AvailABIlity:Europe(1),USA(2),other(3)
Content:7.5mLOverview
CD3isexpressedonallTcellsandisassociatedwiththeTcellreceptor.Approximately70–80%ofhumanperipheralbloodlymphocytesand65–85%ofthymocytesareCD3+.
TheClini
MACSCD3ProductLineconsistsofmurineanti-CD3monoclonalantibodiesconjugatedtosuperparamagneticirondextranparticles.
Onevialcontains7.5mLsterile,non-pyrogenicsolution.
TheperformanceoftheCliniMACSCD3ProductLinedependsontheindividualseparationstrategy.Forinformationonrespectivecapacities,refertotheCliniMACSUserManualorcontactyourlocalrepresentative.
PleaseinquireaboutrequiredCliniMACSSystemcomponentsandaccessories.
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
Applications
TheCliniMACSCD3ProductLinewasdevelopedforthedepletionofunwantedTcellsfromhumanheterogeneoushematologiccellpopulationsincombinationwiththeCliniMACSSystem.Thisapproachmaintainsthestemcellsandimmuneeffectorcells,suchasNKcells,inthecellularproduct.1,2TheCliniMACSCD3ReagentcanalsobeusedincombinationwiththeCliniMACSCD19ReagenttoadditionallyremovetheCD19+Bcellsfromthegraft.3,4
InordertogeneratehighlypurifiedCD56+CD3–NKcells,theCliniMACSCD3ReagentisusedincombinationwiththeCliniMACSCD56Reagent.Inthisapproach,thecellularproductisfirstdepletedofCD3+cellsandthenfurtherenrichedforCD56.5–7
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