Available at research and GMP grade to intensify production of recombinant AAV rAAV viral vectors at any scale from benchtop to 2000L scale bioreactor...
Meet our team at booth #215 and listen to John Ketz Talk talk during Cell & Gene Therapy Manufacturing & Commercialization US!
Accelerate your bioprocessing, analytics, supply chain security and commercialization strategies by accessing novel science, technologies and the contacts you need.
A DoE approach to AAV production and scale up to 500L using FectoVIR®-AAV
Using DoE methodology, Andelyn has developed a scalable suspension platform for AAV production up to 500L. Using FectoVIR®-AAV as the transfection reagent, shake flask harvest titers reached up to 5E+11 VG/mL. The process was successfully scaled up into 50L, 200L, and 500L bioreactors with consistent harvest titers.
Talk by John Ketz, Senior Scientist Process Development, Andelyn Biosciences.
John Ketz is a Senior Scientist in the Process Development group at Andelyn Biosciences. He has been the lead scientist for the upstream and downstream development of the suspension platform for AAV production and its scale up from flask to large bioreactors for the past 5 years. Prior to joining Andelyn his research involved investigations into kidney diseases using mouse as a model system. He obtained his Master of Science degree in Biochemistry and Animal Physiology and Bachelor of Science degree in Biochemistry from West Virginia University.
Monday 29 September – 4:30-4:45pm.
Next-Generation Transfection Reagent for Large Scale AAV Manufacturing
Mathieu Porte, Mégane Denu, Marine Ricordel, Jonathan Havard, Coralie Stritt, Yann Philipson, Malik Hellal, Patrick Erbacher
The number of ATMP therapeutic-based medicines for inherited genetic disorders is in constant growth, with a global 32% increase in new clinical trials in the last 4 years. ATMPs have demonstrated their success with already more than ten approved for commercialization. The success of AAV as the most promising viral vector for gene therapy is due to low immunogenicity, broad tropism and non-integrating properties. One major challenge for translation of promising research to clinical development is the manufacture of sufficient quantities of AAV. Transient transfection of suspension cells is the most commonly used production platform, as it offers significant flexibility for cell and gene therapy development. However, this method presents some limitations in large scale bioreactors: inadequate transfection protocol, reduced transfection efficiency and lower productivity. To address this concern, we present data on a novel transfection reagent showing: i) increased AAV titers, ii) improved transfection protocol for large scale bioreactors and iii) reproducibility of viral titers at different production scale. The aforementioned optimized parameters make this novel transfection reagent ideal for cell and gene therapy developers by combining the flexibility of transient transfection with scalability and speed to market.