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Plasmid Manufacturing Service From GenScript ProBio

We at Geccript ProBio provide Plasmid Manufacturing Service appropriate for the production of viral vectors or mRNA therapeutics. We manufacture our products with strict control under quality control and we are also able to provide documentation for regulatory submissions. guarantee the product quality. For more information, visit our website.

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Plasmid Manufacturing Service From GenScript ProBio

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  1. AcceleratingVaccinedevelopment against COVID-19 GenScriptProBioPlasmidPlatform ConfidentialandPrivileged

  2. CONTENTS VaccinesagainstCOVID-19 GenScriptProBio Plasmid Production Platform Excellent PartnerformRNAvaccine

  3. Threemaingroupsoftherapies Subtypesofvaccine: Nucleicacidvaccine(Novel) Administrationofnucleicacidvaccinesresults intheendogenous generation of viral proteins that mimic antigen produced during naturalviralinfection. 1 Vaccine (forprevention) Training the immune system to recognize andcombatpathogensbyintroducing antigensinto thebodytotriggeran immuneresponse forprevention. TherapiesindevelopmentagainstCOVID-19 Subunitvaccine(conventional) Presents an antigen to the immune system without viral particles, usingaspecific,isolatedproteinofthepathogen, andto stimulatelong-lastingprotective/therapeutic immune responses. 2 Antibody (fortreatment) Passive immunity by blocking parts of the surface of a virion to render its attack ineffective. Wholevirusvaccine(conventional) Uses the entire virus particle, fully destroyed, and can be recognized bytheimmunesystemand evokean adaptiveimmuneresponse. Antiviralagent (fortreatment) 3 Block the viruses from entering the cell or inhibitthe replicationofvirusesincells. Source:WHO

  4. mRNAVaccine DNAVaccine • Vaccine Gene PlasmidDNA Therapeutic DNAvaccine Template mRNA Expression PlasmidinDNAVaccineandmRNA Vaccine Plasmid Vaccination Vaccination GenScriptProBiosupportingplasmidforvaccines 1 2 3 4 Commercialization Earlystage Latestage Clinicaltrials Clinicaltrials DevelopmentCycle PilotProduction IND • PlasmidCMC • GMPro Plasmid • GMPplasmid GenScriptProBio’s Offerings • ProPlasmid

  5. mRNAvaccineagainst COVID-19 GenScriptProBioPlasmidProduction Platform ExcellentPartner for mRNAvaccine CONTENTS

  6. 1 2 3 4 IND Commercialization Earlystage Clinicaltrials Latestage Clinicaltrials DevelopmentCycle PilotProduction • PlasmidCMC • GMPro Plasmid • GMPplasmid GenScriptProBio’s Offerings • ProPlasmid Plasmid Platformat GenScript ProBio Variouslevelsofplasmidavailable PlasmidApplications • Forproductionofviral vectors:AAV,Lentivirus,Adenovirus, HSV,Retrovirus • ForproductionofmRNAvaccine:IVT-mRNA Plasmidasrawmaterials 1 • ComplexedPlasmid DNA; • MinicricleplasmidDNA; • DNAvaccine PlasmidasDS/DP 2

  7. Non-clinicalstage Pilot Production Non-clinicalStage：ProPlasmidManufacturing IND Clinicaltrials • HighestQA control in non-clinicalstage • Detailedrecordsanddocumentsensuretraceability • Animalfree,antibioticfree, reducethe harmtoanimalandhuman body. • HighDensityFermentationHighYield：600—800mg/L. GenScriptAdvantages: Commercialization

  8. EarlyStageClinical PilotProduction EarlyStageClinical:GMProPlasmid Manufacturing IND Clinicaltrials • Animalfree,antibioticfree,reducetheharmtoanimal andhumanbody. • HighDensityFermentationHighYield：600—800mg/L. • ManufacturingprocesscomplianttoGMP,full recordguaranteetraceability. Commercialization

  9. FermentationProcess  • Increaseofyield,OD600bythechangeof fermentationtime • 700 80 PurificationProcess  QCRelease 3 ~95%supercoiledplasmidcontent 70 600 Case Studies– Plasmid ManufacturingProcess 60 500 Yield(μg/mL) 50 1 400 4 2 OD600 R 40 300 30 200 20 100 10 0 0 Agarose gel electrophoresis (AGE): obvious decrease ofRNAcontentthrough1stpurification step. 7 9 1113151719 Fermentationtime(h) 5 HPCL: After the 2ndpurification step, the contentofsupercoiledplasmidhasalready reached 95% Yield (μg/mL) OD600 UnitYield(μg/mL/OD) M1:SupercoiledDNALadderMarker M2:1 kbDNA LadderMarker 1:Lysate 2:Sampleafter1ststep 3:Wasteofsaltelution 4:Wasteofsaltelution 5: Wasteofwaterelution R:RNA bands • Highdensityfermentation • Highyield 1: Solvent;2: Opencircularplasmid; 3:Supercoiledplasmid;4: Dimerplasmid

  10. mRNAvaccineagainst COVID-19 GenScriptProBioPlasmidPlatform Excellent PartnerforVaccines CONTENTS

  11. Buildingarea:130,000m2 GMP Facility Expansion: For Commercial Manufacturing 2021 2023 2022 2018 2019 GMPFacility PlasmidProcess Development Facility Lot Area：1,200m2 AccumulativeArea：1,200m2 GMPVirusFacility GMPPlasmidFacility FACILITY （Clinicaland Commercialmfg. Center) Lot Area：2,500m2 AccumulativeArea：3,700m2 Lot Area：6,400m2 AccumulativeArea：10,100m2 Lot Area：30,000m2 AccumulativeArea：40,100m2 APPLICATION Preclinicalplasmidpreparation Plasmidprocessdevelopment Plasmidforearlyclinicalphase Preclinicalviruspreparation Virus process development Virusforearlyclinicalphase Capacityexpansion Plasmidfor CMC,clinicalphase andcommercialization Plasmid and virus manufacturingforlateclinical phaseandCommercialuse 10

  12. ~60Plasmid& VirusCMC&ClinicalGMPProjects KeyAccounts: • Provideplasmidand lentiviralvectorfor>30big pharma andleadingbiotech • 7 IND approvedfromNMPA&FDA • Over20P&V CMCprojects • Over30clinicalplasmidmfg. batches • Over10clinicallentiviralvectormfg.batches • PlasmidCMCandmfg.forover 10mRNAcustomers • Provideplasmidfor3leadingvaccinecompany GlobalPartnershipsandSolidTrackRecord StemiRNAmRNA AbogenmRNA XLifeScTCRT 2020 02.2020 2019• • 1stround of COVID- 19projectssetupby CNgovernment • CMC • INDsubmissioninNMPA • SuccessfulINDfromNMPA • mRNAprojectagainst COVID-19set up 2020• • ClinicalP&Vmfg. • Clinical trial initiatedinCN • IND clearanceinFDA(Sep.) 04.2020 06.2020 • Clinical plasmidmfg. • Clinicaltrialsinitiate • Clinical plasmidmanufacturing. • Clinicaltrialsinitiate 11

  13. Appendix

  14. MechanismofmRNAvaccine ProductionofmRNAvaccine Inducetheproductionof antibodieswhich willbindto potential pathogens. Produced by in vitro reactions with recombinant enzymes, ribonucleotidetriphosphates(NTPs)andplasmidDNA. • TemplateplasmidDNAproducedinEscherichiacoli,andis linearized • usinga restrictionenzyme; • mRNAissynthesizedfromNTPsbyaDNA-dependentRNA polymerasefrombacteriophage; • TemplateplasmidDNAisdegradedbyincubationwithDNase; • mRNA is enzymatically or chemically capped to enable efficient translationinvivo. TheBasicsofmRNAVaccine Deliveryof thevaccineintothebody. mRNA Synthesis Encoded sequence is translated by the host cells to produce the antigens. • Processed though several purification steps to remove reaction components,includingenzymes,freenucleotides, residualDNA and truncatedRNAfragments; • purification at the clinical scale utilizes derivatized microbeads in batch orcolumnformats(easiertoutilizeatlarge scale) The antigensstimulatethebody’s adaptiveimmune systemto produceantibodiesagainstthepathogen. Purification • Exchangedinto afinal storagebufferand sterile-filteredfor • subsequentfilling intovialsforclinical use. • Storage 13

  15. TheuseofmRNAPlasmid hasseveralbeneficialfeaturesoversubunit,killedandliveattenuated virus, as wellas DNA-basedvaccines. mRNAVaccineShowingSatisfying Performance Higherdelivery rate thanDNAvaccine Fasterto manufacture,easier to manufactureinlarge quantities Higher Safetyand efficacy Producedbyhighyieldsofin vitro transcription reactions,potentialfor rapid, inexpensiveandscalable manufacturing. Manufacturingprocess doesnot involve toxicchemicalsor cell culture,avoid adventitiousviruses; Shortmanufacturingtimepresentsfew opportunitiestointroducecontaminating microorganisms. DNAis supposed to penetratenucleusto allowtranscriptionto happen,while translation happens in cytoplasm, where iseasier topenetrate. 14

  16. THANKYOU! www.genscriptprobio.com

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