Commercial viral vector manufacturing: Current and future state, challenges and opportunities

 

With several recent FDA approvals and a strong drug pipeline, the gene therapy market is providing new hope for patients. As demand for these new therapies increases, a robust and scalable manufacturing process is critical. We will address how to mitigate the risk of contamination by adventitious agents to ensure viral vector safety used in biotherapeutics. One of the first steps in designing a process is whether to use adherent or suspension cell cultures.  Each modality has its advantages and disadvantages. This presentation will outline the key considerations in choosing the right technology and some of the pitfalls that must be overcome to ensure success at large scale will be discussed.

 

We will present three case studies which illustrate the strategies for viral vector manufacturing production. The first case study will demonstrate the production of lentivirus in a fixed bed bioreactor, resulting in a 1.62-fold increase in the average titer (TU/cm2). The second case study will show data regarding the development of AAV9 production in adherent HEK293 cells, utilizing the iCELLis® Nano Bioreactor. Based on conditions developed in this bench-top iCELLis Nano, we scaled production to the fully closed, single-use Xpansion® 200 Multiplate Bioreactor for seed train and the production-scale iCELLis 500 single use bioreactor. Following a production phase, >1016 vector genomes were isolated from crude harvest of the bioreactor.  The last case study will demonstrate scalability of AAV production in suspension HEK293 cells from the AllegroTM STR 50 Bioreactor to the Allegro STR 500 Bioreactor, while achieving similar product yield and quality. 

Speaker

Rachel Legmann, PhD

 

 

 

Commercial viral vector manufacturing: Current and future state, challenges and opportunities

Download our new Gene Therapy eBook!

The Cell Culture Dish have partnered with industry experts Pall Biotech, Cobra Biologics, SCIEX, REGENXBIO Inc., BioTechLogic and Jane Barlow & Associates, LLC to share their perspectives in a new ebook, 'Insights on Successful Gene Therapy Manufacturing and Commercialization'.

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October 2021

Integrity Assurance for Single-Use Systems An End-User’s Perspective

 

What should you consider when building an integrity control strategy for your single-use systems (SUS)? How do you overcome application challenges?

 

Join leading industry experts Charlotte Masy of GSK and Patrick Evrard from Pall Corporation to gain insights and answers in this webinar from BioPharma Asia on integrity Assurance for Single-Use Systems, an End-User’s Perspective. They will present several case studies to show how integrity concerns can be practically addressed for cGMP manufacturing applications and the results observed a few years on. 

 

Attendees will learn about:

 

  • The latest regulatory requirements for integrity assurance of SUS
  • The different technologies available to control integrity of SUS
  • Key parameters that affect integrity measurements

 

Register now for this webinar from industry experts on October 6.

 

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