ABSTRACT
Multivariate data analysis (MVDA) and process analytical technology (PAT) have been introduced into the process development organizations of the biopharmaceutical industry. There are several purposes for the introduction of these methods into the research and development (R&D) environment. First, the U.S. Food and Drug Administration’s PAT initiative (U.S. Department of Health and Human Services et al. 2004) has provided an incentive to include advanced analytical techniques in a manufacturing environment. Management would like data-driven results before entertaining any changes to existing processes, and solid proof of performance must exist before such advanced techniques will be allowed into new processes. The process development organization is an obvious test bed for such techniques, as the implementation details can evolve along with the process while it is still in development. The development of appropriate control strategies for PAT continues to be an activity that is driven in the process development laboratory. Recent industry reviews (Gnoth et al. 2008; Read et al. 2010a) have indicated that the biotechnology industry is making advances in real-time measurement and control of critical quality attributes (CQAs).
