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Advancingthemanufactureanddeploymentofcosteffectivevaccines
EPSRCFutureVaccineManufacturingResearchHub
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FutureVaccineManufacturingResearchHub
• IntroductiontotheFVMRHub• Aimsandobjectives• Hubcapabilitiesandinitiatives• Currentpartners• Opportunitiesforinteraction,partnershipsandproposals
• Discussion
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FutureVaccineManufacturingResearchHub
• IntroductiontotheFVMRHub• Aimsandobjectives• Hubcapabilitiesandinitiatives• Currentpartners• Opportunitiesforinteraction,partnershipsandproposals
• Discussion
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• ThenewFutureVaccineManufacturingResearchHubatImperialCollegeLondon,hasbeenestablishedwith£10million(GBP)offundingfromtheUKDepartmentforHealth,administeredbyEPSRC.
• IncorporatesresearchgroupsacrossImperialCollegeexperiencesinvaccineR&D,processengineeringandmanufacturing
• LinkedtoadditionalUKspokeswithexperienceinformulation,computationalmodelling,processdevelopmentandvaccineQA/QC(NIBSC)
• Establisheddevelopingcountryvaccinemanufacturerspokes,initiallyinIndia,Vietnam,Bangladesh,UgandaandChina
• Lookingtoexpandcollaborationwithadditionalpartners.
FutureVaccineManufacturingResearchHubIntroductiontotheHub
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FutureVaccineManufacturingResearchHub
• IntroductiontotheFVMRHub• Aimsandobjectives• Hubcapabilitiesandinitiatives• Currentpartners• Opportunitiesforinteraction,partnershipsandproposals
• Discussion
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• Wewilladoptanintegratedapproachthatwillbuildonnewdevelopmentsinlifesciences,immunologyandengineeringtoaddresstwokeychallenges
• Howtodesignproductionsystemsthatcanproducetensofthousandsofnewdoseswithinweeksofanewthreatbeingidentified
• Howtoimprovethewayvaccinesaremanufactured,stabilisedandstoredsothatexistingandnewdiseasescanbepreventedeffectively,andcostsreduced
FutureVaccineManufacturingResearchHubAimsandobjectives
Goal:advancingthemanufactureanddeploymentofcosteffectivevaccines
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Responsivetothetreatofemergingandre-emerginginfections
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7billionin2012
Respondingtodevelopingworldvaccineneeds
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Identifyinggapsintechnologytransfer
• ResearchandDevelopmentcapacitytosupporttechnologytransfer,developnovelvaccines,workaroundexistingIP
• Vaccinespecificmodelling– manufacture,distribution,markets• Businesscase/sustainabilitytosupportadoption,adapttochangingmarkets,respondtosupplyanddemand
• Know-how– workforce(training,expertise,retention)• Know-howinemergingtechnology(whentoadoptordrop)• Know-howinprocessoptimisation• QA/QCandregulatoryaffairsfornewtechnologiesandultimatelypre-qualification
Opportunity:leap-frogexistinginvestmentsbyexploitingemergingplatforms
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Technologyowner:rightsandknow-how
(IndustrializedPharma)
Bilateraltechnologytransfer
Jointventures,acquisitionsorwhollyownedsubsidiaries(oneorfewpartners)
PatentLapse
ManufacturersManufacturers
Manufacturers
Manufacturers
Manufacturers Manufacturers
NewmodelforTechnologyTransferAdvancedTechnologyHub
• Spokes• Spokes
• Spokes• Spokes
Know-howSharedIPInnovators
TechnicalAdvisorsQA/QC
ModellersDevelopers
FormulatorsManufacturers
ManufacturersManufacturers
Manufacturers
Manufacturers
Manufacturers Manufacturers
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Engineeringdeliverablesatmultiplelevels• RepliconRNAvaccines• Enhancedyeastexpressionplatforms• Insectcell-baculovirus expressionsystem(IC- BEVS)• GeneralizedModulesforMembraneAntigens(GMMA)• Formulationforheatstabilisation• Processoptimisationofmanufacturingplatforms• Vaccinespecificmodellinganddecisionaltools• R&Dtrainingandsupport• QA&QCsupportandtraining
Risk
Inno
vatio
n
Levelofd
isrup
tion
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R&D Pilot Full production
Fill & Finish
Upstream transfer(seed with know-how)Seed with technology platformPilot stage transfer
Fill and Finish transfer
Enhanced formulation
R&D technical support & trainingQC/QA technical supportPrequalificationProcess optimisation
Self developmentDevelopment with Hub supportTransfer of specific technology
Modelling
Developingappropriatepartnership
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FutureVaccineManufacturingResearchHub
• IntroductiontotheFVMRHub• Aimsandobjectives• Hubcapabilitiesandinitiatives• Currentpartners• Opportunities• Discussion
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1.ProvisionofQA/QCsupportandtraining• DevelopmentofQAassaysfornovelmanufacturingplatforms • Provisionofvaccinepotencyassaysforviralandbacterialvaccines • Developmentofvalidatedassaysandreferencematerialsforemerginginfections
• AdviceonmanufacturingQAandregulatoryapprovalunderpinningprequalification
NationalInstituteforBiologicalStandardsandControls
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2.Provisionofvaccinespecificmodellinganddecisionaltools
§ Objectives:§ operationalefficiencyforcostreduction§ rapidresponseofexistingassets§ end-to-endsystemdesign
§ Wholeprocessanalysisandoptimisationtoaddressbottlenecks§ InLifeSciences:hostcellsystemorvectoroptimisationforimprovedproductivity/quality
§ InEngineering:downstreamseparations,formulationandpackaging
§ Establishedcomputationalplatformformodellingandoptimisingvaccinemanufacturingprocessestoreducecosts
Multi-scalemodellingcapabilities
Plant operations
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Currentcapabilitieswithinthehub§ Wehaveestablishedacomputationalplatformformodellingandoptimisingvaccinemanufacturingprocessestoreducecosts
§ Applywholeprocessoptimisation,systemdesignandprocessintensificationtoimproveoperationalflexibilityandefficiency
§ Processintensificationhasgreatpromiseforcostreductionandimprovementofresponsivenessinvaccinemanufacturing
§ Optimiseusingprocessmapping,bottleneckidentificationandprocessintensification,buildingonworkinbiologicsmanufacturing.
§ Deliverable:Demonstrationofbenefitsofintegratedapproachonprimaryproductionsystems
Downstreamseparationstypicallyincursignificantcostsandin-processtimes
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Exemplarpurificationconcepts§ “processtelescoping”wherebyseveralunitoperationsarecombinedintoone(e.g.expandedbedaffinityadsorptioncombiningsolidsremoval,captureandprimarypurification)
§ continuousoperation(e.g.movingtocontinuouschromatographyusingsimulatedmovingbedtechnology).
§ Ourkeyactivitieswillinvolvehighthroughputexperiments,modelsandbigdataanalytics.
§ Deliverable:Demonstrationofnewvaccineseparationdesignconceptsatlabscale
Design
Modeling
OptimizationControl
Experiments
• Study dynamics• Thorough
system understanding
• Dynamic • High-fidelity• Testing platform
• Optimal operating conditions
• Optimal performance
• Monitoring• Optimal
performance guaranteed
• Only the necessary
• Minimizelabor time& cost
• Re-designcurrent state-of-the-art
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Computationalmodelsforwholesystemsanalysis
§ Multi-scalemodellingofbiologicalprocessesthroughtounitoperationandwholevaluechainswillbeusedforsystemanalysis,designandmanufacturingoperationoptimisation
§ Howdoparameterscharacterisingsingleunitperformancee.g.titre,purity,recovery,formulationrecipeinfluencewholesystemmetricse.g.costperdose,leadtimes?
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3.Processoptimisationofemergingmanufacturingplatforms:Industrialisation,demonstration,deployment
WS4-8
Processconcepts
ManufacturingEngineeringDesignOptimisation
10platformdesigns(“blueprints”)
6physicaldemonstratorsatLMICsitesScaleupandindustrialisationanalysis;Valuechainmodellingandeconomicanalysis,decisionmakingtoolsBuildsonexistingexperienceinoptimisingindustrialprocesses
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4.Formulationforheatstabilisation• Advancedfreeze-dryingformulationsandprocessesforvaccinestabilisation≥6months
• Generationofhighlythermally-stableliquidvaccineformulations• (biocompatibleionicliquids,40°Cfor12months)
• Novelvaccinedeliveryformulationsprovidingdosesparingandenhancedimmunogenicity
• Widerexploitationofdisposablepouchsystemfororalvaccinedelivery
2 ˚C to 8 ˚C 2 ˚C to 8 ˚C 2 ˚C to 8 ˚C 2 ˚C to 8 ˚C
Manufacture Land Transport Aviation Transport Storage Administration
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Centralisedversusdecentralisedmanufacture
Staff/trainingQMSEquipmentConsumablesQA/QCtesting
SeedtechnologytoanynumberofLMICfacilitiescapableofcGMP,fill/finishlabelling
CentralHub
Atoolboxoftechnologies,training,methodologies,andmaterialdesignedtomeetcommonneedsamongemergingvaccinemanufacturers
UptomillionsofdosesNational/regionalNeglecteddiseasesRapidresponsetoemerging
andlocalinfectionsHighflexibility
Singlemanufacturingplant
EconomiesofscaleandvolumeHundredsofmillionsofdosesStandardised QC/QAApplicabletocomplexmanufacture(pneumococcalconjugatevaccine)GlobaldistributionHighupfrontcapitalcostsHighpersonnelcostsLowflexibility
Enhanceddelivery:formulation,route,supplychain…
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RNA
RNA
RNA
RNA
RNA
RNA
RNA
RNA
Identifyingcoreplatformsforfurtherexploitation
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ExploitationofthemultiBac Platform
Baculovirus expressionvectorsystem(BEVS)
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Engineeringenhancedyeastbasedexpressionplatforms
AnumberofindividualstrainmodificationshavebeenidentifiedWeaimtocombinethesetocreatea“super-strain”andre-engineerhumanglycosylationEnsurebioprocessoptimisation
SecretoryPathwayEngineering:• UpregulateUPR• ExpandERsize• ‘bgs’modifications
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GeneralizedModulesforMembraneAntigens(GMMA)
F.Micoli|GMMAtechnology
25
Eleonora Meloni &Taddei Anna Rita C.I.M.E. Institute, Università della Tuscia
Break links
Induce blebbing
GMMA(gemma: Italian for bud or jewel)
X X X
X X X
– Genetic modifications trick bacteria into shedding outer membranes
– GMMA are released yielding pure source of outer membrane– Similar size to virus-like particles– Contain PAMPs: naturally adjuvanting– Multiple antigens are presented in their natural
environment and conformation
GSKVaccinesInstituteforGlobalHealth(GVGH)
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CAg Replicase
Rep
Ag Rep- Antigengene - Antigenprotein - Replicase gene - Replicase protein - CAP - Genomicpromoter
- Subgenomic promoter
Ag
Replicase Ag PolyAC Replicase Ag PolyAC
Replicase Ag PolyAC
Replicase Ag PolyAC
Replicase Ag PolyAC
Ag PolyAC
Ag PolyAC
Ag PolyAC
Ag PolyAC
Ag PolyAC
Ag
AgAg
Ag
Ag
Legend
AgAg
Ag PolyACAg PolyAC
B:Self-amplifyingRNA
A:mRNA
Self-amplifyingRNAbasedvaccines
Chillon'I'et#al.'Methods#in#Enzymology,'2016'''
Mul0ple'op0ons'for'purifica0on'can'be'
considered.''
Note:'5’'capping'and'polyadenyla0on'reac0ons''
performed'before'addi0on'of'Proteinase'K'
Chillon'I'et#al.'Methods#in#Enzymology,'2016'''
Mul0ple'op0ons'for'purifica0on'can'be'
considered.''
Note:'5’'capping'and'polyadenyla0on'reac0ons''
performed'before'addi0on'of'Proteinase'K'
Chillon'I'et#al.'Methods#in#Enzymology,'2016'''
Mul0ple'op0ons'for'purifica0on'can'be'
considered.''
Note:'5’'capping'and'polyadenyla0on'reac0ons''
performed'before'addi0on'of'Proteinase'K'
Chillon'I'et#al.'Methods#in#Enzymology,'2016'''
Mul0ple'op0ons'for'purifica0on'can'be'
considered.''
Note:'5’'capping'and'polyadenyla0on'reac0ons''
performed'before'addi0on'of'Proteinase'K'
Chillon'I'et#al.'Methods#in#Enzymology,'2016'''
Mul0ple'op0ons'for'purifica0on'can'be'
considered.''
Note:'5’'capping'and'polyadenyla0on'reac0ons''
performed'before'addi0on'of'Proteinase'K'
Chillon'I'et#al.'Methods#in#Enzymology,'2016'''
Mul0ple'op0ons'for'purifica0on'can'be'
considered.''
Note:'5’'capping'and'polyadenyla0on'reac0ons''
performed'before'addi0on'of'Proteinase'K'
Capping
RNAcapping
Fullysynthetic,smallfoot-print,low-costrapidmanufacture
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FutureVaccineManufacturingResearchHub
• IntroductiontotheFVMRHub• Aimsandobjectives• Hubcapabilitiesandinitiatives• Currentpartners• Opportunitiesforinteraction,partnershipsandproposals
• Discussion
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CurrentLMICpartnerships
• HillemanLaboratories,India• developmentofathermostablecombinedoralCholera-ETECvaccine
• DalianHissen,China• developmentofrobust,modularandintensifiedmanufacturingprocesscapableofenhancingandacceleratingyeastbasedproduction
• Incepta Pharmaceuticals,Bangladesh• productionofformulatedpilotvaccinesusingnoveltherostable stableformulationsanddemonstrationofthermalstabilityandthereforethelifetimeoftheformulation
• Vabiotech,Vietnam• EstablishmentofamodularplatformforIC-BEVSproductioninVietnam
• UVRI,Uganda• EstablishmentofamodularplatformforRNAproductioninUganda
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AdvancedTechnologyHub
•Cambridge•Nottingham•Bristol• Cranfield
•HillemanLaboratories–India
•UVRI,Uganda
•GSK(GlobalHealth)•DalianHissen,China• InceptaPharmaceuticals,Bangladesh
•Vabiotech,Vietnam
•NIBSC•CPI,Darlington•NHSBTCBC,Bristol
Know-howSharedIPInnovators
TechnicalAdvisorsQA/QC
ModellersDevelopers
Formulators
Manufacturers
Manufacturers
Manufacturers
FutureVaccineManufacturingHub
DevelopingCountriesVaccineManufacturersNetwork GMMA
VLPs
IC-BEVS
Delivery
Yeast
Processinnovation
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FutureVaccineManufacturingResearchHub
• IntroductiontotheFVMRHub• Aimsandobjectives• Hubcapabilitiesandinitiatives• Currentpartners• Opportunitiesforinteraction,partnershipsandproposals
• Discussion
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Opportunitiesforinteractions&partnerships
• QA&QCsupportandtraining• R&Dtrainingandsupport• AccesstoVaccinespecificmodellinganddecisionaltools• Collaborationonprocessoptimisationofmanufacturingplatforms• Partnershipsonformulationforheatstabilisation• Partnershipsonvaccineplatformdevelopment• Leveragingofexistinginvestmenttoattractadditionalfunding
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Proposals
• LMICR&Dandtechnologytransferflexiblefund(£400,000)• VaccineHubtopresent,togetherwithmembersatthepre-meetingsymposium
• DCVMNlikelytoserveasplatformforsmallgrants(applications/management/reporting)
• WillprovideconsultingexpertiseformemberstoadvancewithGMP,processoptimization,regulatorydossiers,PQ,investments,andpartnershipswiththeHub
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FutureVaccineManufacturingResearchHub
• IntroductiontotheFVMRHub• Aimsandobjectives• Hubcapabilitiesandinitiatives• Currentpartners• Opportunitiesforinteraction,partnershipsandproposals
• Discussion