Abstract
Unless allergic, most people worldwide have taken the commonly prescribed antibiotic amoxicillin. Despite its widespread use, healthcare systems continue to face antibiotic shortages alongside the growing threat of antimicrobial resistance (AMR). Humanity finds itself in a unique position where innovative, cost-effective methods for producing antibiotics are needed, but increased antibiotic production risks accelerating AMR. This paradox inspired both components of my research.
My technical thesis details the commercial-scale production of amoxicillin in Australia, and my STS thesis examines how government regulatory strategies can stabilize access to appropriate antibiotics without amplifying resistance in Australia.
My technical thesis focuses on designing a commercial-scale amoxicillin production plant in Australia, a country that currently lacks industrial antibiotic manufacturing facilities. My team designed a six-stage process to produce amoxicillin efficiently and at scale. Our process began by reacting our starting materials to form the active pharmaceutical ingredient (API), amoxicillin. Because our reaction required large volumes of water to fully dissolve the starting materials, we implemented a reverse osmosis stage to remove excess water and enable downstream processing. Following this, amoxicillin is crystallized through pH adjustments using hydrochloric acid and ammonia, causing it to precipitate from the process fluid. The solid amoxicillin is separated from the remaining liquid in centrifugation, washed with a 30% ethanol solution to remove residual impurities, and dried before moving to the final stage. In the final stage, the purified API is combined with excipients and compressed into tablets for sale. In addition to process design, we conducted an economic feasibility analysis to evaluate the viability of construction and the plant’s profitability over its lifespan (~20 years). With a net present value (NPV) of $10.7 million at a 10% discount rate, and an internal rate of return (IRR) of 26%, our analysis supported a “go” decision for building the plant.
My STS research examines strategies to mitigate antibiotic shortages and how government and regulatory policies can stabilize access to appropriate antibiotics, particularly in Australia. Antibiotic shortages in Australia highlight the country’s heavy reliance on international supply networks, specifically in China and India. This reliance limits consistent access to essential medicines and forces hospitals and pharmacies to pursue suboptimal alternative treatments that contribute to the spread of antimicrobial resistance (AMR). Current mitigation strategies largely focus on shifting the location of active pharmaceutical ingredient (API) production domestically to improve stability; this approach is partially what my technical thesis aims to solve. My STS research further focused on analyzing regulatory frameworks and policy interventions implemented in other countries to better understand how Australia could adapt its current strategies. I analyzed two specific policy interventions: Norway’s “need clause,” which limits market entry to antibiotics that do not demonstrate a therapeutic need and an advantage over existing treatments, and Europe’s subscription-style “pull incentive,” which guarantees revenue to manufacturers regardless of sales volume. I propose that aspects of both strategies could be implemented in Australia’s regulatory framework to stabilize access to antibiotics.
Understanding both the technical and social considerations of this work, as with any other, is essential for “good” engineers. A good engineer is not only technically capable but open-minded and understands both the broader picture and the nuances of proposed solutions. At a glance, solving Australia’s antibiotic shortage might seem as simple as building more industrial facilities across the country. However, that approach overlooks the poor prescribing practices that lead to the widespread use of suboptimal treatments and the rise in AMR. The broader picture at play lies in balancing improved access with responsible antibiotic use, requiring engineers to remain open to multiple solutions and to consider diverse perspectives. This mindset is fundamental for addressing complex, interconnected problems that engineers face around the world.
