Hepatitis B Immune Globulin (Human), Nabi-HB^TM, is a sterile solution of immunoglobulin (5 ± 1% protein) containing antibodies to hepatitis B surface antigen (anti-HBs). It is prepared from plasma donated by individuals with high titers of anti-HBs. The plasma is purified by an anion-exchange column chromatography method^1,2 with two added viral reduction steps described below. The product is formulated in 0.075 M sodium chloride, 0.15 M glycine, and 0.01% polysorbate 80, pH6.25. It contains no preservative and is intended for single use by the intramuscular route only. The product appears as a clear to opalescent, nonturbid liquid.

The manufacturing steps are designed to reduce the risk of transmission of viral disease. The solvent/detergent treatment step, using tri-n-butyl phosphate and Triton^® X-100, is effective in inactivating known enveloped viruses such as hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). ³ Virus filtration, using a Plan ova^®35 nm Virus Filter, is effective in reducing some known enveloped and non-enveloped viruses. ⁴The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in the following table:

Table 1 Log Reduction of Test Viruses⁵

The product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard. Each vial contains greater than 312 IU/mL anti-HBs. The potency of each vial of Nabi-HB^TM exceeds the potency of anti-HBs in a U.S. reference hepatitis B immune globulin (FDA). The U.S. reference has been tested by Nabi^® against the WHO standard and found to be equal to 208 IU/mL.

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