Component pathogen inactivation: a critical review

Abstract

While platelet PI has been adopted to reduce bacterial contamination, the ability of PI methods to replace testing for emerging bloodborne infections, or as a substitute for selective pathogen testing, gamma-irradiation or even leucodepletion, make adoption of PI for components increasingly attractive.

Inactivated human platelet lysate with psoralen: a new perspective for mesenchymal stromal cell production in Good Manufacturing Practice conditions

“…This system is routinely used in many blood centers in Europe, the Middle East and many other countries with at least 700000 INTERCEPT treated units transfused world-wide (38,40). The manufacturer has supported an extensive program of post-market surveillance and hemovigilance studies to monitor the introduction of INTERCEPT products in Europe.…”

“…This was done with photochemical treatment by Amotosalem and UVA, a technology that is efficient against the vast majority of known pathogens and which might also prevent the transmission of unknown pathogens (25,(38)(39)(40)(41) INTERCEPT technology is routinely used for PI of PLTs and plasma for clinical use as it is able to inactivate a wide spectrum of bacteria, viruses, and parasites, as well as contaminating leukocytes (42)(43)(44)(45)(46). INTERCEPT process and nucleic acids targeting PI technology is not, however, effective against prion diseases, therefore the risk of prion transmission by treated lysates would remain.…”

Humanes Cytomegalievirus (HCMV)

“…Um die Wirksamkeit und Verträglichkeit von pathogeninaktivierten Thrombozytenprä-paraten zu belegen, wurden in multizentrischen klinischen Studien die Vor-und Nachteile untersucht und gezeigt, dass diese Präparate grundsätzlich sicher und verträglich sind. Jedoch sollte längerfris-tig die Anwendung solcher Präparate wissenschaftlich begleitet werden [150,160]. Verfahren zur Inaktivierung von Pathogenen in Erythrozytenpräparaten sind noch in Entwicklung und müssen in klinischen Studien weiter untersucht werden [155,158].…”

Parvovirus B19 Passive Transmission by Transfusion of Intercept® Blood System-Treated Platelet Concentrate

“…In 2011, Switzerland was the first country introducing nation-wide the pathogen reduction of PCs with amotosalen and UVA (Intercept® blood pathogen reduction system; Cerus Corporation, Amersfoort, Netherlands ) [16]. The degree of B19V reduction achieved has been reported to range from 3.5 to 5 log of B19V by the infectivity assay or up to reach 6 logs as measured by polymerase chain reaction (PCR) inhibition [14,15,17]. …”

“…Pathogen reduction methods for blood components have been shown to be effective for a large number of pathogens including B19V [14,15]. In 2011, Switzerland was the first country introducing nation-wide the pathogen reduction of PCs with amotosalen and UVA (Intercept® blood pathogen reduction system; Cerus Corporation, Amersfoort, Netherlands ) [16].…”