156 - Overcoming Scale-Up Challenges in Pharmaceutical Process Development (S11E6)

The episode dives into the common hurdles encountered during the scale-up of pharmaceutical processes. The starting point discusses the leap from laboratory to commercial production, emphasizing the fundamental shift in dealing with physical factors like mixing, heat transfer, and mass transfer. Key challenges is impurities and process robustness, the episode also explores practical concerns, such as raw material sourcing, equipment maintenance, and cleaning validation. The discussion touches upon aspects like bioavailability and stability as well.

The concept of mechanistic evaluation is explained, highlighting the importance of understanding the underlying scientific principles and the need to go beyond just knowing that a process step works. The importance of the analytical process along with their benefits is also discussed. Several advantages and benefits of scaling up the process are discussed at length in the episode, which concludes with mention of examples that show how to successfully scale-up the medicine and why certain parts may lack in discussion due to proprietary information.