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人類血漿之特異性是一種非常豐富及複雜之生物來源物質。含超過100~200種以上不同的(醣)蛋白(包括凝血因子,蛋白分解酵素抑制劑,蛋白分解酵素,免疫球蛋白),白蛋白,peptide,生長因子….。約17~20種血漿成分已建立治療價值。是一人類治療所必需的兵工廠。1血漿來源SourcePlasma(fromplasmapheresis)RecoveredPlasma(fromwholeblooddonations)2血液的功能運送細胞的產物及廢物,並將養分及氧氣送到細胞。血液內吞噬細胞的功用除了如清道夫外,並且能抵抗外來的感染。為運輸激素的途徑。平衡穩定體內的pH值。將體熱帶到皮膚發散以維持體溫恆定。3456Takeabreak!7891011Virusestransmissibleviabloodandplasmaproducts12HumanVirusesofConcern
WithRespecttoPlasmaDerivativesEnvelopedVirusesHumanImmuneDeficiencyVirus(HIV)HepatitisB(HBV)HepatitisC(HCV)Non-EnvelopedVirusesHumanParvovirusB19(B19)HepatitisA(HAV)NotSignificientRisksHumanT-lymphotrophicvirus(HTLVI&II)Cytomegalovirus(CMV)EpsteinBarrVirus(EBV)UnmeasurableRisksTransmissibleSpongioformEncephalopathies(TSE,esp.CJD)Unidentifiedand/oremergingagents13SignificanceofViralEnvelopeProteinnecessaryforattachmentandpenetrationofhostcellsareonthesurfacesofviruses.Non-envelopedvirusestendtobemoreresistanttophysico-chemicalconditions(heat,solvent-detergent).Thesmallestvirusesarenon-enveloped.14DonorScreeningforViralContamination15GeneralSafetyMeasuresScreeningdonorsMaintainingdonordeferralregistriestoeliminateunsuitabledonorsfromtherollsTestingbloodandplasmadonationsTestingpools,intermediates,and/orfinalcontainersViralclearancestepsinmanufacturingMonitoringandinvestigatingadverseincidentstoensurethatdeficienciesarecorrected16WhatisaPrion?proteinaceousinfectiousagentresiststreatmentsthatdestroynucleicacidsdestroyedbytreatmentsthatdegradeproteinderivedfromtheprionprotein(PrP)isoformofPrPc/subfractionofPrPscpartiallyresistanttoproteinases1718ViraleliminationtreatmentsofplasmaproductsSpecificNanofiltration:filtrationofaproteinthroughamembrane/hollowfiberwithanominalporesizeofafewnanometers(intherangeof15to40nm)inconditionswhereproteinsmigratethroughthenanofilterwhilevirusesareretainedNonspecific:Chromatography,PrecipitationUltrafiltration19MostfrequentlyusedspecificviralinactivationtreatmentsofplasmaproductsAcidpH(IgG)Incubationoftheproteinsolution(IgG)atpH4,withorwithoutthepresenceoftracesofpepsin,at37oCfor22hoursormore.20MostfrequentlyusedspecificviralinactivationtreatmentsofplasmaproductsSolvent-DetergentIncubationofanhomogeneousplasmaproteinsolutioninthepresenceofanorganicsolvent(trin-butylphosphate)andadetergent(Tween80;TritonX-100)for4-6hoursat25to35oC.21MostfrequentlyusedspecificviralinactivationtreatmentsofplasmaproductsDryHeatTreatmentHeat-treatmentofalyophilisedproteinproductorfraction(drystate)fromseveralminutestoseveraldaysattemperaturesfrom60to100oC22MostfrequentlyusedspecificviralinactivationtreatmentsofplasmaproductsPasteurizationHeat-treatmentofanhomogeneousproteinsolution(liquidstate)for10hoursat60oC,generallyinthepresenceofstabilizers(sugars,amino-acids,polyols,…..)23ViralClearanceClearance=Inactivationand/orRemovalIndividualmanufacturingsteps:
-specificallydesignedforviralclearance-intendedprimarilyforpurificationEachclearancestepisseparatelyvalidatedProductionmethodsandpracticesmustconformtovalidatedmethods24ViralClearanceValidationI:Scale-downNecessity:-Undesirabletointroducevirusesintoproductionfacilities;-Limitedabilitytoproducelargeamountsofhightiterviruspreparations;-Risktolaboratoryworkers.Requirements-Labprocessmimicsproductionscale(relativegeometries,volumes,flowrates,etc.)-Labprocessperformslikeproductionprocess(relativecapacity,yield,purification,etc.)25ViralClearanceValidationII:SelectionofrelevantandmodelvirusesTypically,severalvirusesareselectedtoencompasstheanticipatedrisks.Relevant=avirusthatmaybefoundinthebloodorplasma.Model=alaboratorystrainofavirusnotnecessarilyfoundinthebloodorplasma.26ClassificationforbiologicalproductsClassIProductsderivedfromhumantissuesorfluids:(plasmaderivatives,hormonesfromurine,placentalderivatives,etc.)Riskencountered:nospeciesbarrier,unknownviruses.Viralsafety:screeningofthedonorsandthecapacityoftheprocesstoeliminateand/orinactivateviruses.27ClassificationforbiologicalproductsClassIIViralvaccines:killed(inactivated)andliveattenuatedvaccinesRiskencountered:Presenceofresidualactivevirusinkilledvaccines(Cutterincident-1953);reversiontovirulenceoftheattenuatedstrainsorafailureinGMP.Viralsafety:Controloftheinactivationprocedureandgeneticstabilityoftheattenuatedviruses.28ClassificationforbiologicalproductsClassIII
Productsderivedfromanimaltissuesandfluids:collagen,heparins,animalimmunoglobulins,monoclonalantibodiesproducedinascites,etc.Riskencountered:Presenceofvirusesinthestartingmaterial;thescreeningforviralmarkersofthesourcematerialisnotfeasible.Viralsafety:Thereisthespeciesbarrier.Viralsafetyisbasedsolelyonthecapacityoftheprocesstoremoveand/orinactiveviruses.29ClassificationforbiologicalproductsClassIV
Productsderivedfromanimalcellcultures:proteinsobtainedbyrDNA,monoclonalantibodies,cytokines..Riskencountered:Presenceofvirusesinthecellsusedinproductionand/orcontaminationoftheproductbyvirusespresentinthereagentusedintheprocessorabreakthroughinSMP.Viralsafety:Characterizationandcontrolofthecellbanksandofthereagentsusedinproduction;processcapableofgeneratinghighlypurifiedproducts..30ClassificationforbiologicalproductsClassVBacterialvaccines,toxoidesandrDNAproteinsexpressedinbacteriaoryeast.Riskencountered:Residuallivebacteriainvaccinesandthepotentialpresenceofvirusesinthereagentsofanimaloriginusedforsomebacteriologicalmedia(theoreticalrisk).3132
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