Chapter 11. Development Enabling Technologies

Abstract

Over the last decade there have been some significant changes and improvements to enabling technologies in use in the pharmaceutical industry which we have strived to overview in this chapter. In particular, we have seen significant advances in high throughput analytics, which in turn has alleviated the data analysis bottleneck and enabled the development and routine application of medium- to high-throughput screening activities. The ability to run many experiments in parallel has also led to more routine use of multivariate data analysis and in turn this is now commonly applied to address important regulatory areas such as the delineation of design space. Some tools have not evolved greatly, but nonetheless are still as valuable as ever for the precise parameter control they afford when collecting multivariate data for regulatory purposes. Intensification tools (continuous flow, microwave heating, in situ use of PAT tools) have clearly become more routinely adopted; moving forward, the use of micro-fluidic screening and optimization tools, whilst still in its infancy today, is likely to play an increasingly important role in the industry. In conclusion, the enabling technologies available today have been at least partly successful in “closing the gap”, that is to allow increased productivity and understanding in the wake of an environment with ever decreasing resource. We have little doubt that this gap will continue to close in line with the continual evolution of process enabling technology in the coming years.