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

摘要: 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 these such as reduced risk cross contaminations or short lead times. differ terms shape, agitation principle, gassing strategy. Hence, a direct process transfer scale-up can be challenge. Conventional stirred tank bioreactor designs therefore still considered gold standard due their well-defined characterized properties. Based on this knowledge, single-use family from 50 2000 L scale was developed with geometrical ratios similar conventional reusable systems. To follow quality designapproach, evaluated here using engineering methods power input per volume, mixing time, kLa value. The characterization demonstrates that systems suitable cultivations cells, even high density titer applications. data, possible between well Therefore, represents major progress technology.