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Monoclonal Antibodies Handling and Administration Risk Management

Jaadar Y*, Maes B, Vidts LA, Liévin V, Demoulin M

The use of Monoclonal Antibodies (MABs) has provided a new approach to treat various diseases and is in constant evolution.
Hospital at home, new regulations and technologies are the next challenges for which healthcare professionals are confronted with.
Therefore, risk assessment of MAB handling and administration must be considered.
The aim of this study was to develop a tool providing recommendations regarding the MAB handling and administration.
A review of the scientific literature was undertaken to identify MABs hazard characteristics, their immunogenic potential and their
complexity of preparation. A tool was developed to classify MABs requiring a preparation in different groups providing specific
handling and administration recommendations.
An evaluation algorithm was developed to classify MABs regarding their toxicity and complexity of preparation.
28 MABs and 2 fusion proteins were assessed: 6 MABs presented a carcinogenic and/or mutagenic potential in animals. More than
65% of the MABs assessed exhibited teratogenic potential and 25% were highly or moderately immunogenic.
3 groups were defined providing specific recommendations for working staff.
MAB side effects were also listed highlighting particular precautions for administration.
Most of the MABs assessed were not listed in known hazard drug lists (NIOSH, IARC). However, the literature reviewed has
highlighted that some MABs exhibit carcinogenic or mutagenic properties in animal studies. Many of them are toxic for reproduction.
Furthermore, sensitizing reaction and serious side effects can be observed.
Despite their high molecular weight, MABs inhalation (ability to generate aerosol or powder handling) has been described as a
potential route of occupational exposure.
Studies on humans at low dose exposure should be conducted to allow the establishment of clear safety guidance for MABs handling
and administration.

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