Institutional and infrastructure challenges for hospitals producing advanced therapies in the UK: the concept of ‘point-of-care manufacturing readiness’
Abstract
Aim: To propose the concept of point-of-care manufacturing readiness for analyzing the capacity that a country, a health system or an institution has developed to manufacture therapies in clinical settings (point-of-care manufacture). The focus is on advanced therapies (cell, gene and tissue engineering therapies) in the UK. Materials & methods: Literature review, analysis of quantitative data, and qualitative interviews with professionals and practitioners developing and administering advanced therapies. Results: Three components of point-of-care manufacturing readiness are analyzed staff and institutional procedures, infrastructure, and relations between hospitals and service providers. Conclusion: The technical and regulatory experience that has been gained through manufacturing advanced therapies at small scale in hospitals qualifies the UK for more complex and larger-scale production of therapies in the future.
Graphical abstract
Point-of-care manufacturing readiness, its components and its challenges
Plain language summary
Point-of-care manufacture is the production of therapies in hospitals, carried out when there is no time for storing the medicine, which is delivered to the patient with no delays. Such procedures can be useful for advanced therapies derived from techniques such as gene editing, cell manipulation and tissue engineering. Over the last decades, UK hospitals have produced advanced therapies in small quantities. In the future, this production will likely be more thoroughly integrated into clinical routines. In this way, the technical and regulatory experience that hospitals have accumulated so far underpins the more frequent and larger-scale work expected for the future. This accumulation of expertise, infrastructure and institutional contacts provides the foundation for what we call ‘point-of-care manufacturing readiness’.
Papers of special note have been highlighted as: • of interest; •• of considerable interest
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