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Impact of allogeneic stem cell manufacturing decisions on cost of goods, process robustness and reimbursement

Chilima, TDP; Moncaubeig, F; Farid, SS; (2018) Impact of allogeneic stem cell manufacturing decisions on cost of goods, process robustness and reimbursement. Biochemical Engineering Journal , 137 pp. 132-151. 10.1016/j.bej.2018.04.017. Green open access

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Abstract

This article presents a framework to evaluate holistically the operational and economic performance of different manufacturing platforms for the expansion of allogeneic mesenchymal stromal cells (MSCs) across different commercialisation scenarios. The tool comprised models for whole bioprocess economics linked to uncertainty analysis, dynamic scheduling, brute-force optimisation and multi-attribute decision-making. The tool was used to determine the cost of goods (COG), robustness, operational ease and business feasibility of competing cell culture technologies under different scale, demand, reimbursement and dose size scenarios, and to determine the performance improvements required for commercial success. The results revealed that in low annual demand (10 billion cells/year) scenarios, multi-plate bioreactors have superior operational and economic characteristics. At larger annual demands (10 trillion cells/year), however, the tool predicts that microcarrier-based bioreactors are optimal due to their relative cost-effectiveness and operational benefits conferred by their closed and controlled characteristics that outweigh the uncertainties associated with their use. Moreover, whilst further analysis of high dose, high demand (1 billion cells/dose, 10,000 doses/year) scenarios has shown that significant improvement in the performance of cell culture processes may result in satisfactory COG, current limitations in the capacity of downstream processing (DSP) technologies may not allow full market capture.

Type: Article
Title: Impact of allogeneic stem cell manufacturing decisions on cost of goods, process robustness and reimbursement
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.bej.2018.04.017
Publisher version: https://doi.org/10.1016/j.bej.2018.04.017
Language: English
Additional information: This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/
Keywords: Science & Technology, Life Sciences & Biomedicine, Technology, Biotechnology & Applied Microbiology, Engineering, Chemical, Engineering, Allogeneic, Mesenchymal stem/stromal cells, Robustness, Cost of goods, Reimbursement, Multi-attribute decision-making analysis, MESENCHYMAL STROMAL CELLS, THERAPY BIOPROCESS ECONOMICS, HUMAN BONE-MARROW, MACROPOROUS MICROCARRIERS, REGENERATIVE MEDICINE, CULTIVATION SYSTEM, CLINICAL-TRIALS, CULTURE-SYSTEM, PHASE-I, EXPANSION
UCL classification: UCL
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Biochemical Engineering
URI: https://discovery.ucl.ac.uk/id/eprint/1542061
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