From Hospital to Commercial Manufacturing

Along the “Wild Atlantic Way” in the West of Ireland, a unique and established supply chain has been in operation over several years to procure, manufacture and deliver GMP approved clinical therapy (ATMP) products to patients. This involves Galway University Hospital (GUH), Galway Blood and Tissue Establishment (GBTH), the Clinical Research Facility (CRF) and the Centre for Cell Manufacturing (CCMI-REMEDI) at the University of Galway, Ireland.

The Regenerative Medicine Institute (REMEDI) at the University of Galway were instrumental in establishing the Centre for Cell Manufacturing Ireland (CCMI) as part of their translational mission to deliver actual stem cell therapies to the clinic. To that end, after successfully securing regulatory authorisation to manufacture human Mesenchymal Stem Cells (hMSCs) for use in clinical trials, CCMI have delivered on CLI Trial EudraCT. No 2013-003447-37, ADIPOA-2 Trial EudraCT. No 2015-002125 and Nephstrom Trial EudraCT. No 2016-000661-23. The ultimate objective of these clinical programs is to offer patients with debilitating, incurable conditions an alternative treatment through advanced therapies. These State-EU funded treatments were clearly “Not for profit” and the challenge to commercialise such treatments is a pressing goal for all stakeholders in the ATMP – Cell and Gene Therapy space. The intention of this presentation is to offer an insight into the challenges and enablers that may help to commercialise such therapies and is based on experiences gained from delivering such therapies from a Hospital-University setting, albeit these trials were State-EU funded.