Design of a Pembrolizumab Manufacturing Plant Using Continuous Bioprocess Technology and Single-Use Bioreactors; Taking Shots at Shots: How Misinformation on Twitter & Facebook Shapes Risk Perception and Could Lead to the Collapse of the Vaccine Network

Abt, Brian, School of Engineering and Applied Science, University of Virginia
Anderson, Eric, EN-Chem Engr Dept, University of Virginia

My STS research project and my technical capstone project captured two different
perspectives on pharmaceuticals: the public perception of vaccines and the manufacturing of the
protein therapeutics. The technical project is a design of a manufacturing facility for Keytruda, a
cancer drug owned my Merck. The STS research went beyond the manufacturing of the drug to
an analysis of how social media are driving high levels of perceived risk in the public’s mental
model of vaccines and threating the vaccine network. Researching these two topics together
illustrated the disconnect between the pharmaceutical companies and the public that alone is not
obvious. The key insights came from the compassion of the regulatory hoops I jumped through
designing various safety features and protocol juxtaposed with rising trend in vaccine risk
perception via noncredible sources such as Facebook. The specific effects was understanding the
threats to public acceptance of vaccines had on design features of the manufacturing facility,
include choice of input material usage and quality control budgeting which effect the optics or
perceived quality of the product. Conversely, the technical project shaped the way I thought
about vaccines and pharmaceutics in general because it illustrated how stringent the safety
requirements are for vaccines. These include intense quality control and several redundant steps
in the purification stage of manufacturing, which ensure proper removal of everything from
DNA to endotoxins. This detailed understanding of the ways pharmaceutical manufacturers
minimize the risk associated with vaccines caused me to gain trust in the vaccine producers. This
opened my eyes that most non-technical persons who do not gain this understanding do not have
a level of verification in which to base their trust, illustrating to me why they might have risk
perception more susceptible to misinformation.
The technical portion of my thesis produced a design for biomanufacturing facility to
manufacture Merck’s Keytruda. The process was novel in that it was a completely continuous
process and utilized single use materials. These two unique features of the process help improve
efficiency of material usage as well as lower environmental impact. Unlike almost all current
biomanufacturing plants, constantly producing product rather than producing in large batches.
Significantly improves yield efficiency, input material requirements, and physical space
required. We designed a perfusion style bioreactor and networks of chromatography columns to
make this process possible. The bioreactor, rather than growing a batch of genetically modified
cells in prepacked media, is constantly fed and has an outlet stream harvesting the secreted
protein which increases production rate. All of the bioreactor materials being single use greatly
diminishes cleaning material reequipments improving costs and environmental footprint.
Chromatography networks have a precise schedule with residence time designed to always keep
one column accepting product and one column producing product to maintain continuity. The
only significant drawbacks are related to the fact that the process is innovative and thus poses the
risk to unforeseen challenges. The STS research portion of the project caused an increased
attention to be paid to quality control such that these unforeseen challenges do not diminish
safety standards.
The STS research I conducted investigates risk perception from the perspective of the
social media using public. This illustrated how antivaxxer social medias influence on public risk
perception of vaccines can erode the vaccine network. I used foundational reading of Slovic’s
“Beyond Numbers: A Broder Perspective of Risk Perception and Risk Communication” to
understand how exactly groups can use misinformation effectively on social media to influence
public risk perception. I found that by capitalizing on current distrust of the pharisaical
companies with technically confusing language or emotional messaging, the paradigm of
expressed preference favored antivaxxers sentiment. With this in mind, I realized that my
understanding of the both quality control and the research and development process is not
common among the public and thus the viral nature of social media gives misinformation an
amplifying effect which erodes the vaccine network relationships between the public and
relevant actors, especially manufactures. I found this significant because vaccines require high
community enrollment yet the mental models the public hold are more individualistic. My
research into how this has affected analogous GMO and climate change efforts postulates that
vaccine networks also could suffer if either mental model of vaccines do not align with the
vaccine capabilities or social media regulation doesn’t improve.
The STS research portion has a significant effect on the technical design part of the
project because it opened my understanding of how skeptical of the pharmaceutical industry’s
product the public is. By learning about how the manipulation of misinformation on social media
can cause scientifically sound topics to become the subject of public dissatisfaction, I realized
how important optics are. This enriched my technical design by causing us to go above and
beyond the quality control testing requirements. More frequent testing along with a well-thought
out plan of action for test failures were the direct result of considering how this novel process
would appear to the public. Without thinking of the vaccine network, the conservations of the
relationship between the manufacturing and public actors would likely not have been considered
and this aspect of the design done to a minimum government requirements level. By
participating in these projects, I expanded the network I originally expected to utilize to write the
STS research portion. Originally, as seen in blue portions of figure 2, I had expectations of a
small network that consisted of professor feedback and intense internet research. In totality, I
ended up using a larger network with the orange actors in figure 2 playing an important role. My
advice to rising fourth years here would be to think hard early about the actors you will need in
the network of composing your STS research.

BS (Bachelor of Science)
Keytruda, Perfusion, Vaccine

School of Engineering and Applied Science
Bachelor of Science in Chemical Engineering
Technical Advisor: Eric Anderson
STS Advisor: Kathryn Neeley
Technical Team Members: Clayton Burrus, Revathi Moahan, Noah Rustin, Summer Xu

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