(P-TS-34) Development of a Next Generation Illuminator for Photochemical Inactivation of a Broad Spectrum of Pathogens in Platelet Concentrates

The INTERCEPT^® Blood System for Platelets uses amotosalen and ultraviolet A (UVA) light to inactivate a broad spectrum of pathogens and leukocytes in donor platelet concentrates (PC). The current commercial illuminator (INT100) uses fluorescent bulbs to deliver a controlled dose of UVA light. In recent years, Cerus has developed a new LED-based illuminator (INT200) as a planned replacement for the INT100. There is no change to the intended use of the Illuminator. 

The objective of these studies was to compare the performance of the INT200 Illuminator to the INT100 Illuminator through the evaluation of pathogen inactivation levels achieved in PC.

Study

Design/Methods:

Two-arm pool and split studies were performed with apheresis PC (35% plasma/65% PAS-3 and 100% plasma). Pooled PC were spiked with the pathogen of interest and split into two identical units.  The contaminated PC were treated with the INTERCEPT processing sets for platelets. One unit was illuminated using the INT100 Illuminator and the second unit was illuminated using the INT200 Illuminator.

Results/Findings:

Table 1 shows the inactivation levels achieved with amotosalen using the INT100 and INT200 Illuminators, as indicated by the log reduction factors (LRFs). The efficacy of inactivation was tested and compared for a wide spectrum of pathogens in PC.

Conclusions: Equivalent levels of inactivation (LRF difference ≤ 0.5 log) could be achieved for all pathogens in PC at the UVA light doses tested for INT200. Overall, these results demonstrate that the INT200 illuminator can provide similar performance compared to the INT100 for inactivating pathogens in donor PC.