Transfusion and Apheresis Science
Volume 35, Issue 1 , Pages 5-17 , August 2006

The Mirasol™ PRT system for pathogen reduction of platelets and plasma: An overview of current status and future trends

  • Raymond P. Goodrich

      Affiliations

    • Navigant Biotechnologies, Inc., 1215 Quail Street, Lakewood, CO 80215, United States
    • Corresponding Author InformationCorresponding author. Tel.: +1 303 250 2680; fax: +1 303 239 2389.
    • ,
  • Richard A. Edrich

      Affiliations

    • Navigant Biotechnologies, Inc., 1215 Quail Street, Lakewood, CO 80215, United States
    • ,
  • Junzhi Li

      Affiliations

    • Navigant Biotechnologies, Inc., 1215 Quail Street, Lakewood, CO 80215, United States
    • ,
  • Jerard Seghatchian

      Affiliations

    • Blood Components Technology and Haemostasis/Thrombosis Consultancy, 50 Primrose Hill Road, London NW3 3AA, United Kingdom

Received 6 January 2006 ,Accepted 9 January 2006.

References 

  1. Busch M, Kleinman S, Nemo G. Current and emerging infectious risks of blood transfusions. J Am Med Assoc. 2003;289:959–962
  2. In:  DeVita VT,  Hellman S,  Rosenberg SA editor. AIDS: Etiology, diagnosis, treatment and prevention. 3rd ed.. Philadelphia, PA: Lippincott; 1992;
  3. Schochetman G. AIDS testing. 2nd ed.. New York, NY: Springer-Verlag; 1994;
  4. Cummings P, Wallace E, Schorr J, Dodd R. Exposure of patients to human immunodeficiency virus through the transfusion of blood components that test antibody negative. N Engl J Med. 1989;321:941–946
  5. Petarsen L, Satten G, Dodd R, Busch M, Kleinman S, Grindon A, et al. Duration of time from onset of human immunodeficiency virus type I infectiousness to development of detectable antibody. Transfusion. 1994;34:283–289
  6. Lin L, Cook D, Wiesehahn G, Alfonso R, Behrman B, Cimino G, et al. Photochemical inactivation of viruses and bacteria in platelet concentrates by use of a novel psoralen and long-wavelength ultraviolet light. Transfusion. 1997;37:423–435
  7. Ben-Hur E, Horowitz B. Advances in photochemical approaches for blood sterilization. Photochem Photobiol. 1995;62:383–388
  8. Lambrecht B, Mohr H, Knüver-Hopp J, Schmitt H. Photoinactivation of viruses in human fresh plasma by phenothiazine dyes in combination with visible light. Vox Sang. 1991;60:207–213
  9. Wagner S, Skripchenko A, Robinette D, Foiley J, Cincotta L. Factors affecting virus photoinactivation by a series of phenothiazine dyes. Photochem Photobiol. 1998;67:343–349
  10. Matthews J, Sogandares-Bernal F, Judy M, Marengo-Rowe A, Leveson J, Skiles H, et al. Preliminary studies of photoinactivation of human immunodeficiency virus in blood. Transfusion. 1991;31:636–641
  11. Matthews J, Newman J, Sogandares-Bernal F, Judy M, Skiles H, Leveson J, et al. Photodynamic therapy of viral contaminants with potential for blood banking applications. Transfusion. 1988;28:81–83
  12. Li J, de Korte D, Woolum M, Ruane P, Keil S, Lockerbie O, et al. Pathogen reduction technology (PRT) for buffy coat platelet concentrates using riboflavin and light: comparison to PRT treated apheresis platelet products. Vox Sang. 2004;87:82–90
  13. Rivlin R. Riboflavin metabolism. N Engl J Med. 1970;293:463–472
  14. Treadwell G, Metzler D. Photoconversion of riboflavin of lumichrome in plant tissues. Plant Physiol. 1972;49:991–993
  15. Metzler D, Cairns W. Photochemical degradation of flavins VI. J Am Chem Soc. 1971;93:2772–2777
  16. Tapia G, Silva E. Photoinduced riboflavin binding to the tryptophan residues of bovine and human serum albumins. Radiat Environ Biophys. 1991;30:131–138
  17. Silva E, Salim-Hanna M, Edwards A, Becker M, De Ioannes A. A light-induced tryptophan–riboflavin binding: biological implications. In:  Friedman N editors. Nutritional and toxicological consequences of food processing. New York, NY: Plenum; 1991;p. 33–48
  18. Joshi P. Ultraviolet radiation-induced photodegradation and 1O2, O2 production by riboflavin, lumichrome and lumiflavin. Ind J Biochem Biophys. 1989;26:186–189
  19. Speck W, Rosenkranz S, Rosenkranz H. Further observations on the photooxidation of DNA in the presence of riboflavin. Biochim Biophys Acta. 1976;435:39–44
  20. Korycka-Dahl M, Richardson T. Photodegradation of DNA with fluorescent light in the presence of riboflavin and photoprotection by flavin triplet-state quenchers. Biochim Biophys Acta. 1980;610:229–230
  21. Martin C. PhD thesis, The Ohio State University; 2004.
  22. Cadet J, Berger M, Douki T, Morin B, Raoul S, Ravanat JL, et al. Effects of UV and visible radiation on DNA-final base damage. Bio Chem. 1997;378(11):1275–1286
  23. Burgstaller P, Famulok M. Flavin dependent photoclevage of RNA at G-U base pairs. J Am Chem Soc. 1997;119:1137–1138
  24. Cadet J, Decarroz S, Wang Y, Midden W. Mechanisms and products of photosensitized degradation and related model compounds. Isr J Chem. 1983;23:420–429
  25. Joshi P. Comparison of the DNA damaging property of photosensitized riboflavin via singlet oxygen and superoxide mechanisms. Toxicol Lett. 1985;26:211–217
  26. Kasai H, Yamaizumi Z, Berger M, Cadet J. Photosensitized formation of 7,8-dihydro-8-oxo-2′-deoxyguanosine (8-hydroxy-2′-deoxyguanosine) in DNA by riboflavin: a non singlet oxygen mediated reaction. J Am Chem Soc. 1992;114:9692–9694
  27. Yamamoto F, Nishimura S, Kasai H. Photosensitized reactions of 8-hydroxydeoxyguanosine in cellular DNA by riboflavin. Biochem Biophys Res Comm. 1992;187:809–813
  28. Ennever J, Carr H, Speck W. Potential for genetic damage from multivitamin solutions exposed to phototherapy illumination. Pediatr Res. 1983;17:192–194
  29. Mori T, Tano K, Takimoto K, Utsumi H. Formation of 8-hydroxyguanine and 2,6-diamino-4-hydroxy-5-formamidopyrimidine in DNA by riboflavin mediated photosensitization. Biochem Biophys Res Comm. 1988;242:98–101
  30. Ennever J, Speck W. Photochemical reactions of riboflavin: covalent binding to DNA and to poly (dA) poly (dT). Pediatr Res. 1983;17:234–236
  31. Good Laboratory Practices Regulations, United States Code of Federal Regulations, 21 CFR Part 58.
  32. Committee for Proprietary Medicinal Products (CPMP), CPMP/ICH/295/95 (section 4.0–4.3).
  33. FDA Guidance for Industry: Q5A Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, September 1998.
  34. CPMP/ICH/295/95 – Guidance for Industry: Q5A Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, March 4, 1997.
  35. Weusten J, van Drimmelen HA, Lelie PN. Mathematic modeling of the risk of HBV, HCV, and HIV transmission by window-phase donations not detected by NAT. Transfusion. 2002;42:537–548
  36. Macedo de Oliveira A, Beecham BD, Montgomery SP, Lanciotti RS, Linnen JM, Giachetti C, et al. West Nile virus blood-transfusion related infection despite nucleic acid testing. Transfusion. 2004;44:1695–1699
  37. Personal communication between R. Goodrich and L. Petersen.
  38. Slichter S. Extension of platelet storage: fact or fantasy, food and drug administration blood products advisory committee meeting, Gaithersburg, MD, March 14-15, 2002.
  39. Ness P, Braine H, King K, Barrassso C, Kickler T, Fuller A, et al. Single-donor platelets reduce the risk of septic platelet transfusion reactions. Transfusion. 2001;41:857–861
  40. Engelfriet CP, Reesink HW, Blajchman MA, Muylle L, Kragh-Kjeldsen J, Kekomaki R, et al. Bacterial contamination of blood components. Vox Sang. 2000;78:59–67
  41. Brecher M, Holland PV, Pineda AA, Tegtmeier GE, Yomtovian R. Growth of bacteria in inoculated platelets: implications for bacterial detection and the extension of platelet storage. Transfusion. 2000;40:1308–1312
  42. Personal communication between R. Goodrich, R. Yomtovian and M. Brecher, July 2001.
  43. Guidance for industry for platelet testing and evaluation of platelet substitute products, US FDA (CBER), May 1999.
  44. Ruane P, Edrich R, Gampp D, Keil S, Leonard L, Goodrich R. Photochemical inactivation of selected viruses and bacteria in platelet concentrates using riboflavin and light. Transfusion. 2004;44:877–885
  45. Edrich R, Benford L, Urioste M, Lockerbie O, Rice J, Hovenga N, et al. Bacterial decontamination of apheresis platelets using a photochemical treatment process with riboflavin. Transfusion. 2003;43:79A
  46. Seghatchian J. The platelet storage lesion: a comparative analysis of six leukoreduction processes in terms of biocompatability, microvesiculation, retention of prions, and generation/removal of biological response modifiers. Transfus Apheresis Sci. 2005;
  47. Krailadsiri P, Seghatchian J. Effect of processing and storage on platelet activation, cellular injury and microvesiculation. Transfus Apher Sci. 2001;24:23708
  48. Murphy S, Rebulla P, Bertolini F, Holme S, Moroff G, Snyder E, et al. In vitro assessment of the quality of stored platelet concentrates, BEST Task Force. Trans Med Rev. 1994;8:29–36
  49. In:  Vengelen-Tyler V editors. AABB technical manual. 13th ed.. Bethesda, MD: American Association of Blood Banks; 1999;p. 174
  50. Guide to the preparation, use and quality assurance of blood components, 10th ed., Council of Europe Publishing, Strasbourg, France, 2004.
  51. Michelson A, Barnard MR, Hechtman HB, MacGregor H, Connolly RJ, Loscalzo J, et al. In vivo tracking of platelets: circulating degranulated platelets rapidly lose surface P-selectin but continue to circulate and function. Proc Natl Acad Sci USA. 1996;93:11877–11882
  52. Li J, Lockerbie O, de Korte D, Rice J, McLean R, Goodrich RP. Evaluation of platelet mitochondrial integrity after treatment with Mirasol pathogen reduction technology. Transfusion. 2005;45:920–926
  53. Holme S, Moroff G, Murphy S. A multi-laboratory evaluation of in vitro platelet assays: the test for extend of shape change and response to hypotonic shock. Transfusion. 1998;38:31–40
  54. Lin L, Dikeman R, Molini B, Lukehart SA, Lane R, Dupuis K, et al. Photochemical treatment of platelet concentrates with amotosalen and long-wavelength ultraviolet light inactivates a broad spectrum of pathogenic bacteria. Transfusion. 2004;44:1496–1504
  55. Janetzko K, Lin L, Eichler H, Mayaudon V, Flament J, Kluter H. Implementation of the INTERCEPT blood system for platelets into routine blood bank manufacturing procedures: evaluation of apheresis platelets. Vox San. 2004;86:239–245
  56. AuBuchon JP, Herschel L, Roger J, Taylor H, Whitley P, Li J, et al. Efficacy of apheresis platelets treated with riboflavin and ultraviolet light for pathogen reduction. Transfusion. 2004;44(Suppl):16
  57. AuBuchon JP, Herschel L, Roger J, Taylor H, Whitley P, Li J, et al. Efficacy of apheresis platelets treated with riboflavin and ultraviolet light for pathogen reduction. Transfusion. 2005;45:1335–1341

PII: S1473-0502(06)00085-1

doi: 10.1016/j.transci.2006.01.007

Transfusion and Apheresis Science
Volume 35, Issue 1 , Pages 5-17 , August 2006

Article Tools

* Image Usage & Resolution