The screen that monitors the effects of temperature, humidity and other factors on active pharmaceutical ingredients (APIs), excipients or combinations thereof at an earlier-stage than has previously been possible.
The contract research and manufacturing firm said the application of advanced chemistry at an earlier stage offers data and insights that inform critical decisions, particularly around potential scale-up challenges.
Jan-Olav Henck, senior director of scientific Operations at Aptuit, explained that: “Scale-up, in particular, introduces mechanical stresses to a compound which can create issues related to the stability and integrity of the drug.
“The advanced scientific models and techniques we have developed in solid-state chemistry enable reproducible, predictable outcomes that ultimately help guide the development of safe and effective drugs.”
While knowing how an API and excipient will behave in a variety of conditions as early as possible has obvious advantages on the factory floor from the point of view of process development, the benefits of scientific analysis are not limited to production.
For example, early knowledge of an APIs solubility or bioavailability characteristics may have profound implications when it comes to regulatory review, particularly from a quality-by–design (QbD) perspective.
Having detailed performance data at the earliest possible stage can also strengthen a drugmaker’s patent and intellectual property position, which was an advantage of the new screen highlighted by Aptuit CEO Timothy Tyson.
“This new production screen is a prime example of the unparalleled understanding of the science of drug development that our team applies to develop solutions for both individual client programs and broader industry-wide drug development challenges.”