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End‐to‐end continuous bioprocessing: impact on facility design, cost of goods and cost of development for monoclonal antibodies

Mahal, H; Branton, H; Farid, SS; (2021) End‐to‐end continuous bioprocessing: impact on facility design, cost of goods and cost of development for monoclonal antibodies. Biotechnology and Bioengineering , 118 (9) pp. 3468-3485. 10.1002/bit.27774. Green open access

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Abstract

This article presents a systematic approach to evaluate the business case for continuous processing that captures trade-offs between manufacturing and development costs for monoclonal antibodies (mAbs). A decisional tool was built that integrated cost of goods (COG) with cost of development models and new equipment sizing equations tailored to batch, hybrid and end-to-end continuous processes. The COG analysis predicted that single-use continuous facilities (sized using a dedicated DSP train per bioreactor) offer more significant commercial COG savings over stainless steel batch facilities at annual demands of 100-500 kg (~35%), compared to tonnage demands of 1-3 tons (~±10%) that required multiple parallel continuous trains. Single-use batch facilities were found to compete with continuous options on COG only at 100 kg/year. For the scenarios where batch and continuous facilities offered similar COG, the analysis identified the windows of operation required to reach different COG savings with thresholds for the perfusion rate, volumetric productivity and media cost. When considering the project lifecycle cost, the analysis indicated that while end-to-end continuous facilities may struggle to compete on development costs, they become more cost-effective than stainless steel batch facilities when considering the total out-of-pocket cost across both drug development and commercial activities. This article is protected by copyright. All rights reserved.

Type: Article
Title: End‐to‐end continuous bioprocessing: impact on facility design, cost of goods and cost of development for monoclonal antibodies
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1002/bit.27774
Publisher version: https://doi.org/10.1002/bit.27774
Language: English
Additional information: © 2021 The Authors. Biotechnology and Bioengineering Published by Wiley Periodicals LLC 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: Chemistry, manufacturing and controls (CMC), cost of development, cost of goods, end-to-end continuous processing, monoclonal antibody manufacture, 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/10126111
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