Over the last decade, several breakthrough Cell and Gene Therapy products have been approved in the USA and Europe to turn stem cells and immune cells into ‘living cures’, bringing hope to millions living with life-threatening conditions. However, these treatments remain out of reach for 98% of patients suffering from what are now curable conditions. This is partly due to complex, manual, and costly manufacturing processes.
Life science startup Limula announced today that it has raised over €6.2 million to advance their solution for automating cell therapy manufacturing to the next stage of development. The oversubscribed seed round was led by LifeX Ventures, with participation from Verve Ventures, Zühlke Ventures, Oxford Seed Fund, Lichtsteiner Foundation, W.A. de Vigier Foundation, the founders, and a lineup of private individuals who have supported Limula’s vision from its inception.
The company was founded to deliver a disruptive approach to the ‘ex vivo’ manipulation of cells, based on a novel technology. The trio witnessed that outdated manufacturing methods were a speed bump to the adoption of Cell and Gene Therapy products—like chimeric antigen receptor (CAR) T-cells. Combining breakthrough discoveries in genetic engineering and medicine has led to a revolution in medicine, but boosting the patient’s own cells to produce a dose in a laboratory still requires too many manual steps. Highly skilled labor and sterile infrastructures represent the majority of the costs of therapy, leading to a price tag of $500,000 or more per dose. As a result, these treatments are inaccessible to the majority of eligible patients.
To combat this, Limula developed a modular solution for on-demand and at-scale manufacturing of cell therapies in a single device. By combining the functionalities of a bioreactor and a centrifuge into one single closed vessel, Limula’s proprietary solution can handle a wide range of volumes and cell numbers, removing transfer steps and therefore limiting stress, losses, and potential contamination. With potential for scalability, it can be used by cell therapy providers in their transition from pre-clinical evaluation to clinical trials, and later to commercial-scale manufacturing of clinical-grade cell products.
Luc Henry, co-founder and CEO of Limula, said: “Our team is driven by the ambitious goal of developing tools that are based on a fundamentally novel way of manipulating cells outside of the body. Our technology supports manufacturing workflows that are impossible to automate with existing tools. We believe automation is the only route to scalability and digital traceability. These two aspects are key to unlocking the full potential of Cell and Gene Therapy, making them accessible to the many, not just the few.”
Limula’s founders built a high-performing multidisciplinary team, most recently joined by domain experts Olivier Waridel, former CEO of Cytiva-owned Biosafe, Caroline Boudousquié, former Head of Process Development at the Center for Experimental Therapeutics (CTE) of the University Hospital in Lausanne, and Maria Elena Grisostolo, former VP Operations at Lunaphore.
After completing an initial proof of concept, the company launched a program to provide selected industry and academic partners access to the innovative platform ahead of its commercial launch. Aiming to broaden the scope of applications, Limula has signed partnerships with several research centers including the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy—a world-recognized center of excellence for research and clinical translation of cell and gene therapy.
Prof. Bernhard Gentner at the San Raffaele Telethon Institute for Gene Therapy said: “We believe the solution Limula is advancing can support our current process development activities and later enable the manufacturing of these cell products at scale. We also see its potential in improving the status quo in Cell & Gene Therapy manufacturing in general, and in the field of haematopoietic stem cell transplantation in particular.”
Dr. Inaki Berenguer, managing partner at LifeX Ventures, added: “We’re thrilled to stand with the Limula team as they reinvent cell and gene therapy manufacturing. It’s evident that production tools have lagged behind scientific and clinical advancements, particularly in terms of price and scalability. Limula’s commitment to addressing these bottlenecks is crucial to enhancing accessibility for patients.