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1、PharmaceuticalReviewForreprintorders,pleasecontactreprints@future-science.comPharm.Bioprocess.(2013)1(5),487–502Theuseofglutaminesynthetaseasaselectionmarker:recentadvancesinChinesehamsterovarycelllinegenerationprocessesCentraltotheneedsofthebiopharmaceuticalindustrytosupportthedevelopmentLianchunF
2、an*1,ofinnovativebiologicsandbiosimilarsaremoreeffectiveandefficientmanufacturingChristopherCFrye1processeswhichrequirehighlyproductivecelllineswithdesiredqualityattributes.New&AndrewJRacher2designsofmoleculessuchasantibodyhumanizationhavegreatlyreducedimmunogenicity1BioprocessResearch&Development,
3、concerns,andadvancesincellculturetechnologyincludingmediaoptimizationandEliLilly&Company,Indianapolis,IN 46221,USAprocesscontrolhavedrivenmonoclonalantibodyproductivitiesinexcessof10 g/lwith2LonzaBiologicsplc,228BathRoad,peakcelldensitiesinbioreactorsclimbingtoover35 million per ml.However,overthis
4、Slough,Bershire,SL14DX,UKsametimeframe,thefundamentalprocessesutilizedforcelllinegenerationhavenot*Authorforcorrespondence:changedsignificantly,especiallyintheselectionstepfortop-producingclonalcelllines.Tel.:+13172773865CelllinegenerationcontinuestobetimeconsumingandlaborintensiveandhasbecomeFax:+
5、13172768838E-mail:fanlianchun@lilly.comthetimelinelimitingstepforthemajorityoftheindustry.Inordertomeetthe‘Fast-to-Proof-of-Principle’strategy,multipleeffortsincludinghostcellandexpressionplasmidengineeringhavebeenpursuedinordertoimprovetheeffectivenessandefficiencyofcelllinegenerationprocesses.Thi
6、sreviewwillsummarizetherecentadvancementsincelllinegenerationprocessesinChinesehamsterovarycells,withafocusontheglutaminesynthetaseselectionsystem.Sincethefirstapprovalofrecombinantinsu-Choosinganappropriateexpressionsystemlinintheearly1980s,morethan100newisoneofthecriticalstepsforbiopharmaceuti-re
7、combinantproteintherapeuticshavebeencalproductdevelopment.MultipleexpressionapprovedbytheUSFDAortheEuropeansystemsincludingmicro-organisms[4,5],mam-MedicinesAgency[1].Thebiopharmaceuti-maliancelllines[6,7],
