Background and objectives: The newly developed INTERCEPT Blood System for plasma uses the addition of a new psoralen, amotosalen HCl (AMOTOSALEN), followed by illumination with ultraviolet A light, to inactivate viruses, bacteria, protozoa and leucocytes that may contaminate fresh-frozen plasma (FFP). Extensive toxicology studies were performed to characterize the safety of the photochemical treatment process for its intended use with plasma.
Materials and methods: The studies of general toxicology, safety pharmacology, phototoxicity, reproductive toxicity and venous irritation, summarized in this review, provide a comprehensive toxicology profile for photochemically treated 100% plasma.
Results: No specific target organ toxicity (based on clinical or histological pathology), phototoxicity, or reproductive toxicity was observed.
Conclusions: The results of an extensive series of studies have demonstrated no toxicologically relevant effects of photochemically treated 100% plasma prepared using the INTERCEPT Blood System for plasma.
Copyright 2003 Blackwell Publishing