Bicudo, Edison;
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.
10.2217/rme-2022-0064.
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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. CONCLUSIONS: 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.
| Type: | Article |
|---|---|
| Title: | Institutional and infrastructure challenges for hospitals producing advanced therapies in the UK: the concept of ‘point-of-care manufacturing readiness’ |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.2217/rme-2022-0064 |
| Publisher version: | https://doi.org/10.2217/rme-2022-0064 |
| Language: | English |
| Additional information: | This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| Keywords: | Advanced therapy medicinal products (ATMPs), hospital exemption, institutional readiness, point-of-care manufacture, point-of-care manufacturing readiness, regulation |
| UCL classification: | UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > STEaPP UCL > Provost and Vice Provost Offices > UCL BEAMS UCL |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10155366 |
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