Overview

The Centre for Cell Manufacturing Ireland (CCMI) was established as part of the Regenerative Medicine Institute’s (REMEDI) translational mission to manufacture human Mesenchymal Stem Cells (hMSCs) for use in clinical trials.

This vision has now become a reality with the approval for the first clinical trial to commence, using cells manufactured in the CCMI. This study will examine the safety of intramuscular autologous transplantation of escalating doses of mesenchymal stem cells to patients with no option Critical Limb Ischemia (CLI).

The facility is the first of its kind on the island of Ireland and was granted a manufacturing authorisation from the Health Products Regulatory Authority (HPRA) in Ireland in 2013. The facility consists of a 250m² floor space with 2 independent suits, which each consist of three Grade A/B clean rooms. This allows for multiple processes to be manufactured.

Manufacturing Capability

3 independent Grade D suites with Grade A 4-glove isolators: room sizes 15m², 15m², 20m²

• Fully equipped for closed processing
• Liquid Nitrogen Cell Storage
• Support rooms
• Category 2 biological containment
• Flow cytometry suite
• Genomics suit

Process Capability

• Adherent cells
• Suspension cells
• T cells
• Tissue processing
• Gene modified cells
• Patient specific processes
• Bulk allogeneic processes

Experience

Currently manufacturing Human Stem Cells for Clinical Trials on Critical Limb Ischemia (CLI) and Osteoarthritis.

Licenses Held

HPRA IMP11396/00001
HPRA 2015/9013/IMP11396

Team

Production: Aoife Duffy
Quality: Margaret Desmond
QP: Miriam Holohan
Director: Prof. Tim O’ Brien
General Maneger: Andrew Finnerty

Address

3^rd Floor, Orbsen Building,
NUI Galway,
University Road,
Galway, Ireland

Contact

Andrew Finnerty, CCMI General Manager
+353 91 494159
andrew.finnerty@nuigalway.ie