Process analytical technology for chromatography

Abstract

A major United States Food and Drug Administration effort is devoted to process analytical technology (PAT), which is emerging as the likely "surprise" of the second half of the decade. PAT is an approach to monitoring, manufacturing, and other processes on a continuous rather than discrete basis. It carries the future promise of new methods of production. Building PAT into a chromatography system provides a significant cost and quality advantage to high volume multitest laboratories and provides a significant marketing advantage to the first suppliers able to implement such an approach.