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Optimization of Downstream Processing of a Monoclonal Antibody
Chemical and Materials Engineering
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For the past few years, Genentech has worked closely with the Chemical Engineering Department at the University of Nevada Reno on the antibody separation processes for Lucentis. Lucentis is a humanized anti vascular endothelial growth factor (VEGF) monoclonal antibody fragment used to treat macular degeneration. VEGF promotes blood vessel growth in the wet form of macular degeneration which leads to bleeding within the macula and causes blindness. The purpose of this project was to study and design the antibody separation processes which include the homogenizer, centrifugation, chromatography, and membrane separation. The design of the process is to manufacture pure Lucentis which is a fragment antigen binding that is expressed in genetically engineered E.coli. Lucentis “like” material was available to run chromatography and separation experiments on. The design began with 1,000 L of fermented E. coli culture that contains approximately 5 g/L of antibody and 20-25% of solid content (cells and cellular debris). The final production concentration should be between 10-30 g/L with 99% purity. The cells are first lysed using a homogenizer. The lysed cells are then centrifuged, where any cell debris is removed. Next, chromatography steps are used to separate the product. The final step of the process is tangential flow filtration. This removes any additional impurities and prepares Lucentis for clinical use.