Bicudo, Edison and Brass, Irina (2022). Institutional and infrastructure challenges for hospitals producing advanced therapies in the UK:the concept of ‘point-of-care manufacturing readiness'. Regenerative medicine, 17 (10), pp. 719-737.
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 |
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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 |