Evaluation of the Impact of Buffer Management Strategies on Biopharmaceutical Manufacturing Process Mass Intensity

Author:

Gibson Kevin12,Oliveira Jorge C.2ORCID,Ring Denis2

Affiliation:

1. PM Group, T12 C670 Cork, Ireland

2. School of Engineering and Architecture, University College Cork, T12 K8AF Cork, Ireland

Abstract

There is an increasing demand to improve the overall sustainability of the biopharmaceutical industry. A barrier to improvement has been the limited research undertaken in the area of environmental impact of key design decisions. The aim of this study was to perform a comprehensive evaluation of the impact of buffer management strategy and technology selection on overall process efficiency using process mass intensity (PMI) as a metric for comparison. The environmental impact of buffer management has yet to be fully understood, despite buffers being one of the most resource-intensive aspects of biopharmaceutical manufacturing. A detailed process model was used to evaluate the impact of buffer management on a monoclonal antibody (MAB) process at the 2000 L scale. This was achieved by means of a non-replicated full factorial design composed of six variables: product titre, quantity of unique buffers, preparation frequency, single-use threshold and equipment cleaning duration with two levels and buffer preparation strategy type with four levels. The study identified that buffer management has a critical impact on overall process mass intensity, demonstrating a possibility to achieve a reduction in PMI of up to 90% for the best scenario compared to the worst. The findings also indicated that single-use systems are greatly superior to stainless-steel systems in terms of overall process efficiency, which is consistent with established thinking. The results from this research represent a further significant step towards achieving a more sustainable biopharmaceutical industry, establishing buffer management as a critical focus area, quantifying the influence of key variables on process mass intensity and highlighting the benefits of using a process mass intensity metric as part of routine biopharmaceutical design.

Publisher

MDPI AG

Subject

Process Chemistry and Technology,Chemical Engineering (miscellaneous),Bioengineering

Reference21 articles.

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4. ISPE’s Disposables Community of Practice and the Sustainability Sub-Team (2023, March 24). End-of-Life Management for Single-Use Products in Bioproduction | Pharmaceutical Engineering. Available online: https://ispe.org/pharmaceutical-engineering/ispeak/end-life-management-single-use-products-bioproduction.

5. An Environmental Life Cycle Assessment Comparison of Single-Use and Conventional Process Technology for the Production of Monoclonal Antibodies;Pietrzykowski;J. Clean. Prod.,2013

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