UCL Discovery
UCL home » Library Services » Electronic resources » UCL Discovery

Integrated continuous bioprocessing: Economic, operational, and environmental feasibility for clinical and commercial antibody manufacture

Pollock, J; Coffman, J; Ho, SV; Farid, SS; (2017) Integrated continuous bioprocessing: Economic, operational, and environmental feasibility for clinical and commercial antibody manufacture. Biotechnology Progress , 33 (4) pp. 854-866. 10.1002/btpr.2492. Green open access

[thumbnail of Farid_Pollock_et_al-2017-Biotechnology_Progress.pdf]
Preview
Text
Farid_Pollock_et_al-2017-Biotechnology_Progress.pdf - Published Version

Download (552kB) | Preview

Abstract

This paper presents a systems approach to evaluating the potential of integrated continuous bioprocessing for monoclonal antibody (mAb) manufacture across a product's lifecycle from preclinical to commercial manufacture. The economic, operational, and environmental feasibility of alternative continuous manufacturing strategies were evaluated holistically using a prototype UCL decisional tool that integrated process economics, discrete-event simulation, environmental impact analysis, operational risk analysis, and multiattribute decision-making. The case study focused on comparing whole bioprocesses that used either batch, continuous or a hybrid combination of batch and continuous technologies for cell culture, capture chromatography, and polishing chromatography steps. The cost of goods per gram (COG/g), E-factor, and operational risk scores of each strategy were established across a matrix of scenarios with differing combinations of clinical development phase and company portfolio size. The tool outputs predict that the optimal strategy for early phase production and small/medium-sized companies is the integrated continuous strategy (alternating tangential flow filtration (ATF) perfusion, continuous capture, continuous polishing). However, the top ranking strategy changes for commercial production and companies with large portfolios to the hybrid strategy with fed-batch culture, continuous capture and batch polishing from a COG/g perspective. The multiattribute decision-making analysis highlighted that if the operational feasibility was considered more important than the economic benefits, the hybrid strategy would be preferred for all company scales. Further considerations outside the scope of this work include the process development costs required to adopt continuous processing. © 2017 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers Biotechnol. Prog., 2017.

Type: Article
Title: Integrated continuous bioprocessing: Economic, operational, and environmental feasibility for clinical and commercial antibody manufacture
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1002/btpr.2492
Publisher version: http://dx.doi.org/10.1002/btpr.2492
Language: English
Additional information: © 2017 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, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
Keywords: Antibody manufacture, continuous chromatography, fed-batch, perfusion culture, process economics
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/1556886
Downloads since deposit
465Downloads
Download activity - last month
Download activity - last 12 months
Downloads by country - last 12 months

Archive Staff Only

View Item View Item