OVERVIEW:

The global market in potent active pharmaceuticals (APIs) is estimated to be $20 billion in 2021 and growing; contract manufacturing organisations (CMOs) play an important role in the production of these products. Potent APIs are characterised by low therapeutic dose and the potential for significant exposures and health effects during all stages of development and processing. Pharmaceutical that are classed as "potent" can vary in the extent of their hazard by at least 1,000 times; understanding where a product lies within this range should be determined by an occupational toxicologist with experience in interpreting clinical toxicology data. Contract manufacturing organisations who have the capability to safely handle potent APIs, apply a systematic approach to the determination of the risk of handling these products in order to select appropriate process controls operated within a suitable facility. This webinar will provide insights into this systematic approach; the toxicological assessment of these products will be discussed followed by CMO case studies delivered from an occupational health perspective. Finally, the challenges of processing potent APIs in a multipurpose facility will be presented.