Date of Defense

4-14-2020

Date of Graduation

4-2020

Department

Chemical and Paper Engineering

First Advisor

James Springstead

Second Advisor

Said AbuBakr

Abstract

Monoclonal Antibody products are gaining an increased demand for various medical purposes that include, but are not limited to cancer treatment, rheumatoid arthritis, and Crohn’s disease. By researching the known small-scale process, various calculations can be done to determine sizing and production rates. From these calculations, our group worked to design a process to produce Lucentis Monoclonal Antibody at a lower/affordable price viable for the consumers and medical enterprises to purchase. Throughout the research, our group’s determined process became increasingly more complex to ensure that the final theoretical product produced would be as stated. This resulted in many purification steps that would filter out unwanted buffers used throughout the process as well as other impurities in the product. With the buffers utilized in the process, it was also necessary to keep in mind the safety procedures that would need to be in place. To ensure good manufacture practices in the design of the plant, proper safety procedures would have to be followed. These came to include regulations from the Federal Drug Administration as well as the Center for Disease Control due to the medical use of our product and the use of E. coli at the beginning of production. In addition to these, our group also determined procedures to ensure that all of the equipment utilized would remain up to safe standards so that incidents would be considerably less likely to occur during productions. The largest factor that played into those were ensuring the proper clean-in-place procedures were completed. Not only were clean-in-place procedures required for this, but they were also necessary to ensure there was no cross-contamination between the separate batches of product. Overall, as a result of this work and research, the large-scale production of these Monoclonal Antibodies will lead to a larger market as well as the opportunity for expanding clinical studies.

Access Setting

Honors Thesis-Restricted

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