Advanced Granulation Technologya Complete Cell Culture Media Format (AGT™)先进造粒技术（AGT专利）： 规模化与同质化检验 一种完整地细胞培养基格式.pdf

《Advanced Granulation Technologya Complete Cell Culture Media Format (AGT™)先进造粒技术（AGT专利）： 规模化与同质化检验 一种完整地细胞培养基格式.pdf》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。

1、AdvancedGranulationTechnology(AGT™):ScaleUpandHomogeneityTestingofaCompleteCellCultureMediaFormatRobertRadominski,RichardHassett,BarbaraDadey,RichardFike,DavidCadyandDavidJaymeAdvancedGranulationTechnology(AGT™):ScaleUpandHomogeneityTestingofaCompleteCellCultureMediaFormatAbstractDryPowderM

2、edium(DPM)iscommonlyusedasanutrientsourceformanybioprocessapplications.CurrentmethodsofDPMmanufacturinghaveinherentshortcomingsyieldingproductthatissub-optimalforbiopharmaceuticalproduction.Wehavedevelopedanalternativedryformatprocess,termedAdvancedGranulationTechnology(AGT™),toproduceatota

3、llycompleteandhomogeneousnutrientmediumingranularformat.TheadvantagesoftheAGT™processwerepreviouslydemonstratedwithseveralcomplexprotein-freeandchemically-definedmedia.Here,weapplytheAGT™processatseveralmanufacturingscalesfrompilottofull-scaleproductiontodemonstratebiologicalfunctionandbioc

4、hemicalhomogeneity.IntroductionAttributesofDPMthatmaynegativelyimpactmediaprocessingoperationsinbiopharmaceuticalproductionfacilitiesare:(a)itsdustynatureandpotentialforcross-contaminationandemployeeexposure;(b)extendedmixingtimesrequiredforcompletesolubilization;(c)theneedformaterialssegre

5、gationandmultiplecomponentadditionsespeciallyinserum-freeandprotein-freeformulations;and(d)concernsregardinghomogeneityoftracecomponents.Wedevelopedanovelprocess,AdvancedGranulationTechnology(AGT™),toresolvetheseconcerns(1,2).Wepreviouslyreportedpilot-scalemanufactureofseveralcomplexprotein

6、-freeandchemically-definedmediausingthistechnology(3).Toassessscale-upcapabilityoftheAGT™process,wemanufacturedCD-CHO(aprotein-free,chemically-definedmediumforgrowthandproductionofCHOcells)at9kg,90kg,and500kgscales.WeanalyzedphysicalandbiochemicalparametersandCHOcellgrowthandbiologicalprodu

7、ctivityfromreconstitutedmediaateachmanufacturingscale.MethodsandMaterialsManufactureofAGT™CD-CHOAGT™CD-CHOmediumwasproducedbyatopsprayfluidbedgranulationprocess.Allcomponentingredientswereinitiallyprocessedbyhammermillingtoestablishauniformparticlesize.T