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Vox Sang. 2003 Oct;85(3):171-82.

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

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1
Cerus Corporation, Concord, California 94520, USA.

Abstract

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.

[Indexed for MEDLINE]

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