APPLICATION OF CONTINUOUS PROCESSING IN CELL AND GENE THERAPY: CURRENT STATE AND FUTURE OPPORTUNITIES

摘要

For CAR-T and autologous ex vivo gene therapies, cells are first collected from patients via apheresis, modified ex vivo with lentiviral vector (LW) 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 LW has increased exponentially. Current LW 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 LW and the challenges and opportunities of beside manufacturing for autologous gene therapy products.