Kytopen, BlueWhale Bio partner on non-viral cell therapy manufacturing workflow

Kytopen Corp., a cellular engineering technology company based in Cambridge, Massachusetts, said it has entered a collaboration with BlueWhale Bio, a Maryland-based company focused on immune cell therapy manufacturing. The partnership will develop a non-viral manufacturing workflow designed to reduce production bottlenecks and accelerate the delivery of engineered cell therapies to patients, according to the announcement.

The companies said the effort addresses current challenges facing CAR-T therapies, including vein-to-vein times of three to five weeks, high costs, and safety risks. The proposed workflow combines BlueWhale Bio’s Synecta CDNPs, which mimic antigen-presenting cells to activate T cells ex vivo, with Kytopen’s Flowfect continuous flow cellular engineering system, which integrates mechanical, electrical, and chemical forces to optimize transfection efficiency and cell viability.

Kytopen said Flowfect can process hundreds of billions of cells within minutes, while BlueWhale Bio’s Synecta CDNPs are compatible with both viral and non-viral delivery methods. Together, the companies contend these technologies create a streamlined manufacturing process to yield higher numbers of viable engineered cells.

“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,” Kevin Gutshall, Kytopen’s chief commercial officer, said in a statement.

According to the companies, both technologies are already in use. Synecta CDNPs are supporting an investigator-initiated Phase I clinical trial, and Kytopen’s Flowfect Tx platform is being used by partners with multiple therapies advancing toward investigational new drug submissions.