(558b) Proteomics Guided Process Engineering for Anti-HER2 Antibody Production

The high-quality monoclonal antibody (mAb) for cancer treatment is a fast growing market segment of biopharmaceutical industry. Chinese hamster ovary (CHO) cells have been widely used as host cells for mAb production. This study applied a comprehensive proteomics to develop an in-depth understanding of intracellular metabolism regulation and heterologous gene expression, which could benefit the production process optimization. The effect of four basal media and three cell culture operation modes on intracellular protein expression was evaluated in anti-HER2 mAb producing CHO DG44 cell line. A high-titer and high-quality mAb was produced from a fed-batch cell culture process in 2-L bioreactor with titer of >2.5 g/L. Moreover, the possible key host cell regulators of transcription, translation and post translational modification that correlated with important process parameters were identified. Several strategies of rational process engineering were also proposed to guide future cell culture process optimization.