The Centre for Cell Manufacturing Ireland
The Centre for Cell Manufacturing Ireland (CCMI) was launched at NUI Galway in 2014 and is the first Good Manufacturing Practice (GMP) facility on the island of Ireland to be licensed for manufacture of Advanced Therapy Medicinal Products (ATMPs) for use in clinical trials.
The facility is located on the third floor of the Orbsen Research Building on the NUI Galway main campus. It comprises a state-of-the-art cleanroom within which there are two parallel production suites. Each of the two suites are independently capable of clinical-grade manufacturing of ATMPs. Presently, the facility manufactures human adult mesenchymal stem cells (hMSCs) for multiple clinical trials, bridging the gap between REMEDI’s research programmes and the clinic. CCMI has been granted manufacturing authorisation by Ireland’s national regulatory authority (the HPRA) and is accredited as being in compliance with the European Union’s Guide to GMP.
The ongoing clinical trials currently manufactured within CCMI include, ADIPOA-2, NEPHSTROM and VISICORT for the treatment of the life-limiting conditions osteoarthritis of the knee, diabetic kidney disease (DKD) and corneal transplant rejection. These trials are funded by the EU and are coordinated by REMEDI principal investigators in collaboration with leading European research and innovation partners. In addition, a phase 1b trial of autologous MSCs in critical limb ischemia funded by Ireland’s Health Research Board and Science Foundation Ireland was completed in 2019 with results reported in the Journal, Cytotherapy.
Beginning in late 2020, the facility will also perform GMP expansion-production of a novel immune cell therapy for blood cancers - human Natural Killer (NK) Cells, including umbilical cord blood-derived NK cells. For this project, CCMI will work closely with Galway University Hospitals and with the HRB Galway Clinical Research Facility for ethical sourcing of cord blood and for the ultimate translation of allogeneic NK cell therapies into clinical trials for blood cancers. This project, which is funded by Enterprise Ireland under the Disruptive Technology Innovation Fund, has the potential to deliver transformative cell therapies to patients through academically led clinical trials at a fraction of the cost of currently approved cell therapies for cancer.
In addition to its core mission of producing cell therapies for clinical trials, CCMI delivers practical training for production personnel and related specialists in cellular manufacturing, quality control, and microbiological testing. We also regularly organise and host seminars and workshops in the cellular manufacturing field, most notably the Annual Workshop of GMP Manufacturing, Scale-Up and Challenges of ATMPs.