Preclinical safety profile of plasma prepared using the INTERCEPT Blood System.
OBJECTIVE
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.


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.
D000818:Animals; D001800:Blood Specimen Collection; D001803:Blood Transfusion; D017484:Dermatitis, Phototoxic; D046148:Donor Selection; D005260:Female; D011564:Furocoumarins; D006801:Humans; D066298:In Vitro Techniques; D051379:Mice; D009154:Mutation; D009374:Neoplasms, Experimental / Q000209:etiology; D010777:Photochemistry / Q000379:methods; D017319:Photosensitizing Agents; D010949:Plasma / Q000276:immunology; D010956:Plasmapheresis; D011247:Pregnancy; D012098:Reproduction; D012449:Safety; D065227:Transfusion Reaction; D014657:Vasculitis / Q000209:etiology
D011564:Furocoumarins; D017319:Photosensitizing Agents; C118577:amotosalen