产品资料

Polyplus Transfection/PEIpro^®-HQ/Polyplus Transfection-163150/1 Ea

TheuniquePEIsuitableforproductionofclinicalbatchesanduseinGMPprocesses
Perfectlysuitedfortherapeuticvirusproduction
Syntheticreagentfreeofanyanimal-origincomponents
Manufacturedaccordingtoawell-establishedprocess
FullycharacterizedproductwithextensiveQualityControls
SuppliedwithappropriateDocumentation
Robustandlongshelflife

Specifications:

Reagent	PEIpro^®-HQ
Moleculedelivered	DNA
Applications	Productionofclinicalgradevirusesandproteins SuitableforuseinGMPprocesses
Celltypes	AdherentorsUSPensionHEK-293andHEK-293Tcellsandderivativesgrowninsyntheticserum-freemedium
Numberoftransfections	1LiterofPEIpro^®-HQissufficienttotransfectonaverage500Litersofcellculture
Storage	4°C,foratleast2years
Providedwith	CertificateofAnalysis CertificateofOrigin BatchProductionDocumentation Non-HazardousProductStatement

Summary:

Advancedtherapymedicinalproducts(ATMPs)includinggenetherapyandcelltherapymedicineshaveemergedaspromisingtreatmentsforvariousdiseases.ThesetherapiesinvolvetheintroductionoftherapeuticDNAintopatient’sbodyorpatient’scells.Thisprocessisoftenaccomplishedbytheuseofviralvectors.RawmaterialsusedforthemanufacturingoftheseviralvectorsneedtobemanufacturedaccordingtoarobustandreproducIBLeprocess,withappropriateQualityControls.

Orderinginformation:

|||301-400##4x100ml##|||301-01K##10x100ml##|||301-01L##1x1L##|||

Description:

Manufacturedaccordingtoawell-establishedprocess

PEIpro^®-HQisafullysyntheticreagentfreeofanyanimal-origincomponents.PEIpro^®-HQismanufacturedandformulatedusingawell-establishedandcontrolledmanufacturingprocess(Fig.1),allowingthereproduciblesupplyofremarkablyhighqualityproductmeetingverystringentreleasespecifications.

PEIpro-HQ - Manufacturing-process — **Fig.1:ManufacturingprocessofPEIpro^®-HQreagent**

EachlotofPEIpro^®-HQisprovidedwithaBatchProductionDocumentationthatcontainsacomprehensivesummaryofthemanufacturingprocessandthequalitycontrols,whichmakesPEIpro^®-HQperfectlysuitableforuseasaqualifiedrawmaterialfortheproductionofclinicalbatchesofvirusesandproteinsinGMPprocesses.

PEIpro^®-HQisanoptimizedandselectedPEI,trulydeacylated,withanextremelylowpolymerchainlengthvariationandformulatedat1mg/mlinwater.

FullycharacterizedProductwithextensiveQualityControls

Recently,thereisanincreaseinregulatoryscrutinyforreagentsusedasrawmaterialintheproductionofvirusesforearly-phaseclinicaltrials.Alongwiththerecentincreaseinbiopharmaceuticalfundingingenetherapy,itisnowmandatorytomeethigherlevelsofqualitycomplianceatearlierstagesofclinicaldevelopment.WithitsextensiveQualityControlsPEIpro^®-HQfullyanswerstheseneeds.

ThequalityofPEIpro^®-HQiscontinuouslyassessedduringthemanufacturingprocesswithsuitablecontroltesting.AnextensivenumberofQualityControlsareperformedonboththebulkmaterialandtheformulatedproducttoassessidentity,potency,safetyandpurityofPEIpro^®-HQ(Table1).

Indeed,PEIpro^®-HQistestedtoensurecompletesterility,absenceofmycoplasmaandverylowlevelofbacterialendotoxinsfollowingpharmacopoeiastandards.Impurityprofile,residualorganicsolventandheavymetalcontentarealsotestedtoassessthepurityofthereagent.Moreover,astandardizedtransfectionassayisperformedwithasuspensionHEK-293celllineinserum-freemediumtoensurethereliABIlityandreproducibilityofthetransfectionefficiencyunderconditionsthataresuitableforvirusproduction.

PEIpro^®-HQisreleasedwithaCertificateofAnalysisincludingtheresultsoftheQualityControls.AfulllistofQCsisavailableuponrequest(ContacttheTechnicalSupport).

PEIpro^®-HQisalsosuppliedwithaCertificateofOriginconfirmingtheabsenceofcomponentsofanimaloriginandaNon-HazardousProductStatement.

PEIpro-HQ - highly-qualified grade of PEIpro — **Table1:PEIpro^®-HQisahighlyqualifiedgradeofPEIpro^®reagent.**ThequalityofPEIpro^®andPEIpro^®-HQarecontinuouslyassessedduringthemanufacturingprocesswithsuitablecontroltesting.IncomparisontoPEIpro^®,amoreextensivenumberofqualitycontrolsareperformedonboththebulkmaterialandtheformulatedproducttoassessidentity,purity,safety,andpotency.

Applications:

Especiallydevelopedfortherapeuticvirusproduction

PEIpro^®-HQcombinesanexceptionalqualitygradewithrobusttransfectionefficiency.PEIpro-HQ^®iscurrentlyusedfortheproductionoflargequantitiesofviralvectors,includingAdenovirus,AdenoAssociatedVirus(AAV)andlentivirus.PEIpro^®-HQissuitableforuseinmammaliancellssuchasHEK-293andHEK-293Tgrownadherentlyorinsuspensioninbothserumcontainingmediaorsyntheticchemicallydefinedmedia.PEIpro^®-HQcanbeusedinalltypesofcellculturevessels,singleusedbioreactors(SUB),WAVEbagsandfixedbedbioreactorssuchasiCELLIS^®.FollowingPEIpro^®-HQmediatedtransienttransfection,lentivirustitersroutinelyreachupto10^14VG/ml.

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Citations:

ARecognizedQualityManagementSystemPolyplus-transfection®hasbeenawardedISO9001QualityManagementSystemCertificationsince2002,ensuringthatthecompanyhasestablishedreliableandeffectiveprocessesformanufacturing,qualitycontrols,distributionandcustomersupport.OurcustomersareinvitedtoauditPolyplus-transfection®inordertoqualifyourcompanyasasupplierofrawmaterialsusedinthemanufacturingofclinicalgradetherapeuticproducts.PleasecontactusifyouwouldliketoperformanauditofourQualityManagementSystem.StabilityofthereagentsPolyplus-transfection®’sreagentshavearobustandlongshelflifeofaminimumoftwoyears,idealfortimelycompletionofGMPproductionprocesses.

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Polyplus Transfection/PEIpro®-HQ/Polyplus Transfection-163150/1 Ea