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

Director, Gene Therapy and Viral Vectors

Pall Biotech

 

Rachel has more than 20 years of experience in the field of scalable biologics and gene therapy manufacturing of therapeutic products, viral vector and proteins for gene therapy and biologics. She completed her Ph.D. in Food Engineering and Biotechnology at the Technion-Israel Institute of Technology, Israel. 

 

Rachel joined Pall in 2014 and currently serves as a process development services senior lab manager in charge of upstream and downstream process development, scale-up, and manufacturing support activities for the gene therapy and biologics markets. 

 

Prior to joining Pall, Rachel held several scientific and leadership roles at Microbiology & Molecular Genetics department at Harvard Medical School, SBH Sciences, Seahorse Biosciences, and Goodwin Biotechnology.

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

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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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In 2019 Swissfillon were inspected and approved by the FDA to supply drug products into the USA, following on from EU approval in 2018. This young fill finish CMO was started in Switzerland in 2013 and built a state-of-the-art cGMP production facility from the ground up.

Swissfillon recognized early on that single-use systems met their requirements for multi-product manufacturing and would help their clients get their drugs to market faster.

During this case-study webinar, participants will learn:

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