Miljöpåverkan
Pembrolizumab
Miljörisk:
Användning av aminosyror, proteiner och peptider bedöms inte medföra någon miljöpåverkan.
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Detaljerad miljöinformation
Environmental Risk Classification
Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb; protein) of the IgG4/kappa isotype designed to directly block the interaction between programmed death (PD)-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumor regression and ultimately immune rejection.
According to the European Medicines Agency guideline on environmental risk assessments for pharmaceuticals (EMA/CHMP/SWP/4447/00), vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates, lipids, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment (Ref I.)
Even though biomolecules are exempted from environmental risk classification it should be remembered that these molecules may be biologically active.
References
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Committee for Medicinal Products for Human Use (CHMP); Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. 1 June 2006, Ref EMEA/CPMP/SWP/4447/00.