The art of rapid scale-up
During early-phase development usually a point is reached where for the first time kilogram amounts of a new compound are needed quickly. However, the so far used lab-scale synthesis was intended for synthesis of grams and is often lengthy but flexible allowing also the synthesis of analogous compounds. When the first kilogram is needed either this non-optimized research route can be used or a better process can be developed. It has to be decided if already now a significant investment in time and money for process development is appropriated in view of the fact that less than 10% of the early phase compounds reach commercial application. In an environment where companies are following the “faster time to market” principle with rigid timelines and budget control, this gets an even more difficult task.
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