CSEM and cellvie automate mitochondria isolation for clinical use

A new automated platform developed by cellvie and CSEM streamlines mitochondria isolation, advancing therapeutic transplantation for ischemia-reperfusion injury.

Start-up-up cellvie and the Swiss Center for Electronics and Microtechnology (CSEM) have announced a breakthrough in the development of therapeutic mitochondria transplantation (TMT). Together, the partners have created a closed, automated solution for isolating mitochondria at scale, a critical step in bringing this novel therapy closer to patients.

Ischemia-reperfusion injury (IRI) occurs when blood supply returns to tissue after a temporary blockage and is a major cause of death worldwide. It is associated with conditions such as heart attacks, strokes, organ transplantation, and long surgical procedures. With no specific cure available, treatments currently focus on minimizing damage. Cellvie is pioneering the use of active mitochondria, which are the cells’ energy-producing structures, and delivered during or after reperfusion to restore energy metabolism and prevent cell death.

Automating a complex process

A major bottleneck in the field has been the manufacturing process. The original protocol, developed by cellvie’s co-founder Dr. James McCully, required multiple manual steps and open manipulation, limiting scalability and consistency. Supported by an Innosuisse grant of over CHF 700,000, CSEM and cellvie have re-engineered the process into a single automated workflow, ensuring compliance with Good Manufacturing Practice (GMP).

“Establishing a robust and scalable system for mitochondria isolation is essential to ensure bioenergetic functionality and safety, and paves the way to bringing revolutionary mitochondrial therapies one step closer to the clinic,” said Charlotte Fonta, Senior R&D Engineer at CSEM.

Dr. Martijn Brugman, COO of cellvie, emphasized that the system was designed with GMP in mind, allowing high-volume preparations at significantly lower costs.

Toward clinical translation With the new process validated, the next step is transferring the platform to a Contract Development and Manufacturing Organization (CDMO) for Phase I trials. “This will be a major puzzle piece in the clinical translation,” said Alexander Schueller, Founder and CEO of cellvie. “Thanks to the Innosuisse project and the teams’ relentless efforts, we now have a solid starting point.”