Process Intensification in Monoclonal Antibody Manufacturing

This white paper outlines a practical approach to process intensification (PI) in monoclonal antibody (mAb) manufacturing. It details the evolution of the mAb industry towards intensified processing to meet increasing global healthcare demands, particularly in treating various diseases. The paper discusses the significance of PI in enhancing productivity, reducing costs, and improving sustainability in biomanufacturing. It presents strategies for both upstream and downstream PI, emphasizing the role of innovative technologies such as single-use systems, continuous processing, and automation. The document also highlights the challenges faced in downstream processing and the need for efficient manufacturing to ensure lower costs of goods (COGs) and higher product quality. By leveraging advancements in cell line engineering and real-time monitoring tools, the paper aims to guide manufacturers in adopting PI practices that can lead to more cost-effective and accessible therapeutics. The goal is to support the transition towards sustainable biomanufacturing processes that can accommodate the growing demand for mAbs.