AvailABIlity:Europe(1),USA(2),other(3)
Content:1unitOverview
TheClini
MACSProdigy
?representsthenextgenerationinautomatedcellprocessing.Thisdeviceoffersadvancedintegratedsolutionstostreamlinecellprocessingworkflowsfromcellseparationthroughcellculturetoformulationofthefinalproduct.
Disclaimer
TheCliniMACS?Systemcomponents,includingReagents,TubingSets,Instruments,andPBS/EDTABuffer,aredesigned,manufacturedandtestedunderaqualitysystemcertifiedtoISO13485.
IntheEU,theCliniMACSSystemcomponentsareavailableasCE-markedmedicaldevicesfortheirrespectiveintendeduse,unlessotherwisestated.TheCliniMACSReagentsandBiotinConjugatesareintendedforinvitrouseonlyandarenotdesignatedfortherapeuticuseordirectinfusionintopatients.TheCliniMACSReagentsincombinationwiththeCliniMACSSystemareintendedtoseparatehumancells.MiltenyiBiotecasthemanufactureroftheCliniMACSSystemdoesnotgiveanyrecommendationsregardingtheuseofseparatedcellsfortherapeuticpurposesanddoesnotmakeanyclaimsregardingaclinicalbenefit.Forthemanufacturinganduseoftargetcellsinhumansthenationallegislationandregulations-e.g.,fortheEUtheDirective2004/23/EC("humantissuesandcells"),ortheDirective2002/98/EC("humanbloodandbloodcomponents")-mustbefollowed.Thus,anyclinicalapplicationofthetargetcellsisexclusivelywithintheresponsibilityoftheuserofaCliniMACSSystem.
IntheUS,theCliniMACSCD34ReagentSystem,includingtheCliniMACSPlusInstrument,CliniMACSCD34Reagent,CliniMACSTubingSetsTSandLS,andtheCliniMACSPBS/EDTABuffer,isFDAapproved;allotherproductsoftheCliniMACSProductLineareavailableforuseonlyunderanapprovedInvestigationalNewDrug(IND)applicationorInvestigationalDeviceExemption(IDE).
CliniMACSMicroBeadsareforresearchuseonlyandnotforhumantherapeuticordiagnosticuse.Unlessotherwisespecificallyindicated,MiltenyiBiotecproductsandservicesareforresearchonlyandnotfortherapeuticordiagnosticuse.
Details
TheCliniMACSProdigyoffersaflex
IBLeplatformforcellprocessingapplicationsenablingthemagneticseparationofdifferentcelltypesaswellascustomizedcellprocessingprotocols.
Thecellprocessingunitforfullyautomatedwashing,fractionationandcultivationofcellsrepresentsanintegralcomponentoftheCliniMACSProdigy.Forindividualprocedures,itwillrequireasingle-usechamber,whichisincludedaspartofspecificCliniMACSProdigyTubingSets.ALayerDetectionCameraautomaticallydeterminestheoptimalcellfractionationendpointbydiscerningthemacroscopiclayersofthesourcecellproduct.
ThemagneticcellseparationunitcomprisesasecondintegralcomponentoftheCliniMACSProdigyenablingthemagneticseparationofvirtuallyanycelltype.
Applications
TheCliniMACSProdigyhasbeendevelopedasanintegratedcellprocessingdeviceinordertoautomateandstandardizethecompletemanufacturingprocessofcellularproducts:
- Fractionationofstartingmaterial
- Cellwashing
- Targetcelllabeling
- Magneticcellseparation
- Cellcultivation
- Volumereduction
- Finalproductformulation