Process for the preparation of pathogen-inactivated RBC concentrates by using PEN110 chemistry: preclinical studies.

BACKGROUND

A pathogen-inactivation process for RBC concentrates is being developed by using PEN110 chemistry (INACTINE, V.I. Technologies). The objective of this study was to characterize the quality of RBCs prepared by using the PEN110 process and to measure the virucidal effect achieved against two viruses.

STUDY DESIGN AND METHODS

Virology and RBC studies were conducted with standard RBC units treated with 0.1-percent (vol/vol) PEN110 at 22 degrees C for 6 hours. The quality of PEN110-treated human RBCs was assessed with biochemical and phenotypic variables. The in vivo viability of PEN110-treated RBCs in baboons was studied with the double-label (51)Cr/(125)I method.

RESULTS

Decreases in infectious titer by inactivation of greater than a 5 log 50-percent tissue culture infectious doses per mL of bovine viral diarrhea virus (an enveloped RNA virus) and porcine parvovirus (a nonenveloped DNA virus) was observed. RBC hemolysis was less than 1 percent after 42 days of storage, and no changes in RBC antigens were observed. The in vivo viability of PEN110-treated baboon RBCs was unchanged from control.

CONCLUSION

The preparation of RBCs by using the PEN110 process achieved a significant viral reduction of two diverse viruses without causing adverse effects to the RBCs. The process appears to be a promising approach, thus justifying further study.