Impact of extension of fermentation time on the nimotuzumab production process

Abstract

At the Center of Molecular Immunology (CIM), the therapeutic antibody plant (AntYter) produces the humanized monoclonal antibody nimotuzumab (hR3) is produced by culturing the NS0 cell line. The production process of this antibody consists of four steps: cell culture and expansion, fermentation, purification, and formulation and filling. In this project, the impact of the extension of two runs in the fermentation stage was studied, beyond the 120 days established for cells from the moment of thawing, by analyzing the kinetic parameters specific growth rate of the biomass (μ) and specific rate of extracellular product formation (qp); the economic impact of extension is also analyzed. It was determined that, despite the existence of significant statistical differences in the kinetic parameters in the second run evaluated and the decrease in the productivity of fermentation process after 120 days, it is more feasible to extend the run than to start a new one.