Description
Intendeduse:CTS™ImmuneCellSRisintendedtobeusedasaserumreplacementincellandtissuecultureofclinicalsamples.Theproductisforinvitrodiagnosticuse.
CTS™ImmuneCellSerumReplacement(SR)isdesignedtosupportexpansionofinvitroculturedhumanimmunecellssuchasTcellswhenaddedtoabasalcellculturemediasuchasCTS™OpTmizer™TcellExpansionSFMorCTS™AIM-V®SFM.CTS™ImmuneCellSRisadefinedxeno-freeformulationanddoesnotcontainbovineorothernon-human,animal-derivedcomponents.
•Minimizesthesupplyandsafetyrisksassociatedwithhumanserum
•SupportsexpansionofpolyclonalTcells(CD3/CD28bead-activated,OKT3mAb-activated,virus-specificandtumor-specificTcells)
•SupportsTcellphenotype(CD4,CD8,andCD62L)similartohumanserum
•Supportsexpansionofgene-modifiedCARTcells(lentiviraltransduction)
•Reducesthecostandtimeassociatedwithqualifyinghumanserum
•Genericenoughtousewiththebasemediaofyourchoice
SecurityofsupplyandsafetyCTS™ImmuneCellSRisadefinedxeno-freeformulationthatcontainsnobovineorothernon-human,animal-derivedcomponentsattheprimarycomponentlevel.ThesiteisFDAregisteredandhasanISO13485-certifiedqualitymanagementsystem.ThemethodsandcontrolsusedforthemanufacturingareinconformitywithcurrentGoodManufacturingPracticesformedicaldevices,21CFRPart820,oftheregulation.Fulltrace
ABIlitydocumentationsuchasCertificateofOrigin,CertificateofAnalysis,andDrugMasterFileareavailable.Theproductcanbescaledtomeetfutureclinicalandcommercialdemand.Alternatemanufacturingsitesareavailableasfurtherriskmitigation.
TcellqualifiedCTS™ImmuneCellSRcanreplacehumanserumatsimilarconcentrationsandachievesimilarperformance.CTS™ImmuneCellSRsupportsexpansionofpolyclonalTcells(CD3/CD28bead-activatedandTILs),TCellphenotypes(CD4,CD8andCD62L),andexpansionofgene-modifiedCARTcells(lentiviraltransduction).Everylotispre-qualifiedinafunctionalTcellassayusingCTS™Dynabeads®CD3/CD28-activatedprimaryTcellstoensureconsistentperformance.Thisreducesthecostandtimeassociatedwithhumanserumlottesting.
VersatilityCTS™ImmuneCellSRcanreplacehumanserumatsimilarconcentrationswithoutsacrificingperformanceinseveraldifferentbasemediasuchasCTS™OpTmizer™TCellExpansionSFMandCTS™AIM-V®SFMorothercommercialmediadesignedforimmunecells.VaryingdilutionsofCTS™ImmuneCellSRshouldbetestedtodeterminetheoptimalconcentrationneededforyourcelltypeandbasalmedia.
WhatyougetCTS™ImmuneCellSRisavailableina50mLbottleforsmallvolumeusersaswellasa500mLbottleforlargervolumeusers.Foraddedconvenience,theproductcanbefreeze-thawedonceifsmalleraliquotsareneeded.CTS™ImmuneCellSRcanbeaddedtoyourstandardbasemediaatsimilarconcentrationsashumanserum.
ForInVitroDiagnosticUse.