Is There Really a Downstream Processing Bottleneck for Mab Production?

In the production of monoclonal antibodies, gains in upstream productivity have been made through increases in product titer. In the downstream part of the process, there have been limited increases in chromatography binding capacities. Does it follow that Mab production is now downstream limited? This study presents a series of process, economic and scheduling simulations of a “generic” Mab process to determine the conditions under which downstream processing truly limits production. Bottlenecks are most likely to develop in support areas, especially buffer preparation. Several debottlenecking strategies, including in-line buffer dilution and single-use containers, are presented.