Within early process development phases, the synthesis and manufacture of Highly Potent Active Pharmaceutical Ingredients (HPAPIs) is associated with complex challenges: what are HPAPIs and how to categorize them but also how to handle them safely from gram scale to Kg scale. Specific containment strategies, tailored-made equipment, developed at NUVISAN and internal capabilities are presented with a specific focus on the scale-up from gram to multigram scale production of HPAPIs.
