1-s2.0-S1465324918305140-main.pdf (5.01 MB)

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

Download (5.01 MB)
journal contribution
posted on 20.07.2018, 08:02 by Richard P. Harrison, Qasim A. Rafiq, Nick Medcalf
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 A study was undertaken building on previous, so far unpublished, semistructured interviews with key opinion leaders in advanced therapy research, manufacturing and clinical practice.The qualitative findings were applied to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.

Funding

Engineering and Physical Sciences Research Council (EPSRC) Engineering Tissue Engineering and Regenerative Medicine (ETERM) Landscape Fellowship grant (reference EP/ I017801/1) and an EPSRC Fellowships in Manufacturing grant (Nicholas Medcalf; reference EP/ K037099/1).

History

School

  • Mechanical, Electrical and Manufacturing Engineering

Published in

Cytotherapy

Citation

HARRISON, R.P., RAFIQ, Q.A. and MEDCALF, N., 2018. Centralised versus decentralised manufacturing and the delivery of healthcare products: A United Kingdom exemplar. Cytotherapy, 20 (6), pp. 873–890.

Publisher

International Society for Cellular Therapy. Published by Elsevier Inc.

Version

VoR (Version of Record)

Publisher statement

This work is made available according to the conditions of the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Full details of this licence are available at: http://creativecommons.org/licenses/ by/4.0/

Acceptance date

08/05/2018

Publication date

2018

Notes

This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

ISSN

1465-3249

Language

en