Process Development and Optimization
Process development starts at an early stage, when all possible routes of synthesis are reviewed by the global development team in order to implement the most suitable type of chemistry.
The developed manufacturing process is optimized over the course of the product life cycle, particularly when advancing to be used in Phase II or III clinical trials. To avoid potentially discovering new impurities at a later stage of product manufacturing, an analytical method for purity determination and product stability indication is typically developed at an early stage.
Validation of analytical methods is always performed for releasing material to be used in Phase III trials and beyond.