화학공학소재연구정보센터
Biotechnology Progress, Vol.29, No.3, 829-832, 2013
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 25x 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 25x seed condition, as in 14 days using the 1x seed condition. Acidic variants in the 25x seed condition were 12-20% lower than the 1x seed condition. These results indicate that an accelerated 8-day antibody production process utilizing a 25x seeding strategy has the potential of achieving similar product quality and titer as the 1x seeding condition in a 14-day production process. (c) 2013 American Institute of Chemical Engineers Biotechnol. Prog., 29:829-832, 2013