Intensified Lentiviral Vector Production Using TFDF-Based Perfusion Cell Culture

This application note details the production of lentiviral (LV) vectors from a stable producer cell line using a TFDF-based perfusion cell culture strategy. The study demonstrates that the TFDF process achieves over a 10-fold increase in the production of active LV compared to a standard batch process at a 2 L bioreactor scale. The intensified process allows for continuous harvesting of the LV to cold storage, ensuring high functionality. The results indicate that a 10 L TFDF-intensified process can efficiently produce the necessary LV particles for T-cell transduction required in clinical trials, significantly reducing the need for larger bioreactor scales typically used in batch processes. The findings suggest that process intensification not only enhances productivity but also leads to cost savings and a smaller bioreactor footprint, which are critical for the commercialization of CAR-T and other advanced therapies. This application note serves as a practical example of clinical manufacturing sufficient for Phase II or III CAR-T trials.