L Biesert1. 1. Virological Research Group, Octapharma AG, Frankfurt, Germany.
Abstract
OBJECTIVE: A validation study of the viral safety of a new polyvalent intravenous immunoglobulin (OCTAGAM) according to EU-guideline III/8115/89-EN and the requirements of the Federal Agency for Sera and Vaccines in Germany was undertaken in May 1994. The following processing steps were analyzed: Cohn-Oncley fractionation, solvent/detergent (SD) treatment, pH 4 exposure, storage of the final product at low pH and immune neutralisation. METHODS: The following virus reduction factors were obtained: Cohn-Oncley fractionation: HIV-1 > 5.50; sindbis virus > 6.36; pseudorabies virus > 7.28; coxsackievirus-B6 2.70; poliovirus-1 > 3.80; SV40 > 5.51. Solvent/Detergent treatment: HIV-1 > 6.03; sindbis virus > 7.80; pseudorabies virus > 8.38. pH 4 exposure: HIV-1 > 8.60; sindbis virus > 8.94; pseudorabies virus > 5.95; coxsackievirus-B6 2.72; SV40 1.15. Immune neutralisation: coxsackievirus-B6 > 4.98, polio-virus-1 > 5.14, HAV > 3.44, HSV-1 > 5.92. The following virus reduction factors were calculated for the final product: HIV-1 > 20.13; sindbis virus > 23.10; pseudorabies virus > 21.61; coxsackievirus-B6 > 10.4; poliovirus-1: > 8.94; HAV > 3.44; SV40 > 6.66. CONCLUSION: The results of our validation studies demonstrated that in addition to Cohn fractionation and immune neutralization, the two additional steps of solvent/detergent treatment and pH 4 exposure, mainly contribute to the safety of OCTAGAM with respect to both enveloped and non-enveloped viruses.
OBJECTIVE: A validation study of the viral safety of a new polyvalent intravenous immunoglobulin (OCTAGAM) according to EU-guideline III/8115/89-EN and the requirements of the Federal Agency for Sera and Vaccines in Germany was undertaken in May 1994. The following processing steps were analyzed: Cohn-Oncley fractionation, solvent/detergent (SD) treatment, pH 4 exposure, storage of the final product at low pH and immune neutralisation. METHODS: The following virus reduction factors were obtained: Cohn-Oncley fractionation: HIV-1 > 5.50; sindbis virus > 6.36; pseudorabies virus > 7.28; coxsackievirus-B6 2.70; poliovirus-1 > 3.80; SV40 > 5.51. Solvent/Detergent treatment: HIV-1 > 6.03; sindbis virus > 7.80; pseudorabies virus > 8.38. pH 4 exposure: HIV-1 > 8.60; sindbis virus > 8.94; pseudorabies virus > 5.95; coxsackievirus-B6 2.72; SV40 1.15. Immune neutralisation: coxsackievirus-B6 > 4.98, polio-virus-1 > 5.14, HAV > 3.44, HSV-1 > 5.92. The following virus reduction factors were calculated for the final product: HIV-1 > 20.13; sindbis virus > 23.10; pseudorabies virus > 21.61; coxsackievirus-B6 > 10.4; poliovirus-1: > 8.94; HAV > 3.44; SV40 > 6.66. CONCLUSION: The results of our validation studies demonstrated that in addition to Cohn fractionation and immune neutralization, the two additional steps of solvent/detergent treatment and pH 4 exposure, mainly contribute to the safety of OCTAGAM with respect to both enveloped and non-enveloped viruses.
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