Broad-spectrum virus reduction in red cell concentrates using INACTINE™ PEN 110 chemistry

Vox Sanguinis

Volumn 83, Issue 4, 2002, Pages 313-323

  Lazo, Aris ^a   Tassello, J ^a   Jayarama, V ^a   Ohagen, A ^a   Gibaja, V ^a   Kramer, E ^b   Marmorato, A ^a   Billia Shaveet, D ^a   Purmal, A ^a   Brown, F ^b   Chapman, J ^a  

^a VI Technologies Inc   (United States)

^b PLUM ISLAND ANIMAL DISEASE CENTER   (United States)

Author keywords

INACTINE ; Non enveloped virus; Pathogen reduction; PEN110; Red blood cells

Indexed keywords

ANIMAL CELL; ANTIVIRAL ACTIVITY; ARTICLE; ASSAY; BLUETONGUE ORBIVIRUS; BOVINE DIARRHEA VIRUS; CONTROLLED STUDY; CYTOTOXICITY; ERYTHROCYTE CONCENTRATE; ERYTHROCYTE PRESERVATION; FOOT AND MOUTH DISEASE VIRUS; HUMAN; HUMAN ADENOVIRUS 2; HUMAN CELL; HUMAN IMMUNODEFICIENCY VIRUS; KINETICS; NONHUMAN; PARVOVIRUS; PRIORITY JOURNAL; PSEUDORABIES HERPETOVIRUS; REOVIRUS; SINDBIS VIRUS; SWINE VESICULAR EXANTHEMA VIRUS; VESICULAR STOMATITIS VIRUS; VIRUS INACTIVATION;

ANIMALS; ANTIVIRAL AGENTS; CELL LINE; CELL SURVIVAL; ERYTHROCYTE TRANSFUSION; ERYTHROCYTES; HUMANS; KINETICS; POLYAMINES; STERILIZATION; SWINE; VIRUSES;

EID: 6444245559     PISSN: 00429007     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1423-0410.2002.00234.x     Document Type: Article

References (41)

1. Busch MP, Kleinman SH: Committee report: Nucleic acid amplification testing of blood donors for transfusion-transmitted infectious disease. Transfusion 2000; 40:143-155
2. Busch MP: Closing the windows on viral transmission by blood transfusion; in Stramer SL (ed.): Blood Safety in the New Millennium, Bethesda, AABB, 2001; 33-50
3. Goodnough LT, Brecher ME, Kanter ME, AuBuchon JP: Transfusion medicine: Blood transfusion. N Engl J Med 1999; 40:438-447
4. Jordan J, Tiangco B, Kiss J, Koch W: Human parvovirus B19V: Prevalence of viral DNA in volunteer blood donors and clinical outcomes of transfusion recipients. Vox Sang 1998; 75:97-102
5. Handa A, Dickstein B, Young NS, Brown KE: Prevalence of the newly described human circovirus, TTV, in United States blood donors. Transfusion 2000; 40:245-251
6. Desai SM, Meurhoff AS, Leary TP, Erker JC, Simons JN, Chalmers ML, Birkenmeyer LG, Pilot-Matias TJ, Mushahwar IK: Prevalence of TT virus infection in US blood donors and populations at risk for acquiring parenterally transmitted viruses. J Infect Dis 1999; 179:1242-1244
7. Gutierrez RA, Dawson GJ, Knigge MF, Melvin SL, Heynen CA, Kyrk CR, Young CE, Carrick RJ, Schlauder GG, Surowy TK, Dille BJ, Coleman PF, Thiele DL, Lentino JR, Pachucki C, Mushahwar IK: Seroprevalence of GB virus C and persistence of RNA and antibody. J Med Virol 1997; 53:167-173
8. Yeo MD, Matsumoto A, Hisada H, Shih JW, Alter HJ, Geodert JJ: Prevalence of hepatitis G virus in patients with hemophilia and their steady female sexual partners. Sex Transm Dis 2000; 27:178-182
9. Alter HJ, Nakatsuji Y, Melpolder J, Wages J, Wesley R, Shih JW, Kim JP: The incidence of transfusion-associated hepatitis G virus infection and its relation to liver disease. N Engl J Med 1997; 336:747-754
10. Bowden RA, Slichter SJ, Sayers M, Weisdorf D, Cays M, Schoch G, Banaji M, Haake R, Welk K, Fisher L: A comparison of filtered leukocyte-reduced and cytomegalovirus (CMV) seronegative blood products for the prevention of transfusion-associated CMV infection after marrow transplant. Blood 1995; 86:3598-3603
11. Umemura T, Yeo AE, Sottine A, Moratto D, Tanaka Y, Wang RY, Shih JW, Donahue P, Primi D, Alter HJ: SEN virus infection and its relationship to transfusion-associated hepatitis. Hepatology 2001; 33:1334-1335
12. Welch JB, McGowan K, Searle B, Gillon J, Jarvis LM, Simmonds P: Detection of enterovirus viraemia in blood donors. Vox Sang 2001; 80:211-215
13. Purmal A, Valeri CR, Dzik W, Pivacek L, Ragno G, Lazo A, Chapman J: Process for the preparation of pathogen-inactivated RBC concentrates by using PEN110 chemistry: Preclinical studies. Transfusion 2001; 42:139-145
14. Budowsky EI, Zalesskaya MA, Nepomnyashchaya NM, Kostyanovsky RG: Principals of selective inactivation of the viral genome. Dependence of the rate of viral RNA modification on the number of protonizable groups in ethyleneimine oligomers. Vaccine Res 1996; 5:29-39
15. Hemminki K: Reactions of ethyleneimine with guanosine and deoxyguanosine. Chem Biol Interact 1984; 48:249-260
16. O'Connor TR, Boiteux S, Laval J: Ring-opened 7-methylguanine residues in DNA are a block to in vitro DNA synthesis. Nucl Acids Res 1988; 16:5879-5894
17. Haracska L, Washington MT, Prakash S, Prakash L: Inefficient bypass of an abasic site by DNA polymerase eta. J Biol Chem 2001; 276:6861-6866
18. Sanchez G, Mamet-Bratley MD: Transcription by T7 RNA polymerase of DNA containing abasic sites. Environ Mol Mutagen 1994; 23:32-36
19. Lhomme J, Constant J, Demeunynck M: Abasic DNA structure, reactivity and recognition. Biopolymers 1999; 52:65-83
20. Vamvakas S, Vock EH, Lutz WK: On the role of DNA doublestrand breaks in toxicity and carcinogenesis. Crit Rev Toxicol 1997; 27:155-174
21. Golitsina NL, McKenzie A, Purmal A: PEN110 interaction with nucleic acids. Biophys J 2002; 82 Part 2:141a
22. Mintz P, Snyder E, Burks S, Haverstick D, Baril L, Dzik W, Purmal A, Beach K: Pathogen inactivated red blood cells using INACTINE™ technology demonstrate 24 hour post transfusion recovery equal to untreated red cells after 42 days of storage. Blood 2001; 98:711-712a
23. Anon: Note for Guidance on Virus Validation Studies: the Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses. CPMP/BWP/268/95, Final, Version 2. London, The European Agency for the Evaluation of Medicinal Products, 1996
24. Folks TM, Justement J, Kinter A, Dinarello CA, Fauci AS: Cytokine-induced expression of HIV-1 in a chronically infected promonocyte cell line. Science 1987; 238:800-802
25. Chesebro B, Wehrly K: Development of a sensitive quantitative focal assay for human immunodeficiency virus infectivity. J Virol 1988; 62:3779-3788
26. Chesebro B, Buller R, Portis J, Wehrly K: Failure of human immunodeficiency virus entry and infection in CD4-positive human brain and skin cells. J Virol 1990; 64:215-221
27. Chesebro B, Wehrly K, Metcalf J, Griffin DE: Use of a new CD4-positive HeLa cell clone for direct quantitation of infectious human immunodeficiency virus from blood cells of AIDS patients. J Infect Dis 1991; 163:64-70
28. Karber J: Beitrag zur kollectiven behandlung pharmacologische reihenversuche. Arch Exp Pathol Pharmakol 1931; 162:480-483
29. Anon: Note for the Guidance on Plasma Derived Products. CPMP/BWP/269/95. London, The European Agency for the Evaluation of Medicinal Products, 1996
30. Anon: ICH Topic Q5A, Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. CPMP/ICH]295/95. London, The European Agency for the Evaluation of Medicinal Products, 1997
31. Anon: Requirements for Validation Studies to Demonstrate the Virus Safety of Drugs Derived from Human Blood or Plasma. Langen, Germany, Federal Health Office, and Paul Ehrlich Institute Federal Office for Sera and Vaccines, 1994
32. Fast LD, DiLeone G, Edson CM, Purmal AA: INACTINE™ PEN110 treatment functionally inactivates the PBMNC present in RBC units: Comparison to the effects of exposure to gamma-irradiation. Transfusion 2002; 42, in press
33. Aubin JT, Defer C, Vidaud M, Maniez Montreuil M, Flan B: Large-scale screening for human parvovirus B 19V DNA by PCR: Application to the quality control of plasma for fractionation. Vox Sang 2000; 78:7-12
34. Slobedman B, Mocarski ES: Quantitative analysis of latent human cytomegalovirus. J Virol 1999; 73:4806-4812
35. Roback JD, Hillyer CD, Drew WL, Laycock ME, Luka J, Mocarski ES, Slobedman B, Smith JW, Soderberg-Naucler C, Todd DS, Woxenius S, Busch MP: Multicenter evaluation of PCR methods for detecting CMV DNA in blood donors. Transfusion 2001; 41:1249-1257
36. Chun TW, Carruth L, Finzi D, Shen X, DiGiuseppe JA, Taylor H, Hermankova M, Chadwick K, Margolick J, Quinn TC, Kuo YH, Brookmeyer R, Zeiger MA, Barditch-Crovo P, Siliciano RF: Quantification of latent tissue reservoirs and total body viral load in HIV-1 infection. Nature 1997; 387:183-188
37. Ohagen A, Gibaja V, Aytay S, Horrigan J, Lunderville D, Lazo A: Inactivation of the human immunodeficiency virus in blood. Transfusion 2002; 42, in press
38. Ho DD, Moudgil T, Alam M: Quantitation of human immunodeficiency virus type 1 in the blood of infected persons. N Engl JMed 1989; 321:1621-1625
39. Wei X, Ghosh SK, Taylor ME, Johnson VA, Emini EA, Deutsch P, Lifson JD, Bonhoeffer S, Nowak MA, Hahn BH, Saag MS, Shaw GM: Viral dynamics in human immunodeficiency virus type 1 infection. Nature 1995; 373:117-122
40. Layne SP, Merges MJ, Dembo M, Spouge JL, Conley SR, Moore JP, Raina JL, Renz H, Gelderblom HR, Nara PL: Factors underlying spontaneous inactivation and susceptibility to neutralization of human immunodeficiency virus. Virology 1992; 189:695-714
41. Zavizion B, Serebryanik D, Chapman J, Purmal A: Prevention of Yersinia enterocolitica, Pseudomonas fluorescens, and Pseudomonas putida outgrowth in deliberately inoculated blood by a novel pathogen reduction process. Transfusion, in press