The Mirasol™ PRT system for pathogen reduction of platelets and plasma: An overview of current status and future trends
Section snippets
Background
In the developed world, blood products are tested for the presence of some of pathogens prior to administration. Nevertheless, there exists a small, but finite risk of transmission of infectious agents in transfusion medicine [1]. The risks of viral infection are due to the “window period”: the period of time between the infection of a donor and the development of detectable levels of antibodies [2], [3]. Nucleic Acid Amplification Testing (NAT) was introduced for HIV and HCV in the United
Treatment procedure overview
Application of the Mirasol PRT process to standard blood banking operations requires that the photochemical properties of riboflavin be utilized in containers and systems and under conditions that are routine for transfusion medicine practice. The following is a description of the treatment procedure for the Mirasol PRT System for which Navigant Biotechnologies is pursuing regulatory clearance. The process includes the following steps of transferring the platelet or plasma product into an
Performance monitoring: process qualification/validation
In vitro process verification tests have been conducted to assess the performance of the Mirasol PRT System in reducing a variety of viruses and bacteria in platelet and plasma products. In vitro studies have also been conducted to determine the effects of the Mirasol PRT System process on platelet and plasma product quality following the pathogen reduction step. All in vitro pathogen reduction and platelet cell quality studies were performed as Good Laboratory Practice (GLP) studies [31].
Conclusions
The Mirasol PRT process is capable of inactivating significant levels of virus and bacteria in platelets and plasma. The levels of pathogens inactivated by this process may significantly reduce the possibility of transfusion infection by these blood components. A technology with this capability (Solvent Detergent Plasma) has existed for some time now for pooled plasma fractionation and plasma for transfusion. The consequence of its introduction has been a substantial reduction in disease
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