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.
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Acknowledgements
We thank Dr. Jorge Almodovar (Whitaker Post-Doctoral Scholar at Grenoble INP, France) for helpful discussions and inputs regarding the Safe Handling of Cytotoxic Compounds in a Biopharmaceutical Environment.
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Hensgen, M.I., Stump, B. (2013). Safe Handling of Cytotoxic Compounds in a Biopharmaceutical Environment. In: Ducry, L. (eds) Antibody-Drug Conjugates. Methods in Molecular Biology, vol 1045. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-62703-541-5_8
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DOI: https://doi.org/10.1007/978-1-62703-541-5_8
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