PAT as key-enabling technology for QbD in pharmaceutical manufacturing A conceptual review on upstream and downstream processing

摘要

The transition from batch to continuous bioprocesses in regulated industries has been and will continue to be one of the biggest technological changes of the last decades. Necessary technologies to enable continuous biomanufacturing are Process Analytical Technology (PAT) and Quality-by-Design (QbD), which are closely associated with process automatization and control to obtain key process information in real-time. This article provides some insight into the fundamentals and shows a way for PAT as key-enabling technology for a QbD derived process development and control strategy on the example of a monoclonal antibody derived from cell cultivation and harvest by aqueous two-phase extraction (ATPE).