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Table of Contents
Guide to VacciXcell
Upstream BioProcessing
Cell Therapy Processing ............................................................................................. 3
Bioreactors and Fermenters ........................................................................................6
Cell Culture Products ............................................................................................... 14
Formulation
Formulation and Filtration Isolator ..........................................................................21
Filling Line
Robotic Filling ............................................................................................................22
Traditional Filling .......................................................................................................23
Sterility Testing
Sterility Testing Isolator .............................................................................................25
Isolation and Containment Systems
Airflow Containment Products .................................................................................26
Cross Contamination Facility Integrated Barriers ....................................................26
Barrier Isolation Systems ...........................................................................................26
VacciXcell Guide
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ADHERENT BIOPROCESSING SPECIALIST
Cell Processing Center
Features
• Bio-workstationwithHEPA-filteredairflowandUVsterilization
• Aircirculationcanbesinglepassorrecirculating.
• EscoOrbicultTMIncubatorShakerBenchtop
• EscoVersatiTMCentrifuge
• Foot switchdesigned to start and stop centrifugeandincubatorshaker.
• Pressuregaugetomonitordifferentialpressureacrossfilters
andalertuseriffilterreplacementisnecessary.
Applications
• Biologics
• QualityControl
• CellHandlingandManufacturing
• StemCellIsolation
• cGMPProductionofAutologousandAllogeneicTherapy
Esco’sbio-workstationisdesignedtohelpyouproducebiologicsaswellascelltherapyproductsefficiently.Thiseconomicalworkstationisaself-containedsystemthatdeliversanefficientandcosteffectivecGMP-compliantprocessingandmanufacturingsolutionforapplicationsincludingregenerativemedicineandstemcelltherapy.Itisequippedwithallthenecessaryequipmentusedforcellprocessingsuchasabioreactor,centrifuge,incubator,shaker,etc.andisdesignedtobeeasilycustomizeddependingontheclient’srequirements.
Esco’s C-class (ISO 7) modular room
Multi-functionalBio-work station
Self-contained system
Cell Processing Center
The Concept
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VacciXcell Guide
Features
• ULPAfilterswithatypicalefficiencyof99.999%at0.1to0.3micronsprovidesuperiorISOClass5aircleanliness.
• Sentinel™GoldMicroprocessorControlSystemsupervisesallfunctionsandmonitorsairflowandpressuresinreal-time.
• Safeglovechangepermitszeroriskofcontaminatingtheworkzoneorenvironment
• Robustconstructionandenhancedsafetyfeaturesqualifythe Isoclean®HealthcarePlatformIsolatorforthemostdemandinglaboratoryapplications.
• Ergonomically-angledfrontgloveportsimprovereachandcomfort.
• Esco ISOCIDETMantimicrobial coatingonallpaintedsurfacesminimizescontamination.
• Sharpsdisposalsystemandadjustablehydraulicstandareavailableasoptions.
Containment Barrier Isolator (CBI)
Isoclean® Healthcare Platform Isolator (HPI-G3)
Isolatorfacilitatestheisolationofaproductorprocesswhileprovidingtherequiredconditionsforasterile/asepticenvironment.TheCellProcessingIsolatorprovidesacomprehensiverangeofprotection,includingpersonnel,product,surroundingworkarea,andenvironment.
General Applications
• CellProcessing
• ResearchandDevelopment
• AsepticProcessing
• Small-Scalepotentmaterialhandling
• PharmacyCompounding(Chemotherapy/TPN)
• QualityControl
Features
• Controlsexposure/cross-contaminationrisktohazardous/asepticmaterialsforawidevarietyofequipmentandprocesses
• Controlsfalse-positiveriskforsterilitytesting
• ProvidesOperatorExposureLevels(OEL’s)≤1.0μg/m3duringcontrolledoperations
• Levelsof≤0.1μg/m3canbeachievedviaclosed-transferprocessesorbasedonclientSOPs
• EnhancescGMPpractices
• Quiet,energy-efficientandautoadjustableECMfanstocompensateforfilterblockage
• Standarddimensionsareeasilycustomizedtosuitprocessrequirements
• Safeglovechangeandlowcontaminationfilterchange
• FDA-approvedstaticseals
• Pressuretestedclass2ISO10648-2standards
• SystemcomeswithaSemi-automatedorAutomatedPressureHoldTesting
• ConfigurableasClassIIICabinetforBiosafetyLevel(BSL)3and4applications
Upstream BioProcessing - Cell Therapy Processing
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ADHERENT BIOPROCESSING SPECIALIST
CradlePro-IsoCradlePro-IsofullyenclosestheentirecellprocessingprocedureinacGMPisolator.ItfeaturesVacciXcell’sCelCradle™bioreactorsystem,EscoCO2Incubator,EscoOrbicult™Shaker,andEscoVersati™Centrifugeina4-glovedHPI-G3Isolator.
TheCelCradle™bioreactor system iscapableof supportinghigh-densitycultureofadherentoranchorage-dependentcells.Each CelCradle™bottlecanproduceupto5billion(5x109)cellsdependingonthecellline.TheCelCradle™systemoperatesunderthetidemotionprinciple,whereincellsentrappedwithinBioNOC™IIcarriersarealternatelyexposedtoaerationandnutrition.Thisprovidescellswithanenvironmentoflowshearstress,nooxygenlimitation,andnobubblingorfoamingwhichleadslinearscaleup.
EscoCO2incubatorprovidesthebesttemperatureandCO2control,resultinginsuperiorprotectionofcells.TheOrbicult™Shakerprovidestheautomatedshakingfunctionduringcellseedingandcellharvesting,whiletheVersati™Centrifugeseparatesthelivecellsfromothercomponentsduringcellharvesting.
TheCradlePro-Isocanbeeasilycustomizeddependingontheclient’srequirements.
Features
• Speciallydesignedincubatorforisolatorintegrationenablesevenheatinginsidetheincubator
• Simplepressuretestprotocol
• IsolatorprovidesISOClass5environmentinworkzone
• SteriSafeULPA-filteredgasinjectionlines
• Integrated0.22µmhydrophobicPTFEfilterontheCelCradle™bottlecap
• IndividualcontrolofCelCradle™compressionandOrbicult™shakingfunctionenablesindependentuseoftheCelCradle™bottles
• SpeciallytreatedBioNOC™IIcarrierssupportthegrowthofmostadherentcells
Applications
• Autologouscelltherapy–1CelCradle™bottleperpatient
• Vaccineresearch,especiallyforwildtypeandBSL3/4viruses
• Cellbanking
• Proteinresearch
Additional Options
• Microscope
• Liquidtransfersystem
• Benchtopfillingmachine
• BiovapH2O2biodecontaminationsystem
• GloveLeakTester
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VacciXcell Guide
Laboratory Scale Tide Motion Bioreactor: CelCradleTM
CelCradleTM is a cost-effective, single-use,benchtopbioreactorsystemcapableofsupportingthehigh-densitycultureofadherentoranchorage-dependentcells. It isdesignedbasedon theconceptofbellow-inducedintermittentflowofmediaandairthroughporousmatriceswherecellsreside.Thisprovidesalowshearstress,highaeration,andfoam-freecultureenvironment.
During operation, the CelCradle™ bottleis partially filled with culture medium andinoculatedwithcells.Theculturemedium israisedand loweredalternately, to submergeinculturemediumandexposethematricestooxygen,creatingadynamicinterfacebetweenairandmediaonthecellsurfacetomaximizenutrient uptake andoxygen transfer.Whenmatricesexposetoair,cellsuptakeoxygenwhileprotectedbythinlayerofmediainmatrices.
TheCelCradleTMbioreactoristhelaboratoryscalesystemofVacciXcell’stidemotionsystem,whichistheonlybioreactorsystemthatistrulyscalableupto5,000L.
Features
• Pre-sterilized,ready-to-use,disposablebottles
• Lowshearstress,foam-free,noO2limitation
• Highproductivity:OneCelCradleTMbottlehasaproductivityequivalentto18-20of850cm2rollerbottles
• Compactdesign:fitsin6ft3CO2incubator
• Easyprocessoptimization
• Linearscaleuptoproductionscale
• Choiceofbatch,fed-batchorperfusionculturemodes
• Scale-upbymultiplyingthenumberofbottlesorupgradetoTideCell®system
• Nospecialculturemedianeeded
• Speciallytreatedcarriersurfacetogrowmostanchorage-dependentcells
• Alloweasyharvestofcellsandsecretedcomponents
Applications
• HumanandAnimalVaccines
• AutologousandAllogeneicCellTherapy
• Cultureofanchorage-dependentoradherentcells
• Mammalianandinsectcellresearch
• Recombinantproteinresearchandproduction
• Switchingrollerbottlesystemtoasingle-useclosedsystemcellculture
• Replacementofmicrocarrier-stirredtankbioreactortechnology
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ADHERENT BIOPROCESSING SPECIALIST
Laboratory Scale Fermenter: StirCradleTM
TheStirCradle™isabenchtopstirredtankbioreactorsystemthatcandoubleupbothasafermenterandasabioreactor,suitableformicrobialfermentationandsuspensioncellculture.Itisaversatilesystem,capableofsupportingthegrowthofdifferenttypesofbacteria,yeast,plantcells,insectcells,andmammaliancells.Thissystemisavailableinthreecapacitieswithtotalvolumesof5L,7.5L,and10L.
TheStirCradle™systemfeaturesacontroltowerwithfourbuilt-inperistalticpumps,configurableforautomatedfluidaddition.Italsohasapatentedagitationsystemdesignedtoeffectivelyenhancetheoxygentransferrate.
TheStirCradle™systemisexpandableandcompatiblewithavarietyofaccessoriessuchasoxygenenrichmentdevices,multiplegasdevices,externalpumps,andexhaustgasanalyzer,makingitsuitablefortheclient’scultureprocessrequirements.
Features
• Built-inmemoryforreal-timeculturetrenddata-logging
• FreeVNCapplicationcompatiblewithsmartphones,laptops,andPCforinstantremotemonitoring
• AdjustableTouchScreenHMI
• GlassvesselmadeoftemperedglassfromPyrex(US)orSchott(Germany)
• User-friendlyinterfacewithdynamicreal-timedisplayofthecultureprocess
• Variousimpellerdesignsavailablefordifferentcultureconditions
• Variouslevelsofauthorityaccessensuredataprotection
• FiftyStepControlprogrameffectivelyachievesdetailedsegmentationcontrol
Applications
• Fermentation
• CellCulture
• ResearchandDevelopment
• Biopharmaceuticals
• Proteomics
• Laboratory-scaleproductions
Upstream BioProcessing – Bioreactors and Fermenters
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VacciXcell Guide
Pilot and Production Scale Tide Motion Bioreactor: TideCell®
TheTideCell®BioreactorSystemistheworld’slargestsingle-usebioreactorsystem,whichcanbelinearlyscaledfromseedpreparationtoproductionscaleofupto5,000L.Itisacompleteplatformthatsupportslaboratoryresearchtoprocessdevelopmentandfinalproduction.
OneofthemainadvantagesofVacciXcell’sTideMotionBioreactorsystemisthatitfeaturesthesamebioprocessmethodfromseedpreparationtoproductionscale.Ascertaincelllinesdonotgrowwellwhenfirstculturedin2D(forseedpreparation)thenculturedin3D(forcultivation),VacciXcell’stidemotionsystemallowscellcultivationin3DsystemfromseedpreparationtoproductionbyusingCelCradlle™SystemandsuccessiveTideCell®Systemswithsametidemotionprinciple.
EscoVacciXcell’sTideMotionSystemisthehighestyieldandlowestcostpackedbedbioreactorthatcanbeplacedinsideacGMPisolatoratGradeC-Denvironment,makingitanidealsystemfortheproductionofwild-typeviruses.Thisfeaturereducesthecostsofcleanroomsbydecreasingtherequirementsforpersonnelprotectiveequipment(PPE),utilities,viable/non-viablemonitoringandgowningairlocks,whichareallneededinlargerGradeAandBcleanrooms.
Principle
ThetwomaincomponentsoftheTideCell®SystemaretheTideCell®IncubationandControlSystem(TCICS)andtheTideCell®MixingSystem.TheTideCell®IncubationandControlSystem(TCICS)housesthematrixvesselthatholdstheBioNOCTMIIcarriers,whichcellattachtoandgrow,whiletheMixingSystemholdstheculturemedium.TheculturemediumflowsbetweentheMixingSystemandmatrixvesselusinganairpump.
Whenthematrixvesselisfilledwiththeculturemedium,thecellsareexposedtonutrition.Ontheotherhand,whentheculturemediumispumpedbacktothemixingtank,thecellsareexposedtoaerationinwhichexchangeofO2andCO2occurs.Theintermittentflowofmediaandairexposurearesimilartotheprincipleofrollerbottlesystem.
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ADHERENT BIOPROCESSING SPECIALIST
Key Benefits and Features
• Linearlyscalableupto5,000L
• Highproductivity
• Lowerdownstreamprocessingcostsduetolowercelldebris
• Closed,automated,andcontrolledcultureprocess
• Smallspace,utilities,andlaborrequirements
• MinimalbioprocessingoptimizationtimefromR&Dtopilotandproductionscaleduetofasterandeasiertechnology
• Provenvaccineproductioncasesforvarious indicationsincludingHepatitisAandrabies
• Theonlypilot/production scalebioreactor that canbeintegratedintocGMPisolator
Applications
• Cultureofadherent(anchorage-dependent)cells
• Switchingfromrollerbottlestoaclosedandcontrolledsystem
• Humanandanimalvaccinesincludingwildvirusproduction
• Proteinandantibodyproduction
• AllogeneicCellTherapy
• Biosimilarsandbiobetterproduction
• Lowcostvaccineproductionforneglectedtropicaldiseasesandorphandiseases
• CellMassTrainproduction
• Perfusionandcontinuousprocessingatlowercosts
System Comparison
ModelFixed-BedVolume (L)
Culture SurfaceArea (m2)
Equivalent Roller Bottles
(850 cm2)
Equivalent CS-40(25,200 cm2)
Equivalent Cytodex II(0.44 m2/g)
CelCradleTM 0.1 1.65 20 0.65 3.75g
TideCell®-002 1-4 66 800 26 150g
TideCell®-010 5-10 165 2,000 65 375g
TideCell®-020 10-20 330 4,000 130 750g
TideCell®-100 50-100 1,650 20,000 650 3,750g
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VacciXcell Guide
Components and Accessories
Incubation and Control System
Matrix Vessel
TideCell® Incubationand Control System
Mixing SystemFeed/Harvest Tanks
Matrix Vessel AutoFeeder-1200Auto-switch System
TheTideCell®IncubationandControlSystem(TCICS)featurestwoHEPAfilters.ThefirstHEPAfilterisusedtoensuretheairqualityinsidetheincubator,whilethesecondHEPAfilterisusedfortheexhaustairthatallowsthecultivationofBSL3-4virusstrains.Theincubationsystemfurtherprovidesoperator,environment,andsampleprotectionwithitsmagneticdoorinterlockandUVlight.
TheTideCell®IncubationandControlSystem(TCICS)includesaglasswindowonthefrontdoor,whichenablestheusertoobservethematrixvesselwithouttheneedtoopentheincubatordoor,reducingfluctuationsinparametervalues.
VacciXcellofferstwodifferentmodelsoftheTideCell®IncubationandControlSystem:2-20Land100L.Thesystemhasauser-friendlydesignandinterfacewithCFR21Part11compliantcontrols.
VacciXcellprovidesawiderangeofmatrixvesselsdependingonuser’sproductionrequirements.
Single-Use Matrix Vessel Multiple-Use Matrix Vessel
Features TCICS: 2-20L TCICS: 100 L
Matrix Vessel2 L 10 L 20 L 100 L
Multiple-Use Single-Use Multiple-Use Multiple-Use Single-Use Multiple-Use Single-Use
Matrix Volume 1-2L 2-4L 5-10L 10-20L 50-100L
Closed Sampling Port No. 0 1 0 0 1-4 0 1-5
Pre-packed carrier (g) 0 110-220 0 0 550-1100 0 2,750-5,500
Material Glass PP Glass PP PP PP PP
AutoFeeder Integrated/AF-1200 AF-1200
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ADHERENT BIOPROCESSING SPECIALIST
Mixing System Magnetic Stirring System Recirculation ThermostaticMixing System Stir Tank Mixing System
Single/Multiple-use Multiple-use Single-use Multiple-use
ContainerVolume 10L,20L 50L,100L,200L,500L,1,000L 30L,50L,100L,200L,500L,1,000L
Material GlassVessel PPBag StainlessSteel316Vessel
IncubationSystem 2LMatrixVessel 2-100LMatrixVessel 2-100LMatrixVessel
Mixing System
EscoVacciXcell’sTideCell®offersthreedifferenttypesofmixingsystemsdependingonthemixervolumeandtypeofsystemrequiredbytheuser.
Feed/Harvest TankFeed/Harvestsystemisanoptionalsystemthatallowsuserstorunthecultivationinperfusion/continuousmodeforextendedperiodsoftime.
The Feed/Harvest System controls thevolumetricflowofthemediuminandoutbycheckingthemixingtankweight.Inthefed-batchmode,thevolumeofthemediumtobeadded is setandpumped into themixingtankusingtheautofeedersystem.Intheperfusionmode,thetotalweightofthemixingtankismeasuredandthesystemautomaticallyadjuststhevolumetricflowofthemediumtoandfromthemixingvessel,allowingthesamemediumexchangevolumebetweenthefeedandharvesttanks.
Magnetic Stirring System Recirculation Thermostatic Mixing System Stir Tank Mixing System
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VacciXcell Guide
AutoFeeder System
AutoFeedersystemhasthreemajorcontrolfunctions:automaticcontroloffeedandharvestvolumebyweightcalculation,pHcontrol,anddissolvedoxygen(DO)levelcontrol.
Duringfeedingandharvesting,twolargeperistalticpumpsareusedtopumpmediuminandoutataspeedof2,000ml/min.Thisallowsupto900Lofculturemediumtobetransferredperday,whichcanbedividedinto1–96cycles.Astepprogramsystemcanbeusedtosetmediumexchangevolumeinastep-wisemanner.Userscansetthemediumexchangevolumeateachstepandcancreateuptotendifferentsteps.
ForpHcontrol,asmallpumpisusedforthealkaliaddition.Theusercansetthesamplingandflushingtime,aswellasthelowerandupperlimitsofthealarm.DOleveliscontrolledbytheAutofeederthroughlevelsofairandoxygen.
AutoSwitch System
TheAutoSwitchSystemisrecommendediftherearetwofeedingtanksusedduringperfusionculture.Itisconnectedinbetweenthetwofeedingtanks.Thepinchvalveinsidethesystemwilldetectbubbleandautomaticallyswitchfromonetanktoanotheroncethefirstreservoirisempty.Analarmlightwillturnononcethemediainthetankisdepleted;therearetwoindividualalarmlightstoindicatewhichfeedtankisempty.Also,theAutoSwitchSystemincludesin-lineandnon-invasivebubbledetector.
TideCell® Cell Harvesting System
TheTideCell®CellHarvestingSystem(TCCHS)allows theautomatedand closedharvestingofcellsfromthematrixvessel.Theautomatedsystemallows95%viabilityofcellharvestwithin1to3hoursdependingontheharvestcycles.Duringdetachingprocedure, the equipmentshakesthematrixvesselatadistanceof10cmandspeedsofupto300rpm.
Upstream BioProcessing – Bioreactors and Fermenters
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ADHERENT BIOPROCESSING SPECIALIST
Upstream BioProcessing – Bioreactors and Fermenters
Pilot/Production Scale Fermenter: StirCradle-Pro
Applications
• Pilotandproductionscaleoffermentationprocessesofmicrobialssuchasyeast,bacteria,andfungi
• Pilotandproductionscaleofcellculturesuchasinsectcellsandsuspendedmammaliancells
• Pilotandproductionscaleofbiopharmaceuticalsproductssuchasvaccines,recombinantproteins,andmonoclonalantibodies.
Features
• Real-timeculturetrendchartdataloggingwithinternalcontinuousrecordingstorage:
-Upto12.5days:1dataevery30seconds
-Upto25days:1dataeveryminute
-Upto50days:1dataevery2minutes
• QuickdatadownloadviaUSBin.xlsformat
• RemotesharingviaEthernetportorwirelesssharingdevice
• IntegratedLEDlightstofacilitateviewinginsidethetank
• Multipleinoculationoptions
• Fourbuilt-inconfigurablepumps,whichcanbecalibratedandcontrolledbyspeed
• AutomatedSIPsystemforemptyreactorvesselandculturemedium
• OptionalCleaning-In-Place(CIPsystem)
• Optionforbatch,fed-batch,continuous,andsemi-continuousmodes
• Optimumtankdesigntoeliminateblindspots
• SmartimpellerdesignachieveshighbubbledispersionrateefficiencyandkLavalue
• CompleteValidationpackage
• OptionalIQ/OQ/PQdocumentation
• Incaseofpoweroutage,positivepressureiskeptinsidethevesselformorethan24hours
TheStirCradle-Proisafullystainlesssteelsystem,designedwithanautomated5-stepcycleSterilization-In-Place(SIP)systemforbothculturemediumandemptyreactortank.TheStirCradle-Proisavailableinstandardcapacitiesfrom20Lupto1,000L.However,customizedreactorsizesareavailableshouldtheusersrequireit.
StirCradle-Profeaturesvariousenhanceddesignforimprovedperformance,includingareactordesignthateliminatesblindspotsandanimpellerdesignthatincreasesoxygenretentionrate.
VacciXcellfacilitatesscale-upfromlaboratoryscaletopilotandproductionscalebyprovidinganalysisdataasreferenceforscale-upconditions.Moreover,VacciXcelloffersparametricprogrammingandspecialvesseldevelopmentthathelpspeeduptheexperiment.
StirCradle-ProisVacciXcell’spilotandproductionscalefermenter/stirredtankbioreactorthatcompletestheupstreambioprocessingline.
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VacciXcell Guide
BioNOC™ II Carriers
Analytical Tools and Reagents
BioNocTMIIcellculturecarriersarematrixforthegrowthofanchorage-dependentanimal,human,andinsectcells.BioNOCTMIIsupportsgrowthofmanycelllines,includingCHO,CHO-K1,rCHO-hIgG,rC-127-TPA,HEK293,Hybridoma,Vero,Sf-9,Hi-5,BHK-21,rBHK-FactorVIII,HepG2,Hela,Huh7,RK-13,humanforeskinfibroblasts,humanmuscleskeletoncells,humanmesenchymalcells,andhumanembryonicstemcells.
GlucCell®glucosemonitoringsystemsimplifiesandacceleratesglucosemeasurementduringcellculture.Thedisposableglucoseteststripsenablethemeasurementofglucoseconcentrationduringmammaliancellandinsectcellcultureinafewseconds.Justinsertthestrip,addthesampleandreadtheresult.
CrystalVioletDyeNucleiCountcontainscrystalvioletdye,citricacid,anddetergenttodisruptcellsandreleasecellnucleiforcellcounting.Thisprovidesanefficientreagentforcellcountinaporousmatrix.
Features
• 100%purePET(PolyethyleneTerephthalate)material
• Animalcomponent-free
• Lowlint
• Lightweight:1gramofcarriersoccupies15mlofspace
• Highsurfacetovolumeratio(S/V≈150cm-1)
• Highcapacity:1gramcarriersprovidespaceforupto1x109cellstopropagate
• Specialsurfacetreatmenttoenhancebiocompatibility
• Stablehydrophilicityuptofouryears
• Specialgeometricdesigntoenhancemixingandsupportload-bearingcapacityinpacked-bed
• Compressibleforhighercelldensity
• Non-pyrogenicandnon-cytotoxic
• ManufacturedincGMP-compliantfactory
• Sterilizablebyautoclave,gammairradiation,andEOsterilization
Features
• Calibration-free
• Ready-to-use
• Plug&Playsystem
• Disposableteststrips
• Accuracyisindependentwiththeingredientsofculturemediumandserum-relatedcomponents.
• 99.5%correlationwithotherbiochemicalanalyzersavailableonthemarket
Applications
Growthofanchorage-dependentanimal,human,andinsectcellsinfixedbedcellculturesystems:CelCradleTMandTideCell®bioreactorsystem,andothercommerciallyavailablepackedbedbioreactors.
GlucCell® Glucose Monitoring System
Crystal Violet Dye (CVD) Nuclei Counting Kit
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ADHERENT BIOPROCESSING SPECIALIST
Cell Culture Media and Supplement
Plus™MDCK is an animal component-free culturemediumdevelopedspecificallyforMDCKcellculture.
Plus™ MDCK
Features
• Animalcomponent-freeculturemedium
• Enablesserum-freeculturewithcomparablecellgrowthratetocellculturewithserum
• Upto10-foldhigherviraltitrecomparedtocultureusingcommercialmedium
• Availableinpowderorliquidform
Plus™VEROisananimalcomponent-freeculturemediumdevelopedspecificallyforVEROcellculture.
Plus™ VERO
Features
• Noanimalorhumanorigincomponents
• Completelydefinedwithlowproteincontent(≤5μg/ml)
• Enablesserum-freeculture
• Nohydrolysates,yeastextract,peptone,and/orothercomplexcomponents
• Allowscellstoadherewithin5minandsuitableforagitatingculturesystem
• Superiorvirusoutputyieldoverothercommercially-availablemedia
• Availableinpowderorliquidform
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VacciXcell Guide
SuperPlus™isacellculturesupplementdesignedtoreduceoreliminatetherequirementforseruminthebasalmedium.SuperPlus™alsominimizesculturevarianceduetoinconsistentqualitybetweenserumbatches.SuperPlus™-addedmediumsupportsgrowthofmanycelllines,includingMDCK,VERO,BHK,ST,PK-15,HEK-293,andCHO.
Super Plus™
Features
• Compatiblewithcommercialbasalmedium
• Saveupto90%serumorcultureserum-free
• Completelydefinedwithlowproteincontent
• Nohydrolysates,yeastextract,peptone,and/orothercomplexcomponents
• Powderform
VacciXcellprovidesmediumformulamodificationandoptimizationspecificallyforyourcellcultureneeds.
Culture Medium Formulation Platform
Features
• cGMPmanufactureofcustomandhigh-qualityculturemedium
• Optiontopurchasemediumformulaorfinalmediumproducts
• Morethan16yearsofexperienceinmediumformulation
DiscussionCustomerDesign
Formulation
CustomerTest
ResultFeedback
FormulationModification
FormulationAgreement Scale-Up cGMP
Manufacture
ContractManufacturing
orFormulationPurchase
Upstream BioProcessing – Cell Culture Products
Cell Culture Media and Supplement
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ADHERENT BIOPROCESSING SPECIALIST
Cell Culture Equipment
BSCs(BiologicalSafetyCabinets)provideISOClass3workzoneforcelltherapyresearchanddevelopmentprocedures,includingcelllineestablishment,cellpassaging,celltransductionandmore.
Features
• EnergysavingDCECMblowerformostmodels
• ISOCIDETMantimicrobialpowdercoating
• ULPAfilterwith>99.999%efficiencyat0.1-0.3μm
• Largeperformanceenvelope
• Ergonomicdesign
• Lownoise
• Easytoclean
Features
• Preciseparametercontrol
• FastCO2,temperatureandhumidityrecoverywithoutovershoot
• Robustcontaminationcontrolforoptimumprotection:SteriSafeULPAFiltrationSystem,validatedSwiftCon90°CMoistHeatDecontaminationCycle,200°CHighHeatSterilizationCycle,filteredgasinjectionlines,andISOCIDETMantimicrobialcoating
• MonitoringandcontrolsystemforsafeguardingofcellculturesavailableviaVoyagersoftwaresystem
• User-friendlycontrollersoftwareinterfacewithuser-configurablealarms,partsreplacementreminderalarmsystem(CelAlert),andintelligentdataandeventloggerwithbuilt-in16MBflashmemory
• HPA(moistheatdecontamination),ULlisted,andMEA(MouseEmbryoAssay)certifications
Biological Safety Cabinets
CO2 and CO2/O2 Incubators
Biological Safety Cabinets
Class II Type B2NSF Certified
Class II EN Certified
Class III EN Certified
Class II Type A2NSF Certified
Custom Biological Safety Cabinets
Food SafetyCabinets
Stainless Steel Exterior Copper Interior CelSafe®CelCulture®Direct Heat Air-Jacketed,
Water Jacketed and With Cooling System
CelMate®
CO2 and CO2/O2 Incubators
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VacciXcell Guide
TheVersatiTMcentrifugeisequippedwithmaintenance-freemotors,robustmechanismandintelligentEcourageTMmicroprocessorcontrolsystemthatoffersextremereliabilityandsafety.Coveringmicrocentrifugeandlow-to-highspeedgeneral-purposecentrifuge,withavarietyofrotors,adapters,theVersatiTMhasastrongversatilitytofitallyourapplicationneedsandsuitavarietyofconsumabletubes,stripsandplates.
Cell Culture EquipmentVersatiTM Centrifuge
Features
• Maintenance-free,brushlessmotor
• Diversechoiceofrotors
• Incaseofpowerfailureormalfunction,thelidofthecentrifugecanbeopenedmanuallyviatheemergencystopbutton
• DistinctcontrolpanelandintelligentEcourage™microprocessorcontrolsystem
• Motor-drivenlidlockensuressafetyandreliability
• Powerfulcombinationofmotorsandrotors
EscoVersatiTMTCV-1500andTCR-1500
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ADHERENT BIOPROCESSING SPECIALIST
Cell Culture EquipmentLaboratory Shaker
Features
• TriDrive™:Esco’suniquetriple-eccentriccounterbalanceddrivesupportsheavy-dutyandhigh-speedapplications.
• RobustDrive™:ThismechanismeliminatestheneedforlubricationastheBrushlessDCMotorreducesmaintenance.
• SmartRun™:Excellentout-of-balancesensorandproprietyimbalancecompensationalgorithmadjusttheoptimumrevolutionsperminute(rpm)toensuresmoothoperationwithoutanyvibration.
• Dataaresavedevenafterpowerfailure.
• Apttofitanyapplicationrequiredforyouroperation.
• Offersmultiplechoiceofaccessorieswhichallowtocustomizeandsatisfiestheappropriateapplication.
• Twotypesoforbit(19mmand25mm)thatmeetsdifferentapplication.
• ExternalsurfacesarepowdercoatedwithEscoISOCIDE™toeliminate99.9%ofsurfacebacteriawithin24hoursexposure.
• Audibleandvisiblealarmeveryendrun.
• Easy-to-usedesignenablestosetparameterprecisely.
• Historicalsettingscaneasilytrackandreviewfromthetouchscreen.
• Audibleandvisiblealarmsalertanyspeedandtemperaturedeviations.
• Shakerautomaticallyrestartsafterpowerinterruptionforthenon-volatileprogramsavedinthememory.
• Eachshakerisfactorytestedforperformanceassuranceinaccordancewithinternationalstandards.
OrbiCult™BenchtopIncubatorShaker
OrbiCult™BenchtopAmbientShaker
Upstream BioProcessing – Cell Culture Products
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VacciXcell Guide
VacciXcellofferslaboratoryfreezersandrefrigeratorsthatprovidesuperiorproductandsampleproduction,longreliabilityandexceptionalquality.VacciXcellfreezershavetemperaturerangesfrom–10°Cto–40°Candcapacitiesof128L,347L,620Land1,355L,whileVacciXcellrefrigeratorshavetemperaturerangesof+2°Cto+15°Candcapacitiesof128L,347L,620Land1,355L.
Cell Culture EquipmentLaboratory Freezers and Refrigerators
Features
• DoorLock
• ExternalsurfacecoatedwithEscoISOCIDETM,whicheliminates99.9%ofsurfacebacteriawithin24hoursofexposure.
• High-qualitystainlesssteelinteriorforsampleprotection.
• InternalLEDlightingsavesupto70%powerwithlessheatexposurecomparedtofluorescentorincandescentlighting
• Standardwheel/castersaswell,foreasylocationormovement
Forced air design
• Superiorforcedairdesigninsteadofaregularcoldwall,forbothrefrigeratorandfreezer.
• Rapidcool-downandveryfastrecoveryduetofanassistant.
• Fasttemperatureequilibrationandsuperiorsampleprotection.
Intelligent Automatic defrost for additional sample protection
• High-performanceunitusesintelligentdefrosttomaximizesampleprotection
• Computerhasthermocoupleontheevaporator
• Detectsiceformation
• Defrostsonlywhenneededtokeepunitsatoptimumperformance
• Keepschambertemperaturewithinsafelimits
• Nosampleriskwhencoldwallfreezermustbedefrosted
Upstream BioProcessing – Cell Culture Products
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ADHERENT BIOPROCESSING SPECIALIST
Aseptic Containment Isolator (ACTI)
Features
• Fullunidirectionalairflowthatprovidessuperiorasepticworkzone.
• Smoothflushedinteriorofisolatorglazingthatismadeoftoughenedlaminatedsafetyglass.
• Externalsensorsprotectedbyinstrumentfilters.
Typical Applications
• Handlingofbiopharmaceuticalgermseedcellsandasepticcellprocessing
• FormulationofcytotoxicAPI
AsepticContainmentIsolator(ACTI)isanadvancedasepticbarrierprovidingcontrolledenvironmentsforminimizingfalsepositivesduringsterilitytestingorhandlingofcytotoxicdrugs.
Weighing and Dispensing Containment Isolator (WDCI)
Features
• Standardconfigurabledesignsabletoadapttovariousweighinganddispensingquantitiesandaccuracies
• Fullyweldedsingle-pieceSS316Linternalchamberswithroundedcovedcorners
• PressuretestedtoISO14644-7
• Inflatableanti-bacterial,USPClassVIcompliantandfoodgradeFDA-approvedgasketsforproactiveandreactiveasepticsealingmethod
• Safechangeglovesystem
• Integratedanti-vibrationgraniteplatformforweighingscaleplacement
• Safechangefilterstoallowin-processfilterreplacement
• Integratedautomatedheightadjustmentproviding280 mmofmotionforergonomiccomfort
Typical Applications
• FormulationofcytotoxicAPI
WeighingandDispensingContainmentIsolator(WDCI)isanadvancedcontainmentsystem,providingcontrollednegativepressuretoenvironmentsformaximumpersonnelprotectionduringweighinganddispensingofpotentcompounds.
Formulation – Formulation and Filtration Isolator
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VacciXcell Guide
General Processing Platform Isolator (GPPI)
Features
• Unidirectionalairflow
• User-selectablepositiveornegativechamberpressures
• Singlepassorrecirculatingairflowregimes
• FullyweldedSS316Linternalchamberswithroundcovedcorners
• Standarddesign incorporates cGMPandGAMPcompliantfeatures
• Safechangeglovesystem
• Lowcontaminationfilterchangedesign
TheEscoGeneralProcessingPlatformIsolator(GPPI)isahighlyadaptableandunidirectionallaminarairflowisolatorthatcanbeusedforanyprocessthatrequiresanISOClass5(GradeA)asepticenvironment.
ASEPTiCell™
Features
• Integrated -RTU(Ready-To-Use) -Singleuse -Isolator-barrier -Robotics
• Capacity -Vials:2–30ml -Syringes:0.5–20ml -Cartridges:3ml,5ml
• Options:semi-automated/mobile-transfer
• Option:tubexteriorbio-decontamination
ASEPTiCell™isafullyintegratedandhighlyflexiblemanufacturingsystemdesignedtoasepticallyfill-finishsterileinjectable.ASEPTiCell™advancedautomatedfeaturesthatsimplifythefill-finishprocess,provideflexibilityandenhancesterilityassurance.
Formulation – Formulation and Filtration Isolator
Filling Line - Robotic Filling
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ADHERENT BIOPROCESSING SPECIALIST
Automatic TrayloadersFeatures
• Abilitytoloadanexactnumberofvials
• Availableassingle/dualtray
• Tool-freeandquickchangeover
• Smallfootprint
• Simplechangeover
Depyrogenation TunnelFeatures
• cGMP-compliantdesignandconstruction
• Fullrangeoftunnelstochoosefrom,dependingonrequirements
• Detecttheairspeedandkeepitconstantwithaprecisionof0.01 m/s
• HEPA-filteredairsupplyacrosstunnelchambers
• Capableofupto6-logbacterialendotoxinlevelreduction
• RecycledairintheCoolingChamber
• Features a “Night Mode” to save energy while avoidingcontamination
Vial WashingFeatures
• Semi/Fullyautomated
• Centralcolumn&outfeedmechanism
• Individuallyprogrammableintermittentsprayvalves
• Recirculationpackages
• Non-penetratingSprayNozzles
Filling Line - Traditional Filling
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VacciXcell Guide
Automatic Loading / Unloading EquipmentFeatures
• Semi/fullyautomaticloadingsystem
• Laser-Guidedloadingandunloadingsystems
• Self-poweredviabattery:noneedforthex-rail
• Unitturnsitself:noneedforarotatingturret
Capping MachinesFeatures
• Stand-alonecappingmachine
• Spinningvials
• Output:Upto200vials/min
• Vialrange:2-100ml
• Centerstationarydisk
• Maintenance-freedesign
• Integratedfilling/stoppering/cappingmonoblockisavailable
External Vial WasherFeatures
• Hangingvialsforcompleteundersideexposureforcleaninganddrying
• Servomotormainandheightadjustmentdrives
• Universalchangepart(belts):13mmcaps/20mmcaps
• Quicktool-freechangeover
• Built-inlowpressure,highvolumecentrifugalblowerfordrying
• Lowernoisevolume
• Simpletovalidate
• RABS/Isolatorenclosureready
Filling/Stopper Inserting MachinesFeatures
• In-lineorstand-alone
• Fillingstationwithoptionalpre/postnitrogenflush
• Dualstopperinsertingstation
• Vialrange:2-100ml
• Output:upto100vials/min
• Pump:Peristalticpump/rotarypistonpump
• Option:statisticalcheckweighing/rejectStation
• Quickchangeover
• Isolator/RABS(RestrictedAccessBarrierSystem)Ready
-EasilyintegratedwithIsolatororRABS
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ADHERENT BIOPROCESSING SPECIALIST
Supplementary Equipment
Sanitary rotary table Raised-bed sanitary and
non-sanitary conveyors
Loading and unloading tables
Cleanroom pass-through Downed vial reject systems
Sterility Testing Isolator
Features
• PositiveornegativepressureoperationavailableforbothsterilitytestingandQCtestingapplications
• Availableinvariousconfigurations:2-,3-,or4-glovedmainchamberandwithorwithoutatransferchamber
• Transferchamberwithindependentoperationandbio-decontamination
• Full316Lstainlesssteelconstructionwithcriticalchamberthicknessof4mmandtechnicalhousingthicknessof1.5mm
• Frontvisorofthemainchambersandtransferchambermanufacturedfrom10mmthicktoughenedsafetyglass.Themainchambervisorbeinginclinedforergonomiccomfort
• FDA-approvedinflatableseals
• BiologicalClassIIImodeavailablemeetingBSEN14629:2000standards
• Leaktightnessmeetingthatoftype1isolatorinISO14644-7
Thesterilitytestingisolatorprovidesacost-effectivepharmaceutical-gradeisolatorforsterilitytestingandotherQCtestingapplications.
Sterility Testing
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VacciXcell Guide
Cross Contamination Facility Integrated Barrier
Infinity® Pass Boxes, Infinity® Shower Pass Boxes,
Infinity® Cleanroom Transfer Hatches
Cleanroom Air Showers
Soft Capsule® Soft Wall Cleanrooms
Dynamic Passboxes and
Dynamic Floor Label Hatches
Airflow Containment Products
Barrier Isolation Systems
PharmaconTM Downflow Booths Ceiling Laminar Airflow Units Laminar Flow Horizontal Trolleys
Laminar Flow Vertical Trolleys
Isoclean® Pharmacy Compounding Aseptic
Containment Isolators (Recirculating)
Isoclean® Pharmacy Compounding
Aseptic Isolators
Cytotoxic Safety Cabinets
Isolation and Containment Systems
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ADHERENT BIOPROCESSING SPECIALIST
Licensee
Global Offices
Joint Ventures
Distributors
Factories
R&D Centers
Regional Distribution Centers
Since 1978, Esco has emerged as a leader in the development of controlled environment, laboratory and pharmaceutical equipment solutions. Products sold in more than 100 countries include biological safety cabinets, fume hoods, ductless fume hoods, laminar flow clean benches, animal containment workstations, cytotoxic cabinets, hospital pharmacy isolators, and PCR cabinets and instrumentation. With the most extensive product line in the industry, Esco has passed more tests, in more languages, for more certifications, throughout more countries than any biosafety cabinet manufacturer in the world. Esco remains dedicated to delivering innovative solutions for the clinical, life science, research and industrial laboratory community. www.escoglobal.com.
Air Shower • Aseptic Containment Isolator (ACTI) • Ceiling Laminar Airflow Units • Cleanroom Transfer Hatch • Containment Barrier Isolator (CBI)Downflow Booth (DFB) • Dynamic Floor Label Hatch • Dynamic Pass Box • Evidence Drying Cabinet • Garment Storage CabinetGeneral Processing Platform Isolator (GPPI) • Laminar Flow Horizontal Trolley • Laminar Flow Straddle Units, Single and Double Laminar Flow Vertical TrolleyPass Box • Soft Wall Cleanroom • Sputum Booth • Ventilated Balance Enclosure (VBE) • Weighing and Dispensing Containment Isolator (WDCI)
ESCO GLOBAL NETWORK
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VacciXcell Guide
ADHERENT BIOPROCESSING SPECIALIST
21ChangiSouthStreet1,Singapore486777
Tel+6565420833•Fax+6565426920
www.vaccixcell.com•www.escoglobal.com
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