Abstract
Introduction
Australia does not produce any antibiotics domestically, and it imports 90% of its medicines. As a result, if there are major disruptions to supply chains, Australia may not be able to respond, and its citizens may not have access to essential medicines during times of need. For my undergraduate thesis, I took a technical and social science lens to the issue of Australian pharmaceutical manufacturing and supply chain resilience.
In my technical report, my team members and I designed a manufacturing plant to produce amoxicillin in Australia, with the primary goal of determining if domestic production of amoxicillin was economically viable in the country. In my STS research paper, I examined the rise of economic nationalism, particularly in the United States, and how that affected the Australian pharmaceutical industry and their efforts to achieve supply chain resilience for pharmaceuticals.
Technical Report
Amoxicillin is a critical antibiotic to public health. However, this antibiotic is not produced domestically in Australia, a country which imports 90% of its medicines and is reliant on production in China and India. Local production of amoxicillin would enhance pharmaceutical self-sufficiency, improve supply security, and support national Australian objectives related to healthcare resilience. This report details a biocatalytic process to manufacture amoxicillin, with the goal of reaching supply chain independence of the antibiotic in Australia.
Our process begins with a series of four CSTRs, that react 6-APA and HPGME, our two main reactants, into amoxicillin and methanol. To reduce the amount of water in the downstream process, we then pass the product through a reverse osmosis filter. The product then passes to a series of crystallizers, and the amoxicillin is centrifuged to remove it from the liquid and dissolved initial reactants. To finish purification, the amoxicillin is washed with an ethanol solution and dried to yield a purified active pharmaceutical ingredient. Finally, the amoxicillin passes through a tableting process, where excipients are added, and it is packaged and bottled to be sold. The process converts 7.6 kg/h of 6-APA and 6.5 kg/h of HPGME to 11.95 kg/h of amoxicillin API, and 160 million tablets a year, or 8 million 20-count bottles.
Economic analysis indicates strong viability for this process. Our IRR is 26%, and with a reasonable capital cost of $17.2 million USD, this process should be advanced for further consideration. However, additional research on components, including possible in-house production of 6-APA, recycle streams of water and ethanol, and cGMP requirements for the pharmaceutical process is needed. These changes may have significant implications for the IRR, and may change whether or not the plant should be built.
STS Research Paper
Using a mix of economic theory, including supply chain resilience and economic nationalism, and STS theory, in particular actor-network theory as described by Callon, we can assess the Australian pharmaceutical industry, and efforts taken thus far to achieve supply chain resilience. After defining key theories and the current situation, I start with a literature review on the Australia-United States Free Trade Agreement of 2005, and a more recent article on drug shortages.
Then, I move to a series of three contentions. First, both the Australian government and Australian pharmaceutical companies oppose American intervention in the PBS. Second, trade disruptions are more likely than ever, and the effects are more pronounced than ever. This makes the case that the Australian government should be prioritizing supply chain resilience in pharmaceuticals. Third, since 2021, the Australian government has made a commitment to increased domestic production of pharmaceuticals and prevent the effects of supply chain issues, but not enough to promote manufacturing.
In discussion, I apply Callon’s theory of interdefinition, by explicitly defining all of the actors in the system and their goals. I conclude with a menu on options the Australian government has on how to proceed in their goal of supply chain resilience, using the case of South Korea’s biopharmaceutical development, and Callon’s concept of an obligatory passage point, arguing that the Australian government needs to devise and enact a specific plan for pharmaceuticals, while taking the interests of the United States and pharmaceutical companies into account.
