Effect of process change from perfusion to fed-batch on product comparability for biosimilar monoclonal antibody

► A fed-batch process for the production of biosimilar monoclonal antibody has been developed. ► Impact of process change from perfusion to fed-batch on product quality and cell performance was investigated. ► There were no significant quality changes during process transition from perfusion to fed-batch. ► Through scale-up study from 3 L to 12,500 L, it was confirmed that cell performance and product quality could be maintained. ► Product quality from fed-batch process was comparable to that of perfusion process as well as reference product.