The Future Of Cell Based Vaccine Production
The future of cell based vaccineproductionMats Lundgren, Customer Applications Director, GE Healthcare
Vaccine production technology trendsPlatform technologies applied where possible (e.g., cell expansion on microcarriers andpurification by chromatography)Single-use technologies and automated solutionsVaccinebioprocesstechnologyUpdated cell substrates—from eggs and diploid cells to continuous cell linesLive viral vector production—need for efficient platformsProcess economy modelling implemented early in process developmentFocus on analytical technologies driven by increased regulatory requirementsKA747131017PP2
Vaccine production todayProcesses developeddecades agoOld cell substrates oreggsLimited purificationProcesses difficult to scale upUnfavorable process economyIncreased regulatoryrequirementsCentrifugationLow yieldsOpen handlingFixed installationsLong process timesBatch variabilityRoller ignificant expertiserequiredDedicated facilitiesKA747131017PP3
Vaccine production tomorrowProcesses developeddecades agoPlatformcell lines orOld cell substrateseggsLimited ionrequiredbasedonchromatographyIncreased regulatoryrequirementsProcesses difficult to scale upUnfavorable process economyScalabletechnologiesCentrifugationenabled by, e.g.,Fixed installationssingle-useRoller bottlestechnologiesEfficientand rationalLow yieldsprocess designLong process timesOpen allydefined cellSerumsupplementationculturemediaQualityby design (QbD)Batch 47131017PP4
Cell culture and virus propagation
Cell substrates for C-5WI-38VeroMDCKProductionsystemH. influenzaePER.C6 YEASTB. anthracisS. pneumoniaeC. tetaniV. choleraeC. diphtheriaeN. meningitidis B. pertussisCELLSEGGSBACTERIAPSAttenuated Inactivated Subunit VLPViralS. PS conjugated polysaccharides, PS polysaccharides, VLP virus-like particleKA747131017PP6
40 vaccines still to be developedWhere would this trend WI-38VeroMDCKProductionsystemH. influenzaePER.C6 YEASTB. anthracisS. pneumoniaeC. tetaniV. choleraeC. diphtheriaeN. meningitidis B. pertussisCELLSEGGSBACTERIAPSAttenuated Inactivated Subunit VLPViralS. PS conjugated polysaccharides, PS polysaccharides, VLP virus-like particleKA747131017PP7
Selecting a cell line for virus productionCell substrate evolution from primary todiploid to continuous cell linesModern options: Vero, MDCK, EBx, AGE,PER.C6 Requirements KA747131017PPSuitable for GMP productionGood safety track recordAnimal-origin free media preferredGood virus propagationBroadly and highly permissiveScalable to high-volume production8
Cell culture medium and serumSerum—ensure quality,traceability, and originClassical mediumAnimal-origin free mediaComplex media containinghydrolysatesChemically defined mediaKA747131017PP9
Scale-up of adherent and suspension cellsAdherent cellsSuspension cellsCell growth is limited by surfaceareaCell growth is limited by cell concentration in mediumEasier passage and scale-upNeed enzymatic passagingLower virus production/cellMore complex scale-upHigher virus production/cellMicrocarriers increase volumetricoutput by maximizing the surfaceto volume ratio for adherent cellsKA747131017PP10
Introduction to Cytodex 1 and 3 Gamma microcarriersDelivered gamma-sterilized and ready to use. Supplied dry to save storage space andfacilitate transportation.KA747131017PP11
Adenovirus vector
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Clarification NFF TFF Capto Q ImpRes Nuclease treatment Capto Core 700 TFF. 0 10 000 20 000 30 000 40 000 50 000 60 000 70 000 80 000 90 000 0 10 000 20 000 30 000 40 000 50 000 60 000 70 000 80 000 90 000 /batch Capital Materials Consumables Labour Othe
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Le genou de Lucy. Odile Jacob. 1999. Coppens Y. Pré-textes. L’homme préhistorique en morceaux. Eds Odile Jacob. 2011. Costentin J., Delaveau P. Café, thé, chocolat, les bons effets sur le cerveau et pour le corps. Editions Odile Jacob. 2010. Crawford M., Marsh D. The driving force : food in human evolution and the future.
Le genou de Lucy. Odile Jacob. 1999. Coppens Y. Pré-textes. L’homme préhistorique en morceaux. Eds Odile Jacob. 2011. Costentin J., Delaveau P. Café, thé, chocolat, les bons effets sur le cerveau et pour le corps. Editions Odile Jacob. 2010. 3 Crawford M., Marsh D. The driving force : food in human evolution and the future.
