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

Area of Science:

• Biotechnology
• Bioprocessing
• Cell Culture Technology

Background:

• Traditional monoclonal antibody (mAb) production in Chinese hamster ovary (CHO) cell cultures requires 14 days.
• Optimizing production timelines is crucial for biopharmaceutical manufacturing efficiency.

Purpose of the Study:

• To develop an accelerated 8-day mAb production process in CHO cells.
• To evaluate the impact of increased inoculation densities on mAb titer and product quality.

Main Methods:

• Implementation of an Alternating Tangential Flow (ATF™) perfusion system in the N-1 stage.
• Increasing cell inoculation densities up to 25× higher than typical seeding densities in the production bioreactor.

Main Results:

• Achieved similar mAb titer and N-glycosylation profiles in 8 days with a 25× seed condition compared to 14 days with a 1× seed condition.
• Observed 12-20% lower acidic variants in the 25× seed condition compared to the 1× seed condition.
• Demonstrated that the accelerated process maintained product quality and titer.

Conclusions:

• An 8-day mAb production process using a 25× seeding strategy is feasible.
• This accelerated process shows potential for comparable product quality and titer to traditional 14-day methods.
• The developed process offers significant improvements in biopharmaceutical production timelines.