Immune globulin

Intravenous immune globulin (IVIG) preparations consist of concentrated immunoglobulins (Ig), principally immunoglobulin G (IgG), with a subclass distribution that largely reflects that of IgG in normal human serum. Pooled serum is collected from large numbers of donors, ranging from 1,000 to more than 50,000, depending on the manufacturer. All U.S. IVIG manufacturers use Cohn-Oncley ethanol fractionation (fraction II) as an initial step in the preparation of immunoglobulin. Subsequent steps differ among preparations and include ion exchange chromatography, ultrafiltration, enzymatic digestion, manipulation of the pH and salt concentration, and organic solvent-detergent partitioning. These procedures remove contaminants, minimize the concentration of IgG aggregates, and deactivate viral contaminants, such as hepatitis B and C viruses and HIV. Donor serum samples are screened for antibodies to HIV, hepatitis C virus, and hepatitis B surface antigen and for elevated levels of alanine aminotransferase. [#]
Source: Aids Info Drugs - Category: Drugs & Pharmacology Source Type: research