Upstream cell culture process characterization and in-process control strategy development at pandemic speed.

Abstract in brief

• This case study describes how rapid cell culture process development for COVID-19 monoclonal antibody (mAb) treatments was achieved within approximately 4 months, significantly faster than the typical year-long timeline, to address urgent patient needs during the pandemic.
• The approach involved detailed strategies such as risk assessments, scaled-down models, formal process characterization experiments, and in-process control development, all without compromising product quality or safety.
• The methods demonstrated can be applied to accelerate manufacturing process development for other biologics, helping to shorten timelines and respond swiftly to urgent health crises.]