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(1991)
EEC regulatory document. Note for guidance. Validation of virus removal and inactivation procedures. Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety Medicines.Biologicals : journal of the International Association of Biological Standardization, 19 3
(1991)
Note for guidance. Validation of virus removal and inactivation procedures
(1995)
Die IQ - PCR und dievirussicherheit von Plasma - praparaten
Biologicals, 19
T. Nowak, U. Klockman, J. Hilfenhaus (1992)
Inactivation of viruses related to hepatitis C virus by pasteurization in human plasma derivatives.Biologicals : journal of the International Association of Biological Standardization, 20 1
Department of Virology, Research Laboratories, Centeon Pharma (Deceased)
H. Willkommen, J. Löwer (1993)
Theoretical considerations on viral inactivation or elimination.Developments in biological standardization, 81
Masaki Ishizawa, Yoshiteru Kobayashi, T. Miyamura, S. Matsura (1991)
Simple procedure of DNA isolation from human serum.Nucleic acids research, 19 20
J. Bukh, R. Purcell, Roger Miller (1992)
Importance of primer selection for the detection of hepatitis C virus RNA with the polymerase chain reaction assay.Proceedings of the National Academy of Sciences of the United States of America, 89 1
P. Mannucci (1993)
Viral safety of coagulation factor concentrates.Developments in biological standardization, 81
H. Hart, W. Hart, J. Crossley, A.‐M. Perrie, D. Wood, A. John, F. Mcomish (1994)
Effect of Terminal (Dry) Heat Treatment on Non‐Enveloped Viruses in Coagulation Factor ConcentratesVox Sanguinis, 67
Z. Yun, G. Lindh, O. Weiland, B. Johansson, A. Sönnerborg (1993)
Detection of hepatitis C virus (HCV) RNA by PCR related to HCV antibodies in serum and liver histology in swedish blood donorsJournal of Medical Virology, 39
J. Hogle, M. Chow, D. Filman (1985)
Three-dimensional structure of poliovirus at 2.9 A resolution.Science, 229 4720
W. Quint, R. Heijtink, J. Schirm, W. Gerlich, H. Niesters (1995)
Reliability of methods for hepatitis B virus DNA detectionJournal of Clinical Microbiology, 33
B. Horowitz, M. Wiebe, A. Lippin, M. Stryker (1985)
Inactivation of viruses in labile blood derivatives. I. Disruption of lipid‐enveloped viruses by tri(n‐butyl)phosphate detergent combinationsTransfusion, 25
(1989)
Requirements for the collection, processing, and quality control of blood, blood components, and plasma derivatives
Emil-von-Behring-Strasse 76, D-35041 Marburg
H. Hart, F. Mcomish, W. Hart, P. Simmonds, P. Yap (1993)
A comparison of polymerase chain reaction and an infectivity assay for human immunodeficiency virus type 1 titration during virus inactivation of blood componentsTransfusion, 33
Rinderovarzelle (FROv) zur Virusvermehrung
J. Irwin (1953)
Statistical Method in Biological AssayNature, 172
Qi Qi, Ridpath Ridpath, Lewis Lewis (1992)
Analysis of the bovine viral diarrhea virus genome for possible cellular insertionsVirology, 189
BACKGROUND: The viral safety of human plasma products is based on the careful selection of donors and donations and the removal and inactivation of human pathogenic viruses that could potentially contaminate human plasma. For the analysis of the final products for potential virus contamination, the use of polymerase chain reaction (PCR) has been proposed. To test whether this method can discriminate between infectious and inactivated viruses, the following studies were performed. STUDY DESIGN AND METHODS: Infectious and virus‐inactivated preparations were titrated with specific PCR, using viruses such as hepatitis B virus (HBV), hepatitis C virus, bovine viral diarrhea virus, and poliovirus. The inactivation method employed was pasteurization (10 hours, 60 degrees C) or solvent/detergent (SD) treatment; in the case of HBV, there was consecutive treatment by both methods. RESULTS: Pasteurization of HBV and hepatitis C virus as well as SD treatment of HBV or pasteurization of HBV followed by SD treatment did not affect the detectability of these viruses by PCR, whereas an infectivity study in chimpanzees demonstrated that infectious hepatitis C virus was inactivated by pasteurization. Pasteurization also had no effect on the PCR titers of stabilized bovine viral diarrhea virus or poliovirus preparations, but it destroyed the infectivity of these viruses completely after only 4 hours' heat treatment. CONCLUSION: Pasteurization or SD treatment destroys the infectivity of the viruses tested, but neither significantly affects their detectability by specific PCR. Therefore PCR is not a suitable measure for testing the viral safety of finished plasma products that have been subjected to virus inactivation.
Transfusion – Wiley
Published: Sep 1, 1997
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