Chau, Charnett; (2021) Using Life Cycle Assessment as a Tool to Evaluate and Make Recommendations for Future Biopharmaceutical Manufacture. Masters thesis (M.Phil), UCL (University College London).

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Abstract

Life cycle assessment (LCA) is a well-regarded methodology used to evaluate the environmental impacts of a system, essential to supporting the 2030 Agenda for Sustainable Development Goals. Due to the increasing need for companies to act more environmentally friendly, employing LCA to systematically and quantitatively evaluate their products and processes would be necessary. To date, little LCA work has been applied to biopharmaceutical production; this may be due to a lack of inputs and outputs data, methodology available or knowledge related to LCA. Hence, this project sought to develop guidance to apply LCA to biopharmaceutical processes, considering questions that companies would typically require to address. To this end, the LCA methodology was operationalised to the production of a major biopharmaceutical product, 6-APA, to demonstrate the advantages and limitations of LCA. As 6-APA represents the largest production mass output of the industry, industry-wide practical steps and policy considerations to reduce environmental impacts were drawn. A series of LCA analyses, including sensitivity analyses, hot-spot analyses, scenario analyses and comparative study were conducted on the "average" 6-APA manufacturing process, modelled with input including that from industry contacts. This set of analyses ensured that recommendations drawn from the LCA study considered all factors, including the robustness and significance of results and the relationship between process parameters, specifically product titre, scale, location, and environmental impacts. Hot-spot analysis was conducted on nine scenarios where 6-APA production was considered to locate in different countries. Results concurred that the highest impacts in most environmental impact categories were derived from the supply of essential production materials and the electricity mix. This underscored the importance of considering the source (or the choice of suppliers) for the process inputs. The normalisation methodology was applied to estimate the relative impact of 6-APA manufacture globally and to assess the significance of the impacts generated. It showed that ecotoxicity impacts from coal energy generation in China were highly significant when production was scaled to global levels. This posed the question of whether the level of impacts generated in this single location was environmentally damaging. Hence, the thesis suggests that governments may wish to take steps to prevent potential environmental damages from possible over-concentrations of impacts. This thesis also highlights areas of further work, including improvements to inventory data, the assessment of later biopharmaceutical life cycle stages, and economic and social LCA, to complement and enhance the life cycle environmental impact assessment presented here.

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