Author(s): Hicks C; Foley LA; O'Neill P
Abstract: Cell therapies may cure chronic disease, but the use of living cells as therapies raises many supply chain challenges, which are explored in this paper. There are two types of cell therapy. Allogeneic therapies are where a single donor treats many patients. Autologous therapies are where the patient supplies their own cells, which are expanded and implanted back into the patient. Most cell therapies are still manufactured in a research environment. Industrializing allogeneic treatments means scaling up production. Perhaps more challenging, autologous treatments need to be scaled out and require a service model. Lead times and quality are key which requires supply chains need to be Lean and agile. The design of supply chains for cell therapies involves establishing strategic, operational and contractual relationships; developing coordinated, robust, lean and agile processes; maintaining quality with traceability; together with fast and reliable logistics.
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Dr Lucy Foley
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