Limula has unveiled LimONE, a cell therapy manufacturing solution that automates complex and fragmented processes into a seamless workflow.

Through consolidation of multiple unit operations into a single closed consumable, LimONE enables end-to-end production of highly personalized treatments—reducing labor, equipment, and infrastructure costs while ensuring process standardization and scalability.

LimONE is designed for both hospitals and biopharma companies, providing a versatile tool that supports the production of multiple types of cell therapy, including CAR-T and gene-edited hematopoietic stem cells. Using the exact same single-use consumable at all stages of therapeutic development eliminates lengthy technology transfer that often delays the start of clinical trials by months. As a result, LimONE empowers cell therapy developers to accelerate the transition from research and development through clinical trials leading to commercialization.

Limula collaborated with the Stockholm-based industrial design firm Fjaryl to incorporate input from over 20 academic and industry experts into the design of LimONE. This collaborative approach involved conducting in-person feedback sessions at Limula’s headquarters, where end users from both academic and industry sectors participated. By bringing together end users from diverse backgrounds, Limula aimed to ensure that LimONE meets the diverse needs of its target customers in the cell therapy manufacturing industry.

Features of LimONE include:

• User-friendly software interface for streamlined protocol elaboration and process control.
• Design features and functionalities allowing for use in both pre-clinical research laboratories and GMP-compliant manufacturing settings.
• Intuitive human-machine interaction that simplifies handling of the device and consumables by operators, reducing the risk of human errors.

“We have always valued transparency and collaboration,” said Luc Henry, CEO of Limula. “It takes a village to build something that has both great value and utility. We look forward to sharing the outcome of these efforts with additional early adopters in the coming months.”