title: Life-cycle and cost of goods assessment of fed-batch and perfusion-based manufacturing processes for mAbs.
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 toward 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 CO2than the FB 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 CO2was 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. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:1324-1335, 2016.
authors.affiliation: Dept. of Biochemical Engineering, University College London, London, U.K.
authors.forename: Phumthep
authors.initials: P
authors.lastname: Bunnak
authors.affiliation: Alliance Manchester Business School, University of Manchester, Manchester, U.K.
authors.forename: Richard
authors.initials: R
authors.lastname: Allmendinger
authors.affiliation: Dept. of Biochemical Engineering, University College London, London, U.K.
authors.forename: Sri V
authors.initials: SV
authors.lastname: Ramasamy
authors.affiliation: Dept. of Chemical Engineering, University College London, London, U.K.
authors.forename: Paola
authors.initials: P
authors.lastname: Lettieri
authors.affiliation: Dept. of Biochemical Engineering, University College London, London, U.K.. Nigelth@ucl.ac.uk.
authors.forename: Nigel J
authors.initials: NJ
authors.lastname: Titchener-Hooker
mesh_terms: D000911:Antibodies, Monoclonal / Q000032:analysis* / Q000191:economics*; D004784:Environmental Monitoring / Q000191:economics*; D010477:Perfusion
chemical_list: D000911:Antibodies, Monoclonal
keywords: decision-making; environmental assessment; life-cycle assessment (LCA); monoclonal antibody; sustainability