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| Reagents | invivo-jetPEI®,jetPEI®andtheirderivatives |
|---|---|
| Moleculedelivered | DNA,siRNA,miRNA,Oligonucleotides,mRNA |
| Applications | Preclinicalstudies |
| Targetedorgans | Allorgans/celltypes |
| Injectionroutes | Systemicinjection(intravenous) |
| Amountofreagent | Uponrequest |
| Storage | -20°C,foratleast2years |
| Providedwith | CertificateofAnalysis |
PreclinicalstudiesareaprerequisitetoanINDoranIMPDsubmissiontoassessmainlysafetybutalsoperformanceofanewdrug.Theyusuallyencompasspharmacodynamicsandtoxicologystudiesbutalsobiodistributionandpharmacokinetics.TheFDArequiresresearcherstouseGoodLaboratoryPractices(GLP)forpreclinicallaboratorystudies.
ForGLPpreclinicalstudiesrequiringthedeliveryofnucleicacids,Polyplus-transfection®suppliespreclinicalgradereagentsthatmeetallthecriteriaforsuchstudies.
Polyplus-transfection®reagentsarealsoperfectlysuitedforCellTherapyTrialsrequiringatransfectionstep.Indeed,ourreagentsaremanufacturedinaccordancewithrequirementsforrawmaterialsinAdvancedTherapyMedicinalProductmanufacturingforthegenerationofenhanced/modifiedcells.
invivo-jetPEI®hasbeenselectedasadeliveryvectorforseveraldrugdevelopmentprogramsduetoitsdeliveryefficiency.TherearecurrentlyseveralongoingpreclinicalstudiesandphaseIandIIclinicaltrials,mainlyforcancertherapies,usinginvivo-jetPEI®(Fig.1).
Moreover,asanexampleoftheuseofPolyplus’transfection®reagentsinaCellTherapytrial,aclinicaltrialforEnhancedAngiogenicCellTherapyfollowingAcuteMyocardialInfarctionusingjetPEI®-Macrophage,approvedbyHealthCanada,iscurrentlyongoingatOttawaResearchHospitalInstitute(Ottawa).
Withyearsofextensiveexpertise,Polyplus-transfection®hasawell-establishedmanufacturingprocess,allowingthesupplyofremarkablyhighqualityreagentsmeetingverystringentreleasespecifications.ThesereagentsaremanufacturedincompliancewithGoodLaboratoryPractices(GLP)andaresuitablefortheuseinpreclinicalstudies.TheycanalsobeusedasrawmaterialsforCellTherapyandRegenerativeMedicinetrials.
PreclinicalgradereagentsandreagentsdedicatedtoCellTherapytrialsarereleasedwithaCertificateofAnalysisincludinginprocessandfinalproductQualityControlsforsterility,mycoplasmaandendotoxintesting.
AdditionalQualityControlsorassaysareavailableuponrequesttofulfillspecificneedsofourcustomers.
AfullycustomizedasepticFillandFinishservice(formulation,sterilization,asepticfilling…)isoffereduponrequestwithallpreclinicalgradereagents,aswellasforreagentsusedasrawmaterialsinCellTherapytrials.
Polyplus-transfection®’sreagentshavearobustandlongshelflifeofaminimumoftwoyears,idealfortimelycompletionofpreclinicalorcelltherapystudies.Stabilitystudyprogramsaswellasretainofmaterialforretestsareavailableuponrequest.
Withadedicatedteamforpreclinicalandclinicalcustomers,Polyplus-transfection®offersthehelpandsupportrequiredtoaccompanyyourclinicalprojectfromR&DthroughtoInvestigationalNewDrug(IND)ApplicationorInvestigationalMedicinalProductDossier(IMPD)andfromPhaseItoPhaseIIIclinicaltrials.
Foranyinquiryconcerningyourproject,pleasecontactus.
Ohana,P.,Gofrit,O.,Ayesh,S.,Al-Sharef,W.,Mizrahi,A.,Birman,T.,Schneider,T.,Matouk,I.,deGroot,N.,Tavdy,E.,Sidi,A.A.,Hochberg,A.(2004).RegulatorysequencesoftheH19geneinDNAbasedtherapyofbladdercancer.GeneTherapyandMolecularBIOLOGy8,181-1.
Taljaard,M.,Ward,M.R.,Kutryk,M.J.,Courtman,D.W.,Camack,N.J.,Goodman,S.G.,Parker,T.G.,Dick,A.J.,Galipeau,J.,Stewart,D.J.(2010).RationaleanddesignofEnhancedAngiogenicCellTherapyinAcuteMyocardialInfarction(ENACT-AMI):thefirstrandomizedplacebo-controlledtrialofenhancedProgenitorcelltherapyforacutemyocardialinfarction.AmHeartJ.2010Mar;159(3):354-60.
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vectorlabs/Biotinylated Aleuria Aurantia Lectin (AAL)/B-1395/1 mg
vectorlabs/VECTASTAIN® Elite® ABC-HRP Kit (Peroxidase, Mouse IgG)/PK-6102/1 kit
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