As a molecule approaches commercial launch and more is known about the potential market demand, companies are often faced with the decision to scale up or scale out their manufacturing processes. Generally, when scale-up requires production vessels larger than 2,000 L, this decision also involves moving from single-use bioreactors (S.U.B.s) to traditional stainless-steel systems. An alternative approach to meeting market demand may be to improve batch volumetric productivity through process intensification. However, many traditional S.U.B.s, particularly at larger scales, are becoming excessively challenged in terms of oxygen transfer rate (OTR) for intensified processes, making scale-up unfeasible. A next-generation S.U.B., the Thermo Scientific™ DynaDrive™ S.U.B., is now enabling scale-up to 5,000 L and process intensification above previous limits while continuing to leverage benefits of S.U.B.s.
In this study we evaluate the performance of the 50 L DynaDrive S.U.B. using four different cell lines, together with processes that were previously developed, specific to those cell lines, for manufacturing at the 2,000 L scale using other single-use technology.