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Lentiviral vector bioprocess economics for cell and gene therapy commercialization

Comisel, RM; Kara, B; Fiesser, FH; Farid, SS; (2021) Lentiviral vector bioprocess economics for cell and gene therapy commercialization. Biochemical Engineering Journal , 167 , Article 107868. 10.1016/j.bej.2020.107868. Green open access

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Abstract

Traditional viral vector processes rely on lab-scale methods that need to be industrialised so as to avoid viral vector supply shortages during commercialisation of cell and gene therapies such as CAR T-cell and HSC gene therapies. This paper describes the application of a decisional tool to identify the most cost-effective scalable cell culture technologies used in the manufacture of lentiviral vectors (LVs) across a range of products. The tool consists of a whole bioprocess economics model linked to an optimisation algorithm and analyses the cost of goods (COG) associated with adherent (e.g. 10-layer vessels (CF10)) and suspension (e.g. single-use stirred tank bioreactor (SUB)) cell culture technologies. The SUB was the most cost-effective technology across most scenarios when a suspension-adapted cell line was available, while the fixed bed bioreactor (FB) was the most costeffective when adherent cell culture was preferred instead. At large scale, the COG reduction achieved by switching from CF10 to SUB or FB was at least 90 %. The SUB capacity limits were highlighted for high dose and high demand scenarios. The cost drivers were explored and the target harvest titre required to drive down LV cost contributions to cell therapy costs was identified. Finally, the tool highlighted the impact of increasing the specific productivity in the FB on COGLV/dose for transient transfection and stable producer cell line scenarios.

Type: Article
Title: Lentiviral vector bioprocess economics for cell and gene therapy commercialization
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.bej.2020.107868
Publisher version: https://doi.org/10.1016/j.bej.2020.107868
Language: English
Additional information: This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)
Keywords: Lentiviral vectors, Single-use cell culture technologies, Cost of goods modelling, Autologous gene-modified cell therapies, CAR T-cell, TCR, Haematopoietic stem cell gene therapy, Plasmid DNA
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/10119408
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