Ramasamy, SVP; (2018) A framework to support environmentally-based decision-making in the biopharmaceutical industry. Doctoral thesis (Ph.D), UCL (University College London).

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Abstract

The past decade has seen an increasing focus on the issues surrounding climate change and this has triggered governments internationally to develop environmental legislation and policies for the energy-intensive industries (EIIs) that can help reduce their anthropogenic greenhouse gases (GHGs) emissions. The biopharmaceutical industry is a relatively new EII. As the industry matures, the level of environmental scrutiny is increasing. Therefore, there is a need for the development of a framework specific to this industry to help guide the selection of manufacturing and disposal routes that reflect the potential environmental impact. In this doctorate, a framework based on the life cycle assessment (LCA) tool was developed. The application of the framework for evaluating manufacturing and solid waste management alternatives is demonstrated via case studies that focus on production of therapeutic monoclonal antibodies using mammalian cell culture process at 200 L operational scale using either traditional or a hybrid based on a mix of traditional and disposable modes of production. The framework was employed to identify the process (whether traditional or hybrid) that contributes least to environmental impact, and also to identify the most suitable solid waste management method (landfill, incineration and pyrolysis). The life cycle inventory of the manufacturing processes, and the methodology used to obtain the inventory are presented. It is expected that this information will be beneficial for future studies in this area of research. The analysis also utilised sensitivity analysis studies to assess critically the uncertainties in the assumptions made in the case study. Finally, the application of the framework in evaluating the cumulative environmental impact, from manufacture in support of clinical stages up to production was assessed. Here, the focus was not only to evaluate the cumulative environmental impact, but also to explore the benefits of employing single-use technologies during clinical phase manufacture when developing a monoclonal antibody for therapeutic use. The work in this thesis highlights the benefits of adopting a consistent engineering framework to guide process and technology selections in the biopharmaceutical industry by improving the overall quality of decision-making. This in turn will help the industry to predict and to control their environmental performance.

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