Downstream bioprocessing: recent advances and future promise

Dramatic improvements in cell culture titers, product quality constraints, new regulatory directives, and the emergence of biosimilars have necessitated the development of more efficient downstream bioprocesses for biopharmaceuticals. This has resulted in significant improvements in traditional separation processes as well as the emergence of entirely new approaches. In this review, we highlight some of these recent advances. This includes chromatographic phases with elevated capacities and unique selectivities, new classes of monoliths and membrane adsorbers for the recovery of large bioproducts, high resolution membrane systems for polishing operations, continuous downstream processes for multicomponent separations, affinity tags with self-cleaving inteins, responsive biopolymers for single step separations, the implementation of high throughput process development, and designing proteins for biomanufacturability.

► Increased titers, product quality constraints, and regulatory directives have driven advances in downstream bioprocessing. ► Improvements in traditional separation processes as well as the emergence of entirely new approaches have occurred. ► Topics include chromatography, continuous processes, high-throughput screening, and designing for biomanufacturability.