Because rabies immune globulin (human) may partially suppress active production of antibody in response to the rabies vaccine, do not give more than the recommended dose of rabies immune globulin (human).(1)
HYPERRAB is a clear or slightly opalescent, and colorless or pale yellow sterile solution of human antirabies immune globulin for infiltration and intramuscular administration. HYPERRAB is provided in a single-dose vial and contains no preservative. HYPERRAB is prepared from pools of human plasma collected from healthy donors (hyperimmunized with rabies vaccine) by a combination of cold ethanol fractionation, caprylate precipitation and filtration, caprylate incubation, anion-exchange chromatography, nanofiltration and low pH incubation. HYPERRAB consists of 15 to 18% protein at pH 4.1 to 4.8 in 0.16 to 0.26 M glycine. The product is standardized against the U.S. Standard Rabies Immune Globulin to contain a potency value of not less than 300 IU/mL. The U.S. unit of potency is equivalent to the international unit (IU) for rabies antibody.
When medicinal biological products are administered, infectious diseases due to transmission of pathogens cannot be totally excluded. However, in the case of products prepared from human plasma, the risk of transmission of pathogens is reduced by epidemiological surveillance of the donor population and selection of individual donors by medical interview; testing of individual donations and plasma pools; and the presence in the manufacturing processes of steps with demonstrated capacity to inactivate/remove pathogens.
In the manufacturing process of HYPERRAB, there are several steps with the capacity for virus inactivation or removal.(6) The main steps of the manufacturing process that contribute to the virus clearance capacity are as follows:
To provide additional assurance of the pathogen safety of the final product, the capacity of the HYPERRAB manufacturing process to remove and/or inactivate viruses has been demonstrated by laboratory spiking studies on a scaled down process model using a wide range of viruses with diverse physicochemical properties.
The combination of all of the above mentioned measures provides the final product with a high margin of safety from the potential risk of transmission of infectious viruses.
The caprylate/chromatography manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD), and Creutzfeldt-Jakob disease (CJD) agents.(6) These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed by the caprylate/chromatography manufacturing process.