Manufacturing & Analytical Characterization
Joe Galati, PhD
Sr. Director, Global Toxicology Services
Thermo Fisher Scientific
Mississauga, Ontario, Canada
With oncology growth rates on the rise and the increasing need for rapid discovery of cancer therapeutics, pharmaceutical companies are pressured to manufacture life-saving therapies with speed and agility. Due to the complexities in the mechanisms of action and toxicity profiles of oncology drugs, ranging from oral small molecule targeted-cancer therapies to non-selective classic cytotoxic agents and injectable large molecule antibody-drug conjugates, there are significant challenges to their safe manufacturing. These include worker safety concerns due to potential risk of exposure to these highly potent molecules in the workplace, as well as patient safety issues from possible drug product cross-contamination. During this presentation, direction and recommendations will be provided to show how to protect workers and patients when manufacturing oncology drugs, including identifying criteria for evaluating highly potent oncology drugs using toxicity banding systems; calculating health-based exposure limits for worker safety and patient safety; and recognizing safety and handling strategies through engineering controls and additional methods.