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Hillsboro, OR, United States

Aubry M.,Institute Louis Malarde | Richard V.,Institute Louis Malarde | Green J.,Cerus Corporation | Broult J.,Sanguine | Musso D.,Institute Louis Malarde
Transfusion | Year: 2016

BACKGROUND Zika virus (ZIKV) is an arthropod-borne virus (arbovirus) transmitted by mosquitoes. The potential for ZIKV transmission through blood transfusion was demonstrated during the ZIKV outbreak that occurred in French Polynesia from October 2013 to April 2014. Pathogen inactivation of blood products is a proactive strategy that provides the potential to reduce transfusion-transmitted diseases. Inactivation of arboviruses by amotosalen and ultraviolet A (UVA) illumination was previously demonstrated for chikungunya, West Nile, and dengue viruses. We report here the efficiency of this process for ZIKV inactivation of human plasma. STUDY DESIGN AND METHODS Plasma units were spiked with ZIKV. Viral titers and RNA loads were measured in plasma before and after amotosalen and UVA photochemical treatment. RESULTS The mean ZIKV titers and RNA loads in plasma before inactivation were respectively 6.57 log TCID50/mL and 10.25 log copies/mL. After inactivation, the mean ZIKV RNA loads was 9.51 log copies/mL, but cell cultures inoculated with inactivated plasma did not result in infected cells and did not produce any replicative virus after one passage, nor detectable viral RNA from the second passage. CONCLUSION In this study we demonstrate that amotosalen combined with UVA light inactivates ZIKV in fresh-frozen plasma. This inactivation process is of particular interest to prevent plasma transfusion-transmitted ZIKV infections in areas such as French Polynesia, where several arboviruses are cocirculating. © 2015 The Authors Transfusion published by Wiley Periodicals, Inc. on behalf of AABB. Source

Irsch J.,Cerus Europe BV | Lin L.,Cerus Corporation
Transfusion Medicine and Hemotherapy | Year: 2011

Background: The transmission of pathogens via blood transfusion is still a major threat. Expert conferences established the need for a pro-active approach and concluded that the introduction of a pathogen inactivation/reduction technology requires a thorough safety profile, a comprehensive pre-clinical and clinical development and an ongoing hemovigilance program. Material and Methods: The INTERCEPT Blood System utilizes amotosalen and UVA light and enables for the treatment of platelets and plasma in the same device. Preclinical studies of pathogen inactivation and toxicology and a thorough program of clinical studies have been conducted and an active hemovigilance-program established. Results: INTERCEPT shows robust efficacy of inactivation for viruses, bacteria (including spirochetes), protozoa and leukocytes as well as large safety margins. Furthermore, it integrates well into routine blood center operations. The clinical study program demonstrates the successful use for very diverse patient groups. The hemovigilance program shows safety and tolerability in routine use. Approximately 700,000 INTERCEPT-treated products have been transfused worldwide. The system is in clinical use since class III CE-mark registration in 2002. The safety and efficacy has been shown in routine use and during an epidemic. Conclusion: The INTERCEPT Blood System for platelets and plasma offers enhanced safety for the patient and protection against transfusion-transmitted infections. © 2011 S. Karger AG, Basel. Source

Corash L.,Cerus Corporation | Corash L.,University of California at San Francisco
Expert Review of Hematology | Year: 2011

Bacterial contamination of platelet components (PC) is the most prevalent risk for transfusion-transmitted infection. Based on the recent studies with optimal culture methods of expired PC, the prevalence of bacterial contamination is estimated to occur in approximately one in 750 to one in 1000 PC. Only within the last few years have the magnitude of the risks and the range of clinical outcomes associated with bacterial contamination been extensively characterized. Despite increased recognition of bacterial contamination of PC, transfusion-related sepsis is infrequently reported. This has largely been attributed to passive reporting systems, and low levels of clinical awareness for transfusion-related sepsis by primary care physicians. The risk for transfusion of contaminated PC has generally been characterized per component. Importantly, because patients require repeated transfusions of PC during a period of transfusion-dependent thrombocytopenia, it is appropriate to express the risk to receive a contaminated PC on a patient exposure basis. Assuming that the average hematology oncology patient may receive seven PC during a 28-day period of support, the risk of exposure to a contaminated PC is in the range of one in 150 per patient. This level of risk would not be acceptable for other intravenous medications. With increased appreciation of the risk of bacterial contamination, methods were developed to limit the risk of transfusion- transmitted bacteremia. This article focuses on those interventions that have been implemented in routine practice. The most important methods employed to mitigate the risk are improved skin disinfection, initial blood draw diversion, bacterial detection and pathogen inactivation/reduction. These technologies are now undergoing increased use in the clinical practice of transfusion medicine. With increased use, additional data are being generated to more fully characterize the effects of these interventions. Improved disinfection, blood diversion and bacterial detection have decreased, but not resolved the risk of bacterial contamination. Pathogen inactivation/reduction offers the potential for a further substantial decrease of the risk for transfusion of PC contaminated with bacteria. © 2011 Expert Reviews Ltd. Source

Kleinman S.,University of British Columbia | Stassinopoulos A.,Cerus Corporation
Transfusion | Year: 2015

BACKGROUND Red blood cell (RBC) transfusion risks could be reduced if a robust technology for pathogen inactivation of RBC (PI-RBCs) were to be approved. MATERIALS AND METHODS Estimates of per-unit and per-patient aggregate infectious risks for conventional RBCs were calculated; the latter used patient diagnosis as a determinant of estimated lifetime exposure to RBC units. Existing in vitro data for the two technologies under development for producing PI-RBCs and the status of current clinical trials are reviewed. RESULTS Minimum and maximum per-unit risk were calculated as 0.0003% (1 in 323,000) and 0.12% (1 in 831), respectively. The minimum estimate is for known lower-risk pathogens while the maximal estimate also includes an emerging infectious agent (EIA) and endemic area Babesia risk. Minimum and maximum per-patient lifetime risks by diagnosis grouping were estimated as 1.5 and 3.3%, respectively, for stem cell transplantation (which includes additional risk for cytomegalovirus transmission); 1.2 and 3.7%, respectively, for myelodysplastic syndrome; and 0.2 and 44%, respectively, for hemoglobinopathy. DISCUSSION There is potential for PI technologies to reduce infectious RBC risk and to provide additional benefits (e.g., prevention of transfusion-associated graft-versus-host disease and possible reduction of alloimmunization) due to white blood cell inactivation. PI-RBCs should be viewed in the context of having a fully PI-treated blood supply, enabling a blood safety paradigm shift from reactive to proactive. Providing insurance against new EIAs. Further, when approved, the use of PI for all components may catalyze operational changes in blood donor screening, laboratory testing, and component manufacturing. © 2015 AABB. Source

Cerus Corporation | Date: 2014-10-31

The present invention provides pathogen-inactivated red blood cell compositions suitable for infusion into a subject.

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