1-s2.0-S1465324917306321-main.pdf (1.19 MB)

Decentralized manufacturing of cell and gene therapies: Overcoming challenges and identifying opportunities

Download (1.19 MB)
journal contribution
posted on 25.08.2017 by Richard Harrison, Steven Ruck, Nick Medcalf, Qasim A. Rafiq
Decentralized or “redistributed” manufacturing has the potential to revolutionize the manufacturing approach for cell and gene therapies (CGTs), moving away from the “Fordist” paradigm, delivering health care locally, customized to the end user and, by its very nature, overcoming many of the challenges associated with manufacturing and distribution of high volume goods. In departing from the traditional centralized model of manufacturing, decentralized manufacturing divides production across sites or geographic regions. This paradigm shift imposes significant structural and organisational changes on a business presenting both hidden challenges that must be addressed and opportunities to be embraced. By profoundly adapting business practices, significant advantages can be realized through a democratized value chain, creation of professional-level jobs without geographic restriction to the central hub and a flexibility in response to external pressures and demands. To realize these potential opportunities, however, advances in manufacturing technology and support systems are required, as well as significant changes in the way CGTs are regulated to facilitate multi-site manufacturing. Decentralized manufacturing is likely to be the manufacturing platform of choice for advanced health care therapies—in particular, those with a high degree of personalization. The future success of these promising products will be enhanced by adopting sound business strategies early in development. To realize the benefits that decentralized manufacturing of CGTs has to offer, it is important to examine both the risks and the substantial opportunities present. In this research, we examine both the challenges and the opportunities this shift in business strategy represents in an effort to maximize the success of adoption.

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

Cytotherapy

Citation

HARRISON, R. ...et al., 2017. Decentralized manufacturing of cell and gene therapies: Overcoming challenges and identifying opportunities. Cytotherapy, 19 (10), pp. 1140-1151.

Publisher

© The Authors. Published by Elsevier Inc. on behalf of the International Society for Cellular Therapy

Version

VoR (Version of Record)

Publisher statement

This work is made available according to the conditions of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) licence. Full details of this licence are available at: https://creativecommons.org/licenses/by-nc-nd/4.0/

Acceptance date

10/07/2017

Publication date

2017

Notes

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/

ISSN

1465-3249

eISSN

1477-2566

Language

en

Exports

Logo branding

Exports