Christian Löffelholz

CFD as tool for engineering characterization of single-use bioreactors and scaling-up of biopharmaceutical production processes


During the past 10 years, single-use bioreactors have been well-accepted in modern biopharmaceutical production processes targeting high value products. Up to now, such processes have mainly been small or medium scale mammalian cell culture-based seed inoculum-, vaccine- or antibody productions. However, recently first attempts have been made to modify existing single-use bioreactors for the cultivation of plant cells and tissue cultures, and microorganisms. This has even led to the development of new single-use bioreactor types. Moreover, due to safety issues it has become clear that single-use bioreactors are the "must have" for expanding human stem cells for delivering cell therapeutics, the biopharmaceuticals of the next generation. So it comes as no surprise that numerous different dynamic single-use bioreactor types, which are suitable for a wide range of applications, already dominate the market today. Bioreactor working principles, main applications and bioengineering data are presented in this review, based on a current overview of greater than millilitre-scale, commercially available, dynamic single-use bioreactors. The focus is on stirred versions, which are omnipresent in R&D and manufacturing.

Finally, we examine development trends for single-use bioreactors, after discussing proven approaches for fast scaling-up processes.