Miljöpåverkan
Trastuzumab
Miljörisk:
Användning av aminosyror, proteiner och peptider bedöms inte medföra någon miljöpåverkan.
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Detaljerad miljöinformation
Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER 2. The HER2 (or c-erbB2) proto-oncogene encodes a transmembrane receptor protein of 185 kDa, which is structurally related to the epidermal growth factor receptor.
Trastuzmab contains a primary amino acid sequence is similar to HER-2. (Ref III). Use of amino acids/peptides/proteins has been considered to result in insignificant environmental impact. Even though biomolecules are exempted from environmental risk classification it should be remembered that these molecules may be biologically active. (Ref II)
According to the European Medicines Agency guideline on environmental risk assessments for pharmaceuticals (EMA/CMP/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).
References
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ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm
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Environmental classification of pharmaceuticals at www.fass.se: Guidance for pharmaceutical companies. 2012. https://www.fass.se/pdf/Environmental_classification_of_pharmaceuticals-120816.pdf