Limula’s LimONE System Targets Consistency in Stem Cell Transplants

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Limula, a Swiss life sciences tools company focused on advancing automated solutions for cell and gene therapy (CGT) manufacturing, announced on Sept. 15, 2025 a collaboration with France-based Institut Paoli-Calmettes (IPC) to explore the cell-processing capabilities of Limula’s LimONE technology for hematopoietic stem cell (HSC) transplantation applications (1).

LimONE is an automated and closed processing system designed to handle complex steps in preparing stem cell products. Under the agreement, IPC will use the platform to advance techniques for autologous transplantation, a procedure that impacts nearly 50,000 patients across Europe each year (2). The collaboration is focused on improving product quality by refining the removal of cryoprotectants and cellular debris from thawed apheresis samples prior to infusion.

According to clinicians, this stage of processing remains one of the most technically demanding and patient-sensitive steps in stem cell therapy (3). By introducing greater automation, the goal is to ensure not only more consistent results but also improved safety and tolerability for patients.

“We are impressed with the improvements we saw during the development of LimONE and are eager to adopt the platform into our facility,” said Boris Calmels, head of the Cellular Manufacturing Unit at IPC, in a company press release (1). “I see strong potential for Limula’s technology to play a key role in improving both our cell processes and the patient’s experience during stem cell transplantation.”

What impact can this collaboration have on biomanufacturing?

The collaboration illustrates how automated systems are beginning to reshape workflows that have traditionally relied heavily on manual expertise. In stem cell transplantation, process variability can affect both product consistency and patient outcomes. A reliable, closed, and automated system could reduce operator-dependent variability, address contamination risks, and standardize procedures across institutions, according to Limula.

This collaboration also highlights the broader push in the biopharmaceutical industry toward technologies that streamline the preparation of cellular therapies. Automation is becoming an essential strategy for scaling advanced therapies while meeting regulatory expectations for reproducibility and product safety, as emphasized at the Parenteral Drug Association (PDA) Regulatory Conference 2025 held last week on Sept. 8–10 in Washington, D.C. (4).

“This collaboration is a powerful demonstration of the versatility of our platform. We are proud to support IPC in their mission to deliver high-quality transplantation products to their patients,” Luc Henry, CEO of Limula, said in the company’s release.

What broader impact can the biopharma industry expect to see?

The initiative launched by Limula and IPC reflects a growing industry trend—that of integrating automation into every stage of cell and gene therapy manufacturing. As therapy developers seek to expand access to advanced treatments, reducing bottlenecks in product preparation has become critical. Stem cell transplantation, with its high patient volume and reliance on complex handling, is a clear area where improvements could drive meaningful impact.

If successful, IPC’s integration of LimONE may serve as a case study for other cancer centers and therapy manufacturers seeking to modernize their processes, the institute said in the press release. Beyond stem cell transplantation, the platform’s modular approach suggests potential applicability across a wide range of cell and gene therapy modalities. By focusing on process reliability and patient-centered outcomes, the collaboration underscores how the adoption of advanced tools is shaping the future of cell therapy manufacturing.

References

1. Limula. Limula Announces Collaboration with Leading Cancer Centre to Improve Blood Products Processing for Stem Cell Transplantation. Press Release. Sept. 15, 2025.
2. Passweg, J. R.; Baldomero, H.; Atlija, M.; et al. The 2023 EBMT Report on Hematopoietic Cell Transplantation and Cellular Therapies. Increased Use of Allogeneic HCT for Myeloid Malignancies and of CAR-T at the Expense of Autologous HCT. Bone Marrow Transplant. 2025, 60, 519–528. DOI: 10.1038/s41409-025-02524-2
3. Acker, J. P.; Bondarovych, M.; Brunotte, R.; et al. Preservation and Storage of Cells for Therapy: Current Applications and Protocols; Springer Nature Switzerland, 2022. https://ossiumhealth.com/wp-content/uploads/2023/02/Acker-2022.pdf
4. Mirasol, F. PDA 2025: How Automation Assures Product Quality for Next-Gen Biopharma. BioPharmInternational.com. Sept. 11, 2025.