Advances in antibody manufacturing using mammalian cells

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1、95AdvancesinantibodymanufacturingusingmammaliancellsK.JohnMorrowJr.NewportBiotechnologyConsultants,625WashingtonAvenue,Newport,KY41071,USAAbstract.Inthisreview,wedescriberecentadvancesinantibodyprocessingtechnologyinclud-ing:(1)developmentofproprietarycell

2、lines;(2)improvedexpressionsystemsoptimizedbyselectivetechnologiestoboostunderperformers;(3)improvedprotein-freeandserum-freeculturemedia;and(4)attentiontoglycosylationandotherpost-translationalmodifications.Advancesincomputertechnologyandsophisticatedredesi

3、gnofbioreactorshavebeenmajorcontributorstothedramaticimprovementsinantibodyyieldsthathavebeendocumentedinthelastdecade.Disposablebioreactorcomponentsarenowwidespread,resultinginimprovedyields,betterqualityproductandlowercostsforproducers.Downstreaminnovatio

4、nsinclude(1)disposabledevicesforclarificationandpurification,(2)improvedresinsandligands,and(3)newdesignsofhardwareforimprovedperformance.Whiletherearenumerousfactorscontributingtotheincreasedyieldsthathavebeenobtained,themostsustainedoftheseistheintroduction

5、ofdisposabletechnologiesonboththeupstreamandthedownstreamendsoftheprocess.Withthecontinuingintroductionofimprovedcomputertechnologyandtechno-logicalinnovation,thereiseveryreasontobelievethatqualityandquantityofantibodyproductswillcontinuetoimproveinthecomin

6、gyears,andsupplywillbeadequatetomeettheforthcomingneedsoftheindustry.Keywords:recombinantantibodies,proprietarycelllines,protein-freeandserum-freeculturemedia,glycosylation,bioreactordesign,disposabledevicesforclarificationandpurification,affinityligands,prote

7、insAG,andL,disposablebioreactorcomponents,disposableproteinpurificationdevices.IntroductionAntibodyprocessinghasmaturedoverthelastthreedecadesintoacompre-hensivedisciplineincludingbioengineering,equipmentdesign,molecularbio-logy,cellgenetics,cellculturetechn

8、ology,anddownstreampurificationtechnologies.Theseadvanceshavebeenforcedbytheeverincreasingdemandsfortherapeuticantibodies,whichhasledtorapidexpansionofglobalmanufacturingcapacity,increasingsizeofreactor