Centre for Cell Manufacturing Ireland
A supporting platform for REMEDI Translational Research. A dedicated facility to produce cellular therapeutic products. Formerly known as the National GMP Facility
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 will translate as well as manufacture stem cell research from REMEDI's various programmes into cell based medicinal products for GMP investigational patient enrolled clinical trials.
The CCMI is a versatile cleanroom with standout features including two parallel production suites. Each of the two suites are capable of clinical grade manufacturing of cellular therapy products and small molecules for therapeutic applications. The facility is served by dedicated utilities including CO², on site Liquid Nitrogen generation and HEPA filtered air. The facility is custom-designed with validated HEPA air system to isolate manufacturing, intermediate and gowning/de-gowning rooms from each other. Local isolation areas are of EU GMP Grade A air quality, are in both suites. Each suite is equipped with fully-validated equipment, necessary for the production of the clinical products.
Each suite is controlled by separate air handling units and so this can facilitate the production of two different products in each suite at the same time. 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. The facility also has a Quality Control (QC) testing laboratory and a facility monitoring system. The facility undergoes environmental microbiological monitoring, with alert and action levels.
The CCMI is certified as an EU GMP Annex 1 compliant cleanroom and is recertified as a cleanroom on an annual basis. This certification is a key step towards achieving a license from the Irish Medicines Board (IMB) to manufacture and cryopreserve clinical grade cellular therapeutic products. The facility is on schedule to achieve IMB accreditation for administration to patients.
The Facility has been funded by Science Foundation Ireland (SFI) and also the Higher Education Authority (HEA).
GMP Clinical Treatments
The CCMI represents the apex for translation of REMEDI's research carried out in the laboratory to the clinic in settings of unment medical need. These would include Osteoarthritis (OA), Diabetes Mellitus, Crohns' Disease and Peripheral Vascular Disease. The CCMI together with the Clinical Research Facility (CRFG, www.crfg.ie) based at Galway University Hospital represents a significant and unique opportunity to translate cutting-edge stem cell research at REMEDI into reflective therapies for patients in Ireland.
As well as having local and national collaborative research links, the CCMI is collaborating in a number of international projects such as
• Purstem (link to website, www.purstem.eu). An EU 7th Framework Programme funded project aiming to establish standard methods and tools for the production of large amounts of mesenchymal stem cells.
• EuroStemCell (www.eurostemcell.org). An EU funded 7th Framework Programme funded project uniting more than 90 European Stem Cell and regenerative medicine research laboratories in a coordinated effort to engage with the public about this new and exciting field of medical science.
The Facility has been funded by Science Foundation Ireland (SFI) the Higher Education Authority (HEA) and NUI Galway
The facility has a full team of qualified staff:
General Manager: Andrew Finnerty
Qualified Person: Miriam Holohan
Quality: Margaret Desmond, Marc Eglon, Lisa O'Reilly
Production: Aoife Duffy, Chaansha Dawood
Logistics: David Forde
Facility Technician: Alan Leahy (Aramark)
Scientific Directors: Professor Frank Barry and Professor Timothy O'Brien
For further information contact:
Tel: +353 91 494159
Fax: +353 91 495547