The last few years have seen increasing use of single-use disposable systems in the biopharmaceutical industry for development as well as manufacturing and storage of a wide range of intermediates, process buffers and finished goods such as vaccines, therapeutic proteins and monoclonal antibodies.
Biopharmaceutical processes are often complex, multi-stepped and thus involve a high number of process intermediates, each with different conditions and objectives. The use of stainless-steel systems for such processes, which until recently was the only solution, is a costly affair and requires time consuming CIP/SIP procedures as well as extensive validations. Single-Use Systems (SUS) on the other hand, offer increased process flexibility due to simple reconfiguration of manufacturing operations along with reduced capital expenditure and change-over time. They require minimum pre-and post-use activities. The other tangible benefit of the SUS is the remarkable lowering of contamination risk.
SUS facilitate continuous processing, and also enable research scientists as well as process owners to work with various pharmaceutical products and intermediates within the same facility. Eliminating the cumbersome CIP/SIP procedures also provides more room and time for innovation. The overall result is faster lab to market movement of new lifesaving biopharmaceutical drugs.