Key Account Manager
Business Director EMEA
Optimization of AAV Production for Scalable GMP Processes : March 22, 2022 at 11:45 a.m CET
Presented by Bhargavi Kondragunta, PhD, Director of Internal R&D and Process Development &
George Buchman, PhD, Vice President, Preclinical and Process Development, from Catalent Cell & Gene Therapy
Adeno-associated viral vectors (AAV) are the primary vector used for viral vector-based gene therapies. Some of the challenges facing AAV manufacturing are scalability and the lack of advanced platform processes. This presentation will discuss strategies to develop advanced processes using novel transfection reagents including the results of Catalent’s collaborative study with Polyplus to evaluate the FectoVIR®-AAV reagent for scalable production in suspension HEK-293 cells.
Lentiviral Vector Process Development and Manufacturing Using PEIpro as the Transfection Reagent : March 23, 2022 at 10:00 a.m CET
Presented by Filipe Cristóvão, Head of the USP Development Department, from VIVEbiotech
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% increasein 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 usedproduction platform, as it offers significant flexibility for cell and gene therapy development. However, this method presents some limitations in largescale 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) Cost-effectiveness with reduced cost per dose for therapy affordability, iii) improved transfection protocol for large scale bioreactors and iv) reproducibility of viral titers at different production scale. Withour continuous commitment in supporting CGT manufacturers, FectoVIR®-AAV is available at GMP grade, the highest quality grade for ancillary materials aligned with quality standards recommended by health authoritiestoensure patient safety.