Transient transfection at large scale for clinical AAV9 vector manufacturing
AAV9 production in adherent HEK293 cells was scaled from the pilot iCELLis® Nano bioreactor to the large scale iCELLis 500 bioreactor (200 m2 and 333 m2 surface area). A HEK293 cell seed train was utilized, using the Xpansion® 200 bioreactor. Media components were evaluated and replenished as needed throughout the run using the perfusion process of the iCELLis bioreactor. Following a production phase, >1016 vector genomes were isolated from crude harvest of the bioreactor.
Speaker
Rachel Legmann
Director, Technical Consultancy - Gene Therapy and Viral Vectors
Pall Biotech, USA
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.
Transient transfection at large scale for clinical AAV9 vector manufacturing
Learn about scalable, single-use solutions for purification of viral vectors
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Biotech | Pall Corporation 웨비나 시리즈
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:
- How working in partnership with a supplier can be part of a QbD approach to minimize risk
- Strategies & design improvements for single-use systems to reduce risk in the process
- How a shadowboard can be used to make single-use system leak tests, PUPSIT and the filtration process fast, safe and simple