ABSTRACT
All signs seem to suggest that the future of process analytical technology (PAT) in biopharmaceutical process development and manufacturing is promising. This is based on the realization that to ensure efficient high-quality manufacturing, a deeper understanding of the details of the various process steps will be required. Thus, given the complexity and cost of many of these emerging biopharmaceutical processes, it seems clear that the industry will be doing everything possible to maximize throughput while reducing product variability. In addition, the need for better process understanding is also supported by the recent introduction of quality by design (QbD) by the US Food and Drug Administration (FDA) and the corresponding European International Harmonization activities. In contrast to this promise, however, is the current situation with PAT. It is felt by many that the industry is not embracing PAT, or more importantly, modern product quality and manufacturing approaches, with the enthusiasm and commitment that it should. In this concluding chapter, we shall explore both the current impediments and opportunities, real or perceived, and the future vision of PAT.
