title: Case Study: an accelerated 8-day monoclonal antibody production process based on high seeding densities.
abstract: 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.
authors.affiliation: Bioprocess Development, Merck Research Laboratories, Merck & Co., Inc., Rahway, NJ 07065, USA.
authors.forename: Ishai
authors.initials: I
authors.lastname: Padawer
authors.forename: Wai Lam W
authors.initials: WL
authors.lastname: Ling
authors.forename: Yunling
authors.initials: Y
authors.lastname: Bai
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000032:analysis* / Q000378:metabolism*; D019149:Bioreactors; D016466:CHO Cells; D002452:Cell Count; D018929:Cell Culture Techniques / Q000379:methods*; D049109:Cell Proliferation; D002470:Cell Survival; D006224:Cricetinae; D003412:Cricetulus; D005374:Filtration; D006031:Glycosylation
chemical_list: D000911:Antibodies, Monoclonal