Pathogen reduction system to treat plasma

The US Food and Drug Administration (FDA) has approved Cerus Corporation’s Intercept Blood System for plasma - said to be the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections (TTI). The system may be used to reduce pathogens in plasma derived from whole blood and plasma obtained by apheresis, a collection process that separates red blood cells from plasma and then returns the red cells to the donor.

The inactivation of certain potential pathogens in plasma treated using the system is achieved through a photochemical process involving controlled exposure to ultraviolet light and amotosalen, a chemical that facilitates the inactivation process. The plasma is then purified to remove the chemical and its by-products.

Plasma prepared using the system for plasma was evaluated in eight clinical studies consisting of a total of 704 patients. The adverse events experienced by patients who received plasma prepared using the system for plasma were comparable to those experienced by participants who received plasma that had not been treated with the pathogen reduction device.

Pathogens that may be reduced using the system include HIV, hepatitis B and C viruses and West Nile virus. There is currently no pathogen inactivation process that has been shown to eliminate all pathogens.

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