A Stagewise Approach to High Potency Drug Product Clinical Development & Commercialization
Summary: High potency drugs are increasingly prevalent in the drug development pipeline. While highly potent compounds have benefits in treating medical conditions such as cancer, rare diseases etc., companies with promising high potency active pharmaceutical ingredients (HPAPIs) can face significant challenges in developing and bringing these innovative medicines to market. This is specially the case for virtual, small, mid-sized biopharmaceutical companies. Key challenges revolve around phase appropriate containment systems that ensure workers and the environment are protected, along with demonstrable and adequate controls to mitigate cross-contamination risks in a multi-purpose environment.