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Decisional tool for cost of goods analysis of bioartificial liver devices for routine clinical use

Mendonça da Silva, J; Stamatis, C; Chalmers, S-A; Erro, E; Selden, C; Farid, SS; (2021) Decisional tool for cost of goods analysis of bioartificial liver devices for routine clinical use. Cytotherapy , 23 (8) pp. 683-693. 10.1016/j.jcyt.2021.04.006. Green open access

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Abstract

BACKGROUND AIMS: Bioartificial liver devices (BALs) are categorized as advanced therapy medicinal products (ATMPs) with the potential to provide temporary liver support for liver failure patients. However, to meet commercial demands, next-generation BAL manufacturing processes need to be designed that are scalable and financially feasible. The authors describe the development and application of a process economics decisional tool to determine the cost of goods (COG) of alternative BAL process flowsheets across a range of industrial scales. METHODS: The decisional tool comprised an information database linked to a process economics engine, with equipment sizing, resource consumption, capital investment and COG calculations for the whole bioprocess, from cell expansion and encapsulation to fluidized bed bioreactor (FBB) culture to cryopreservation and cryorecovery. Four different flowsheet configurations were evaluated across demands, with cell factories or microcarriers in suspension culture for the cell expansion step and single-use or stainless steel technology for the FBB culture step. RESULTS: The tool outputs demonstrated that the lowest COG was achieved with microcarriers and stainless steel technology independent of the annual demand (1500-30 000 BALs/year). The analysis identified the key cost drivers were parameters impacting the medium volume and cost. CONCLUSIONS: The tool outputs can be used to identify cost-effective and scalable bioprocesses early in the development process and minimize the risk of failing to meet commercial demands due to technology choices. The tool predictions serve as a useful benchmark for manufacturing ATMPs.

Type: Article
Title: Decisional tool for cost of goods analysis of bioartificial liver devices for routine clinical use
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.jcyt.2021.04.006
Publisher version: https://doi.org/10.1016/j.jcyt.2021.04.006
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: bioartificial liver, cell factories, cost of goods, microcarriers, single use, stainless steel
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Inst for Liver and Digestive Hlth
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/10129639
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