Application of continuous processing in cell and gene therapy: Current state and future opportunities
October 6-10, 2019
For CAR-T and autologous ex vivo gene therapies, cells are first collected from patients via apheresis, modified ex vivo with lentiviral vector (LVV) or other gene addition/gene editing methods, expanded in culture, and frozen as a living drug product. With the rapid growth of the cell and gene therapy field, the demand for LVV has increased exponentially. Current LVV production methods using transient transfection are robust but will ultimately be constrained volumetrically and temporally. To overcome these constraints, an alternative production process using stable clonal cell lines may be required to meet future demand. Stable producer cell lines will enable multi-day, continuous and scalable lentiviral vector production. The drug product manufacturing processes for autologous therapies present an ideal opportunity for continuous manufacturing, going beyond decentralized manufacturing to point-of-care or even bedside manufacturing. This presentation will provide an overview of our efforts to advance continuous bioprocessing for LVV and the challenges and opportunities of beside manufacturing for autologous gene therapy products.
Susan Abu-Absi, Lesley Chan, and Ken Kotz, "Application of continuous processing in cell and gene therapy: Current state and future opportunities" in "Integrated Continuous Biomanufacturing IV", Veena Warikoo, Roche, USA Alois Jungbauer, BOKU, Austria Jon Coffman, Boehringer Ingelheim, USA Jason Walther, Sanofi, USA Eds, ECI Symposium Series, (2019). https://dc.engconfintl.org/biomanufact_iv/69