Adherent Lentivirus Suspension Production & Manufacturing - PowerPoint PPT Presentation

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Adherent Lentivirus Suspension Production & Manufacturing

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GenScript ProBio is the world's leading biotech company founded in 2002 in New Jersey USA. We at GenScript ProBio provide various solutions based on gene synthesis technology including lentivirus manufacturing, CAR-T IND filing, plasmid manufacturing & production, and many more. – PowerPoint PPT presentation

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Title: Adherent Lentivirus Suspension Production & Manufacturing


1
Adherent Lentivirus Suspension Production
Manufacturing
2
  • GenScript ProBio is the world's leading biotech
    company founded in 2002 in New Jersey USA. We at
    GenScript ProBio provide various solutions based
    on gene synthesis technology including lentivirus
    manufacturing, CAR-T IND filing, plasmid
    manufacturing production, and many more. 
  • GenScript ProBio has also established integrated
    innovative biologics CDMO platforms that cover
    all your needs from the pre-clinical to clinical
    phases. We offer flexible and best-quality
    lentiviral vector production services to cover
    all your needs from the pre-clinical to clinical
    phases.

3
One-Stop Solutions We Provide
4
Cell Banking
  • GenScript ProBio offers cell bank manufacturing
    services to customers. We ensure that our
    Lentivirus production is fully compliant with GMP
    and with full characterization. 
  • Our cell banks support customers projects moving
    forward smoothly from the clinical phase to
    commercialization.
  • We also have our own cell banks ready for
    lentiviral vector production
  • MCB/WCB Construction
  • Cell Bank Characterization
  • Cell Bank Stability Test

5
Process Development (PD)
  • We have a developed adherent as well as
    suspension culture system in a dedicated PD lab.
    We are experienced in developing and providing
    successful deliveries over the past year which
    has enabled us to reduce the development cycle
    and streamline processes.
  • Upstream Process Development
  • Downstream Process Development
  • Small Scale Production

6
Analytical Development (AD)
  • At GenScript ProBio, we offer a wide range of
    assays, which have been developed and optimized,
    to ensure quality lentiviral products. 
  • The analytical support for customers includes
    analytical development, qualification, validation
    and transfer, which is also essential in CMC
    study for regulatory filings.
  • GenScript ProBio also develops assays tailored
    to customers requirements for specific
    applications or types of products.
  • Analytical Method Development
  • Analytical Method Qualification

7
Lentiviral Vector Production
  • We are experienced in the manufacturing of
    lentiviral vectors adopting both adherent
    lentivirus production and suspension systems,
    providing customers with quality products for
    preclinical, clinical and commercial supply.

8
Manufacturing with an adherent system
  • The largest manufacturing scale is 75CF10
  • High final product titer of 5E7 TU/m

Manufacturing with the suspension system
  • up to 200L manufacturing scale
  • Proprietary cell line PowerSTM-293T
  • Yield improves 45 times compared with another
    commercial cell line
  • 50 material cost reduction

9
Stability Test
  • GenScript ProBio provides influencing factors
    and accelerated and long-term stability studies
    according to ICH guidelines to monitor product
    integrity over time. 
  • Accelerated Stability Test
  • Influencing Factor Stability Test
  • Long-term Stability Test

10
Thank You
  • Website www.genscriptprobio.com
  • Email cdmo.us_at_genscript.com
  • Call Us 17328859188 18774367274
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