Transformation of biomanufacturing by single-use systems and technology

Abstract

Biomanufacturing has been and continues to be transformed by the rapid innovation and adoption of single use technology (SUT). SUT has changed how bioprocesses are designed, scaled, operated, controlled, and the speed at which new technology can be incorporated into biomanufacturing. We are continually seeing advances in single use bioreactors, mixing vessels, harvest technology, and downstream bioprocess equipment. This transformation has not been limited to bioprocess equipment. In this contribution, a summary of how SUT is rapidly transforming bioprocesses and the facilities they operate in will be discussed, including SUT enabled bioprocess intensification through high cell density perfusion and continuous biomanufacturing processes. Examples of how SUT has opened up new approaches to achieving regulatory and bioprocess requirements resulting in simplified, less costly facilities to build and to operate will be presented.