Kytopen Announces Collaboration with BlueWhale Bio to Revolutionize Cell Therapy Manufacturing

• Kytopen and BlueWhale Bio join forces to develop non-viral cell therapy manufacturing workflow.
• BlueWhale Bio's Synecta™ cell-derived nanoparticles (CDNPs) technology mimics the immune system's natural T-cell priming ex vivo and are built to scale, while Kytopen's Flowfect^® continuous flow technology enables the gentle, high-efficiency processing of billions of cells in just minutes.
• This partnership has the potential to change how cell therapies are manufactured, giving patients access to more effective, lifesaving, personalized treatments more quickly.

CAMBRIDGE, Mass., Sept. 9, 2025 /PRNewswire/ -- Kytopen Corp., a leader in providing continuous flow cellular engineering technologies, announced today its collaboration with BlueWhale Bio, Inc., a company dedicated to accelerating the growth and adoption of cell-based therapies by transforming the manufacturing process of immune cell therapies. The initiative aims to develop a non-viral manufacturing workflow that eliminates current bottlenecks, accelerating the delivery of lifesaving engineered cell therapies to patients.

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 synergy between Kytopen and BlueWhale Bio's technologies offers 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™ 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 viral and non-viral delivery systems, giving therapy developers flexibility in manufacturing.
  
  
• Kytopen's Flowfect^® continuous flow cellular engineering technology is a highly tunable system. It is unique in that it combines mechanical, electrical, and chemical forces and allows the adjustment of multiple parameters to maximize transfection efficiency, cell health, and cell yield, while continuous flow enables the processing of hundreds of billions of healthy, high-quality engineered cells in just minutes.

Together, these technologies enable a streamlined, non-viral gene-delivery workflow capable of achieving more advanced and 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."

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.

For further information:

Kytopen:

Investor Contact:
Michael Chiu PhD., CEO
[email protected]

Business and Corporate Development Contact:
Kevin Gutshall, CCO
[email protected]

About BlueWhale Bio:

BlueWhale Bio is dedicated to accelerating the growth and adoption of cell-based therapies by transforming the manufacturing process of immune cell therapy. The company is developing a portfolio of critical materials that bring the full benefits of higher-performing cell therapies to more patients faster and at lower costs. BlueWhale's innovations are based on cutting-edge discoveries in cell activation led by Dr. Carl June and Dr. Jim Riley at the University of Pennsylvania. For more information, visit www.bluewhale.bio and follow us on LinkedIn.

About Kytopen:

The innovative leader in non-viral, continuous flow cellular engineering technologies, Kytopen, headquartered in Cambridge, Massachusetts, is transforming how cell therapies are manufactured by maximizing yields, delivering hundreds of billions of engineered cells in minutes – faster than any other technology – and thereby accelerating the discovery, development, and manufacture of advanced engineered cell therapies. Its Flowfect^® cellular engineering technology is highly tunable, gentle on cells, and has demonstrated performance across a range of cell types, payloads, and therapeutic applications. Kytopen has recently disclosed strategic partnerships with industry-leading biotechnology companies, contract development and manufacturing organizations (CDMOs), and cell therapy-focused medical centers. Kytopen continues to engage strategic partners and is committed to enabling their partners' success by providing innovative technology and developing close collaborative relationships to bring lifesaving, next generation cell therapies to patients worldwide. www.kytopen.com

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SOURCE Kytopen