Enablers of continuous processing of biotherapeutic products

Abstract

The benefits of continuous processing over batch manufacturing are widely acknowledged across the biopharmaceutical industry, primary of which are higher productivity and greater consistency in product quality. Furthermore, the reduced equipment and facility footprint lead to significantly lower capital costs. Technology enablers have a major role in this migration from batch to continuous processing. In this review, we highlight the various enablers that are facilitating adoption of continuous upstream and downstream bioprocessing. This includes new bioreactors and cell retention devices for upstream operations, and on-column and continuous flow refolding, novel continuous chromatography, and single-pass filtration systems for downstream processes. We also elucidate the significant roles of process integration and control as well as of data analytics in these processes.

Keywords: continuous chromatography; continuous processing; continuous refolding; data analytics; perfusion bioreactor; process integration; single-pass tangential flow filtration; viral inactivation.