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

Background Single-use bioreactors continue to gain large interest in the biopharmaceutical industry. They are excessively used for mammalian cell cultivations, e.g. production of monoclonal antibodies and vaccines [1]. This is motivated by several advantages of these bioreactors like reduced risk of cross contaminations or shortening lead times [2]. Singleuse bioreactors differ in terms of shape, agitation principle and gassing strategy [3]. Hence, a direct process transfer or scale-up between different systems can be a challenge. Reusable bioreactors are still regarded as gold standard due to their well-known and defined geometrical properties. Based on this knowledge a stirred single-use bioreactor family from 50 to 2000 L scale was developed with similar geometrical ratios like commonly used reusable systems. To follow a Quality by Design approach the key process parameters for a modern mammalian cell cultivation were specified. Therefore, the kLa-value, mixing time and the power input per volume were evaluated by using process engineering methods for all scales.