Increased productivity demand and a diversifying clinical drug pipeline have pushed the industry to explore new strategies and technologies in biomanufacturing. So what are next-generation processes?
These processes overarch the whole manufacturing chain—from cell to molecule and upstream to downstream. They include semi-continuous and continuous approaches, focus on operational excellence, implementation of disruptive technologies both up- and downstream, or supplier partnership. This article will center the discussion around two large concepts:
- Continuous manufacturing: continuous unit operations with high volumetric productivities
- Process intensification for eliminating existing bottlenecks: often refers to the shortening of process times or reducing non-value-added process steps. In upstream processing, this can be exemplified by intensified seed train or intensified production bioreactor operations. In downstream processing, it can be intensified capture, in-line virus inactivation, flow through polishing, in-line virus filtration, or single-pass filtration.