Inactivation of parvovirus B19 during pasteurization of human serum albumin

Inactivation of parvovirus B19 during pasteurization of human serum albumin BACKGROUND : It has been shown that HSA may be contaminated with parvovirus B19 (B19) DNA. However, the presence of B19 DNA does not necessarily indicate infectious virus. HSA is pasteurized at 60°C for 10 hours and it remains unclear whether this procedure inactivates B19. Studies with animal parvoviruses indicate considerable heat resistance at 60°C. However, due to the lack of a suitable cell culture system, the pasteurization process has not been investigated in the past. STUDY DESIGN AND METHODS : The recently described cell clone KU812Ep6 was used to establish a system for investigation of B19 inactivation during pasteurization. Virus‐infected cells were detected by immunofluorescent staining of viral capsid antigen and by RT‐PCR assay of virus‐specific capsid mRNA. RESULTS : B19 was inactivated after 10 minutes at 60°C for ≥4 log . In contrast, porcine parvovirus was widely resistant at 60°C. Inactivation of B19 was independent of the analyzed albumin products (5, 20, and 25% albumin from three manufacturers) and from the specific virus source used for the inactivation experiments. Degradation of B19 DNA by deoxyribonuclease I treatment after pasteurization indicated that the virus capsid is destroyed during heat treatment. CONCLUSION : Heat resistance of B19 markedly differs from heat resistance of animal parvoviruses. While animal parvoviruses widely withstand pasteurization of albumin, B19 was rapidly inactivated. These results confirm the safety of pasteurized albumin and are in line with its good clinical safety record with respect to B19 infection. However, conclusions regarding the safety of other blood‐derived medicinal products should not be derived from B19 inactivation in albumin, because different processes or different composition of product intermediates may significantly influence B19 stability during heat treatment. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Transfusion Wiley

Inactivation of parvovirus B19 during pasteurization of human serum albumin

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Publisher
Wiley
Copyright
Copyright © 2002 Wiley Subscription Services, Inc., A Wiley Company
ISSN
0041-1132
eISSN
1537-2995
D.O.I.
10.1046/j.1537-2995.2002.00158.x
Publisher site
See Article on Publisher Site

Abstract

BACKGROUND : It has been shown that HSA may be contaminated with parvovirus B19 (B19) DNA. However, the presence of B19 DNA does not necessarily indicate infectious virus. HSA is pasteurized at 60°C for 10 hours and it remains unclear whether this procedure inactivates B19. Studies with animal parvoviruses indicate considerable heat resistance at 60°C. However, due to the lack of a suitable cell culture system, the pasteurization process has not been investigated in the past. STUDY DESIGN AND METHODS : The recently described cell clone KU812Ep6 was used to establish a system for investigation of B19 inactivation during pasteurization. Virus‐infected cells were detected by immunofluorescent staining of viral capsid antigen and by RT‐PCR assay of virus‐specific capsid mRNA. RESULTS : B19 was inactivated after 10 minutes at 60°C for ≥4 log . In contrast, porcine parvovirus was widely resistant at 60°C. Inactivation of B19 was independent of the analyzed albumin products (5, 20, and 25% albumin from three manufacturers) and from the specific virus source used for the inactivation experiments. Degradation of B19 DNA by deoxyribonuclease I treatment after pasteurization indicated that the virus capsid is destroyed during heat treatment. CONCLUSION : Heat resistance of B19 markedly differs from heat resistance of animal parvoviruses. While animal parvoviruses widely withstand pasteurization of albumin, B19 was rapidly inactivated. These results confirm the safety of pasteurized albumin and are in line with its good clinical safety record with respect to B19 infection. However, conclusions regarding the safety of other blood‐derived medicinal products should not be derived from B19 inactivation in albumin, because different processes or different composition of product intermediates may significantly influence B19 stability during heat treatment.

Journal

TransfusionWiley

Published: Aug 1, 2002

References

  • Inactivation of the human immunodeficiency viruses (HIV‐1 and HIV‐2) during the manufacturing of placental albumin and gammaglobulins.
    Grandgeorge, Grandgeorge; Pelloquin, Pelloquin
  • Chromatographic removal and heat inactivation of hepatitis B virus during the manufacture of human albumin.
    Adcock, Adcock; MacGregor, MacGregor; Davies, Davies
  • Inactivation of parvovirus B19 in coagulation factor concentrates by UVC radiation: assessment by an in vitro infectivity assay using CFU‐E derived from peripheral blood CD34+ cells.
    Sugawara, Sugawara; Motokawa, Motokawa; Abe, Abe
  • Infection of the erythroid cell line, KU812Ep6 with human parvovirus B19 and its application to titration of B19 infectivity.
    Miyagawa, Miyagawa; Yoshida, Yoshida; Takahashi, Takahashi
  • The canine parvovirus empty capsid structure.
    Wu, Wu; Rossmann, Rossmann
  • The transfusion‐ associated transmission of parvovirus B19.
    Azzi, Azzi; Morfini, Morfini; Mannucci, Mannucci

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