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Award-winning technology combines a bioreactor and a centrifuge into one single vessel for the first time, a new approach gentler to patient cells during process steps.

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 in part due to complex, manual and costly manufacturing processes.

Life science startup Limula announces today it has raised CHF6.2M ($6.8M) to take 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 been supporting Limula’s vision from its inception.

The company was founded in 2020 by Dr. Yann Pierson, Dr Luc Henry. Dr. Thomas Eaton 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 The trio witnessed that outdated manufacturing methods were a speed bump to the adoption of Cell and Gene Therapy products – like chimeric antigen receptor (CAR) T-cells.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 led to a revolution in medicine, but boosting the patients’ own cells to produce a dose in a laboratory still requires too many manual steps. Highly skilled labour and sterile infrastructures represent the majority of the costs of a therapy, leading to a price tag of $500,000 or more per dose. As a result, these treatments are inaccessible for a 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 a potential for scalability, it can be used by cell therapy providers in their transition from pre-clinical evaluation to clinical trials, and later 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 keys 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. With the aim to broaden the scope of applications, Limula has signed partnerships with several research centres including San Raffaele Telethon Institute for Gene Therapy in Milan, Italy - a world-recognized centre of excellence for research and clinical translation of cell and gene therapy.

Prof. Bernhard Gentner at 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.”

Looking ahead, Limula will use its new seed capital to significantly advance the development of the proprietary platform composed of a device and single use consumables, towards meeting good manufacturing practice (GMP) requirements. The solution developed by Limula is an enabling tool for a rapidly growing market. The potential of Cell and Gene Therapies to save the lives of millions of patients globally has generated significant interest – and investment – leading to a significant pipeline and several recent approvals by health authorities. Both industrial and academic players are now eager to adopt next-generation automated and scalable solutions with the shared goal to significantly increase market reach and broaden accessibility.
www.limula.com

 


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