespectiveindustry,thesepotentialadvantagesderivedfromsingle-useequipmentanddisposablescanbesignificantlydiminishedbylackofdetailedprocesscostanalysis,missingeconomicanalysisandcostcomparisonbetweenconventionalandSUtechnologiesaswellasunderestimatingthecostoflongtermdependencyonconsumables.Duetomissingappropriatestandards,thereisawidelynon-compatibilitybetweentheequipmentandconsumablesofthevarioussuppliers,resultinginastrongdependenceontheconsumablesofasinglesupplieronceasingle-useequipmenthasbeenpurchased,curiouslyleavingsomecustomerswithsurprisethattheyhardlyhaveanyroomforpricenegotiationsontherequiredconsumables.“TheChinaBiomanufacturingSingleUseConference2017”tobeheldonthe26th-27thinOct.ShanghaihasinvitedDr.JoachimWalterfromWalterBiotechConsultancytodiscusstheevaluationandsuitabilityandprocesseconomyofsingleusetechnologyinbiopharmaceuticalmanufacturing.Dr.Walter’spresentationwillfocusontheverydifferentargumentsfortheapplicationofSUequipmentandconsumables,includingadvantagesandlimitationsofSUT,understandingimprovementofprocessrobustness,contributiontoleanproductionaswellasenvironmentalimpactofdisposables.Inaddition,Ms.VickyXiatheProjectDirectorfromBioPlanAssociates,Inc.willpresentonthetopicof10-YearTrendsinGlobalSingle-useTechnologies,andSUSAdoptionbyChina’sRapidlyGrowingBiopharmaIndustry;Mr.JasonLi,theVicePresidentGenorBiopharma/WalvasBiotechnologywilldiscusstheDevelopmentandApplicationTrendsofOneSingleUseTechnologyintheDownstreamProcessofBiopharmaceuticalindustry;andMr.WeiKang,theSeniorProcessSpecialistofNNEwilltalkabouttheengineeringdesignforbiologicsfacilitywithglobalpractice.“TheChinaBiomanufacturingSingleUseConference2017(BSUT2017)”willgather200+worldwideleadingbiopharmaceuticalcompanies,biotechnologycompanies,CDMOs/CMOs;Singleusesolutionproviders,Materialssuppliers,AssociationsandRegulatorsetc.toaddressstandardsandguidanceprotocolsthataddresstheuseofdisposableproductsandsingleusesystemsinbiomanufacturing;Singleusesystemverificationrequirementsandlocalizedverificationservices;theprocessandpatientsafetyissuesassociatedwithleachablesandextractables;DiscusstheinteroperabilityofSingleUseSystem;HowtoControltheRiskintheSupplyChainetc.industryhotissues,tohelpyouIdentifytherightstrategyforimplementingdisposableproductsandsingleusesystems;buildupprofitableandsustainablebusinesspartnershipandachievesuccessin2017andbeyond!Formoreinformationandregistrationaboutthisconferencepleasecontact:Mr.KlausQian021-52710299*8002；Klaus.qian@grccinc.comhttp://www.biomanufacturingsingleuseconference.com/