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Genentech: Purification of Monoclonal Antibody
Chemical and Materials Engineering
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Lucentis, a monoclonal antibody fragment produced in Escherichia coli, is used to treat wet age-related macular degeneration, one of the leading causes of legal blindness. The objective of this thesis is to analyze the process of antibody fragment separation and to purify a solution of “Lucentis like” protein provided by Genentech to a 99% purity. This paper focuses on the chromatography aspect of the process and investigates the multiple types of chromatography used in both the base case and alternative case presented with a focus on cation exchange chromatography. The project was completed over an eight-month time period spanning two semesters. The team studied various theories, design models, performance equations,, chromatography techniques, literature reviews, and economic analyses. The results obtained from experimental analysis, and after consulting with various teams, instructors, and Genentech employees, highly suggested that the “Lucentis like” protein used was denature and no longer had the properties of the desired protein.