Safety first: Controlling occupational exposure in oncology drug development


When it comes to oral solid dose oncology drugs, active pharmaceutical ingredients (APIs) are often highly potent and potentially toxic, even at small doses. This poses occupational exposure risks as well the possibility of cross contamination with other drugs in the manufacturing environment. Underestimating the risks can threaten operator and patient safety, while overestimating them can lead to unnecessary spending on containment, increasing overall project costs. This whitepaper provides a roadmap for assessing toxicological and potency risks of small molecule oncology compounds, focusing specifically on the following considerations: Criteria for evaluating highly potent small molecules, toxicity banding systems, potency downgrading and safety and handling strategies.