Apr
17
2019
On demand

Optimizing process development to simplify manufacturing scale up of therapeutic viral vectors

With the progress in developing new viral vector systems guided by safety, specificity and potency considerations, several gene and cell-based therapies are now close to being clinically approved and commercially available to treat genetic diseases. These viral vectors systems are based on the production of mainly adeno-associated viruses (AAV) and lentiviruses by transient transfection of human embryonic kidney (HEK)-293 derived producer cell lines.

One of the bottlenecks that needs to be addressed is optimization of production during Upstream Process Development to simplify manufacturing scale-up of therapeutic viral vectors to support advanced clinical trials and commercialization. This is why, virus vector production using the right transient transfection approach and combined cell culture system is crucial to achieve process performance, while complying with Quality requirements for process development and clinical-grade manufacturing. With the available quality grades of PEI, PEIpro®, PEIpro®-HQ and recently launched PEIpro®-GMP, Polyplus-transfection® offers a complete and reliable PEI transfection method that guarantees direct scalability and seamless transition from process development up to large-scale clinical-grade viral vector manufacturing.

During this On Demand you will hear from experts in transfection, advanced culture systems and gene therapy viral vector manufacturing to optimize your process development and simplify your manufacturing scale-up.

  • Improve transfection step efficiency to optimise viral vector production
  • Simplify and introduce flexibility to your vector scale-up process
  • Ensure reproducability across various platforms
  • Improve performance through reliable PEI sourcing
  • Comply with raw material quality requirements for ATMPs throughout the transition to therapeutic/clinical-grade viral vector production
  • Anticipate challenges with large-scale manufacturing

Chris Lorenz
SVP, Technical Operations
Valerie Kedinger
GMP & Analytical Subcontractor Manager at Polyplus-transfection
Rachel Legmann
Senior Cell Culture Process Development Manager at Pall Biotech
Kathy Webb
Senior Director, GMP, Upstream at Catalent Pharma Paragon Bioservices

SPEAKERS

Chris Lorenz
SVP, Technical Operations
Valerie Kedinger
GMP & Analytical Subcontractor Manager at Polyplus-transfection
Rachel Legmann
Senior Cell Culture Process Development Manager at Pall Biotech
Kathy Webb
Senior Director, GMP, Upstream at Catalent Pharma Paragon Bioservices

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