MatTek’spatentedEpiDermsystemisaleADInginvitrotestingtechnologyfordermaltoxicologistsandformulationscientists.WithmultipleECVAMvalidationsandOECDacceptedtestguidelines,EpiDermisaproveninvitromodelsystemforchemical,pharmaceuticalandskincareproducttesting.SkinIrritation(OECDTG439)andCorrosion(OECDTG431)TestingProducedunderGMPExcellentinvitro–invivocorrelationTechnology:AlsoknowngenericallyasaReconstructedHumanEpidermis(RHE),EpiDermisaready-to-use,highlydifferentiated3Dtissuemodelconsistingofnormal,human-derivedepidermalkeratinocytes(NHEK)culturedonspeciallypreparedtissuecultureinserts.TissueCultureInsertCulturedattheair-liquidinterface(ALI),EpiDermallowsfortheevaluationoftopicallyappliedcompounds,chemicals,cosmetic/personalcareproductingredientsandfinalformulations.Withourstraightforwardprotocolsand20+yearsofdata,EpiDermisthegoldstandardforabroadrangeofhighlypredictiveinvitroapplications.EpiDermexhibitshumanepidermaltissuestructureandcellularmorphologywithgreateruniformityandreproducibility.It’s3Dstructureconsistingoforganizedandproliferativebasalcells,spinousandgranularlayers,andcornifiedepidermallayersaremitoticallyandmetabolicallyactive.Applications:TheEpiDerm3Dhumantissuemodelisusedacrossadiverserangeofapplicationsincludingsafetyandriskassessment,andBIOLOGicalefficacy.WithAir-liquidInterface(ALI)culturetechnology,EpiDermcanbeusedtoevaluatebiologicalresponsestotopicalapplicationsofformulationsoringredients.Simpleprotocolsandtheevaluationofearlycellularendpointsallowresearchtoacquiredataindays,notweeksormonths.SkinIrritation(OECDTG439)UseEpiDermtodeterminetheskinirritationpotentialofliquids,solids,gels,lotions,ointmentsorcreams.TissueviABIlityresultsareacquiredwithin3days.SkinIrritationTestProtocolSkinCorrosion(OECDTG431)Determinetheskincorrosionpotentialoftestmaterialsinasingleday.SkinCorrosionProtocolSkinHydrationMeasuretheelectricalimpedanceofEpiDermtoassesstheefficacyoftopicallyappliedmoisturizersincludingcreams,gelsandlotions.TheSkinHydrationprotocolallowsfordataanalysiswithin24hours.SkinHydrationApplicationNoteDermalDrugDeliveryUtilizeexistingtransdermalpermeationequipmentorMatTek’ssimplesingleinsertpermeationdevicestoassessAPIpermeationandflux.DeterminerelativesafetywiththeEpiDermMTTET-50assay.PercutaneousAbsorptionProtocolPhototoxicityIdentifyphototoxiceffectsoftopicalorsystemictestsubstancesusingtheEpiDermPhototoxicityAssay(pre-validated)PhototoxicityProtocolDermalGenotoxicityIdentifygenotoxiceffectsoftopicalorsystemictestsubstancesusingEpiDermGenotoxicityAssays(pre-validated)MicronucleusAssayProtocolCometAssayProtocolEpidermalDifferentiationEvaluateactivecompoundsforeffectsonepidermaldifferentiationusingtheunder-developedEpiDermtissuemodelBrowseourreferencelibrarytoseehowourEpiDermtissuehasbeenusedintheseareasofstudy. a[rel~="mtli_filesize109MB"]:after {content:" (1.09 MB)"}a[rel~="mtli_filesize79407kB"]:after {content:" (794.07 kB)"}a[rel~="mtli_filesize48179kB"]:after {content:" (481.79 kB)"}a[rel~="mtli_filesize22423kB"]:after {content:" (224.23 kB)"}a[rel~="mtli_filesize14213kB"]:after {content:" (142.13 kB)"}TechSpecs:TissueKit:AstandardEpiDermkit(EPI-200)consistsof24tissues.(Tissue“kits”containtissues,asmallamountofculturemedium,andplasticware;contactMatTekforspecifickitcontents)Formats:9mm&22mmindividualinsertsand96-wellHTSplates–tissueculturesubstrateischemicallymodifieswithaporesizeof0.4μmCulture:Air-liquidinterfaceHistology:8-12celllayersplusstratumcorneum(basal,spinous,andgranularlayers)Lotnumbers:Tissuelotsproducedeachweekareassignedaspecificlotnumber.Aletterofthealphabetisappendedtotheendofthelotnumbertodifferentiatebetweenindividualkitswithinagivenlotoftissues.Alltissuekitswithinalotareidenticalinregardstocells,medium,handling,cultureconditions,etc.Shipment:At4°Conmedium-supplemented,agarosegelsShipmentday:EveryMonday.ShipmentonThursdayalsopossIBLeuponspecialrequestDelivery:TuesdaymorningviaFedExpriorityservice(US).OutsideUS:Tuesday-ThursdaydependingonlocationShelflife:Includingtimeintransit,tissuesmaybestoredat4°Cforupto6dayspriortouse.However,extendedstorageperiodsarenotrecommendedunlessnecessary.Inaddition,thebestreproducibilitywillbeobtainediftissuesareusedconsistentlyonthesameday,e.g.Tuesdayafternoonorfollowingovernightstorageat4°C(Wednesdaymorning)Lengthofexperiments:Culturescanbecontinuedforupto3weekswithgoodretentionofnormalepidermalmorphology.Culturesmustbefedeveryotherdaywith5.0mloflonglifemaintenancemedium(EPI-100-LLMM),standardmaintenancemedium(EPI-100-MM),ornewmaintenancemedium(EPI-100-NMM).Extendedcultureexperimentsrequiretheuseofculturestands(MEL-STND;seephoto)orwashers(EPI-WSHR)in6-wellplatestoallowforculturingin5.0mlofculturemediumCellsType:Normalhumanepidermalkeratinocytes(NHEK)Geneticmake-up:SingledonorDerivedfrom:Neonatal-foreskintissue(NHEK)Alternatives:NHEKfromadultbreastskinScreenedfor:HIV,Hepatitis-B,Hepatitis-C,mycoplasmaMediumBasemedium:Dulbecco’sModifiedEagle’sMedium(DMEM)Growthfactors/hormones:Epidermalgrowthfactor,insulin,hydrocortisoneandotherproprietarystimulatorsofepidermaldifferentiationSerum:NoneAntibiotics:Gentamicin5µg/ml(10%ofnormalgentamicinlevel)Anti-fungalagent:AmphotericinB0.25µg/mlpHIndicator:PhenolredOtheradditives:Lipidprecursorsusedtoenhanceepidermalbarrierformation(proprietary)Alternatives:Phenolred-free(EPI-200-PRF),antibiotic-free(EPI-200-ABF),anti-fungal-free(EPI-200-AFF),orhydrocortisone-freemediumandtissue(EPI-200-HCF)areavailable.Agentsareremovedatleast3dayspriortoshipment.PleasediscussyourspecificmediaformulationandtissueneedswithMatTekscientificpersonnelbeforeplacingyourorder.Assay/Maintenancemedium:Threemaintenancemediaareavailable.EPI-100-MMisequivalenttotheassaymediumusedforshorttermtoxicologicaltesting.LongLifeMaintenanceMedium,EPI-100-LLMM,containsα-MSHandβ-FGF.NewMaintenanceMedium,EPI-100-NMM,containsKeratinocyteGrowthFactor(KGF),butdoesnotcontainα-MSHandβ-FGF.Althoughallmediawillresultingoodretentionofepidermalmorphologyforupto3weeks(5.0mlchangedeveryotherday),useofEPI-100-NMMwillgivetheoptimalhistologyforlongtermstudies.QualityControlandSterilityVisualinspection:Alltissuesarevisuallyinspectedandifphysicalimperfectionsarenoted,tissuesarerejectedforshipmentEnd-usetesting:Tissuesareexposedto1%TritonX-100for4,6,8and12.5hours.Thetimeofexposurerequiredtoreducethetissueviability(ET-50)usingtheMTTviabilityassayisdetermined(SeeMatTekEpiDermMTTET-50Protocol)foreachlotoftissue.ET-50’smustfallwithintherangeofthe1996EpiDermdatabaseof4.77–8.72hours.ET-50’sincustomers’labsmaydifferslightlyfromtheMatTekresults.Sterility:Allmediausedthroughouttheproductionprocessischeckedforsterility.Maintenancemediumisincubatedwithandwithoutantibioticsfor1weekandcheckedforsterility.Theagarosegelfromthe24-wellplateusedforshippingisalsoincubatedfor1weekandcheckedforanysignofcontaminationScreeningforpathogens:AllcellsarescreenedandarenegativeforHIV,hepatitisBandhepatitisCusingPCR.However,noknowntestmethodcanoffercompleteassurancethatthecellsarepathogenfree.Thus,theseproductsandallhumanderivedproductsshouldbehandledatBSL-2levels(biosafetylevel2)orhigherasrecommendedintheCDC-NIHmanual,“Biosafetyinmicrobiologicalandbiomedicallaboratories,”1998.Forfurtherassistance,pleasecontactyoursiteSafetyOfficerorMatTektechnicalserviceNotificationoflotfailure:IfatissuelotfailsourQCorsterilitytesting,thecustomerwillbenotifiedandthetissueswillbereplacedwithoutchargewhenappropriate.BecauseourQCandsterilitytestingisdonepost-shipment,notificationwillbemadeassoonaspossible(Undernormalcircumstances,ET-50failureswillbenotifiedbyWednesday5p.m.;sterilityfailureswillbenotifiedwithin8daysofshipment)