Elimination of Viruses (Human Immunodeficiency, Hepatitis B, Vesicular Stomatitis and Sindbis Viruses) from an Intravenous Immunoglobulin Preparation

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Abstract
More than 104 plaque-forming units (pfu)/ml of HIV are inactivated during the alcohol fractionation step from plasma to fraction (Fr)-II+III, > 104 pfu/ml is inactivated from Fr-II+III to Fr-II and > 04 pfu/ml is inactivated during the polyethylene glycol (PEG) fractionation process from Fr-II+III to intravenous IgG (IVIG). The total inactivation rate from plasma to IVIG via Fr-II+III or Fr-II was calculated to be greater than 108 or 1012 respectively. The PEG fractionation method produces an intact and unmodified IVIG. In addition, the PEG fractionation method at a low ionic strength was found to be effective for the elimination of greater than 105 units of other viruses, including hepatitis B, vesicular stomatitis and Sindbis viruses.