Sustainability analysis of biopharmaceuticals manufacturing

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Lalor, Fergal
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University College Cork
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The production of biopharmaceutical treatments is increasing globally at a rapid pace, leading to the treatment of more and more disorders, many of which historically were untreatable and debilitating. This increase in production poses sustainability concerns, with economic unsustainability from erratic returns on investment, societal concerns around treatment cost and access, and a dearth of published research on pathways to environmentally sustainable production methods. Recombinant protein production by perfusion cell culture under stainless-steel and single-use technologies was investigated using life cycle assessment (LCA) to determine the impact on environmental factors. The ReCiPe for LCA method was utilised, and the single-use scenario was found to result in 40% impacts than stainless-steel alternative across all production volumes. Factors influencing the difference in environmental impacts include infrastructural variables, such as the electricity source to the facility, and process variables, such as the interval between ultrafiltration/diafiltration batches. The feasibility of environmentally sustainable manufacturing processes were investigated, with novel technologies such as water-for-injection (WFI) production by reverse osmosis, the use of biologically-sourced polymeric materials for single-use items and the benefits of increased containment using single-use equipment on cleanroom maintenance evaluated. The results of this analysis indicate reductions in environmental impacts across both single-use and stainless-steel scenarios of 60%, but with further research required to fully understand the process impacts resulting from adopting these technologies. A multiple-criteria decision-making framework was developed to evaluate the economic, environmental and social sustainability of biopharmaceutical manufacturing processes under varying value orientations, enabling the comparison of treatments produced under different modalities. This framework may be utilised to assess treatments for regulatory approval and governmental reimbursement in a holistic manner, as opposed to a reductionist economic standpoint. Further research is required to account for greater complexities in the biopharmaceutical industrial system such as feedback loops between various stakeholders and to provide and document indices from existing processes to be used for evaluation of prospective treatments.
Sustainability , Process engineering
Lalor, F. M. 2020. Sustainability analysis of biopharmaceuticals manufacturing. PhD Thesis, University College Cork.