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Pathogen inactivation of RBCs: PEN110 reproductive toxicology studies

BACKGROUND:  The novel PEN110 chemistry (INACTINE, V.I. Technologies) process for the purification of blood for transfusions involves treating WBC‐reduced RBCs with PEN110 to inactivate a wide spectrum of pathogens. The washed RBC preparation has a residual PEN110 level of less than 0.00005 mg per mL. It is important to verify that the trace amounts of residual PEN110 in blood prepared for transfusions will not produce adverse effects on reproduction, fertility, or fetal development.