QbD/PAT for bioprocessing: moving from theory to implementation

Abstract

In the last ten years since the concepts of Quality by Design (QbD) and Process Analytical Technology (PAT) were introduced to the biotech industry, the major regulatory agencies as well as the biotech industry have spent considerable efforts to facilitate their implementation with mixed outcomes. Although only a single biotech therapeutic has been approved under the QbD paradigm so far, the tools and approaches that fall under these two concepts are well engrained in the work processes of most global pharmaceutical manufacturers. This article aims to achieve two major objectives. First, review the progress that has been made in the recent years (2010–2014). Second, provide a perspective on implementation of QbD and PAT and identify areas where opportunities lie for further contributions.