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1、MechanismInvestigationforPoloxamer188RawMaterialVariationinCellCultureHaofanPengCellCultureDevelopment,Biogen,ResearchTrianglePark,NC27709AmrAliCellCultureDevelopment,Biogen,Cambridge,MA02142MaureenLananCellCultureDevelopment,Biogen,Cambridge,MA02142ErikHughesManufacturingSciences,Biogen,Research
2、TrianglePark,NC27709KellyWiltbergerCellCultureDevelopment,Biogen,ResearchTrianglePark,NC27709BingGuanCellCultureDevelopment,Biogen,Cambridge,MA02142ShashiPrajapatiCellCultureDevelopment,Biogen,Cambridge,MA02142WeiweiHuCellCultureDevelopment,Biogen,ResearchTrianglePark,NC27709DOI10.1002/btpr.2268P
3、ublishedonlineApril27,2016inWileyOnlineLibrary(wileyonlinelibrary.com)Variabilityinpoloxamer188(P188)rawmaterial,whichisroutinelyusedincellculturemediatoprotectcellsfromhydrodynamicforces,playsanimportantroleintheprocessper-formance.Eventhoughtremendouseffortshavebeenspenttounderstandthemechanism
4、ofpoloxamersprotection,therootcauseforlot-to-lotvariationwasnotclear.Arecentstudyreportedthatthelowperformancewasnotduetotoxicitybutinefficiencytoprotectcells(Pengetal.,BiotechnolProg.2014;30:14111418).Inthisstudy,itwasdemonstratedforthefirsttimethattheadditionofothersurfactantsevenataverylowlevelc
5、aninterferewithP188resultinginalossofefficiency.ItwasalsofoundthattheperformanceofP188lotscorrelatedwellwithitsfoamstability.Foamgeneratedfromlowperforminglotsinbaffledshakerflasklastslonger,whichsuggeststhatthecomponentsinthefoamlayersaredifferent.Thespikingoffoamgeneratedfromalowperforminglotintot
6、hemediacontainingahighperformancelotresultedincelldamageandlowgrowth.Analyticalstudiesusingsizeexclusionchromatography(SEC)identifieddifferencesinhighmolecularweight(HMW)speciespresentintheP188lots.ThesedifferencesaremuchclearerwhencomparingtheHMWregionoftheSECchromatogramoffoamvs.bulkliquidsample
7、s.ThisstudyshowsthatlowperforminglotshaveenrichedHMWspeciesinfoamsamplesduetohighhydropho-bicity,whichcanbepotentiallyusedasascreeningassay.VC2016AmericanInstituteofChemicalEngineersBiotechnol.Prog.,32:767775,2016Keywo
