Cytiva rolls out new CAR-T manufacturing platform developed with Gilead's Kite

Cytiva, a biopharma research and manufacturing specialist, rolled out a new cell therapy manufacturing platform the company developed as part of a collaboration with Gilead Sciences’ Kite Pharma unit.

Dubbed Sefia, the new platform is designed to tackle challenges with producing autologous cell therapies such as a heavy dependence on manual labor, limited manufacturing capacity and the risk of batch failures, the company said in a May 29 press release.

Currently there are 10 autologous CAR-T cell therapies approved in the U.S., the European Union and in the Asia-Pacific region. With more than 1,000 clinical trials of cell therapies underway globally, the current and future patient demand for such therapies underscores the need for flexible, scalable, and efficient manufacturing, the company said.

“Our goal has always been to help our customers scale-up the manufacture of these therapies while reducing risk factors,” Emmanuel Abate, Cytiva’s president for genomic medicine, said in the release. “The Sefia platform was designed to help increase manufactured doses by up to 50% per year as compared to industry standard, which can help ultimately reduce the cost burden.”

The new platform automates cell isolation, harvest and formulation steps as well as the process of cell activation, transduction and cell expansion. Through automation, the platform is able to eliminate many manual steps that can be susceptible to human error.

Additionally, the Sefia platform can connect to Cytiva’s automation software that monitors manufacturing operations and manages supply chain logistics.

Cytiva’s new platform rollout news came the same day Ori Biotech announced its IRO platform that automates, digitizes and standardizes the labor-intensive parts of the cell and gene therapy manufacturing workflow. Ori plans to deploy its first IRO units to the market by the first quarter of 2025.

Earlier in May, Japan's Astellas and Yaskawa Electric Corporation announced that they agreed to explore potential advancements in automated cell therapy production.