RONALD A. RADER
BioPlan Associates, Inc., Rockville, MD USA

Abstract

Parts of continuous bioprocessing, notably perfusion, have been in use commercial manufacturing for decades, but until recently have been confined to only a few companies manufacturing a few products.  There are yet no fully continuous operating facilities, with only some unit bioprocesses well adapted to run in continuous mode.  Perfusion, with continuous chromatography trailing, are now experiencing accelerating market growth, particularly adoption for early clinical manufacturing.  Survey data show very high levels of interest in adopting continuous bioprocessing, including a majority of facilities now evaluating equipment.  But there is also ambivalence with various problems, such as increased complexity, associated with continuous bioprocessing, with nearly all commercial manufacturing continuing to use batch processing.  With increased engineering complexity at commercial scales (with analogies to single-use systems), it will likely be about 10 years before we see substantial adoption of continuous bioprocessing for commercial products manufacturing (other than some products with lower volumetric needs).

When will continuous bioprocessing be adopted for commercial manufacturing?   The answer is not simple, with continuous bioprocessing even more than other (batch) bioprocessing involving integrating multiple unit processes such that they work together and process continuously at similar rates.

In BioPlan’s 2020 17th Annual Report and Survey of Biopharmaceutical Manufacturing(1), we note with continuous bioprocessing, different unit processes are each at different stages of continuous adoption and adoptability; and continuous bioprocessing is not actually new, with its use spanning old/legacy and new products manufacturing. This includes there being major differences in the adoption of up- and downstream continuous bioprocessing, particularly at different scales, with both up- and downstream continuous bioprocessing involving multiple unit processes only a few of which have yet been implemented in continuous mode. 

New showpiece ‘continuous bioprocessing’ facilities (but with only some unit operations in continuous mode) have in recent years ...