Manufacturing an RNA Therapeutic for Duchenne Muscular Dystrophy; A Distribution of Responsibility for the Sinking of the Titanic using Actor Network Theory and the Problem of Many Hands 470 views

My technical work and my STS work are connected through the idea of responsibility for ensuring the safety of the people using your product. However, the two works differ in that one discusses precautions taken to ensure that no accident occurs while the other one focuses on assigning moral responsibility for the failure of an engineering invention. In what follows, I will first describe a proposal for the industrial design of a new therapeutic for treating Duchenne Muscular Dystrophy (DMD), a genetic mutation that results in muscle degradation. Then, I will use the STS framework Actor Network Theory (ANT) and the criteria of the problem of many hands to analyze who is responsible for the failure of the Titanic’s actor network. The technical project details the design of a biochemical process to manufacture an RNA therapy for DMD and formulate it for delivery. The objective of this project will be to design the optimal conditions for each stage of this process from the transcription of the RNA through the ultrafiltration/diafiltration and chromatography steps. These steps will encapsulate the creation of the RNA therapeutic to its eventual formulation for injection. Most importantly, we must insure a high degree of purity by running our product through several different sterilization steps. If these sterilization steps are not done correctly, it could lead to severe complications to our patients’ health. The output of the process as a whole will be a high purity, high potency RNA therapeutic, formulated for delivery to the patient. This RNA therapeutic will help alleviate symptoms of DMD from patients by producing a truncated version of the dystrophin protein that is absent among those suffering from the disease. My STS project is an analysis that assigns moral responsibility for the sinking of the Titanic using Actor Network Theory (ANT) and the criteria for the problem of many hands. Using ANT, I outline the major actors in this network that played a role in the Titanic’s sinking. Next, I use the criteria for moral responsibility to show that, despite no individuals being responsible for the accident, a collective group of actors within the Titanic’s actor network were responsible. Working on the STS project alongside the technical project greatly enhanced the awareness for me and my group members about the responsibility we have to ensure a safe product is produced. In the pharmaceutical world, it is rare to have individual workers blamed for side effects relating to the purity or effectiveness of the therapeutics they produce. However, the Titanic’s sinking displays just how important each individual actor in a network is in preventing accidents from occurring. Because of this, my group and I aspired to achieve purity levels above the minimum required by the FDA in the event that any of our calculations or assumptions had errors that would result in higher impurity levels than we anticipated.

BS (Bachelor of Science)

Pharmaceutical; RNA

School of Engineering and Applied Science Bachelor of Science in Chemical Engineering Technical Advisor: Eric Anderson STS Advisor: Benjamin Laugelli Technical Team Members: Emma Laudermilch, Catherine Barton, Daniel Torrico

English

2021-05-18