Affiliations: [a] Iranian Blood Transfusion Organization and Iranian Blood Research and Fractionation, Research centre, Tehran, Iran | [b] Department of Immunology, Faculty of Medical Science, Tarbiat Modares University, Tehran, Iran | [c] Department of Clinical Biochemistry, Faculty of Medical Science, Tarbiat Modares University, Tehran, Iran
Correspondence:
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Corresponding author: Dr. A. Aghaie, Iranian Blood Transfusion Organization and Iranian Blood Research and Fractionation, Research centre, Tehran, P.O. BOX 14665-1157, Iran. Tel.: +98 21 88601501; Fax: +98 21 88601555; E-mail: [email protected].
Abstract: The safety of plasma derived medicinal products, such as immunoglobulin, depends on viral inactivation steps that are incorporated into the production process. Several attempts have been made to validate the effectiveness of these inactivation methods against a range of physio-chemically diverse viruses. Treatment with solvent/detergent (S/D) and pasteurization (P) has been continuously used in our IgG production and these methods were analysed in this study as models of viral inactivation. Bovine Viral Diarrhoea Virus (BVDV), Herpes Simplex Virus (HSV) and Vesicular Stomatitis Virus (VSV) were employed as models of HCV, HBV and HIV respectively. Polio and Reo viruses also were used as stable viruses to chemical substances. The infectivity of a range of viruses before and after treatment with two methods of viral inactivation was measured by end point titration and their effectiveness expressed as Logarithmic Reduction Factors (LRF). Solvent/detergent treatment reduced the amount of enveloped viruses by 5–6 logs. The reduction factor was between 5–6 logs for all viruses used in the pasteurization process. A final log reduction factor was obtained as the sum of the two individual methods. Both inactivation methods have advantages and disadvantages with respect to their ability to inactivate viruses. Thus,combination of two robust virus inactivation steps, solvent/detergent and pasteurization, increases the safety margin of immunoglobulin preparations.
