A nonenveloped virus with a lipid envelope: hepatitis A virus as used in virus-reduction studies

Transfusion

Volumn 57, Issue 6, 2017, Pages 1433-1439

  Kapsch, Anna Maria ^a   Farcet, Maria R ^a   Antoine, Gerhard ^a   Kreil, Thomas R ^a  

^a SHIRE   (Austria)

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN SERUM ALBUMIN; LIPID; SERUM ALBUMIN;

ARTICLE; CELL CULTURE; CONTROLLED STUDY; HEAT SENSITIVITY; HEAT TREATMENT; HEPATITIS A VIRUS; LIPID ENVELOPE VIRUS; NONHUMAN; PHENOTYPE; VIRAL CLEARANCE; VIRUS ENVELOPE; VIRUS PARTICLE; VIRUS SPIKE; ANIMAL; CELL LINE; CHEMISTRY; CHLOROCEBUS AETHIOPS; GENETICS; HEAT; HUMAN; PHYSIOLOGY; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; VIRUS INACTIVATION;

ANIMALS; CELL LINE; CERCOPITHECUS AETHIOPS; HEPATITIS A VIRUS; HOT TEMPERATURE; HUMANS; REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION; SERUM ALBUMIN; VIRUS INACTIVATION;

EID: 85017110111     PISSN: 00411132     EISSN: 15372995     Source Type: Journal    
DOI: 10.1111/trf.14091     Document Type: Article

References (28)

1. Mannucci PM. Outbreak of hepatitis A among Italian patients with haemophilia. Lancet 1992;339:819.
2. Peerlinck K, Vermylen J. Acute hepatitis A in patients with haemophilia A. Lancet 1993;341:179.
3. Gerritzen A, Schneweis KE, Brackmann HH, et al. Acute hepatitis A in haemophiliacs. Lancet 1992;340:1231-2.
4. Temperley IJ, Cotter KP, Walsh TJ, et al. Clotting factors and hepatitis A. Lancet 1992;340:1466.
5. The European Medicines Agency (EMA). Note for guidance on plasma derived medicinal products—revised (CPMP/BWP/269/95/rev 4). London (UK): EMA; 2009.
6. World Health Organization. Guidelines on viral inactivation and removal procedures intends to assure the viral safety of human blood plasma products—Annex 4; WHO Technical Report 19 11-2004 Series 924. Geneva (Switzerland): World Health Organization, 2004.
7. Farcet MR, Kindermann J, Modrof J, et al. Inactivation of hepatitis A variants during heat treatment (pasteurization) of human serum albumin. Transfusion 2012;52:181-7.
8. Adcock WL, MacGregor A, Davies JR, et al. Chromatographic removal and heat inactivation of hepatitis A virus during manufacture of human albumin. Biotechnol Appl Biochem 1998;28 (Pt 1):85-94.
9. Hilfenhaus J, Nowak T. Inactivation of hepatitis A virus by pasteurization and elimination of picornaviruses during manufacture of factor VIII concentrate. Vox Sang 1994;67(Suppl 1):62-6.
10. Kim IS, Bae JE, Sung HM, et al. Removal and inactivation of viruses during the manufacture of a high-purity antihemophilic factor IX from human plasma. Biotechnol Bioprocess Eng 2009;14:716-24.
11. Murphy P, Nowak T, Lemon SM, et al. Inactivation of hepatitis A virus by heat treatment in aqueous solution. J Med Virol 1993;41:61-4.
12. Lemon SM, Murphy PC, Smith A, et al. Removal/neutralization of hepatitis A virus during manufacture of high purity, solvent/detergent factor VIII concentrate. J Med Virol 1994;43:44-9.
13. Kim IS, Choi YW, Lee SR, et al. Removal and inactivation of hepatitis A virus during manufacture of urokinase from human urine. Biotechnol Bioprocess Eng 2002;7:340.
14. Shimasaki N, Kiyohara T, Totsuka A, et al. Inactivation of hepatitis A virus by heat and high hydrostatic pressure: variation among laboratory strains. Vox Sang 2009;96:14-9.
15. Yunoki M, Sakai K, Totsuka A, et al. Hepatitis A virus strain KRM238 resistant at heat inactivation. Transfusion 2013;53:2103-4.
16. Kreil TR, Farcet MR. In reply. Transfusion 2013;53:2104-5.
17. Daemer RJ, Feinstone SM, Gust ID, et al. Propagation of human hepatitis A virus in African green monkey kidney cell culture: primary isolation and serial passage. Infect Immun 1981;32:388-93.
18. Binn LN, Lemon SM, Marchwicki RH, et al. Primary isolation and serial passage of hepatitis A virus strains in primate cell cultures. J Clin Microbiol 1984;20:28-33.
19. Cromeans T, Sobsey MD, Fields HA. Development of a plaque assay for a cytopathic, rapidly replicating isolate of hepatitis A virus. J Med Virol 1987;22:45-56.
20. Lemon SM, Murphy PC, Shields PA, et al. Antigenic and genetic variation in cytopathic hepatitis A virus variants arising during persistent infection: evidence for genetic recombination. J Virol 1991;65:2056-65.
21. Jansen RW, Newbold JE, Lemon SM. Complete nucleotide sequence of a cell culture adapted variant of hepatitis A virus: comparison with wild-type virus with restricted capacity for in vitro replication. Virology 1988;163:299-307.
22. Feng Z, Hensley L, McKnight KL, et al. A pathogenic picornavirus acquires an envelope by hijacking cellular membranes. Nature 2013;496:367-71.
23. Parenteral Drug Association. Preparation of virus spikes used for virus clearance studies. PDA Technical Report No. 47. Bethesda (MD): Parenteral Drug Association, Inc.; 2010.
24. The European Agency for the Evaluation of Medicinal Products (EMEA)/Committee for Proprietary Medicinal Products (CPMP). EMEA workshop on viral safety of plasma-derived medicinal products with particular focus on non-enveloped viruses. CPMP/BWP/BPWG/4080/00 from September 13. London (UK): EMEA; 2000.
25. The European Agency for the Evaluation of Medicinal Products (EMEA)/Committee for Proprietary Medicinal Products (CPMP). 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/rev. London (UK): EMEA; 1996.
26. Farcet MR, Lackner C, Antoine G, et al. Hepatitis E virus and the safety of plasma products: investigations into the reduction capacity of manufacturing processes. Transfusion 2016;56:383-91.
27. Seggewiß N, Paulmann D, Dotzauer A. Lysosomes serve as a platform for hepatitis A virus particle maturation and nonlytic release. Arch Virol 2016;161:43-52.
28. Hirai-Yuki A, Hensley L, McGivern DR, et al. MAVS-dependent host species range and pathogenicity of human hepatitis A virus. Science 2016;353:1541-5.