Dr. Shawn Yin
Scientific Director, Materials Science and Engineering, Drug Product & Development
Bristol-Myers Squibb Co.


Abstract

It is well known that some key drug substance physical properties, like crystal form, crystallinity, size, morphology, etc., can be altered during drug substance and/or product processes, and potentially during the product shelf life. Therefore, acquiring a good knowledge of how both the DS and DP process impacting on these critical product quality attributes is one of the key development activities, aiming at ensuring a success product development and bringing a robust product to the market. This presentation described, via real development/manufacturing examples, several risk factors including regulatory risk of DS/DP process induced API physical changes. These risks are assessed based on physical characteristics of material single crystal structures, surface/bulk physical characterizations and their relevant biopharmaceutical properties. The impacts of these risks on DS/DP CMC activities, product quality and patients are also discussed.