MatTek/EpiCorneal™/epicorneal/1 Ea

MatTek’sEpiCornealtissuemodelconsistsofnormalhumancornealepithelialcellsculturedtoformastratified,squamousepitheliumwhichcloselyparallelsnormalhumancornealtissue.Thecornealcells,culturedonspeciallypreparedcellcultureinsertswithserum-freemedium,differentiatetoformamulti-layeredstructure.

Usedindrugdeliveryanddrugdevelopment,EpiCornealisamitoticallyandmetabolicallyactivetissuewithbarrierpropertiesapproachingthoseofthehumancornea.EpiCornealcanbestimulatedtoreleasemanycytokinesknowntobeimportantininflammationanddiseasessuchasdryeye.Further,theadvanced3Dtissuemodelexpressescorneaspecificdrugtransportersandmetabolizingenzymes.

CornealDrugDeliveryandCornealToxicity

EpiCornealcloselyrecapitulatesthephysiology,3Dtissuearchitecture,andfunctionofthehumancorneaforuseinpharmaceuticaldevelopmentapplications.

ContactDr.YuliaKaluzhnyformoreinformation.

Tissue

Kit:AstandardEpiCornealkit(COR-100)consistsof24tissues.(Tissue“kits”containtissues,asmallamountofculturemedium,andplasticware;contactMatTekforspecifickitcontents)

Formats:9mmindividualinserts–tissueculturesubstrateischemicallymodifiedwithaporesizeof0.4μm

Culture:Air-liquidinterface

Histology:4-5celllayers–stratified,squamousmorphologyandtissuestructure

Lotnumbers:Tissuelotsproducedeachweekareassignedaspecificlotnumber.Aletterofthealphabetisappendedtotheendofthelotnumbertodifferentiatebetweenindividualkitswithinagivenlotoftissues.Alltissuekitswithinalotareidenticalinregardstocells,medium,handling,cultureconditions,etc.

Shipment:At4°Conmedium-supplemented,agarosegels

Shipmentday:EveryMonday

Delivery:TuesdaymorningviaFedExpriorityservice(US).OutsideUS:Tuesday-Thursdaydependingonlocation

Shelflife:Includingtimeintransit,tissuesmaybestoredat4°Cforupto3dayspriortouse.However,extendedstorageperiodsarenotrecommendedunlessnecessary.Inaddition,thebestreproducibilitywillbeobtainediftissuesareusedconsistentlyonthesameday,e.g.Tuesdayafternoonorfollowingovernightstorageat4°C(Wednesdaymorning)

Cells

Type:Normalhumancornealepithelialcells(HCEC)

Geneticmake-up:Singledonor

Derivedfrom:Healthydonor

Screenedfor:HIV,Hepatitis-B,Hepatitis-C,mycoplasma

Medium

Basemedium:Dulbecco’sModifiedEagle’sMedium(DMEM).

Growthfactors/hormones:Epidermalgrowthfactor,insulin,hydrocortisoneandotherproprietarystimulatorsofcornealepithelialdifferentiation.

Serum:None.

Antibiotics:Penicillin(50U/ml)/Streptomycin(50µg/ml)

Anti-fungalagent:AmphotericinB(0.125µg/ml).

pHIndicator:Phenolred.

Alternatives:Phenolred-free,antibiotic/anti-fungal-free,orhydrocortisone-freemediumandtissueareavailable.Agentsareremovedatleast3dayspriortoshipment.

Maintenancemedium:MostexperimentswithEpiCorneal™areperformedwithin48hours.However,forlongerexperiments,thetissuecanbemaintainedinCOR-100-MM(identicaltoEpiCorneal™assaymedium).

QualityControlandSterility

Visualinspection:Alltissuesarevisuallyinspectedandifphysicalimperfectionsarenoted,tissuesarerejectedforshipment

Sterility:Allmediausedthroughouttheproductionprocessischeckedforsterility.Maintenancemediumisincubatedwithandwithoutantibioticsfor1weekandcheckedforsterility.Theagarosegelfromthe24-wellplateusedforshippingisalsoincubatedfor1weekandcheckedforanysignofcontamination

Screeningforpathogens:AllcellsarescreenedandarenegativeforHIV,hepatitisBandhepatitisCusingPCR.However,noknowntestmethodcanoffercompleteassurancethatthecellsarepathogenfree.Thus,theseproductsandallhumanderivedproductsshouldbehandledatBSL-2levels(biosafetylevel2)orhigherasrecommendedintheCDC-NIHmanual,“BiosafetyinmicroBIOLOGicalandbiomedicallaboratories,”1998.Forfurtherassistance,pleasecontactyoursiteSafetyOfficerorMatTektechnicalservice

Notificationoflotfailure:IfatissuelotfailsourQCorsterilitytesting,thecustomerwillbenotifiedandthetissueswillbereplacedwithoutchargewhenappropriate.BecauseourQCandsterilitytestingisdonepost-shipment,notificationwillbemadeassoonaspossIBLe(Undernormalcircumstances,ET-50failureswillbenotifiedbyWednesday5p.m.;sterilityfailureswillbenotifiedwithin8daysofshipment)