Preparation and Safety

Every batch of IVIg is made by cold ethanol fractionation of human plasma derived from pools of 3,000 to 10,000 donors. The outcome is purified by enzymatic treatment at a low pH, which is followed by fractionation and chromatography. The purified immunoglobulin is stabilized with glucose, maltos, glycine, sucrose, mannitol, or albumin. The final product contains more than 95% IgG, less than 2.5% IgA, and a negligible amount of IgM.

The IVIg preparations accessible in the United States are now safe with respect to the transmission of known viruses or infections. Donors are examined for the human immunodeficiency virus (HIV), the human T-cell lymphotropic virus, and the hepatitis A, B, and C viruses. Moreover, HIV and the hepatitis B virus are inactivated by the fractionation process. The effectiveness of this was confirmed experimentally by intentionally adding HIV to IVIg. Also, treatment with solvents, detergents, or enzymes and incubation at low pH, inactivates the hepatitis C virus and other viruses. The human immunodeficiency virus has never been transmitted theoough the use of IVIg.

Medicine has its office, it does its share and does it well; but without hope back of it, its forces are crippled and only the physician's verdict can create that hope when the facts refuse to create it.

- Mark Twain -