The first three years of life are extremely influential when it comes to a child’s development. Research has shown that there are “critical windows” for different mental abilities, many of which occur during that early developmental period. Once a given brain region has passed that window, the opportunity to “rewire” it is significantly limited.
Nurturing a new drug product through discovery, development and finally to manufacturing is very much the same. There are “critical windows” during the development process that are important to the evolution of a pharmaceutical with the desired attributes. One such window is that of scale up. Use the right analytical tools during this step, to understand your design space and your process, and a low maintenance (in tech. transfer terms), well understood new drug product can be introduced to the world.
Let me give you an example that I read about recently.
The issue was that of processing Active Pharmaceutical Ingredient (API) into a drug product intermediate, in this case a granule, prior to tableting. The granule needed to be a preferred size and morphology. Keeping the ratios of API and excipients was critical to the final drug product quality. The drug product granule from each scale of process equipment was examined for uniformity. API content, using Raman spectroscopy interfaced to a microscope, was examined as a function of circular equivalent diameter using the microscope.
The analysis enabled the process to be scaled and produce granules with consistent API content, giving the perfect bouncing baby granule, both chemically and morphologically. Of course, a whole new set of issues may occur during the teenage years as the drug product approaches patent expiration!