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Life-Cycle and Cost of Goods Assessment of Fed-batch and Perfusion-based Manufacturing Processes for mAbs

Bunnak, P; Allmendinger, R; Ramasamy, SV; Lettieri, P; Titchener-Hooker, NJ; (2016) Life-Cycle and Cost of Goods Assessment of Fed-batch and Perfusion-based Manufacturing Processes for mAbs. Biotechnology Progress , 32 (5) pp. 1324-1335. 10.1002/btpr.2323. Green open access

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Abstract

Life-cycle assessment (LCA) is an environmental assessment tool that quantifies the environmental impact associated with a product or a process (e.g. water consumption, energy requirements, and solid waste generation). While LCA is a standard approach in many commercial industries, its application has not been exploited widely in the bioprocessing sector. To contribute towards the design of more cost-efficient, robust and environmentally-friendly manufacturing process for monoclonal antibodies (mAbs), a framework consisting of an LCA and economic analysis combined with a sensitivity analysis of manufacturing process parameters and a production scale-up study is presented. The efficiency of the framework is demonstrated using a comparative study of the two most commonly-used upstream configurations for mAb manufacture, namely fed-batch (FB) and perfusion-based processes. Results obtained by the framework are presented using a range of visualization tools, and indicate that a standard perfusion process (with a pooling duration of 4 days) has similar cost of goods than a FB process but a larger environmental footprint because it consumed 35% more water, demanded 17% more energy, and emitted 17% more CO2 than the fed-batch process. Water consumption was the most important impact category, especially when scaling-up the processes, as energy was required to produce process water and water-for-injection, while CO2 was emitted from energy generation. The sensitivity analysis revealed that the perfusion process can be made more environmentally-friendly than the FB process if the pooling duration is extended to 8 days.

Type: Article
Title: Life-Cycle and Cost of Goods Assessment of Fed-batch and Perfusion-based Manufacturing Processes for mAbs
Open access status: An open access version is available from UCL Discovery
DOI: 10.1002/btpr.2323
Publisher version: http://doi.org/10.1002/btpr.2323
Language: English
Additional information: Copyright © 2016 The Authors. Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers. This is an open access article under the terms of the Creative Commons Attribution License (CC BY 4.0) (https://creativecommons.org/licenses/by/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
Keywords: Life-cycle Assessment (LCA), decision-making, environmental assessment, monoclonal antibody, sustainability
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 Chemical Engineering
URI: https://discovery.ucl.ac.uk/id/eprint/1504644
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