Assessment of the Effects of Ionizing Radiation on Biologic Drugs: mAb Product Quality and Risk Evaluation for Global Shipping Logistics

These findings provide valuable assurance regarding the stability and safety of mAb-related biologics when subjected to X-ray radiation during transportation and security screenings. Our goal is that this work will stimulate further discussion and guidance from drug sponsors and health authorities to evaluate ionizing radiation impact on current biologics and others new modalities to ensure drug and patient safety.