Limula delivers LimONE device to CDMO partner in a major milestone in EU-funded project

Limula training the Stemmatters team on LimONE at their facility in Guimarães, Portugal.

• Limula installed LimONE device at Stemmatters, delivering ‘all-in-one’ automated cell and gene therapy manufacturing
• The technology transfer is part of the final phase the EIC-funded PAT4CGT project, which pioneers automated, non-invasive process monitoring
• LimONE reduces manual interventions and accelerates scale-up to clinical manufacture by leveraging a novel and proprietary design

Lausanne, Switzerland, June 16, 2025 – Limula, a Swiss life sciences tools company advancing automated solutions for cell and gene therapy (CGT) manufacturing, has successfully installed its first LimONE device at Stemmatters, a boutique contract development and manufacturing organization (CDMO) based in Portugal and specialised in advanced therapies.

This delivery represents a major milestone in both Limula’s product development journey and the completion of the PAT4CGT project aimed at accelerating the development of personalized advanced therapies, towards broader patient accessibility.

LimONE is a fully integrated, closed-system platform that automates all critical steps in the CGT manufacturing workflow. Its design significantly reduces manual interventions and contamination risk, improving process reliability and consistency, increasing product quality. By consolidating all critical steps into one device, LimONE enhances throughput by lowering equipment, consumable and infrastructure costs, while its scalable architecture supports seamless transition from early-stage development to clinical-grade and commercial manufacturing.

Limula and Stemmatters have been collaborating closely for over three years, with Stemmatters actively contributing design inputs and feedback throughout LimONE’s product development. This partnership has taken a Quality by Design approach instrumental in ensuring the device, consumable and software meet real-world manufacturing needs, towards readiness for GMP environments.

“We are proud to be among the first partners to adopt this novel approach to automated cell therapy manufacturing,” said Rui Sousa, CEO of Stemmatters. “Over the past three years, we have worked closely with Limula and have been consistently impressed by the evolution of their technology. We see significant potential in Limula’s technology streamlining manufacturing processes and accelerating the development of advanced therapies for our partners.”

“Delivering LimONE into a CDMO setting is a landmark moment for Limula,” added Fabien Jammes, Product Lead at Limula. “Feedback from experienced GMP operators during the training at Stemmatters has validated our design approach and highlighted the tangible benefits of our integrated automation strategy.”

Limula’s all-in-one and scalable approach supports a wide range of CGT processes, enabling therapeutic developers to simplify tech transfer, reduce time to clinic, and ultimately make personalized treatments more accessible.

About Limula

Limula SA is a life science platform technology company based in Lausanne, Switzerland, dedicated to transforming the manufacturing of Cell & Gene Therapies. Their mission is to accelerate the development and commercialisation of new advanced therapies through an automated, on-demand, and scalable manufacturing solution. Limula’s proprietary platform integrates all functionalities into a single device, empowering therapeutics developers to bring life-saving treatments to patients more efficiently.

About Stemmatters

Stemmatters is a Portugal-based CDMO specializing in bespoke product and process development, cGMP production, and the clinical translation of impactful medicinal products. The company’s expertise covers multiple products, including advanced therapies, biologics, and raw materials supporting the life cycle of regenerative medicine solutions. Stemmatters has a proven track record in the isolation and banking of diverse cell types and provides its clients with reliable, cost-effective solutions designed to support long-term commercial success.

About PAT4CGT

The project entitled ‘Automated online monitoring & control to improve processes and decision making in cell and gene therapy manufacturing’ received funding from the European Union’s Horizon Europe research and innovation programme under grant agreement No 101070922. It was selected amongst the 8 projects selected out of the 132 submissions to the 2021 EIC Pathfinder Challenge call for ‘Emerging Technologies for Cell & Gene Therapies’. The interdisciplinary consortium brings together internationally recognized experts across 6 EU countries and Switzerland.

Contact Details

Luc Henry, DPhil
media@limula.ch
www.limula.ch