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.

Publication DOI: https://doi.org/10.2217/rme-2022-0064
Divisions: College of Business and Social Sciences > School of Social Sciences & Humanities > Sociology and Policy
College of Business and Social Sciences > School of Social Sciences & Humanities > Centre for Health and Society
Additional Information: This work is licensed under the Attribution 4.0 License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/
Uncontrolled Keywords: advanced therapy medicinal products (ATMPs),hospital exemption,institutional readiness,point-of-care manufacture,point-of-care manufacturing readiness,regulation,Biomedical Engineering,Embryology
Publication ISSN: 1746-076X
Last Modified: 09 Dec 2024 09:05
Date Deposited: 12 Sep 2023 11:48
Full Text Link:
Related URLs: http://www.scop ... tnerID=8YFLogxK (Scopus URL)
https://www.fut ... 7/rme-2022-0064 (Publisher URL)
PURE Output Type: Article
Published Date: 2022-10-01
Accepted Date: 2022-08-10
Authors: Bicudo, Edison
Brass, Irina

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