Economics of lentiviral vector processes
January 27-31, 2019
With the recent market approvals of autologous CAR T-cell therapies, lentiviral vectors (LVs) have been in the spotlight as a potential bottleneck to their already hindered scalability. Unstable at room temperature, LVs are routinely manufactured in multi-layered vessels using transient transfection methods. However these traditional processes are not sufficiently scalable or cost-effective for future anticipated demands. This poster discusses five different cell culture platforms that have been reported to deliver LVs: the 10-layer vessels, hollow fibre bioreactors, fixed bed bioreactors, rocking motion bioreactors in microcarrier mode and single-use bioreactors in suspension mode. These are compared from a process economics perspective across a range of scenarios that include different titre and dose size scenarios. The use of LVs for two therapeutic approaches are explored, namely for CAR T-cell therapies and haematopoietic stem cell/gene therapies. Costs of goods (COG) trends are described for a range of demands, target process parameters are identified and uncertainty analysis is carried out to capture the impact of variations in titre on the performance of each type of process.
Ruxandra-Maria Comisel, Bo Kara, and Bo Kara, "Economics of lentiviral vector processes" in "Advancing Manufacture of Cell and Gene Therapies VI", Dolores Baksh, GE Healthcare, USA Rod Rietze, Novartis, USA Ivan Wall, Aston University, United Kingdom Eds, ECI Symposium Series, (2019). http://dc.engconfintl.org/cell_gene_therapies_vi/9