title: Safe handling of cytotoxic compounds in a biopharmaceutical environment.
abstract: Handling cytotoxic drugs such as antibody-drug conjugates (ADCs) in a biopharmaceutical environment represents a challenge based on the potency of the compounds. These derivatives are dangerous to humans if they accidentally get in contact with the skin, are inhaled, or are ingested, either as pure compounds in their solid state or as a solution dissolved in a co-solvent. Any contamination of people involved in the manufacturing process has to be avoided. On the other hand, biopharmaceuticals need to be protected simultaneously against any contamination from the manufacturing personnel. Therefore, a tailor-made work environment is mandatory in order to manufacture ADCs. This asks for appropriate technical equipment to keep potential hazardous substances contained. In addition, clearly defined working procedures based on risk assessments as well as proper training for all personnel involved in the manufacturing process are needed to safely handle these highly potent pharmaceuticals.
authors.affiliation: Bioconjugates R&D, Lonza Ltd, Visp, Switzerland.
authors.forename: Miriam I
authors.initials: MI
authors.lastname: Hensgen
authors.forename: Bernhard
authors.initials: B
authors.lastname: Stump
mesh_terms: D001702:Biopharmaceutics; D062067:Chemical Safety / Q000379:methods*; D003603:Cytotoxins / Q000009:adverse effects; D018796:Immunoconjugates; D016273:Occupational Exposure / Q000517:prevention & control*; D016272:Occupational Health; D011482:Protective Devices; D018570:Risk Assessment; D017751:Safety Management; D018505:Waste Management
chemical_list: D003603:Cytotoxins; D018796:Immunoconjugates