In her lecture at the 8th Annual High Potent Medicines Conference on 24 / 25 May 2023 in Milan, Dr. Martina Breuer, Head of Operations, Aenova Group, addressed current challenges and strategies in handling of high-potent active pharmaceutical ingredients (HPAPIs).

The agenda included an overview of the definition of high potent APIs /products, and their toxicology and safety implications in the processing, market insights and the smart and efficient production concept for handling HPAPIs with examples from Aenova's development and manufacturing sites.

HPAPIs are significantly growing in today’s drug therapy and R&D pipelines. Today’s pharmaceutical development and manufacturing see a strong trend in outsourcing to service providers being experts in their fields. To master the challenges in flexibility and efficiency CDMOs must implement a holistic concept to HPAPI handling.

Dr. Breuer focused on the aspect of shared facilities versus dedicated facilities and the regulatory requirements for high quality, safe and flexible manufacturing in shared facilities.

For deeper insights see the Aenova whitepaper on “Safe and Efficient Handling of high-potent Drug Products”.