Miljöpåverkan
Koriongonadotropin alfa, humant rekombinant
Miljörisk:
Användning av aminosyror, proteiner och peptider bedöms inte medföra någon miljöpåverkan.
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Detaljerad miljöinformation
Choriogonadotropin alfa is a recombinant human glycoprotein expressed by a stable transfected Chinese Hamster Ovary (CHO) cell line under controlled culture conditions. Due to its essential homology with the naturally occurring human chorionic gonadotropin, it is therefore likely to follow the same metabolic pathway in patients: proteolysis followed by degradation to simple sugars and amino-acids. A minor portion undergoes internalization followed by lysosomal degradation as a consequence of binding to specific cell surface receptors, while a minor bioactive quantity is excreted into the urines. As for the endogenous human hormone, choriogonadotropin alfa is absorbed in a biologically active form only when it is administered by a parentera! route. If any of the active substance should reach the environment during therapeutic use of the drug product, dilution and rapid catabolism by common environmental microflora would rapidly lead to its disappearance and utilisation by normal metabolic pathways.
Choriogonadotropin alfa is the active substance of Ovitrelle® 250 micrograms/0.5 ml solution for injection. Ovitrelle is intended for treatment of a relatively small patient population on only one or very few occasions, to trigger ovulation and luteinization (i.e., within assisted reproductive technique protocols) and the amount of active component that could eventually reach the environment is expected to be very small.
Additionally, choriogonadotropin alfa is a recombinant human protein and 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.
Even though biomolecules are exempted, they should still be regarded as biologically active.