Efficient CHO Platform Development for Anti-HER2 Monoclonal Antibody Production

Chinese hamster ovary (CHO) has become a nearly ubiquitous platform for biopharmaceutical production over the last few decades. Efficient antibody production platforms with high quality and improved efficacy are increasingly necessary due to emerging antibody-based therapies. In this study, CHO cells were genetically engineered for high yield, stable anti-HER2 antibody expression. Subsequent processes including basal medium screening, bioreactor parameter optimization, and antibody purification with next-generation chromatography (NGC) were developed and optimized to obtain a robust and scalable platform for anti-HER2 antibody production. Additionally, proteomics analysis was used to understand the relationship between the host cell protein profiles and the bioprocesses associated with recombinant protein expression. The achievement of this study can benefit the development of both biosimilar and innovative biopharmaceutical production platforms.