Production of a Bevacizumab Biosimilar Using Continuous Manufacturing Practices/The Fukushima Daiichi Disaster: A Failure of Engineering Virtues and Complacency Culture

In my technical paper, my team and I developed a manufacturing process for a biosimilar of a monoclonal antibody (mAb), while in my STS research paper, I analyzed the Fukushima Daiichi disaster through virtue ethics. Both projects emphasize the critical role of responsible engineering, especially in fields that affect many people. Both papers highlight virtue ethics, with the technical paper emphasizing commitment to quality. They show two sides of engineering: one as a cautionary tale of ethical failure, the other as a model for how ethics-driven engineering can improve global health. Together, they argue that technical excellence must be grounded in strong ethical foundations to serve society effectively and sustainably.

My project involved designing a continuous manufacturing process to produce a biosimilar to Genentech’s Avastin, bevacizumab, a monoclonal antibody used to treat various cancers. With Avastin’s patent expiring in 2019, biosimilars offer a cost-effective alternative. The goal was to develop a more affordable version of the drug using economical materials, single-use technology, and continuous production. The process uses CHO cells transfected with bevacizumab DNA, followed by cell culture, clarification, Protein A chromatography, viral inactivation, concentration, and formulation. The facility integrates single-use systems and continuous processing for scalability. The final design can produce 908,695 vials annually, with a $31.8 million capital investment, and is projected to generate over $257 million in positive cash flow with an 811% internal rate of return over 10 years. Priced at $600 per vial, a 29% reduction from the reference product, this biosimilar significantly improves affordability. By addressing clinical demand and economic barriers, this project demonstrates the viability of biosimilar production and supports broader goals of improving global cancer care.

My STS Research Paper argues that the Fukushima Daiichi meltdown was primarily caused by a culture of complacency within the organizations involved. Through virtue ethics, it identifies the neglect of objectivity, communication, and competence as central to the failure. These shortcomings underscore the need for engineers to prioritize ethical responsibility and sound judgment to prevent future disasters. Collectively, these failures reflect how complacency and neglect of essential engineering virtues contributed to the catastrophe. This research informs risk management and engineering ethics and highlights the need to foster responsibility and objectivity to prevent real-world engineering failures.

Working on both projects helped me develop a deeper understanding of the relationship between engineering practice and ethical responsibility. Both emphasized the importance of responsible engineering, especially in fields where decisions affect human health and safety. My STS work deepened my understanding of how ethical failures can have catastrophic consequences, as seen in Fukushima. This led me to reflect more critically on the ethical dimensions of my technical work. It reinforced the importance of quality, transparency, and public welfare in biopharmaceutical engineering, where reliability directly affects patient outcomes. Together, these projects underscored that technical excellence must rest on strong ethical foundations. I hope to carry these insights into future projects to ensure my engineering designs are ethically informed and socially responsible.

School of Engineering and Applied Science

Bachelor of Science in Chemical Engineering

Technical Advisor: Eric Anderson

STS Advisor: Benjamin J. Laugelli

Technical Team Members: Kenneth Chao, Jack Fox, and Morgan-Elizabeth McKnight