160 - Addressing Impurities and By-Products in Pharmaceutical Process Development (S11E10)

This episode explores the strategies and analytical techniques employed to identify, control, and manage impurities and by-products during the development and manufacturing of drug substances. The importance of strategic planning is laid out in the beginning, and then leads into the different methods of making the base and how things are extracted and pulled from the substance. How the analytical chemicals play into making new formulas, methods and proceduresThe discussion delves into the importance of Genotoxic Impurities and their specific need to be removed, and what happens when they don't. How specific chemicals need certain methods for their creation that are difficult to replace, etc. The conversation then hits back to the good and consistent nature of manufacturing with that of purity. the discussion is about analytical tools, testing and everything that would be needed in the manufacturing process.