No abstract

Single‐use (SU) components are a common standard in the biopharmaceutical industry. Mixing units for buffer and media preparation, bioreactors for cell cultivation, bags for storage of liquids etc. have meanwhile become integral SU components within many biopharmaceutical manufacturing processes. However, there is still a lack of SU systems incorporating multiple process steps into a SU system which constitutes a dedicated unit operation for research and development and production of e.g. monoclonal antibodies. The FlexAct® approach fills this gap and has been developed to supply scalable and configurable SU systems for upstream‐ and downstream processing. Typical unit operations are, e.g., buffer and media preparation, cell harvest, virus inactivation and ultrafiltration.