Safety First: Considerations When Formulating High Potency Compounds

By Carolina Bonifacio, Head of Drug Product Development

The rapid growth of highly potent APIs (HPAPIs), particularly in oncology, is creating new challenges for pharmaceutical development and manufacturing. While these compounds can deliver therapeutic benefits at extremely low doses, their potency demands rigorous approaches to containment, operator safety, contamination control, and process design.

Successfully developing HPAPI products requires more than specialized facilities. Effective risk assessment, appropriate exposure controls, robust cleaning strategies, and validated analytical methods are essential for protecting personnel, preventing cross-contamination, and maintaining product quality. Development teams must also balance these safety requirements with the pressure to accelerate clinical timelines, often while working with limited quantities of API.

From small-scale formulation and scale-up to commercial manufacturing, specialized expertise and infrastructure play a critical role in managing complexity and reducing risk. Explore key considerations for handling highly potent compounds safely and efficiently while supporting development goals, regulatory expectations, and reliable commercial supply.