From Unknowns to Controls: Quantifying Risk for Radiopharma, ADCs, & Novel Biologics
- Modelling exposure and consequences across radiological, biological, and highpotency modalities to identify when BSCs, isolators, or engineered enclosures are essential, preventing the removal of critical controls and reducing costly incidents
- Mapping gaps in SDS and hazard communication for gene and cell therapies to expose where traditional 16-section formats fall short, and introducing a supplemental “BioRisk Communication Sheet” to enhance compliance and worker protection
- Measuring validation and contractor performance metrics, such as leak tests and rework rates, to demonstrate how manufacturer-led validation windows cut leaks, stress, and lifecycle risk while strengthening the business case for early investment
- Using AI for enhanced EHS biological safety data sheets to save resources needed for this task