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.