Process design of a fully integrated continuous biopharmaceutical process using economic and ecological impact assessment

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Author(s)Ding, Chaoying
Author(s)Ardeshna, Hiren
Author(s)Gillespie, Christopher
Author(s)Ierapetritou, Marianthi
Date Accessioned2022-10-06T18:01:16Z
Date Available2022-10-06T18:01:16Z
Publication Date2022-09-15
DescriptionThis is the peer reviewed version of the following article: Ding, C., Ardeshna, H., Gillespie, C., & Ierapetritou, M. (2022). Process design of a fully integrated continuous biopharmaceutical process using economic and ecological impact assessment. Biotechnology and Bioengineering, 1– 17. https://doi.org/10.1002/bit.28234, which has been published in final form at https://doi.org/10.1002/bit.28234. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions. This article may not be enhanced, enriched or otherwise transformed into a derivative work, without express permission from Wiley or by statutory rights under applicable legislation. Copyright notices must not be removed, obscured or modified. The article must be linked to Wiley’s version of record on Wiley Online Library and any embedding, framing or otherwise making available the article or pages thereof by third parties from platforms, services and websites other than Wiley Online Library must be prohibited. This article will be embargoed until 09/15/2023.en_US
AbstractContinuous biomanufacturing is a promising alternative to current batch operation as it offers benefits in terms of improved productivity, product quality, and reduced footprint. This study aims to build a fully integrated continuous platform for monoclonal antibody (mAb) production incorporating novel technologies (like intensified seed expansion and continuous high cell density perfusion operations, single-pass tangential flow filtration, and single-use technologies) as well as media and buffer preparation steps. Economic assessment is performed on the basis of the total cost of goods (COGs), which is $102.2/g in the base-case scenario with a bioreactor scale of 500 L. E-factor is used as an environmental indicator and the result shows that 4865.6kg of process water and 11.1 kg of consumables are required to produce 1 kg mAbs. After the development and analysis of the benchmark process, scenario analysis is performed to assess the impacts of the bioreactor scale (60–2000 L) and upstream titers (1.12–2.08 g/L) on the process economics as well as on the environmental footprint. With the increase of bioreactor scale and mAb titer, the operating COGs per unit product decrease. Moreover, increasing the mAb titer is more favorable in terms of the ecological impacts. To investigate the production capacity, the upstream production is increased and the downstream bottlenecks are determined. It is found that only the multicolumn chromatographic (MCC) operations become the process bottleneck and the order of the MCC unit operation that becomes the process bottleneck depends on capacity utilization for that step. Finally, a new platform is built with the integration of membrane chromatography and the two designed processes are compared in terms of economic and ecological impacts.en_US
SponsorThis study wasperformed under a Project Award Agreement from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and financial assistance award 70NANB17H002 from the US Department of Commerce, National Institute of Standards and Technology.en_US
CitationDing, C., Ardeshna, H., Gillespie, C., & Ierapetritou, M. (2022). Process design of a fully integrated continuous biopharmaceutical process using economic and ecological impact assessment. Biotechnology and Bioengineering, 1– 17. https://doi.org/10.1002/bit.28234en_US
ISSN1097-0290
URLhttps://udspace.udel.edu/handle/19716/31448
Languageen_USen_US
PublisherBiotechnology and Bioengineeringen_US
Keywordscontinuous biopharmaceutical manufacturingen_US
Keywordsecology analysisen_US
Keywordseconomic assessmenten_US
Keywordsmembrane chromatographyen_US
Keywordsprocess bottlenecksen_US
Keywordsscenario analysisen_US
TitleProcess design of a fully integrated continuous biopharmaceutical process using economic and ecological impact assessmenten_US
TypeArticleen_US
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