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Decentralised manufacturing of cell and gene therapy products: learning from other healthcare sectors

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journal contribution
posted on 19.01.2018 by Richard Harrison, Steven Ruck, Qasim A. Rafiq, Nick Medcalf
Decentralised or 'redistributed' manufacturing represents an attractive choice for production of some cell and gene therapies (CGTs), in particular personalised therapies. Decentralised manufacturing splits production into various locations or regions and in doing so, imposes organisational changes on the structure of a company. This confers a significant advantage by democratising supply, creating jobs without geographical restriction to the central hub and allowing a more flexible response to external pressures and demands. This comes with challenges that need to be addressed including, a reduction in oversight, decision making and control by central management which can be critical in maintaining quality in healthcare product manufacturing. The unwitting adoption of poor business strategies at an early stage in development has the potential to undermine the market success of otherwise promising products. To maximise the probability of realising the benefits that decentralised manufacturing of CGTs has to offer, it is important to examine alternative operational paradigms to learn from their successes and to avoid their failures. Whilst no other situation is quite the same as CGTs, some illustrative examples of established manufacturing paradigms are described. Each of these shares a unique attribute with CGTs which aids understanding of how decentralised manufacturing might be implemented for CGTs in a similar manner. In this paper we present a collection of paradigms that can be drawn on in formulating a roadmap to success for decentralised production of CGTs.

Funding

This study was supported by an Engineering and Physical Sciences Research Council (EPSRC) Engineering, Tissue Engineering and Regenerative Medicine (ETERM) Landscape fellowship grant (Richard Harrison) 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

Biotechnology Advances

Citation

HARRISON, R.P. ... et al, 2017. Decentralised manufacturing of cell and gene therapy products: learning from other healthcare sectors. Biotechnology Advances, 36 (2), pp.345-357.

Publisher

Elsevier © The Authors

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/

Publication date

2017

Notes

This is an Open Access Article. It is published by Elsevier under the Creative Commons Attribution 4.0 International Licence (CC BY). Full details of this licence are available at: http://creativecommons.org/licenses/by/4.0/

ISSN

0734-9750

Language

en

Licence

Exports