Updating The Economics Of Biologics Manufacturing With 5,000-L Single-Use Bioreactors: A Paradigm Shift

By Mark Thomas Smith, Levi Morin Larsen, Kevin M. Mullen, and Jeffrey Johnson

Biopharmaceutical pipelines with high production demands and low titers historically drove manufacturers toward large (e.g., 15,000 L) stainless-steel (SS) bioreactor facilities for efficiency’s sake. Within the past two decades, single-use bioreactors (SUBs) with sizes up to 2,000 L have disrupted preclinical and clinical SS manufacturing networks, providing flexibility, modularity, and other advantages. Herein, we consider the implications and economics of large SUBs in upstream bioprocess. We compare 2,000-L and 5,000-L SUBs with 15,000-L SS bioreactors at manufacturing facilities and contract manufacturing organization (CMO) sites. SUBs of 5,000 L — such as the 5,000-L HyPerforma DynaDrive SUB — are promising technologies that provide volume efficiency, single-use (SU) flexibility, and cost effectiveness across a broad range of production volumes and titers.