Monoclonal antibodies safety and occupational hazard: current practice in Australia

Biological therapies are the mainstay of management for ulcerativecolitis and Crohn’s disease. These molecules are large and complexand require careful handling to ensure they maintain their potency and integrity during preparation and administration. There have been widespread concerns that some or all of these biological agents, particularly the monoclonal antibodies, may also pose some occupational exposure risks for healthcare workers involved in their preparation or administration. Principally, this has arisen from their initial use to manage forms of malignant disease. Both European and US guidelines for safe handling of hazardous substances have grouped all the monoclonal antibodies together and recommended that they be treated as potentially hazardous. In 2014, the US agency responsible for guidance around hazardous substances, the National Institute for Occupational Safety and Health (NIOSH) removed most monoclonal antibodies from its hazardous substances list.