Richard P Harrison1,2,3, Nicholas Medcalf1, Qasim A Rafiq4,3. 1. Centre for Biological Engineering, Holywell Park, Loughborough University, Loughborough, LE11 3TU, UK. 2. Wolfson Centre for Stem cells, Tissue Engineering & Modelling (STEM), The University of Nottingham, Centre for Biomolecular Sciences, University Park, Nottingham, NG7 2RD, UK. 3. Department for Biochemical Engineering, School of Life & Health Sciences, Aston University, Aston Triangle, Birmingham, B4 7ET, UK. 4. Department of Biochemical Engineering, Faculty of Engineering Science, University College London, Gower Street, London, WC1E 6BT, UK.
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' cell-based 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.
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' cell-based 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.
Entities:
Keywords:
automation; bioprocessing; cell expansion; cell factories; cost of goods (COG); manufacturing; process economics; stem cell therapy
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