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Current opinions on the role of pathogen reduction technology in improving the viral safety of blood and derivatives
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Transfusion and Apheresis Science 39 (2008) 49–50 intl.elsevierhealth.com/journals/tras
Guest editorial
Current opinions on the role of pathogen reduction technology in improving the viral safety of blood and derivatives
With the current concept that patients’ safety must be optimised, through evidence-based multilayered interventional measures, and the general belief that safety is only the control of risk and not the avoidance of risk, several pathogen reduction systems have been developed and validated to further improve the safety of blood and its derivatives. These technologies, which are designed to reduce the potential impacts of the residual risk of transfusion transmitted infections, also offer some added measures to stop bacterial growth, the highest risk contamination of cellular components and probably eradicating the risk of TA-GVHD, by inactivating the residual donor leukocytes. The ideal technology, however, must have a broad spectrum ability to reduce the viral load of the infected donors in the window period (approximately about 10E 8–10 genomes equivalent/ml) though the infectivity may not always correspond to the number of genomes. Moreover, while current inactivation methods can potentially prevent the transmission of some unknown and emerging infectious agents from blood, some may also introduce some undesirable outcomes such as reduction of cellular circulatory life span and reduced functionality. On the other front, the possible link between transfusion and the transmission of vCJD and the impact of various precautionary measures might create even more problems related to the sufficiency of the blood supply. In this respect, some specific filters were designed to reduce infectivity from red cell and whole blood. While such processes do not grossly impair the quality of treated products, it is necessary to fully investigate the biocompatibility of such devices.
This International Forum is based on opinions expressed, on the PRT, by invited experts, in a symposium in Oslo in honour of Professor Bjarte Solheim’s retirement. We begin with an overview focusing on current important questions on the implementation of pathogen reduction technology, prepared by Professor Solheim and myself to provide a brief update on the current perspective on the implementation of the available validated methodology. The next 3 accompanying papers deal, respectively, with current states and future trends of how we are progressing on the aspects of threat by various transfusion transmitted infections and the potential of various available pathogen reduction technologies. Dr Tor-Einar Svae produced a comprehensive overview of prion safety of plasma and plasma proteins. This is followed by the presentation of Professor Peter Hellstern covering the topic of current interest related to FFP, pathogen reduced single donor plasma or bio-pharmaceutical plasma. Finally, Professor Bjarte Solheim has covered pathogen reduction of all blood components. Clearly the expected implementation of the modified mini-pool solvent-detergent treatment of plasma and cryoprecipitate, including the elimination of the solvent and detergent using oil extractions, currently in trial in Egypt, will give blood transfusion services, in some developing countries, a very good future in producing SD-plasma derived cryoprecipitate in an independent and flexible way, in small disposable plastic bags without any heavy and complicated technology used for large scale manufacturing of the SD plasma. To sum up; while each of these presentations, on the basis of available data, provided some answers to many important
1473-0502/$ - see front matter Ó 2008 Elsevier Ltd. All rights reserved. doi:10.1016/j.transci.2008.05.008
50
Guest editorial / Transfusion and Apheresis Science 39 (2008) 49–50
questions on the appropriateness of the implementation of PR technology, either selectively or universally, but in view of increased operational complexity, in particular the application in the current blood bank environments and the loss of some active principles as well as the overall safety/efficacy/cost effectiveness and regulatory aspects a consensus conference is required to address the merit and advantage/disadvantage of PR technology. The Canadian Blood Service and Hema-Quebec held such a conference in March 2007.
Jerard Seghatchian Blood Components/Apheresis Technology and Haemostasis/Thrombosis Consultancy, 50 Primrose Hill Road, London, NW3 3AA England, UK Tel./fax: +44 207 722 9596 E-mail address: [email protected] International Forum: Norway
Transfusion and Apheresis Science 39 (2008) 49–50 intl.elsevierhealth.com/journals/tras
Guest editorial
Current opinions on the role of pathogen reduction technology in improving the viral safety of blood and derivatives
With the current concept that patients’ safety must be optimised, through evidence-based multilayered interventional measures, and the general belief that safety is only the control of risk and not the avoidance of risk, several pathogen reduction systems have been developed and validated to further improve the safety of blood and its derivatives. These technologies, which are designed to reduce the potential impacts of the residual risk of transfusion transmitted infections, also offer some added measures to stop bacterial growth, the highest risk contamination of cellular components and probably eradicating the risk of TA-GVHD, by inactivating the residual donor leukocytes. The ideal technology, however, must have a broad spectrum ability to reduce the viral load of the infected donors in the window period (approximately about 10E 8–10 genomes equivalent/ml) though the infectivity may not always correspond to the number of genomes. Moreover, while current inactivation methods can potentially prevent the transmission of some unknown and emerging infectious agents from blood, some may also introduce some undesirable outcomes such as reduction of cellular circulatory life span and reduced functionality. On the other front, the possible link between transfusion and the transmission of vCJD and the impact of various precautionary measures might create even more problems related to the sufficiency of the blood supply. In this respect, some specific filters were designed to reduce infectivity from red cell and whole blood. While such processes do not grossly impair the quality of treated products, it is necessary to fully investigate the biocompatibility of such devices.
This International Forum is based on opinions expressed, on the PRT, by invited experts, in a symposium in Oslo in honour of Professor Bjarte Solheim’s retirement. We begin with an overview focusing on current important questions on the implementation of pathogen reduction technology, prepared by Professor Solheim and myself to provide a brief update on the current perspective on the implementation of the available validated methodology. The next 3 accompanying papers deal, respectively, with current states and future trends of how we are progressing on the aspects of threat by various transfusion transmitted infections and the potential of various available pathogen reduction technologies. Dr Tor-Einar Svae produced a comprehensive overview of prion safety of plasma and plasma proteins. This is followed by the presentation of Professor Peter Hellstern covering the topic of current interest related to FFP, pathogen reduced single donor plasma or bio-pharmaceutical plasma. Finally, Professor Bjarte Solheim has covered pathogen reduction of all blood components. Clearly the expected implementation of the modified mini-pool solvent-detergent treatment of plasma and cryoprecipitate, including the elimination of the solvent and detergent using oil extractions, currently in trial in Egypt, will give blood transfusion services, in some developing countries, a very good future in producing SD-plasma derived cryoprecipitate in an independent and flexible way, in small disposable plastic bags without any heavy and complicated technology used for large scale manufacturing of the SD plasma. To sum up; while each of these presentations, on the basis of available data, provided some answers to many important
1473-0502/$ - see front matter Ó 2008 Elsevier Ltd. All rights reserved. doi:10.1016/j.transci.2008.05.008
50
Guest editorial / Transfusion and Apheresis Science 39 (2008) 49–50
questions on the appropriateness of the implementation of PR technology, either selectively or universally, but in view of increased operational complexity, in particular the application in the current blood bank environments and the loss of some active principles as well as the overall safety/efficacy/cost effectiveness and regulatory aspects a consensus conference is required to address the merit and advantage/disadvantage of PR technology. The Canadian Blood Service and Hema-Quebec held such a conference in March 2007.
Jerard Seghatchian Blood Components/Apheresis Technology and Haemostasis/Thrombosis Consultancy, 50 Primrose Hill Road, London, NW3 3AA England, UK Tel./fax: +44 207 722 9596 E-mail address: [email protected] International Forum: Norway