rme-2017-0103.pdf (1.09 MB)
Cell therapy-processing economics: small-scale microfactories as a stepping stone toward large-scale macrofactories
journal contributionposted on 2018-03-08, 16:09 authored by Richard Harrison, Nick Medcalf, Qasim A. Rafiq
Aim: Manufacturing methods for cell-based therapies differ markedly from those established for noncellular pharmaceuticals and biologics. Attempts to ‘shoehorn’ these into existing frameworks have yielded poor outcomes. Some excellent clinical results have been realized, yet emergence of a ‘blockbuster’ cellbased therapy has so far proved elusive. Materials & methods: The pressure to provide these innovative therapies, even at a smaller scale, remains. In this process, economics research paper, we utilize cell expansion research data combined with operational cost modeling in a case study to demonstrate the alternative ways in which a novel mesenchymal stem cell-based therapy could be provided at small scale. Results & Conclusions: This research outlines the feasibility of cell microfactories but highlighted that there is a strong pressure to automate processes and split the quality control cost-burden over larger production batches. The study explores one potential paradigm of cell-based therapy provisioning as a potential exemplar on which to base manufacturing strategy.
EPSRC ETERM Landscape Fellowship grant (R Harrison) reference EP/I017801/1 and an EPSRC Fellowships in manufacturing grant (N Medcalf) reference EP/K037099/1.
- Mechanical, Electrical and Manufacturing Engineering
Published inRegenerative Medicine
CitationHARRISON, R.P., MEDCALF, N. and RAFIQ, Q.A., 2018. Cell therapy-processing economics: small-scale microfactories as a stepping stone toward large-scale macrofactories. Regenerative Medicine, 13 (2), pp.159-173.
PublisherFuture Medicine (© Richard P Harrison)
- VoR (Version of Record)
Publisher statementThis 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/
NotesThis work is licensed under the Creative Commons Attribution 4.0 License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ To view the supplementary data that accompany this paper please visit the journal website at: www.futuremedicine.com/doi/suppl/10.2217/rme-2017-0103