Cytiva launches new CAR-T platform with Kite

Cytiva, a specialist in biopharma research and manufacturing, unveiled a new cell therapy manufacturing platform developed in collaboration with Kite Pharma, a unit of Gilead Sciences. The platform, named Sefia, aims to address several challenges in producing autologous cell therapies, including heavy reliance on manual labor, limited manufacturing capacity, and the risk of batch failures. The announcement was made on May 29 through a press release.

Autologous cell therapies, particularly CAR-T cell therapies, are gaining traction globally, with 10 approved treatments in the U.S., European Union, and Asia-Pacific regions. With over 1,000 clinical trials underway worldwide, the demand for these therapies is on the rise. This growing demand highlights the necessity for flexible, scalable, and efficient manufacturing solutions.

Emmanuel Abate, Cytiva’s president for genomic medicine, stated in the release that the company’s objective has always been to assist their customers in scaling up the production of these therapies while minimizing risk factors. He mentioned that the Sefia platform is designed to enhance the number of doses manufactured by up to 50% annually compared to industry standards, potentially reducing the cost burden.

The Sefia platform automates several critical steps in cell therapy manufacturing, including cell isolation, harvest, and formulation, as well as cell activation, transduction, and expansion. This automation aims to eliminate many manual processes vulnerable to human error. Furthermore, Sefia can integrate with Cytiva’s automation software, which oversees manufacturing operations and manages supply chain logistics.

The introduction of Cytiva’s Sefia platform coincided with Ori Biotech’s announcement of its IRO platform on the same day. Ori's IRO platform aims to automate, digitize, and standardize the labor-intensive aspects of cell and gene therapy manufacturing workflows, with plans to roll out the first IRO units by the first quarter of 2025.

Earlier in May, another significant development in the field was announced by Japan's Astellas and Yaskawa Electric Corporation. The two companies agreed to explore potential advancements in automated cell therapy production, indicating a broader industry trend towards automation in this space.

In summary, Cytiva’s new Sefia platform represents a significant advancement in the manufacturing of autologous cell therapies. By automating critical steps and integrating with comprehensive automation software, the platform aims to increase manufacturing efficiency, reduce costs, and meet the growing global demand for these therapies. This development, along with other recent industry announcements, underscores a shift towards more automated and scalable solutions in cell and gene therapy manufacturing.