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Title: Cell therapy-processing economics: small-scale microfactories as a stepping stone toward large-scale macrofactories
Authors: Harrison, Richard P.
Medcalf, Nick
Rafiq, Qasim A.
Keywords: Automation
Bioprocessing
Cell expansion
Cell factories
Cost of goods (COG)
Manufacturing
Process economics
Stem cell therapy
Issue Date: 2018
Publisher: Future Medicine (© Richard P Harrison)
Citation: HARRISON, 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.
Abstract: 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.
Description: This 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
Sponsor: EPSRC ETERM Landscape Fellowship grant (R Harrison) reference EP/I017801/1 and an EPSRC Fellowships in manufacturing grant (N Medcalf) reference EP/K037099/1.
Version: Published
DOI: 10.2217/rme-2017-0103
URI: https://dspace.lboro.ac.uk/2134/32152
Publisher Link: https://doi.org/10.2217/rme-2017-0103
Related Resource: http://www.futuremedicine.com/doi/suppl/10.2217/rme-2017-0103
ISSN: 1746-0751
Appears in Collections:Published Articles (Mechanical, Electrical and Manufacturing Engineering)

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