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• W2000584770 abstract "RATIONALE: Efficient elimination of enveloped and non-enveloped viruses as well as TSE agents (prions) was demonstrated for the manufacturing process of IgPro20, a new liquid, L-proline-stabilized 20% subcutaneous immunoglobulin (SCIG) product. IgPro20 is specifically designed for subcutaneous administration, ensuring safety and tolerability, and is optimized to benefit patients with lower infusion volumes.METHODS: IgG was purified as per Stucki et al. (Biologicals 2008;36:239-47) for a comparable 10% IVIG product (IgPro10/Privigen). Reduction of enveloped (HIV, WNV, BVDV, PRV) and non-enveloped (EMCV, MVM) viruses at each step was tested by spiking experiments. TSE agent removal was demonstrated using different prion-spike preparations and three prion quantification methods.RESULTS: Enveloped viruses were effectively inactivated by the low-pH incubation step. Virus filtration eliminated all viruses tested to below detection limit. Octanoic acid fractionation and subsequent depth filtration completely reduced enveloped viruses; qPCR confirmed partitioning into the discarded filter cake. HIV, PRV and EMCV were removed by a further partitioning step. Validation studies showed overall reduction factors of >18 to >24 log10 for enveloped, and >7 to >9 log10 for non-enveloped viruses.Partitioning and virus filtration significantly reduced three TSE spike preparations, resulting in reductions of >11 log10. Bioassay, Western blot analysis and conformation-dependent immunoassay gave comparable results. The results reflect those seen in Stucki et al.CONCLUSIONS: The application of three different efficient mechanisms of virus reduction in the IgPro20 manufacturing process for reducing a wide variety of model pathogens provides confidence in the inactivation and/or removal of known and emerging pathogens. RATIONALE: Efficient elimination of enveloped and non-enveloped viruses as well as TSE agents (prions) was demonstrated for the manufacturing process of IgPro20, a new liquid, L-proline-stabilized 20% subcutaneous immunoglobulin (SCIG) product. IgPro20 is specifically designed for subcutaneous administration, ensuring safety and tolerability, and is optimized to benefit patients with lower infusion volumes. METHODS: IgG was purified as per Stucki et al. (Biologicals 2008;36:239-47) for a comparable 10% IVIG product (IgPro10/Privigen). Reduction of enveloped (HIV, WNV, BVDV, PRV) and non-enveloped (EMCV, MVM) viruses at each step was tested by spiking experiments. TSE agent removal was demonstrated using different prion-spike preparations and three prion quantification methods. RESULTS: Enveloped viruses were effectively inactivated by the low-pH incubation step. Virus filtration eliminated all viruses tested to below detection limit. Octanoic acid fractionation and subsequent depth filtration completely reduced enveloped viruses; qPCR confirmed partitioning into the discarded filter cake. HIV, PRV and EMCV were removed by a further partitioning step. Validation studies showed overall reduction factors of >18 to >24 log10 for enveloped, and >7 to >9 log10 for non-enveloped viruses. Partitioning and virus filtration significantly reduced three TSE spike preparations, resulting in reductions of >11 log10. Bioassay, Western blot analysis and conformation-dependent immunoassay gave comparable results. The results reflect those seen in Stucki et al. CONCLUSIONS: The application of three different efficient mechanisms of virus reduction in the IgPro20 manufacturing process for reducing a wide variety of model pathogens provides confidence in the inactivation and/or removal of known and emerging pathogens." @default.
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• W2000584770 date "2009-02-01" @default.
• W2000584770 modified "2023-10-16" @default.
• W2000584770 title "Pathogen Safety of a New 20% Liquid Immunoglobulin Product" @default.
• W2000584770 doi "https://doi.org/10.1016/j.jaci.2008.12.314" @default.
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