Design space definition for a stirred single-use bioreactor family from 50 to 2000 L scale.

Single-use bioreactors continue to gain large interest in the biopharmaceutical industry. They are frequently used for mammalian cell cultivations, e.g. production of monoclonal antibodies and vaccines. This is motivated by several advantages of these bioreactors such as reduced risk of cross contaminations or short lead times. Single-use bioreactors differ in terms of shape, agitation principle, and gassing strategy. Hence, a direct process transfer or scale-up can be a challenge. Conventional stirred tank bioreactor designs are therefore still considered as the gold standard due to their well-defined and characterized properties. Based on this knowledge, a stirred single-use bioreactor family from 50 to 2000 L scale was developed with geometrical ratios similar to conventional reusable systems. To follow a quality by designapproach, the single-use bioreactor family evaluated here was characterized by using process engineering methods such as the power input per volume, the mixing time, and the kLa value. The process engineering characterization demonstrates that these systems are suitable for cultivations of mammalian cells, even for high cell density and high titer applications. Based on the data, a scale-up or process transfer is possible between this bioreactor family as well as reusable systems. Therefore, this bioreactor family represents a major progress for the single-use technology. [ABSTRACT FROM AUTHOR]