Design of a Pembrolizumab Manufacturing Plant in Ireland Using Continuous Bioprocess Technology and Single-Use Bioreactors; The Relationship Between Patents on Insulin, Drug Access, and Innovation in the United States

Protein therapeutics is a class of drugs where proteins are engineered in the laboratory for pharmaceutical purposes. They are an extremely effective class of drug because of their high specificity, far reaching patent protection, as well as faster clinical approval and development from the FDA. As a result, the demand for protein therapeutics is increasing over time (Creative Proteomics, 2020). The global protein therapeutic market was 140,109 dollars in 2016, and is predicted to grow to 217,591 million in 2023 (Sumant & Shaikh, 2017). Both the technical work and the STS research in this portfolio focus on two different types of protein therapeutics. The technical portion focuses on the drug Keytruda, and building a manufacturing facility to expand Merck’s production of the drug. The STS research focuses on the protein therapeutic insulin, and how patent influence the innovation and access of the drug. Both the technical and STS research focuses on engineering ways to increase the production of these drugs due to their growing demand, as well as better understanding the access to and innovation of these drugs respectively. Both the technical and STS research help to better understand the science behind and social implications of protein therapeutics as they become more prevalent.
The technical portion of the research focuses on building a facility in Dublin, Ireland in order to increase the production of Keytruda. Keytruda is a type of immunotherapy that works by blocking the PD-1 pathway, preventing cancer cells from hiding. This as a result allows the immune system to detect and kill cancer cells in the body (Merck, 2020). The plant design was focused around continuous bioprocessing which has been shown to lead to greater efficiency and product quality (Kakes, 2018). In order to limit the impact to the environment the plant was also designed using single use systems throughout the plant. The benefits of this design was too decrease the environmental impacts that come with multiple use systems associated with cleaning and sterilizing these components. A single use perfusion bioreactor was used in order to provide continuous bioprocessing upstream, while downstream multiple filters, protein A chromatography units, and diafiltration steps will be used to ensure a continuous downstream processing within each plant campaign.
The STS research focused on the protein therapeutic Insulin. The research focused on analyzing the connection to patents on insulin to the innovation and access of the drug in the United States. The STS research used the frameworks of Political Technology and the Technological fix to analyze the role that patents have played in the increasing innovation of the drug insulin and the lack of access to the drug. The political technology framework was used to analyze how U.S. laws and regulations surrounding patents influenced the development of insulin and how consumers purchase the drug. Additionally, the technological fix framework examines the economic, social, and political implications that lead to people not having access to insulin and dying of diabetes. Overall, the STS research provides a better understanding of how the U.S. patent system influences and impacts the drug insulin. The methods that were included in this research was a historical case study, political analysis, and wicked problem framing looking at past and current laws regarding patents and how that influenced insulin’s development and access throughout history.

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