Development of blood transfusion product pathogen reduction treatments: A review of methods, current applications and demands

Transfusion and Apheresis Science - Tập 52 - Trang 19-34 - 2015
Vishal Salunkhe1, Pieter F. van der Meer2, Dirk de Korte1,2, Jerard Seghatchian3, Laura Gutiérrez1
1Department of Blood Cell Research, Sanquin Research and Landsteiner Laboratory, Academic Medical Centre (AMC), University of Amsterdam (UvA), Amsterdam, The Netherlands
2Department of Product and Process Development, Sanquin Blood Bank, Amsterdam, The Netherlands
3International Consultancy In Blood Components Quality/Safety Improvement and DDR Strategy, London, UK

Tài liệu tham khảo

WHO. Blood safety and availability fact sheet. p. Fact Sheet Nr. 279; 2014. American Cancer Society. Blood transfusion and donation; 2013. Repine, 2006, The use of fresh whole blood in massive transfusion, J Trauma, 60, S59, 10.1097/01.ta.0000219013.64168.b2 Szczepiorkowski, 2013, Transfusion guidelines: when to transfuse, Am Soc Hematol Educ Program, 2013, 638, 10.1182/asheducation-2013.1.638 Allain, 2009, Transfusion-transmitted infectious diseases, Biologicals, 37, 71, 10.1016/j.biologicals.2009.01.002 de Korte, 2014, Platelet concentrates: reducing the risk of transfusion-transmitted bacterial infections, J Clin Transfus Med, 2, 29, 10.2147/IJCTM.S40037 Allain, 2005, Protecting the blood supply from emerging pathogens: the role of pathogen inactivation, Transfus Med Rev, 19, 110, 10.1016/j.tmrv.2004.11.005 Cable, 2003, Risk and prevention of transfusion-transmitted babesiosis and other tick-borne diseases, Curr Opin Hematol, 10, 405, 10.1097/00062752-200311000-00002 Theodossiades, 2001, Transfusion-transmitted infections: epidemiology, risks and prevention, Haema, 4, 24 Brecher, 2004, Improving platelet safety: bacterial contamination of platelets, Curr Hematol Rep, 3, 121 Goodrich, 2009, A laboratory comparison of pathogen reduction technology treatment and culture of platelet products for addressing bacterial contamination concerns, Transfusion, 49, 1205, 10.1111/j.1537-2995.2009.02126.x Yomtovian, 2006, Evolution of surveillance methods for detection of bacterial contamination of platelets in a university hospital, 1991 through 2004, Transfusion, 46, 719, 10.1111/j.1537-2995.2006.00790.x Brecher, 2005, Bacterial contamination of blood components, Clin Microbiol Rev, 18, 195, 10.1128/CMR.18.1.195-204.2005 Kuehnert, 2001, Transfusion-transmitted bacterial infection in the United States, 1998 through 2000, Transfusion, 41, 1493, 10.1046/j.1537-2995.2001.41121493.x de Korte, 2006, Effects of skin disinfection method, deviation bag, and bacterial screening on clinical safety of platelet transfusions in the Netherlands, Transfusion, 46, 476, 10.1111/j.1537-2995.2006.00746.x AuBuchon, 2011, Update on the status of pathogen inactivation methods, ISBT Sci Ser (Vox Sang), 6, 181, 10.1111/j.1751-2824.2011.01471.x Custer, 2010, The cost-effectiveness of pathogen reduction technology as assessed using a multiple risk reduction model, Transfusion, 50, 2461, 10.1111/j.1537-2995.2010.02704.x Epstein, 2003, FDA approach to evaluation of pathogen reduction technology, Transfusion, 43, 1347, 10.1046/j.1537-2995.2003.00584.x Seghatchian, 2013, Pathogen inactivation of whole blood and red cell components: an overview of concept, design, developments, criteria of acceptability and storage lesion, Transfus Apher Sci, 49, 357, 10.1016/j.transci.2013.07.023 Webert, 2008, Proceedings of a Consensus Conference: pathogen inactivation-making decisions about new technologies, Transfus Med Rev, 22, 1, 10.1016/j.tmrv.2007.09.001 Seghatchian, 2011, Effect of pathogen inactivation on the storage lesion in red cells and platelet concentrates, Transfus Apher Sci, 45, 75, 10.1016/j.transci.2011.06.006 Cardigan, 2003, The quality of platelets after storage for 7 days, Transfus Med, 13, 173, 10.1046/j.1365-3148.2003.00449.x McClaskey, 2009, Clinical trials for pathogen reduction in transfusion medicine: a review, Transfus Apher Sci, 41, 217, 10.1016/j.transci.2009.09.008 Stramer, 2009, Emerging infectious disease agents and their potential threat to transfusion safety, Transfusion, 49, 1S, 10.1111/j.1537-2995.2009.02279.x Hess, 2010, Red cell changes during storage, Transfus Apher Sci, 43, 51, 10.1016/j.transci.2010.05.009 Bryant, 2007, Pathogen inactivation: the definitive safeguard for the blood supply, Arch Pathol Lab Med, 131, 719, 10.5858/2007-131-719-PITDSF Seghatchian, 2001, Current strategies for the provision of safer plasma and its derivatives: an update, Transfus Apher Sci, 25, 185, 10.1016/S1473-0502(01)00118-5 Jordan, 1998, Human parvovirus B19: prevalence of viral DNA in volunteer blood donors and clinical outcomes of transfusion recipients, Vox Sang, 75, 97, 10.1046/j.1423-0410.1998.7520097.x Pamphilon, 2000, Viral inactivation of fresh frozen plasma, Br J Haematol, 109, 680, 10.1046/j.1365-2141.2000.02019.x Solheim, 2000, Viral safety of solvent/detergent-treated plasma, Transfusion, 40, 84, 10.1046/j.1537-2995.2000.40010084.x Hellstern, 2011, The use of solvent/detergent treatment in pathogen reduction of plasma, Transfus Med Hemother, 38, 65, 10.1159/000323552 Octaplas.us. FDA Approves Octaplas® Expanding Octapharma U.S. Transfusion Medicine Therapies; 2013. Heger, 2009, Biochemical quality of the pharmaceutically licensed plasma OctaplasLG after implementation of a novel prion protein (PrPSc) removal technology and reduction of the solvent/detergent (S/D) process time, Vox Sang, 97, 219, 10.1111/j.1423-0410.2009.01190.x Solheim, 2008, Pathogen reduction of blood components, Transfus Apher Sci, 39, 75, 10.1016/j.transci.2008.05.003 Seghatchian, 2006, Pathogen-reduction systems for blood components: the current position and future trends, Transfus Apher Sci, 35, 189, 10.1016/j.transci.2006.10.002 Cardigan, 2009, Thrombin generation and clot formation in methylene blue-treated plasma and cryoprecipitate, Transfusion, 49, 696, 10.1111/j.1537-2995.2008.02039.x Dewachter, 2011, Anaphylactic reaction after methylene blue-treated plasma transfusion, Br J Anaesth, 106, 687, 10.1093/bja/aer009 Nubret, 2011, Anaphylactic shock to fresh-frozen plasma inactivated with methylene blue, Transfusion, 51, 125, 10.1111/j.1537-2995.2010.02800.x Pandey, 2012, Adverse effects of plasma transfusion, Transfusion, 52, 65S, 10.1111/j.1537-2995.2012.03663.x Larrea, 2009, The influence of riboflavin photochemistry on plasma coagulation factors, Transfus Apher Sci, 41, 199, 10.1016/j.transci.2009.09.006 Irsch, 2010, Intercept plasma: comparability with conventional fresh-frozen plasma based on coagulation function – an in vitro analysis, Vox Sang, 98, 47, 10.1111/j.1423-0410.2009.01224.x Burnouf, 2004, Assessment of the viral safety of antivenoms fractionated from equine plasma, Biologicals, 32, 115, 10.1016/j.biologicals.2004.07.001 Borkow, 2005, Copper as a biocidal tool, Curr Med Chem, 12, 2163, 10.2174/0929867054637617 Borkow, 2008, Deactivation of human immunodeficiency virus type 1 in medium by copper oxide-containing filters, Antimicrob Agents Chemother, 52, 518, 10.1128/AAC.00899-07 Borkow, 2007, Neutralizing viruses in suspensions by copper oxide-based filters, Antimicrob Agents Chemother, 51, 2605, 10.1128/AAC.00125-07 AABB, American Association of Blood Banks (AABB.org). Listing of countries in which pathogen reduction technology systems and products are in use; 2013 Svae, 2008, Prion safety of transfusion plasma and plasma-derivatives typically used for prophylactic treatment, Transfus Apher Sci, 39, 59, 10.1016/j.transci.2008.05.006 Macopharma. FAQ about Methylene Blue situation in France; 2014. Schlenke, 2014, Pathogen inactivation technologies for cellular blood components: an update, Transfus Med Hemother, 41, 309, 10.1159/000365646 Harmening, 2012, 18 Hanson, 1992, Photochemical inactivation of viruses with psoralens: an overview, Blood Cells, 18, 7 Lin, 1997, Photochemical inactivation of viruses and bacteria in platelet concentrates by use of a novel psoralen and long-wavelength ultraviolet light, Transfusion, 37, 423, 10.1046/j.1537-2995.1997.37497265344.x Moroff, 1992, Factors influencing virus inactivation and retention of platelet properties following treatment with aminomethyltrimethylpsoralen and ultraviolet A light, Blood Cells, 18, 43 van Rhenen, 2000, Functional characteristics of S-59 photochemically treated platelet concentrates derived from buffy coats, Vox Sang, 79, 206, 10.1046/j.1423-0410.2000.7940206.x Osman, 2014, Effects of pathogen reduction systems on platelet microRNAs, mRNAs, activation, and function, Platelets, 1–10 van Rhenen, 2003, Transfusion of pooled buffy coat platelet components prepared with photochemical pathogen inactivation treatment: the euroSPRITE trial, Blood, 101, 2426, 10.1182/blood-2002-03-0932 McCullough, 2004, Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT Trial, Blood, 104, 1534, 10.1182/blood-2003-12-4443 Janetzko, 2005, Therapeutic efficacy and safety of photochemically treated apheresis platelets processed with an optimized integrated set, Transfusion, 45, 1443, 10.1111/j.1537-2995.2005.00550.x Kerkhoffs, 2010, Clinical effectiveness of leucoreduced, pooled donor platelet concentrates, stored in plasma or additive solution with and without pathogen reduction, Br J Haematol, 150, 209 Lozano, 2011, A multi-centre study of therapeutic efficacy and safety of platelet components treated with amotosalen and ultraviolet A pathogen inactivation stored for 6 or 7 d prior to transfusion, Br J Haematol, 153, 393, 10.1111/j.1365-2141.2011.08635.x Marschner, 2011, Pathogen reduction technology treatment of platelets, plasma and whole blood using riboflavin and UV light, Transfus Med Hemother, 38, 8, 10.1159/000324160 Ruane, 2004, Photochemical inactivation of selected viruses and bacteria in platelet concentrates using riboflavin and light, Transfusion, 44, 877, 10.1111/j.1537-2995.2004.03355.x Perez-Pujol, 2005, Effects of a new pathogen-reduction technology (Mirasol PRT) on functional aspects of platelet concentrates, Transfusion, 45, 911, 10.1111/j.1537-2995.2005.04350.x Li, 2005, Platelet glycolytic flux increases stimulated by ultraviolet-induced stress is not the direct cause of platelet morphology and activation changes: possible implications for the role of glucose in platelet storage, Transfusion, 45, 1750, 10.1111/j.1537-2995.2005.00582.x Zeddies, 2014, Pathogen reduction treatment using riboflavin and ultraviolet light impairs platelet reactivity toward specific agonists in vitro, Transfusion, 54, 2292, 10.1111/trf.12636 2010, A randomized controlled clinical trial evaluating the performance and safety of platelets treated with Mirasol pathogen reduction technology, Transfusion, 50, 2362, 10.1111/j.1537-2995.2010.02694.x Asano, 2007, Treatment with riboflavin and ultraviolet light prevents alloimmunization to platelet transfusions and cardiac transplants, Transplantation, 84, 1174, 10.1097/01.tp.0000287318.94088.d7 Fast, 2006, Mirasol PRT treatment of donor white blood cells prevents the development of xenogeneic graft-versus-host disease in Rag2-/-gamma c-/- double knockout mice, Transfusion, 46, 1553, 10.1111/j.1537-2995.2006.00939.x Seghatchian, 2012, Characteristics of the Theraflex UV-platelets pathogen inactivation system – an update, Transfus Apher Sci, 46, 221, 10.1016/j.transci.2012.01.008 Seltsam, 2011, UVC irradiation for pathogen reduction of platelet concentrates and plasma, Transfus Med Hemother, 38, 43, 10.1159/000323845 Pohler, 2014, Pathogen reduction by ultraviolet C light effectively inactivates human white blood cells in platelet products, Transfusion Pohler, 2012, Evaluation of the tolerability and immunogenicity of ultraviolet C-irradiated autologous platelets in a dog model, Transfusion, 52, 2414, 10.1111/j.1537-2995.2012.03583.x Vamvakas, 2011, Meta-analysis of the randomized controlled trials of the hemostatic efficacy and capacity of pathogen-reduced platelets, Transfusion, 51, 1058, 10.1111/j.1537-2995.2010.02925.x Vamvakas, 2012, Meta-analysis of the studies of bleeding complications of platelets pathogen-reduced with the Intercept system, Vox Sang, 102, 302, 10.1111/j.1423-0410.2011.01555.x Cid, 2012, Therapeutic efficacy of platelet components treated with amotosalen and ultraviolet A pathogen inactivation method: results of a meta-analysis of randomized controlled trials, Vox Sang, 103, 322, 10.1111/j.1423-0410.2012.01614.x The Nederlands Trial Register. The PREPAReS Study: Pathogen Reduction Evaluation & Predictive Analytical Rating Score; 2014. Bakkour, 2014, Development of a mitochondrial DNA real-time polymerase chain reaction assay for quality control of pathogen reduction with riboflavin and ultraviolet light, Vox Sang, 107, 351, 10.1111/vox.12173 Macopharma. Theraflex UV-Platelets; 2014. Benjamin, 2005, Therapeutic efficacy and safety of red blood cells treated with a chemical process (S-303) for pathogen inactivation: a phase III clinical trial in cardiac surgery patients, Transfusion, 45, 1739, 10.1111/j.1537-2995.2005.00583.x Cancelas, 2011, Stored red blood cell viability is maintained after treatment with a second-generation S-303 pathogen inactivation process, Transfusion, 51, 2367, 10.1111/j.1537-2995.2011.03163.x Information on Clinical Trials and Human Research Studies (ClinicalTrials.gov). Study to Evaluate Efficacy and Safety of S303 Treated Red Blood Cells (RBCs) in Subjects with Thalassemia Major Requiring Chronic RBC Transfusion; 2014. Cancelas, 2011, In vivo viability of stored red blood cells derived from riboflavin plus ultraviolet light-treated whole blood, Transfusion, 51, 1460, 10.1111/j.1537-2995.2010.03027.x Goodrich, 2010, Design and development of a method for the reduction of infectious pathogen load and inactivation of white blood cells in whole blood products, Biologicals, 38, 20, 10.1016/j.biologicals.2009.10.016 Reddy, 2013, Development of a riboflavin and ultraviolet light-based device to treat whole blood, Transfusion, 53, 131S, 10.1111/trf.12047 Goodrich, 2009, Evaluation of potential immune response and in vivo survival of riboflavin-ultraviolet light-treated red blood cells in baboons, Transfusion, 49, 64, 10.1111/j.1537-2995.2008.01940.x Roberts, 2013, Removal of TSE agent from plasma products manufactured in the United Kingdom, Vox Sang, 104, 299, 10.1111/vox.12004 Mays, 2012, Prion inhibition with multivalent PrPSc binding compounds, Biomaterials, 33, 6808, 10.1016/j.biomaterials.2012.06.004 Korth, 2001, Acridine and phenothiazine derivatives as pharmacotherapeutics for prion disease, Proc Natl Acad Sci U S A, 98, 9836, 10.1073/pnas.161274798 Ghaemmaghami, 2009, Continuous quinacrine treatment results in the formation of drug-resistant prions, PLoS Pathog, 5, e1000673, 10.1371/journal.ppat.1000673 Bian, 2014, Quinacrine promotes replication and conformational mutation of chronic wasting disease prions, Proc Natl Acad Sci U S A, 111, 6028, 10.1073/pnas.1322377111 Yamasaki, 2014, Comparison of the anti-prion mechanism of four different anti-prion compounds, anti-PrP monoclonal antibody 44B1, pentosan polysulfate, chlorpromazine, and U18666A, in prion-infected mouse neuroblastoma cells, PLoS ONE, 9, e106516, 10.1371/journal.pone.0106516 Murphy, 2009, In vitro assessment of red-cell concentrates in SAG-M filtered through the MacoPharma P-CAPT prion-reduction filter, Transfus Med, 19, 109, 10.1111/j.1365-3148.2009.00918.x Sowemimo-Coker, 2005, Removal of exogenous (spiked) and endogenous prion infectivity from red cells with a new prototype of leukoreduction filter, Transfusion, 45, 1839, 10.1111/j.1537-2995.2005.00640.x Heger, 2012, Removal of prion infectivity by affinity ligand chromatography during OctaplasLG(R) manufacturing – results from animal bioassay studies, Vox Sang, 102, 294, 10.1111/j.1423-0410.2011.01563.x Sanquin. Plasma products: Omniplasma; 2014. WHO. Background document: potential Ebola therapies and vaccines; 2014. WHO. Position paper on collection and use of convalescent plasma or serum as an element in filovirus outbreak response; 2014. Gulland, 2014, First Ebola treatment is approved by WHO, BMJ, 349, g5539, 10.1136/bmj.g5539 Burnouf, 2014, Ebola virus convalescent blood products: where we are now and where we may need to go, Transfus Apher Sci, 51, 120, 10.1016/j.transci.2014.10.003 Schubert, 2010, Proteomics meets blood banking: identification of protein targets for the improvement of platelet quality, J Proteomics, 73, 436, 10.1016/j.jprot.2009.08.002 Shevchenko, 2006, In-gel digestion for mass spectrometric characterization of proteins and proteomes, Nat Protoc, 1, 2856, 10.1038/nprot.2006.468 Thiele, 2007, Proteomics of blood-based therapeutics: a promising tool for quality assurance in transfusion medicine, Biodrugs, 21, 179, 10.2165/00063030-200721030-00005 Schubert, 2012, Riboflavin and ultraviolet light treatment potentiates vasodilator-stimulated phosphoprotein Ser-239 phosphorylation in platelet concentrates during storage, Transfusion, 52, 397, 10.1111/j.1537-2995.2011.03287.x Marrocco, 2013, Proteomic analysis of platelets treated with gamma irradiation versus a commercial photochemical pathogen reduction technology, Transfusion, 53, 1808, 10.1111/trf.12060 Thiele, 2012, Profiling alterations in platelets induced by Amotosalen/UVA pathogen reduction and gamma irradiation – a LC-ESI-MS/MS-based proteomics approach, Blood Transfus, 10, s63 Hechler, 2013, Preserved functional and biochemical characteristics of platelet components prepared with amotosalen and ultraviolet A for pathogen inactivation, Transfusion, 53, 1187, 10.1111/j.1537-2995.2012.03923.x Mohr, 2009, A novel approach to pathogen reduction in platelet concentrates using short-wave ultraviolet light, Transfusion, 49, 2612, 10.1111/j.1537-2995.2009.02334.x Prudent, 2014, LC-MS/MS analysis and comparison of oxidative damages on peptides induced by pathogen reduction technologies for platelets, J Am Soc Mass Spectrom, 25, 651, 10.1007/s13361-013-0813-8 Krailadsiri, 1997, Microvesicles in blood components: laboratory and clinical aspects, Clin Appl Thromb Hemost, 3, 86, 10.1177/107602969700300203 Lemoinne, 2014, The emerging roles of microvesicles in liver diseases, Nat Rev Gastroenterol Hepatol, 11, 350, 10.1038/nrgastro.2014.7 Krailadsiri, 2006, The effects of leukodepletion on the generation and removal of microvesicles and prion protein in blood components, Transfusion, 46, 407, 10.1111/j.1537-2995.2006.00737.x Gitz, 2014, CLEC-2 expression is maintained on activated platelets and on platelet microparticles, Blood, 124, 2262, 10.1182/blood-2014-05-572818 Tissot, 2013, Blood microvesicles: from proteomics to physiology, Transl Proteomics, 1, 38, 10.1016/j.trprot.2013.04.004 van der Pol, 2013, Innovation in detection of microparticles and exosomes, J Thromb Haemost, 11, 36, 10.1111/jth.12254 Aatonen, 2014, Isolation and characterization of platelet-derived extracellular vesicles, J Extracell Vesicles, 3, 10.3402/jev.v3.24692 Nollet, 2013, Microparticle formation in apheresis platelets is not affected by three leukoreduction filters, Transfusion, 53, 2293 Garcia, 2005, The platelet microparticle proteome, J Proteome Res, 4, 1516, 10.1021/pr0500760 Varon, 2012, Involvement of platelet derived microparticles in tumor metastasis and tissue regeneration, Thromb Res, 130, S98, 10.1016/j.thromres.2012.08.289 Varon, 2009, Role of platelet-derived microparticles in angiogenesis and tumor progression, Discov Med, 8, 237 Bosman, 2012, The proteome of erythrocyte-derived microparticles from plasma: new clues for erythrocyte aging and vesiculation, J Proteomics, 76, 203, 10.1016/j.jprot.2012.05.031 Kriebardis, 2008, RBC-derived vesicles during storage: ultrastructure, protein composition, oxidation, and signaling components, Transfusion, 48, 1943, 10.1111/j.1537-2995.2008.01794.x Almizraq, 2013, Storage of red blood cells affects membrane composition, microvesiculation, and in vitro quality, Transfusion, 53, 2258 Rubin, 2013, Red blood cell-derived microparticles isolated from blood units initiate and propagate thrombin generation, Transfusion, 53, 1744, 10.1111/trf.12008 Boudreau, 2014, Platelets release mitochondria serving as substrate for bactericidal group IIA-secreted phospholipase A2 to promote inflammation, Blood, 124, 2173, 10.1182/blood-2014-05-573543 Borkow, 2008, Neutralising pathogens in blood in developing countries – thinking outside the screening box, Eur Hematol, 2, 85 Solheim, 2009