What We Can Do
GMP Manufacturing and Translational Research
The Centre for Cell Manufacturing Ireland (CCMI) is a 250m² state of the art cleanroom, housed in the National Centre for Biomedical Engineering Sciences (NCBES) at NUI, Galway. The facility manufactures human adult stem cells (hMSCs) for use in clinical trials, bridging the gap between REMEDI’s research programmes and the clinic.
CCMI is accredited under EU GMP and was granted a manufacturing authorization by the Irish Medicines Board (IMB) in 2013 for the manufacture of adult stem cells, enabling the manufacture of clinical grade Advanced Therapeutic Medicinal Products (ATMPs) for clinical trials.
The facility consists of 2 parallel independent production suites certified to EU GMP grade A/B, allowing the aseptic production of multiple batches of advanced therapeutics.
The cleanrooms are served by HEPA filtered air and a dedicated carbon dioxide supply. An on-site Liquid Nitrogen generation plant allows the controlled freezing and cryogenic storage of clinical grade products.
The facility is staffed by dedicated personnel and has implemented a Quality Management System (QMS) to ensure full compliance with EU legislation for manufacture of cell based IMP.
There are dedicated QC testing laboratories for batch release testing, including flow cytometry (immunophenotyping) and karyotyping, as well as microbiological and environmental monitoring.
Video: Using Adult Stem Cells to Treat Diabetic Wounds
Pre-clinical research has generated some very promising findings using adult stem cells for the treatment of diabetic wounds. The research carried out by scientists at the National University of Ireland Galway, is published in Diabetes, the official journal of the American Diabetes Association. The work was led by researchers at the University's Regenerative Medicine Institute (REMEDI), which is supported by Science Foundation Ireland.