QualitybyDesign(QbD)BasedProcessDevelopmentforCell-FreeTherapeuticsUsingExosomeandExtracellularMatrix(ECMs)-DerivedfromAdiposeTissue
- Title
- QualitybyDesign(QbD)BasedProcessDevelopmentforCell-FreeTherapeuticsUsingExosomeandExtracellularMatrix(ECMs)-DerivedfromAdiposeTissue
- Other Titles
- 지방유래엑소좀및세포외기질을이용한무세포치료제의QbD기반생산공정개발
- Author
- 최영찬
- Alternative Author(s)
- 최영찬
- Advisor(s)
- 조용우
- Issue Date
- 2021.2
- Publisher
- 한양대학교
- Degree
- Doctor
- Abstract
- Biopharmaceuticalsareadrugthatusescells,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.
- URI
- http://hanyang.dcollection.net/common/orgView/200000485686https://repository.hanyang.ac.kr/handle/20.500.11754/188173
- Appears in Collections:
- GRADUATE SCHOOL[S](대학원) > BIONANOTECHNOLOGY(바이오나노학과) > Theses (Ph.D.)
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