DESIGN OF AN AMGEN TRASTUZUMAB MANUFACTURING FACILITY TO CONTINUOUSLY PRODUCE KANJINTI, A HER2+ BREAST CANCER TREATMENT BIOSIMILAR; AN EXAMINATION OF THE EVOLUTION OF ACCOMMODATIONS OF NEURODIVERSE STUDENTS IN US PUBLIC EDUCATION

The ability to abstract information using our powers of observation,
contemplation, and action has enabled the human race to create a society that strives to
ethically balance the generation of fierce competition for innovations with the continuous
maintenance of humans’ right to life, liberty, and the pursuit of happiness. Cancer
severely decreases a person’s quality of life by causing a slow and painful death. The
intersection of academically inspired research and corporate driven ideologies led to the
creation of targeted breast cancer therapeutic trastuzumab, and increasing access to such
treatment serves to benefit myriads of people. Such innovation requires efficient and
distributed investment in human capital, especially through the design and continuous
evaluation of social institutions such as healthcare and education. Increasing access to
both trastuzumab for cancer patients and effective accommodations for students with
learning differences in United States public education require the utilization of
continuous processes to produce constant, targeted solutions.

A continuous bioprocess using upstream and downstream technologies demands
the use of human capital for its both design and operation. Successful operation of such a
bioprocess would not only increase access to its product, but also alleviate human capital
affected by the devastation of cancer. Modeling of cell growth and protein production can
be done in conjunction with critical parameters such as temperature, power, and oxygen
transfer to determine optimal bioreactor conditions. Using a perfusion reactor with
tangential flow filtration allows for cell recycle, and therefore continuous 30-day
operation. Downstream operations utilize membrane- and chromatography-based
separations enables a purified product that meets FDA standards. Single-use materials are
employed for the bioreactor, tubing, and buffer holding to reduce costs and waste
produced.

The proposed Kanjinti manufacturing process would reduce the cost of treatment
by more than 18% compared to the name-brand Herceptin treatment. By lowering the
price of treatment, it is expected that Amgen would capture 17% of the global
trastuzumab market by producing 111.7 kg of Kanjinti each year. It is recommended that
Amgen moves forward with the proposed project. Given the consistent high demand of
trastuzumab, this manufacturing facility will be a feasible in its goal of increasing access
to high-quality cancer treatment and ensuring a financially viable long-term investment.

An efficient and equitable public education system is essential for effective
investment in human capital for any nation. Currently, the US ranks relatively low
compared to other modernized nations in terms of human capital investment in healthcare
and education. Unbalanced influences and poor communication between influential social
groups can prevent students with learning differences from accessing individualized and
functional accommodations. The theory of social construction of technology provides a
framework to evaluate the evolution of accommodations, and suggests that flaws in social
groups that create the provision of such accommodations can be greatly mitigated
through renovations that allow for constant communication between medical researchers,
educators, and policy makers. Carefully reviewed research in the past couple decades
proves rigorous mentoring, early social interventions, and further advocacy of
accessibility and support groups for students with learning differences can reveal
unprecedented human capital for the United States.

In conclusion, renovating society’s constituents through continuous collaboration
of social and physical systems will allow said constituents to experience a greater quality
of life. Investing in continued collaboration will enable improved access to proven
solutions and allow society to flourish in higher excellence.

School of Engineering and Applied Science
Bachelor of Science in Chemical Engineering
Technical Advisor: Eric Anderson
STS Advisor: Catherine Baritaud
Technical Team Members: Geoffrey Burns, Molly Caveney, David Lee, Joseph Letteri, Morgan Pellegrin