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dc.contributor.advisor조용우-
dc.contributor.author최영찬-
dc.date.accessioned2024-03-01T07:30:50Z-
dc.date.available2024-03-01T07:30:50Z-
dc.date.issued2021.2-
dc.identifier.urihttp://hanyang.dcollection.net/common/orgView/200000485686en_US
dc.identifier.urihttps://repository.hanyang.ac.kr/handle/20.500.11754/188173-
dc.description.abstractBiopharmaceuticalsareadrugthatusescells,proteins,geneticmaterials,andcomplexesfrombiologicaltissuesasatreatmentfordiseases.Andbiopharmaceuticalshavebeeninthespotlightasatherapeutictoolforincurablediseasestoreplaceexistingchemicaldrugs.Comparedtoconventionalchemicaldrugs,biopharmaceuticalshavedistinguishedcharacteristicssuchaslargermolecularweight(morethan150kDa),complexmolecularstructureandformulation.Complicatedandheterogeneousbiopharmaceuticalformulationrequirescomplexandrepetitiverefiningproceduresforproductbiopharmaceuticals,resultinginsignificantdifficultyandcostincreaseinproduction.Besides,understandingthecorrelationbetweenproductqualityandprocessparametersisstillbeingleaked.However,therearemanycasesinwhichclinicaltrialsforbiopharmaceuticalshavereportedtheamazingefficacyofvariousdiseases,thereforebiopharmaceuticalsareinthespotlightasanewtreatmentplatformforovercomingincurablediseases. Herein,theisolationandfunctionalizationofstemcellexosomesandextracellularmatrix(ECM)derivedfromadiposetissueswerestudiedandevaluatedonabasisofqualitybydesign(QbD)conception.Asarawmaterial,humanandporcineadiposetissuescaneasilybeobtainedthroughahugeamountofbiologicalwastes.thestemcellexosomes,whichareoneofthemainfactorsintheparacrineactionofstemcelltherapy,wereextractedfromhumanadipose-derivedstemcells(hASCs),andstemcellexosomeswereeffectivelyproducedthroughthetangentialflowfiltration(TFF)andsize-exclusionchromatographyprocess,wherearecompatibletomass-productionandgoodmanufacturingpractice(GMP).Ievaluatedthecorrelationbetweenprocessparametersandthequalityofstemcellexosomes,andthisallowedthemanufactureofhigh-purifiedstemcellexosomeswithanti-inflammatoryeffects.ECMwasisolatedfromhumanandporcineadiposetissueandtheECMwasmodifiedbymechanicalandbiochemicalprocessestoenhancetheirsafetyandfunctionality.ThesefunctionalECMcouldbeappliedtohemostatandadiposetissueregeneration.Moreover,themanufacturingprocessofbiopharmaceuticalsderivedfrombiologicalresourcescouldbeoptimizedandtheprocessoptimizationwasachievedbyunderstandingthecorrelationbetweenproductperformancesandprocessconditions.Moreover,thesestudiesofprocessdevelopmentforbiopharmaceuticalscouldbeusedasapracticalexampleoftheQbDbasedprocessdevelopmentforbiopharmaceuticals.-
dc.publisher한양대학교-
dc.titleQualitybyDesign(QbD)BasedProcessDevelopmentforCell-FreeTherapeuticsUsingExosomeandExtracellularMatrix(ECMs)-DerivedfromAdiposeTissue-
dc.title.alternative지방유래엑소좀및세포외기질을이용한무세포치료제의QbD기반생산공정개발-
dc.typeTheses-
dc.contributor.googleauthorChoi,YoungChan-
dc.contributor.alternativeauthor최영찬-
dc.sector.campusS-
dc.sector.daehak대학원-
dc.sector.department바이오나노학과-
dc.description.degreeDoctor-
Appears in Collections:
GRADUATE SCHOOL[S](대학원) > BIONANOTECHNOLOGY(바이오나노학과) > Theses (Ph.D.)
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