Limula has unveiled LimONE, a disruptive 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 these highly personalised treatments—reducing labour, equipment, and infrastructure costs while ensuring process standardization and scalability. LimONE was officially presented by Luc Henry, CEO of Limula at Advanced Therapies Week in Dallas, Texas, on January 22, 2025, during the Innovation Zone Tech Spotlight Session.
Image Credit: Limula
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 have combined ‘Swiss Made’ precision engineering and Cell and Gene Therapy expertise to build a product that meets the most stringent user requirements. They partnered with Stockholm-based industrial design firm Fjaryl to incorporate input from over 20 academic and industry experts into key design choices following a series of in-person feedback sessions held at the company in Lausanne, Switzerland.
Bringing together end users from both academic and industry for these workshops was invaluable in shaping LimONE’s design. It will help us meet the needs of the variety of target customers working in cell therapy manufacturing, ensuring that LimONE is not just a technological innovation, but a practical, user-centred solution."
Caroline Boudousquié, onco-immunology expert and Head of Solutions, Limula
This approach prioritized an intuitive design for all components of the product – a hardware device, single use consumable and a software suite for protocol creation – ensuring ease of adoption and a smooth user experience that addresses key industry needs, including:
- 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.
Workshop participant Susanne Kortekaas from LUMC Center for Cell and Gene Therapy in the Netherlands added: “The collaboration involved in the development of LimONE was highly productive and our feedback was carefully considered. I look forward to seeing the finalized version and hope to have the opportunity to routinely use it in the future.”
Limula’s mission is to improve accessibility and scalability, ultimately ensuring that more patients can benefit from these life-saving therapies. “We have always valued transparency and collaboration," said Luc Henry, CEO of Limula. "Our partners act as an extension of our team. We need to include their expert feedback if we want to offer a truly innovative tool to this industry. 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."