Front Cover - VacciXcell€¦ · Guide to VacciXcell ... microbial fermentation and suspension cell...

Front CoverADHERENT BIOPROCESSING SPECIALIST

Product Guide 2016-2017

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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

Upstream BioProcessing - Cell Therapy Processing

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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


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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

Upstream BioProcessing – Bioreactors and Fermenters

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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


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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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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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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.


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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

Upstream BioProcessing – Cell Culture Products

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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


Cell Culture Media and Supplement

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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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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


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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


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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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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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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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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


21ChangiSouthStreet1,Singapore486777

Tel+6565420833•Fax+6565426920

[email protected]

www.vaccixcell.com•www.escoglobal.com

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