(P-TS-13) Amotosalen/UVA Treatment of Plasma to Inactivate Bacteria, Including Common Environmental Strains Using the INTERCEPT Blood System with INT200 Illuminator

Background/Case Studies: The INTERCEPT® Blood System for Plasma utilizes amotosalen and UVA light to inactivate a wide range of pathogens in plasma and is available in Europe, the US and other geographies. The system consists of two key components: amotosalen containing processing sets and a UVA Illuminator. This illuminator used in these studies will be referred to as the INTERCEPT LED illuminator (INT200 illuminator). Cerus has developed the recently CE-marked UVA light emitting diode (LED)-based technology as a replacement for the current INT100 illuminator using representative bacteria that include potential environmental contaminants.

Study

Design/Methods: The aim of this study was to evaluate the inactivation of selected environmental bacteria in human plasma using amotosalen and UVA treatment with the INT200 device as part of the INTERCEPT LED Illuminator system.

Human plasma donations were collected and pooled to yield individual units of ~650 mL. A minimum of three replicates were performed for each strain of transfusion-relevant bacteria, including A. baumannii, C. minutissimum, L. lactis, S. epidermidis, S. saprophyticus, K. pneumoniae, S. aureus, P. fluorescens, and C. perfringens, with each replicate consisting of one unit spiked with a single bacterial strain. The contaminated plasma units were then treated with amotosalen and UVA light. Samples were taken pre- and post-UVA treatment (5 mL and 50 mL, respectively) and were analyzed for bacterial titer by plating on appropriate media (100 µL–5 mL/plate).

Results/Findings: Treatment of the contaminated plasma units with amotosalen and UVA resulted in robust bacterial inactivation (Table 1).

Conclusions: Amotosalen-UVA treatment with the INT200 illuminator consistently inactivated high titers of A. baumannii, C. minutissimum, L. lactis, S. epidermidis, S. saprophyticus, K. pneumoniae, S. aureus, P. fluorescens, and C. perfringens at the challenging condition of high plasma volume (650 mL).This high volume of 650 mL represents a challenge for pathogen inactivation due to the longer light path through the illumination container and the decreased amotosalen concentration of approximately 135 µM, compared to 150 µM at nominal volume (585 mL). The data demonstrates robust inactivation, including common environmental transfusion-relevant bacterial strains using treatment with amotosalen and the INT200 Illuminator.