Optimizing T cell transduction: a novel transduction device for efficient and scalable gene delivery.

BACKGROUND: Viral transduction is a critical step in the manufacturing of genetically modified T cells for immunotherapies, yet conventional transduction methods suffer from low to medium efficiency, high vector consumption, and limited scalability. METHODS: To address these challenges, we introduce the Transduction Boosting Device (TransB), an innovative, automated, and closed-system platform designed to enable efficient and scalable gene delivery and overcome the limitations of conventional transduction methods. TransB improves cell-virus interactions by facilitating proximity between target cells and viral vectors. RESULTS: TransB demonstrated up to 1-fold decrease in processing time, 3-fold reduction in viral vector consumption, and 0.7-fold increase in transduction efficiency compared to 24-well plate method for donor T cell transduction in studies evaluating its impact on transduction process. Comparison studies transducing T cells from three different donors with Lenti-GFP vectors showed that TransB achieved an average 0.5-fold improvement in transduction efficiencies while maintaining comparable post-transduction cell recovery, viability, growth, and phenotype compared to 24-well plate. Furthermore, TransB delivered consistent performance across two different input cell numbers demonstrating scalability of the process. CONCLUSION: These findings suggest that TransB could significantly shorten the transduction time, reduce the transduction cost and improve the transduction efficiency for manufacturing genetically modified T cell therapies. It shows strong potential as a robust, efficient, and scalable platform to enhance T cell therapy manufacturing and help overcome current manufacturing challenges in the field.