Case Study: An accelerated 8-day monoclonal antibody production process based on high seeding densities



This study describes the development work to shorten the monoclonal antibody (mAb) production time in CHO cell cultures from 14 days to 8 days without impacting mAb titer or product quality. The proposed process increases cell inoculation densities up to 25× higher than a typical seeding density in the final production bioreactor, with the implementation of an ATF™ perfusion system in the N − 1 stage. Similar antibody titer and N-glycosylation profiles were reached in 8 days using the 25× seed condition, as in 14 days using the 1× seed condition. Acidic variants in the 25× seed condition were 12–20% lower than the 1× seed condition. These results indicate that an accelerated 8-day antibody production process utilizing a 25× seeding strategy has the potential of achieving similar product quality and titer as the 1× seeding condition in a 14-day production process. © 2013 American Institute of Chemical Engineers Biotechnol. Prog., 29:829–832, 2013