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Plasmid Manufacturing Service from GenScript ProBio Presentation Transcript

Slide 1 - Accelerating Vaccine development against COVID-19 GenScript ProBio Plasmid Platform Confidential and Privileged
Slide 2 - Vaccines against COVID-19 GenScript ProBio Plasmid Production Platform Excellent Partner for mRNA vaccine CONTENTS
Slide 3 - Therapies in development against COVID-19 Three main groups of therapies Vaccine (for prevention) Training the immune system to recognize and combat pathogens by introducing antigens into the body to trigger an immune response for prevention. Antibody (for treatment) Passive immunity by blocking parts of the surface of a virion to render its attack ineffective. Antiviral agent (for treatment) Block the viruses from entering the cell or inhibit the replication of viruses in cells. Subtypes of vaccine: Nucleic acid vaccine (Novel) Administration of nucleic acid vaccines results in the endogenous generation of viral proteins that mimic antigen produced during natural viral infection. 1 Subunit vaccine (conventional) Presents an antigen to the immune system without viral particles, using a specific, isolated protein of the pathogen, and to stimulate long-lasting protective/therapeutic immune responses. 2 Whole virus vaccine (conventional) Uses the entire virus particle, fully destroyed, and can be recognized by the immune system and evoke an adaptive immune response. 3 Source: WHO 2
Slide 4 - Plasmid in DNA Vaccine and mRNA Vaccine Development Cycle Pilot Production IND Early stage Late stage Clinical trials Clinical trials Commercialization GenScript ProBio’s Offerings ProPlasmid Plasmid CMC GMPro Plasmid GMP plasmid Vaccination Plasmid DNA Template Therapeutic mRNA Vaccination DNA vaccine Expression Plasmid mRNA Vaccine  DNA Vaccine Vaccine Gene 3 1 2 3 4 GenScript ProBio supporting plasmid for vaccines
Slide 5 - CONTENTS mRNA vaccine against COVID-19 GenScript ProBio Plasmid Production Platform Excellent Partner for mRNA vaccine
Slide 6 - Plasmid Platform at GenScript ProBio Development Cycle Pilot Production IND Early stage Clinical trials Late stage Clinical trials Commercialization GenScript ProBio’s Offerings ProPlasmid Plasmid CMC GMPro Plasmid GMP plasmid Various levels of plasmid available Plasmid as raw materials Plasmid as DS/DP For production of viral vectors: AAV, Lentivirus, Adenovirus, HSV, Retrovirus For production of mRNA vaccine: IVT-mRNA Complexed Plasmid DNA; Minicricle plasmid DNA; DNA vaccine Plasmid Applications 1 2 1 2 3 4 5
Slide 7 - Non-clinical Stage：ProPlasmid Manufacturing Pilot Production IND Clinical trials Commercialization Highest QA control in non-clinical stage Detailed records and documents ensure traceability Animal free, antibiotic free, reduce the harm to animal and human body. High Density Fermentation  High Yield：600—800 mg/L. 6 Non-clinical stage GenScript Advantages:
Slide 8 - Early Stage Clinical: GMPro Plasmid Manufacturing Animal free, antibiotic free, reduce the harm to animal and human body. High Density Fermentation  High Yield：600—800 mg/L. Manufacturing process compliant to GMP, full record guarantee traceability. Early Stage Clinical Pilot Production IND Clinical trials Commercialization 7
Slide 9 - Case Studies – Plasmid Manufacturing Process High density fermentation 0 10 20 30 40 50 60 70 0 100 200 300 400 500 600 5 OD600 Yield (μg/mL) 7 9 11 13 15 17 19 Fermentation time (h) Yield (μg/mL) OD600 Unit Yield (μg/mL/OD) Agarose gel electrophoresis (AGE): obvious decrease of RNA content through 1st purification step. M1: Supercoiled DNA Ladder Marker M2: 1 kb DNA Ladder Marker 1: Lysate 2: Sample after 1st step 3: Waste of salt elution R Fermentation Process  Increase of yield, OD600 by the change of fermentation time 700 80 High yield 1 2 3 ~95% supercoiled plasmid content 4 HPCL: After the 2nd purification step, the content of supercoiled plasmid has already reached 95% 1: Solvent; 2: Open circular plasmid; 3: Supercoiled plasmid; 4: Dimer plasmid 4: Waste of salt elution 5: Waste of water elution R: RNA bands Purification Process  8 QC Release
Slide 10 - CONTENTS mRNA vaccine against COVID-19 GenScript ProBio Plasmid Platform Excellent Partner for Vaccines
Slide 11 - GMP Facility Expansion: For Commercial Manufacturing 10 FACILITY 2022 2023 2021 Lot Area：2,500m2 Accumulative Area：3,700m2 Plasmid Process Development Facility Lot Area：1,200m2 Accumulative Area：1,200m2 GMP Virus Facility Lot Area：30,000m2 Accumulative Area：40,100m2 GMP Facility （Clinical and Commercial mfg. Center) GMP Plasmid Facility Lot Area：6,400m2 Accumulative Area：10,100m2 Building area: 130,000 m2 Capacity expansion Plasmid for CMC, clinical phase and commercialization Preclinical plasmid preparation Plasmid process development Plasmid for early clinical phase Preclinical virus preparation Virus process development Virus for early clinical phase Plasmid and virus manufacturing for late clinical phase and Commercial use APPLICATION 2018 2019
Slide 12 - 11 Provide plasmid and lentiviral vector for >30 big pharma and leading biotech Provide plasmid for 3 leading vaccine company Global Partnerships and Solid Track Record mRNA project against COVID-19 set up 02.2020 StemiRNA mRNA Clinical plasmid mfg. Clinical trials initiate 04.2020 CMC IND submission in NMPA Successful IND from NMPA Clinical P&V mfg. Clinical trial initiated in CN IND clearance in FDA (Sep.) 2019 • 2020 • XLifeSc TCRT 1st round of COVID- 19 projects set up by CN government 2020 Abogen mRNA Clinical plasmid manufacturing. Clinical trials initiate 06.2020 ~60 Plasmid & Virus CMC & Clinical GMP Projects Key Accounts: 7 IND approved from NMPA&FDA Over 20 P&V CMC projects Over 30 clinical plasmid mfg. batches Over 10 clinical lentiviral vector mfg. batches Plasmid CMC and mfg. for over 10 mRNA customers
Slide 13 - Appendix
Slide 14 - The Basics of mRNA Vaccine Mechanism of mRNA vaccine Production of mRNA vaccine Produced by in vitro reactions with recombinant enzymes, ribonucleotide triphosphates (NTPs) and plasmid DNA. Induce the production of antibodies which will bind to potential pathogens. mRNA Synthesis Template plasmid DNA produced in Escherichia coli, and is linearized using a restriction enzyme; mRNA is synthesized from NTPs by a DNA-dependent RNA polymerase from bacteriophage; Template plasmid DNA is degraded by incubation with DNase; mRNA is enzymatically or chemically capped to enable efficient translation in vivo. Purification Processed though several purification steps to remove reaction components, including enzymes, free nucleotides, residual DNA and truncated RNA fragments; purification at the clinical scale utilizes derivatized microbeads in batch or column formats (easier to utilize at large scale) Exchanged into a final storage buffer and sterile-filtered for subsequent filling into vials for clinical use. Storage Delivery of the vaccine into the body. Encoded sequence is translated by the host cells to produce the antigens. The antigens stimulate the body’s adaptive immune system to produce antibodies against the pathogen. 13
Slide 15 - mRNA Vaccine Showing Satisfying Performance Manufacturing process does not involve toxic chemicals or cell culture, avoid adventitious viruses; Short manufacturing time presents few opportunities to introduce contaminating microorganisms. The use of mRNA Plasmid has several beneficial features over subunit, killed and live attenuated virus, as well as DNA-based vaccines. Higher delivery rate than DNA vaccine Faster to manufacture, easier to manufacture in large quantities DNA is supposed to penetrate nucleus to allow transcription to happen, while translation happens in cytoplasm, where is easier to penetrate. 14 Higher Safety and efficacy Produced by high yields of in vitro transcription reactions, potential for rapid, inexpensive and scalable manufacturing.
Slide 16 - THANK YOU ! www.genscriptprobio.com
 

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