Introduction:
Scaling-up production of lentiviral vectors (LV)-based therapies is a challenge for biomanufacturers. However, researchers from McGill University have developed a semi-continuous manufacturing system that integrates upstream and downstream bioprocesses. This new approach significantly increases the quantity of LVs produced, enhances recovery, reduces instability, and improves product quantity. Compared to batch processing, the semi-continuous system cuts processing time by four-fold.
- The semi-continuous manufacturing system developed by McGill University researchers combines clarification and capture-step loading processes.
- This system improves the recovery of functional vector particles by 26% and total vector particles by 18%.
- The system cuts processing time by four-fold compared to batch processing.
- Potency, measured as the ratio of vector genome units to transducing units, is 75 in semi-continuous mode.
- Using this semi-continuous system, overall manufacturing time at commercial-scale is reduced to 12.75 days compared to 18.25 days with perfusion upstream/batch downstream processing and 84.5 days with batch processing for both up- and downstream processing.
Conclusion:
The semi-continuous manufacturing system developed by McGill University offers a promising solution for scaling-up the production of lentiviral vectors. This system increases production efficiency, reduces processing time, and improves product quantity. Implementing this semi-continuous system could significantly advance the development of LV-based therapies.
