mAb Production Modeling and Design Space Evaluation Including Glycosylation Process

Abstract

Due to high demand, monoclonal antibodies (mAbs) production needs to be efficient, as well as maintaining a high product quality. Quality by design (QbD) via predictive process modeling greatly facilitates process understanding and can be used to adjust process parameters to further improve the unit operations. In this work, mechanistic and dynamic kriging models are developed to capture the protein productivity and glycan fractions under different temperatures and pH levels. The design of experiments is used to generate input and output data for model training. The dynamic kriging model shows good performance in capturing the dynamic profiles of cell cultures and glycosylation using only limited input data. The developed model is further used for feasibility analysis, and successfully identifies the operating design space, maintaining high productivity and guaranteed product quality.