Design of a Pembrolizumab Manufacturing Plant Using Continuous Bioprocess Technology and Single-Use Bioreactors; A Care Ethics Analysis of the Pharmaceutical Pollution and Resultant Antimicrobial Resistance in Hyderabad

Mohan, Revathi, School of Engineering and Applied Science, University of Virginia
Anderson, Eric, EN, University of Virginia
Laugelli, Benjamin, EN, University of Virginia

This past year, I conducted an in-depth analysis of the Hyderabadi pharmaceutical pollution crisis while also formulating a technical report on the design of a pembrolizumab manufacturing facility that uses continuous bioprocessing technology to produce the cancer-treating drug, Keytruda. One has to consider many ethical and social concerns with the design of any drug manufacturing facility, such as the treatment of effluents in order to prevent environmental damage and resultant harm of neighboring residents. The relationship I see between the two projects is that if I do not take ethical and social concerns into consideration with my manufacturing design in my technical report, its everlasting effects could be similar to those of the Hyderabadi pharmaceutical pollution crisis.
My technical report focuses on the design of a proposed pembrolizumab manufacturing facility in Ireland that works to manufacture Keytruda, a very popular cancer-treating drug manufactured by Merck & Company, using continuous bioprocessing technology. The design centers on the use of perfusion reactors and single-use reactor bags. Incorporating single-use reactor bags will decrease the need for extensive cleaning protocols, save time and reduce employment costs (Jacquemart et al., 2016). Using perfusion reactors will allow for the continuous production of Keytruda, by culturing cells over longer periods of time by continuously feeding and removing media while keeping cells in culture (Bielser, Wolf, Souquet, Broly, & Morbidelli, 2018). This will increase product yields and subsequently decrease production costs. My capstone team hopes that incorporating these design considerations will help reduce the base price of the drug.
My STS Research Paper focuses on a study conducted by the Changing Markets Foundation in the Indian city of Hyderabad, one of the world’s largest bulk drug manufacturing sites. This study confirmed that Hyderabadi pharmaceutical companies were disposing of their untreated chemical effluents into neighboring bodies of water, which has contributed to environmental destruction and antimicrobial resistance that has harmed Hyderabadi people (Changing Markets Foundation et al., 2018). My STS Research Paper uses the lens of care ethics, Joan Tronto’s four sub-elements of care, and other sources of evidence to argue that the actions of the Hyderabadi pharmaceutical companies are immoral due to their failure to address the duty of care they owe to the environment and people of Hyderabad by reason of their greater power, wealth, and knowledge. The overall goal of my research is to help society understand the moral responsibilities powerful industries like the Hyderabadi pharmaceutical companies owe to those who need care.
Conducting both projects simultaneously allowed for me to apply knowledge gained from one project to the other. My STS Research Paper allowed for me to better understand the responsibilities I have as a professional engineer, including the responsibilities to comprehend and address ethical concerns that come with projects. This influenced my technical design by ensuring that I prioritized the design of a proper waste treatment and collection system to send treated waste to a local waste treatment center. My technical work improved my understanding of manufacturing design, so I could approach my STS research with a more developed technical background. Overall, working on both projects simultaneously taught me various aspects of ethics and engineering that go hand in hand, aspects I will take with me into the real world as a professional engineer.

BS (Bachelor of Science)
Care Ethics, Continuous Bioprocess Technology, Pharmaceutical Pollution

School of Engineering and Applied Science
Bachelor of Science in Chemical Engineering
Technical Advisor: Eric Anderson
STS Advisor: Ben Laugelli
Technical Team Members: Brian Abt, Clayton Burruss, Revathi Mohan, Noah Rushin, Summer Xu

Issued Date: