Intensified and Continuous mAb Production with Single-Use Systems

Abstract

Therapeutic monoclonal antibodies (mAbs) are the fastest-growing class of biotherapeutics. They are mainly used to treat cancer, inflammatory, metabolic and autoimmune diseases. Their commercial production processes are mainly based on Chinese hamster ovary (CHO) suspension cells, which are currently cultivated in fed-batch mode at cubic meter scale. The annually growing market for therapeutic mAbs and the pressure on producers to reduce their manufacturing costs have led to the increasing development of intensified and continuous production processes in recent years. Single-use systems are used in both upstream and downstream processing. This book chapter describes the main intensification approaches and operational architectures of continuous processes realized today, based on the developmental status of single-use technologies used for the up- and downstream processing of mAbs. In this context, the terms “process intensification” and “continuous process” are defined, while the preferential application of single-use systems is described using literature, and further by own studies. Based on the findings, the main challenges for the implementation of intensified and continuous mAb production using single-use systems are identified.