Toxicity Testing of a Novel Riboflavin-Based Technology for Pathogen Reduction and White Blood Cell Inactivation

Transfusion Medicine Reviews

Volumn 22, Issue 2, 2008, Pages 133-153

  Reddy, Heather L ^a,b,c   Dayan, Anthony D ^a,b,c   Cavagnaro, Joy ^a,b,c   Gad, Shayne ^a,b,c   Li, Junzhi ^a,b,c   Goodrich, Raymond P ^a,b,c  

^a Navigant Biotechnologies Inc   (United States)

^b Access BIO   (United States)

^c Gad Consulting Services   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

2 KETOFLAVIN; 4 KETOFLAVIN; FORMYLMETHYLFLAVIN; LUMICHROME; RIBOFLAVIN; RIBOFLAVIN DERIVATIVE; UNCLASSIFIED DRUG;

ANTIGENICITY; ARTICLE; BLOOD; BLOOD DONOR; CYTOTOXICITY; GENOTOXICITY; HISTOCOMPATIBILITY TEST; HUMAN; IN VITRO STUDY; IN VIVO STUDY; INSTRUMENTATION; LEUKOCYTE; MIRASOL PRT SYSTEM; NONHUMAN; PHOTOLYSIS; PHOTOTHERAPY; PLASMA; RECOMMENDED DRUG DOSE; THROMBOCYTE; TOXICITY TESTING; ULTRAVIOLET RADIATION;

ANIMALS; BLOOD COMPONENT TRANSFUSION; BLOOD PRESERVATION; BLOOD-BORNE PATHOGENS; LEUKOCYTE REDUCTION PROCEDURES; MODELS, ANIMAL; RATS; RIBOFLAVIN; TOXICITY TESTS; ULTRAVIOLET RAYS;

EID: 40749148572     PISSN: 08877963     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.tmrv.2007.12.003     Document Type: Article

References (107)

1. Busch M.P., Kleinman S.H., and Nemo G.J. Current and emerging infectious risks of blood transfusions. JAMA 289 (2003) 959-962
2. Vamvakas E.C., and Blajchman M.A. Deleterious clinical effects of transfusion-associated immunomodulation: Fact or fiction?. Blood 97 (2001) 1180-1195
3. Lee J.H., and Klein H.G. From leukocyte reduction to leukocyte transfusion: The immunological effects of transfused leukocytes. Baillieres Best Pract Res Clin Haematol 13 (2000) 585-600
4. Gould D.S., and Auchincloss H.J. Direct and indirect recognition: The role of MHC antigens in graft rejection. Immunol Today 20 (1999) 77-82
5. Llewelyn C.A., Hewitt P.E., Knight R.S., et al. Possible transmission of variant Creutzfeldt-Jakob disease by blood transfusions. Lancet 363 (2004) 417-421
6. Hewitt P.E., Llewelyn C.A., Mackenzie J., et al. Creutzfeldt-Jakob disease and blood transfusion: Results of the UK Transfusion Medicine Epidemiological Review study. Vox Sang 91 (2006) 221-230
7. Wroe S.J., Pal S., Siddique D., et al. Clinical presentation and pre-mortem diagnosis of variant Creutzfeldt-Jakob disease associated with blood transfusion: A case report. Lancet 368 (2006) 2061-2067
8. Peden A.H., Head M.W., Ritchie D.L., et al. Preclinical vCJD after blood transfusion in a PRNP codon 129 heterozygous patient. Lancet 364 (2004) 527-529
9. Blajchman M.A. Bacterial contamination of cellular blood components: Risks, sources and control. Vox Sang 87 Suppl (2004) 98-103
10. US Food and Drug Administration. Minutes of 36th Meeting of the Blood Product Advisory Committee; 1992, May 28-29; Bethesda, Maryland (1992), USFDA, Washington (DC)
11. Yomtovian R., Lazarus H.M., Goodnough L.T., et al. A prospective microbiologic surveillance program to detect and prevent the transfusion of bacterially contaminated platelets. Transfusion 33 (1993) 902-909
12. Schroeder M.L. Transfusion-associated graft-versus-host disease. Br J Haematol 117 (2002) 275-287
13. Saunders C., Herbert P., Rowe G., et al. In vitro evaluation of the PALL Leukotrap Affinity Prion Reduction Filter as a secondary device following primary leucoreduction. Vox Sang 89 (2005) 220-228
14. Blajchman M.A., Goldman M., and Baeza F. Improving the bacteriological safety of platelet transfusions. Transfus Med Rev 18 (2004) 11-24
15. Cohen N.D., Munoz A., and Reitz B.A. Transmission of retroviruses by transfusion of screened blood in patients undergoing cardiac surgery. N Engl J Med 320 (1989) 1172-1176
16. Nelson K.E., Donahue J.G., Munoz A., et al. Transmission of retroviruses from seronegative donors by transfusion during cardiac surgery. A multicenter study of HIV-1 and HTLV-I/II infections. Ann Intern Med 117 (1992) 554-559
17. Grant I.H., Gold J.W., Wittner M., et al. Transfusion-associated acute Chagas disease acquired in the United States. Ann Intern Med 111 (1989) 849-851
18. Leiby D.A., Lenes B.A., Tibbals M.A., et al. Prospective evaluation of a patient with Trypanosoma cruzi infection transmitted by transfusion. N Engl J Med 341 (1999) 1237-1239
19. Wu D.G., Mason B., Jong J., et al. Parvovirus B19 transmission by a high-purity factor VIII concentrate. Transfusion 45 (2005) 1003-1010
20. Biggerstaff B.J., and Petersen L.R. Estimated risk of transmission of the West Nile virus through blood transfusion in the US. Transfusion 43 (2002) 1007-1017
21. Custer B., Tomasulo P.A., Murphy E.L., et al. Triggers for switching from minipool testing by nucleic acid technology to individual-donation nucleic acid testing for West Nile virus: Analysis of 2003 data to inform 2004 decision making. Transfusion 44 (2004) 1547-1554
22. Hellstern P. Solvent/detergent-treated plasma: Composition, efficacy, and safety. Curr Opin Hematol 11 (2004) 346-350
23. Williamson L.M., Cardigan R., and Prowse C.V. Methylene blue-treated fresh-frozen plasma: What is its contribution to blood safety?. Transfusion 43 (2003) 1322-1339
24. Corash L., and Lin L. Novel processes for inactivation of leukocytes to prevent transfusion-associated graft-versus-host disease. Bone Marrow Transplant 33 (2004) 1-7
25. Lin L., Dikeman R., Molini B., et al. Photochemical treatment of platelet concentrates with amotosalen and long-wavelength ultraviolet light inactivates a broad spectrum of pathogenic bacteria. Transfusion 44 (2004) 1496-1504
26. Lin L., Hanson C.V., Alter H.J., et al. Inactivation of viruses in platelet concentrates by photochemical treatment with amotosalen and long-wavelength ultraviolet light. Transfusion 45 (2005) 580-590
27. Unna K., and Greslin J.G. Studies on the toxicity and pharmacology of riboflavin. J Pharmacol 76 (1942) 75-80
28. Hayashi M., Kishi M., Sofuni T., et al. Micronucleus tests in mice on 39 food additives and eight miscellaneous chemicals. Food Chem Toxicol 26 (1988) 487-500
29. Kuhn R., and Boulanger P. Uber die Giftigkeit der Flavine. Hoppe Seylers Z Physiol Chem 241 (1936) 233-238
30. Studer A., Zbinden G., and Uehlinger E. Die pathologie der avitaminosen and hypervitaminosen. In: Buchner F., Letterer E., and Roulet F. (Eds). Handbuch der Allgemeinen Pathologie Band II (1962), Springer Verlag, Berlin 734-987
31. Williams Jr. J.R., Grantham P.H., Yamamoto R.S., et al. Effect of dietary riboflavin on azo dye reductase in liver and in bacteria of cecal contents of rats. Biochem Pharmacol 19 (1970) 2523-2525
32. Scotto J.M., Stralin H.G., Lageron A., et al. Influence of carbon tetrachloride or riboflavin on liver carcinogenesis with a single dose of aflatoxin b1. Br J Exp Pathol 56 (1975) 133-138
33. Leclerc J. Influence of thiamine, riboflavin and vitamin B6 content in food on tissue content of these vitamins in the female lactating rat and young rats. Ann Nutr Aliment 28 (1974) 11-20
34. Lim-Sylianco C. Genotoxic studies of street soils in Quezon City, Philippines. In: Sumino K. (Ed). Environmental and occupational chemical hazards, no. 8. Proceedings of the Asia-Pacific Symposium in Environmental and Occupational Toxicology, 1987, Oct 4-10; Singapore (1987), Kobe University School of Medicine, Kobe, Japan
35. Munoz N., Hayashi M., Bang L.J., et al. Effect of riboflavin, retinol, and zinc on micronuclei of buccal mucosa and of esophagus: A randomized double-blind intervention study in China. J Natl Cancer Inst 79 (1987) 687-691
36. Sugiyama M., Ando A., Nakao K., et al. Influence of vitamin B2 on formation of chromium(V), alkali-labile sites, and lethality of sodium chromate(VI) in Chinese hamster V-79 cells. Cancer Res 49 (1989) 6180-6184
37. Haveland-Smith R.B. Evaluation of the genotoxicity of some natural food colours using bacterial assays. Mutat Res 91 (1981) 285-290
38. De Flora S. Study of 106 organic and inorganic compounds in the Salmonella/microsome test. Carcinogenesis 2 (1981) 283-298
39. Kale H., Harikumar P., Nair P.M., et al. Assessment of the genotoxic potential of riboflavin and lumiflavin. Mutat Res 298 (1992) 9-16
40. Zempleni J., Galloway J.R., and McCormick D.B. Pharmacokinetics of orally and intravenously administered riboflavin in healthy humans. Am J Clin Nutr 63 (1996) 54-66
41. Kumar V., Lockerbie O., Keil S.D., et al. Riboflavin and UV-light based pathogen reduction: Extent and consequence of DNA damage at the molecular level. J Photochem Photobiol 80 (2004) 15-21
42. Hardwick C.C., Herivel T.R., Hernandez S.C., et al. Separation, identification and quantification of riboflavin and its photoproducts in blood products using high-performance liquid chromatography with fluorescence detection: a method to support pathogen reduction technology. J Photochem Photobiol 80 (2004) 609-615
43. Holmstrom B. Spectral studies of the photobleaching of riboflavin phosphate. Arkiv for Kemi 22 (1964) 281-301
44. Dekker R.H., Srinivasan B.N., Huber J.R., et al. Photochemistry of flavins-I. Conventional and laser flash photolysis study of alloxazines. J Photochem Photobiol 18 (1973) 457-466
45. Koziol J. Studies of flavins in organic solvents-I. Spectral characteristics of riboflavin, riboflavin tetrabutyrate and lumichrome. J Photochem Photobiol 5 (1966) 41-54
46. Ruane P.H., Edrich R., Gampp D., et al. Photochemical inactivation of selected viruses and bacteria in platelet concentrates using riboflavin and light. Transfusion 44 (2004) 877-885
47. -/-gc-/- double knockout mice. Transfusion 46 (2006) 1553-1560
48. Fast L.D., DiLeone G., Li J., et al. Functional inactivation of white blood cells by Mirasol treatment. Transfusion 46 (2006) 642-648
49. Cardo L.J., Rentas F.J., Ketchum L., et al. Pathogen inactivation of Leishmania donovani infantum in plasma and platelet concentrates using riboflavin and ultraviolet light. Transfusion 90 (2006) 85-91
50. Rentas F.J., Harman R., Salata J., et al. Inactivation of Orientia tsutsugamushi in RBCs, plasma, and platelets using riboflavin and light, as demonstrated in an animal model. Transfusion 47 (2007) 240-247
51. Li J., de Korte D., Woolum M.D., et al. Pathogen reduction of buffy coat platelet concentrates using riboflavin and light: Comparisons with pathogen-reduction technology-treated apheresis platelet products. Vox Sang 87 (2004) 82-90
52. Li J., Lockerbie O., de Korte D., et al. Evaluation of platelet mitochondria integrity after treatment with Mirasol pathogen reduction technology. Transfusion 45 (2005) 920-926
53. Kumar V., Motheral T., Luzniak G., et al. Mirasol (TM) plasma pathogen reduction technology: Riboflavin-based process conserves, protein C, protein S and antithrombin activities. Transfusion 43 Suppl (2003) 80A (abstr)
54. Kumar V., Motheral T., Luzniak G., et al. Mirasol (TM) pathogen reduction technology: Riboflavin-based process retains functional activities of immumoglobulins. Transfusion 43 Suppl (2003) 80A (abstr)
55. Perez-Pujol S., Tonda R., Lozano M., et al. Effects of a new pathogen-reduction technology (Mirasol PRT) on functional aspects of platelet concentrates. Transfusion 45 (2005) 911-919
56. Goodrich R.P., Li J., Pieters H., et al. Correlation of in vitro platelet quality measurements with in vivo platelet viability in human subjects. Vox Sang 90 (2006) 279-285
57. AuBuchon J.P., Herschel L., Roger J., et al. Efficacy of apheresis platelets treated with riboflavin and ultraviolet light for pathogen reduction. Transfusion 45 (2005) 1335-1341
58. WHO. Twenty-fifth report of the Joint FAO/WHO Expert Committee on Food Additives. Evaluation of certain food additives. Tech Rep Ser 669 (1981) 1-48
59. EVM. Expert Group on Vitamins and Minerals; revised review of riboflavin. 2002. 1-48
60. Federation of American Societies for Experimental Biology. Evaluation of the health aspects of riboflavin and riboflavin-5`-phosphate as food ingredients, SCOGS-114. Life Sciences Research Office, Federation of American Societies for Experimental Biology, Bethesda, Maryland. Prepared for US Food and Drug Administration, Washington, DC (1979) 1-25
61. In: Martindale W., and Sweetman S.C. (Eds). The complete drug reference. 33rd ed. (2002), Pharmaceutical Press, London, UK 1386
62. BIBRA. Working Group: Riboflavin and its derivatives: toxicity profile (1990), BIBRA, Epscm, Surrey, UK 1-7
63. Direct Food Substances Affirmed as Generally Recognized as Safe; Riboflavin. 21 CFR Sect. 184.1695 (2001)
64. European Commission Health and Consumer Protection Directorate-General, Scientific Committee on Food. Opinion of the Scientific Committee on Food on the tolerable upper intake level of vitamin B2. (2000), European Commission, Brussels, Belgium 1-10
65. Sisson T.R., Kendall N., Shaw E., et al. Phototherapy of jaundice in the newborn infant. II. Effect of various light intensities. J Pediatr 81 (1972) 35-38
66. Sisson T.R. Photodegradation of riboflavin in neonates. Fed Proc 46 (1987) 1883-1885
67. Bates C.J. Human requirements for riboflavin. Am J Clin Nutr 46 (1987) 122-123
68. Kostenbauder H.B., DeLuca P.P., and Kowarski C.R. Photobinding and photoreactivity of riboflavin in the presence of macromolecules. J Pharm Sci 54 (1965) 1243-1251
69. Yurdakok M., Erdem G., and Tekinalp G. Riboflavin in the treatment of neonatal hyperbilirubinemia. Turk J Pediatr 30 (1988) 159-161
70. Olsen J.H., Hertz H., Kjaer S.K., et al. Childhood leukemia following phototherapy for neonatal hyperbilirubinemia (Denmark). Cancer Causes Control 7 (1996) 411-414
71. Speck W.T., and Rosenkranz H.S. Phototherapy for neonatal hyperbilirubinemia-A potential environmental health hazard to newborn infants: A review. Environ Mutagen 1 (1979) 321-336
72. Maisels M.A., and Kring E.A. Does intensive phototherapy produce hemolysis in newborns of 35 or more weeks of gestation?. J Perinatol 26 (2006) 498-500
73. Stein G., Sperschneider H., and Koppe S. Vitamin levels in chronic renal failure and need for supplementation. Blood Purif 3 (1985) 52-62
74. Allman M.A., Truswell A.S., Tiller D.J., et al. Vitamin supplementation of patients receiving haemodialysis. Med J Aust 150 (1989) 130-133
75. Gentile M.G., Porrini M., Manna G.M., et al. Water- and fat-soluble vitamin status in chronic renal insufficiency patients. Contrib Nephrol 98 (1992) 89-97
76. Fouty B., Frerman F., and Reves R. Riboflavin to treat nucleoside analogue-induced lactic acidosis. Lancet 352 (1998) 291-292
77. Schoenen J., Jacquy J., and Lenaerts M. Effectiveness of high-dose riboflavin in migraine prophylaxis. Neurology 50 (1998) 466-470
78. Luzzati R., Del Bravo P., Di Perri G., et al. Riboflavine and severe lactic acidosis. Lancet 353 (1999) 901-902
79. International Organisation for Standardisation. International Standard ISO 10993 biological evaluation of medical devices-Part 1: Evaluation and testing (2003), International Organisation for Standardisation, Geneva, Switzerland
80. International Organisation for Standardisation. International Standard ISO 10993 biological evaluation of medical devices-Part 11: Tests for systemic toxicity (1993), International Organisation for Standardisation, Geneva, Switzerland
81. International Organisation for Standardisation. International Standard ISO 10993 biological evaluation of medical devices-Part 10: Tests for irritation and sensitization (1995), International Organisation for Standardisation, Geneva, Switzerland
82. International Conference on Harmonisation of Technical Requirements for Pharmaceuticals (ICH): M3(R1) nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals (1997), ICH, Geneva, Switzerland
83. Ames B., McCann J., and Yamasaki E. Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutagenicity test. Mutat Res 31 (1975) 347-364
84. Green M.H.L., and Muriel W.J. Mutagen testing using trp+ reversion in Escherichia coli. Mutat Res 38 (1976) 3-32
85. Evans H.J. Cytological methods for detecting chemical mutagens. In: Hollaender A. (Ed). Chemical mutagens, principles and methods for their detection vol. 4 (1976), Plenum Press, New York (NY)
86. Swierenga S.H.H., Heddle J.A., Sigal E.A., et al. Recommended protocols based on a survey of current practice in genotoxicity testing laboratories, IV. Chromosome aberration and sister-chromatid exchange in Chinese hamster ovary, V79 Chinese lung and human lymphocyte cultures. Mutat Res 246 (1991) 301-322
87. Galloway S.M., Ardema AM.J., Ishidate M.J., et al. Report from working group on in vitro tests for chromosomal aberrations. Mutat Res 312 (1994) 241-261
88. Heddle J.A. A rapid in vivo test for chromosomal damage. Mutat Res 18 (1973) 187-190
89. Mavournin K.H., Blakey D.H., Cimino, et al. The in vivo micronucleus assay in mammalian bone marrow and peripheral blood. A report of the U.S. Environmental Protection Agency Gene-Tox Program. Mutat Res 239 (1990) 29-80
90. Hayashi M., Tice R.R., Macgregor J.T., et al. In vivo rodent erythrocyte micronucleus assay. Mutat Res 312 (1994) 293-304
91. Arndt P.A., Garratty G., Hill J., et al. Two cases of immune haemolytic anaemia, associated with anti-piperacillin, detected by the 'immune complex' method. Vox Sang 83 (2002) 273-278
92. Creech H.J., and O'Connell A.P. Immunochemistry of conjugates prepared from serum albumins and acridine nitrogen mustards (ICR mutagens). Cancer Res 41 (1981) 3844-3851
93. Dise C.A., Burch J.W., and Goodman D.B. Direct interaction of mepacrine with erythrocyte and platelet membrane phospholipid. J Biol Chem 257 (1982) 4701-4704
94. Chen R.F. Fluorescence of quinacrine mustard conjugated to proteins. Arch Biochem Biophys 172 (1976) 39-50
95. Jusko W.J., and Levy G. Plasma protein binding of riboflavin and riboflavin 5′-phosphate in man. J Pharm Sci 58 (1969) 58-62
96. Tapia G., and Silva E. Photo-induced binding to the tryptophan residues of bovine and human serum albumin. Radiat Environ Biol 30 (1991) 131-138
97. Diaz M., Ines Becker M., De Ioannes A.E., et al. Development of monoclonal antibodies against a riboflavin-tryptophan photoinduced adduct: Reactivity to eye lens proteins. J Photochem Photobiol 63 (1996) 762-767
98. Innis W.S.A., McCormick D.B., and Merrill A.H. Variations in riboflavin binding by human plasma: Identification of immunoglobulins as the major proteins responsible. Biochem Med 34 (1985) 151-156
99. Merrill A.H., Innis-Whitehouse W.S.A., and McCormick D.B. Characterization of human riboflavin-binding immunoglobulins. In: Edmondson D.E., and McCormick D.B. (Eds). Flavins and flavoproteins (1987), Walter de Gruyter & Co, Berlin 445-448
100. International Organisation for Standardisation. International Standard ISO 10993 biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity (1999), International Organisation for Standardisation, Geneva, Switzerland
101. International Organisation for Standardisation. International Standard ISO 10993 biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood (2002), International Organisation for Standardisation, Geneva, Switzerland
102. Material Sciences Toxicology Laboratories. Autian method, ATTP-I (1977), University of Tennessee Center for the Health Sciences, Memphis (TN)
103. Hemolysis-Rabbit blood, evaluation of hemodialyzers and dialysis membranes. 77-1294, 213. 1977. DHEW Publication (NIH).
104. Hellstern P., Sachse H., Schwinn H., et al. Manufacture and in vitro characterization of a solvent/detergent-treated human plasma. Vox Sang 63 (1992) 178-185
105. International Conference on Harmonisation of Technical Requirements for Pharmaceuticals (ICH). S3B Pharmacokinetics: Guidance for Repeat Dose Tissue Distribution Studies (1995), ICH, Geneva, Switzerland
106. Goodrich R.P., Edrich R.A., Li J., et al. The Mirasol PRT System for pathogen reduction of platelets and plasma: An overview of current status and future trends. Transfus Apheresis Sci 35 (2006) 5-17
107. Goodrich R.P., Edrich R.A., Goodrich L., et al. The antiviral and antibacterial properties of riboflavin and light: Applications to blood safety and transfusion medicine. In: Silva E., and Edwards A.M. (Eds). Flavins: Photochemistry and photobiology (2006), The Royal Society of Chemistry, Cambridge (UK) 83-113