Kytopen, a company providing continuous-flow cellular engineering technologies, and BlueWhale Bio, which focuses on accelerating the growth and adoption of cell-based therapies by transforming the manufacturing processes for immune cell therapies, have signed an agreement to jointly develop a non-viral manufacturing workflow that eliminates current bottlenecks, accelerating the delivery of lifesaving engineered cell therapies to patients.
Kytopen and BlueWhale Bio join forces to develop A non-viral cell therapy manufacturing workflow.
While commercially available CAR-T cell products have demonstrated the promise of autologous CAR therapies, they continue to face significant challenges — including vein-to-vein times of 3-5 weeks, high costs, and safety risks.
These hurdles have limited their development and slowed their broader adoption worldwide. Next-generation therapies must overcome these shortcomings by decreasing manufacturing bottlenecks, increasing therapeutic effectiveness and durability, and enabling scalability to ensure accessibility of these lifesaving treatments.
The collaboration between Kytopen and BlueWhale Bio’s technologies is expected to result in a transformative approach — a rapid, gentle, and highly scalable cell processing that yields large quantities of healthy, viable engineered cells — that is poised to change how personalized cell therapies are manufactured.
- BlueWhale Bio’s Synecta™ cell-derived nanoparticles (CDNPs) mimic antigen-presenting cells—the body’s native, potent T-cell activators—delivering Signals 1–3 ex vivo. They display TCR-stimulating and co-stimulatory ligands together with membrane-bound cytokines on a membrane enriched with adhesion molecules to enhance CDNP–T-cell interactions. Synecta™ CDNPs are compatible with both viral and non-viral delivery systems, providing therapy developers with flexibility in manufacturing.
- Kytopen’s Flowfect® continuous flow cellular engineering technology is a highly tunable system. It is unique in combining mechanical, electrical, and chemical forces and in allowing adjustment of multiple parameters to maximize transfection efficiency, cell health, and cell yield, while continuous flow enables processing hundreds of billions of healthy, high-quality engineered cells in just minutes.
Together, these novel technologies enable a streamlined, non-viral gene-delivery workflow that delivers more advanced, more effective therapeutic doses quickly while preserving cell fitness.
“Our mission is to deliver the highest quality cell therapies to patients in the shortest time possible, while driving down manufacturing costs,” added Kevin Gutshall, Chief Commercial Officer at Kytopen.
“We believe this partnership represents a pivotal step forward in personalized cell therapy—bringing us significantly closer to drastically reduced vein-to-vein times for lifesaving treatments,” Gutshall added.
Both technologies are already being utilized by leading clinical-stage innovators. Synecta™ CDNPs are in use in an investigator-initiated Phase I clinical trial, while the Flowfect Tx® platform is supporting partners who have multiple therapies advancing toward IND submission.
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