Chapter 12: The Analytical Interface and the Impact on Pharmaceutical Process Development

In this chapter, the pursuits of the modern analytical laboratory, supporting pharmaceutical process development, will be discussed. The field of pharmaceutical process development is an ever changing landscape. As the drive to reduce cycle time increases, the need to gain as much information as possible about a process, and fully exploit the available data generated, becomes more critical. Analytical chemistry is constantly evolving to address the changes in paradigm and provide more detailed assessment of reaction kinetics and impurity profiling. The ability to develop analytical methodology in hours, rather than days, has enabled the synthetic chemist to move from fume hood to pilot plant more rapidly, while the use of on-line analytical tools at the location of the reaction, collecting data in real time, has provided greater confidence in scaling of reactions. Reductions in cycle times cannot occur at the expense of quality, and the need for validated methodology to support agency regulations has not relaxed. The synergy between process and analytical chemistry grows ever stronger, and the importance of a flexible interface between analytical and process becomes even more critical in addressing the associated challenges. The analytical function is no longer just a confirmation of the desired product and assurance of quality, but also a critical support function, guiding all aspects of the synthetic endeavour. The valuable information generated in well planned analytical experiments not only assists the process chemist in developing a more efficient process which impacts the overall cost of goods, but also impacts operator and ultimately the patient safety.