Manufacturing & Analytical Characterization
Robert Sussman, PhD, DABT (he/him/his)
Managing Director
SafeBridge Regulatory & Life Sciences Group
New York, New York
Description: As more highly potent and targeted pharmaceuticals make their way from the research laboratory to the marketplace, a systematic and scientific multi-faceted approach is necessary to reduce occupational health risk and minimize product cross-contamination in safely handling these active pharmaceutical ingredients and drug products. CMOs, CDMOs and CROs need to protect their workers and ensure product safety as they have become the majority provider of these compounds to the marketplace. Within this “space”, there are “contenders”, those CMOs who understand both the “hardware” (containment and controls) and “software” (procedures, practices and programs) and “pretenders”, those who say they have the appropriate elements needed to safely handle these compounds, but don’t. This presentation will provide examples of what can go right and what can go wrong when taking on projects with potent APIs and drug products, requirements and elements of a scientific and systematic program to support potent compound safety and quality assurance programs with potent APIs at CMOs and drug innovators, and guidance on quantitative assessments needed to verify the adequacy of containment, controls and work practices for the safety of workers and also for patients taking these vital therapies.