Small Is Powerful: A Globally Unique Capability For Nanoforming HPAPIs

By Dr. David Rowe, Head of Manufacturing, and Antonio da Silva, Senior Director Business Operations, Nanoform

The benefits presented by lower dosage forms, such as reduced side effects for patients, are causing demand for high-potency active pharmaceutical ingredients (HPAPIs) to rise. HPAPIs require fewer excipients, are faster acting, and improve bioavailability, which when low is a leading cause of clinical drug failure. However, high potency necessitates further considerations for the development and manufacturing processes.

Specialized facilities with HPAPI handling capabilities are crucial to ensure the safe handling of these drug substances. Nanoform's HPAPI nanoparticle production capabilities are expanding in response to the recent rise in demand and offer optimized safety conditions. The proprietary CESS^® nanoforming process reduces exposure concerns and permits an occupational exposure limit (OEL) of 30 ng/m³.

HPAPIs are also considered precious materials and batch failure can have significant financial consequences for pharma companies. Partnering with a manufacturer with the technologies and expertise to handle HPAPIs safely and effectively is essential as you aim to incorporate the enormous potential of HPAPI particles for patient-optimized therapeutics into your drug development and manufacturing processes.