Design of a Pembrolizumab Manufacturing Plant Utilizing a Perfusion Bioreactor and Precipitation Chromatography; Key Causes of Monoclonal Antibody Access Limitations

Monoclonal antibodies are used to treat many diseases including cancer, asthma, rheumatoid arthritis, and multiple sclerosis. The first therapeutic monoclonal antibody product, muromonab-CD3 (Orthochlone OKT3), was produced in 1986 and was used to prevent kidney transplant rejection. In 2015, sales of monoclonal antibodies were estimated to increase by $20 billion per year with over 30 monoclonal antibodies approved by the FDA for human treatment. During this time, sources estimated at least 70 monoclonal antibody products to be developed by 2020 with world-wide sales exceeding $125 billion. However, in 2019, sales of monoclonal antibodies were much greater than estimated, approximately $163 billion, making up 60 percent of the total $230 billion biopharmaceutical revenue; over 139 monoclonal antibody products were produced by 2020.

This data shows the rapid advancement in monoclonal antibody production over the past 30 years and its dominance in the pharmaceutical industry today. My technical project describes the design of a manufacturing plant for a particular monoclonal antibody, pembrolizumab, also known as Keytruda, to assist with its growing demand. My team and I utilize process intensification methods to reduce the cost and energy required for pembrolizumab production. In relation to my STS project, my technical project offers solutions to improve access to monoclonal antibodies; a more efficient production method of pembrolizumab will increase the affordability for patients, increasing global access. My STS research question is: “What are the leading issues that prevent access to monoclonal antibodies?” I analyze the social and technological factors in monoclonal antibody access and its relation to society using the actor-network theory.