UCL Discovery
UCL home » Library Services » Electronic resources » UCL Discovery

Centralised versus decentralised manufacturing and the delivery of healthcare products: A United Kingdom exemplar

Harrison, RP; Rafiq, QA; Medcalf, N; (2018) Centralised versus decentralised manufacturing and the delivery of healthcare products: A United Kingdom exemplar. Cytotherapy , 20 (6) pp. 873-890. 10.1016/j.jcyt.2018.05.003. Green open access

[thumbnail of Rafiq_Centralised versus decentralised manufacturing and the delivery of healthcare products. A United Kingdom exemplar_Proof.pdf]
Preview
Text
Rafiq_Centralised versus decentralised manufacturing and the delivery of healthcare products. A United Kingdom exemplar_Proof.pdf - Published Version

Download (5MB) | Preview

Abstract

BACKGROUND: The cell and gene therapy (CGT) field is at a critical juncture. Clinical successes have underpinned the requirement for developing manufacturing capacity suited to patient-specific therapies that can satisfy the eventual demand post-launch. Decentralised or ‘redistributed’ manufacturing divides manufacturing capacity across geographic regions, promising local, responsive manufacturing, customised to the end user, and is an attractive solution to overcome challenges facing the CGT manufacturing chain. METHODS: A study was undertaken building on previous, so far unpublished, semi-structured interviews with key opinion leaders in advanced therapy research, manufacturing and clinical practice. The qualitative findings were applied to construct a cost of goods model that permitted the cost impact of regional siting to be combined with variable and fixed costs of manufacture of a mesenchymal stromal cell product. RESULTS: Using the United Kingdom as an exemplar, cost disparities between regions were examined. Per patient dose costs of ~£1,800 per 75,000,000 cells were observed. Financial savings from situating the facility outside of London allow 25–41 additional staff or 24–35 extra manufacturing vessels to be employed. Decentralised quality control to mitigate site-to-site variation was examined. Partial decentralisation of quality control was observed to be financially possible and an attractive option for facilitating release ‘at risk’. DISCUSSION: There are important challenges that obstruct the easy adoption of decentralised manufacturing that have the potential to undermine the market success of otherwise promising products. By using the United Kingdom as an exemplar, the modelled data provide a framework to inform similar regional policy considerations across other global territories.

Type: Article
Title: Centralised versus decentralised manufacturing and the delivery of healthcare products: A United Kingdom exemplar
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.jcyt.2018.05.003
Publisher version: https://doi.org/10.1016/j.jcyt.2018.05.003
Language: English
Additional information: © 2018 International Society for Cellular Therapy. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Keywords: advanced manufacturing technology, cell and gene therapy, cost of goods, decentralised manufacturing, organisational change, quality control
UCL classification: UCL
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Biochemical Engineering
URI: https://discovery.ucl.ac.uk/id/eprint/10050318
Downloads since deposit
287Downloads
Download activity - last month
Download activity - last 12 months
Downloads by country - last 12 months

Archive Staff Only

View Item View Item