This work will examine the feasibility of a novel high-pressure, low-temperature method and apparatus for inactivating viral contaminants in intravenous immunoglobulin, a human blood-product. The method has the potential to improve the safety, increase the yield and lower the cost of these products. Most current methods do not inactivate non-enveloped viruses, may introduce potentially toxic or carcinogenic chemicals, result in loss of therapeutic value of the product or are time consuming and expensive. The method investigated here is effective against both enveloped and non-enveloped viruses and may be capable of a reduction in viral load of greater than 6 orders of magnitude. The process may be performed on the product that is hermetically sealed in plastic, thus greatly reducing the possibility of contamination with environmental pathogens. In the proposed research, we will add human immunodeficiency virus (HIV-1), bovine viral diarrhea virus (BVDV, a surrogate for hepatitis C virus), duck hepatitis B virus (a surrogate for human hepatitis B virus) and porcine parvo virus (PPV, a thermostable virus) to commercial preparations of intravenous immunoglobulin and treat the mixture with this novel process. Process parameters will be optimized and the viral inactivation rates and therapeutic protein function of IVIG will be measured.
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