What We Can Do

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.  

 

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