Progress in improving the pathogen safety of red cell concentrates.

Current methods of preparing red cell concentrates do not include a process step to decontaminate pathogens potentially present in the transfusion product. Although substantial progress has been made in the reduction of the frequency of transmission of HIV, HCV, HBV and HTLV-I as a result of the implementation of diagnostic screening processes, the need for further reduction in transmission rate of these viruses remains. In addition, there are viruses which are known to be be present in blood but for which no screening test has been implemented to remove contaminated units from the blood supply. These viruses include but are not limited to TTV, HGV and Parvo B19. Finally, the lack of a pathogen inactivation process for red cells maintains the blood supply in a state of vulnerability to new viruses or virus variants as they enter the donor population. Recently, substantial progress has been made in the research and development of a class of chemical compounds designated as INACTINE. These compounds are being investigated for their potential to inactivate viruses in red cells without adversely affecting their physiologic function. One of the INACTINE compounds, designated as PEN110, is now in the clinical trial phase of development.