Kytopen Corp., a leader in continuous flow cellular engineering technologies, announced a collaboration with BlueWhale Bio, a company dedicated to transforming the manufacturing of immune cell therapies.

Together, the two organizations will develop a non-viral manufacturing workflow designed to eliminate key bottlenecks and accelerate the delivery of lifesaving engineered cell therapies to patients.

Commercially available CAR-T therapies have shown the potential of autologous CAR approaches, but they continue to face major challenges including vein-to-vein times of three to five weeks, high costs, and safety concerns. These obstacles have slowed development and adoption, underscoring the need for next-generation solutions that reduce manufacturing delays, improve therapeutic effectiveness and durability, and enable large-scale accessibility.

The collaboration between Kytopen and BlueWhale Bio brings together two breakthrough technologies to address these limitations. BlueWhale Bio’s Synecta cell-derived nanoparticles (CDNPs) mimic antigen-presenting cells—the body’s natural T-cell activators—by delivering signals 1–3 ex vivo. They display TCR-stimulating and co-stimulatory ligands, along with membrane-bound cytokines on an adhesion molecule–rich surface, enhancing interactions with T cells. Synecta CDNPs are designed to scale and are compatible with both viral and non-viral delivery systems, offering therapy developers flexibility in manufacturing.

Kytopen’s Flowfect continuous flow technology provides a tunable system that combines mechanical, electrical, and chemical forces to optimize transfection efficiency, cell health, and cell yield. Its unique continuous flow approach enables the rapid processing of hundreds of billions of high-quality engineered cells in just minutes, maintaining both viability and functionality.

Together, these platforms create a streamlined non-viral gene delivery workflow capable of producing advanced therapeutic doses more quickly, cost-effectively, and with improved preservation of cell fitness. This synergy represents a potential paradigm shift in how personalized cell therapies are manufactured, ultimately helping patients access more effective treatments faster.

Both technologies are already being used by leading clinical-stage innovators. Synecta CDNPs are supporting an investigator-initiated Phase I clinical trial, while Kytopen’s Flowfect Tx platform is advancing multiple therapies toward IND submission.