HYPERHEP B Solution for injection Ref.[10825] Active ingredients: Human hepatitis B immunoglobulin

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

Hepatitis B Immune Globulin (Human) — HyperHEP B is a clear or slightly opalescent, and colorless or pale yellow or light brown sterile solution of human hepatitis B immune globulin for intramuscular administration. HyperHEP B contains no preservative. HyperHEP B is prepared from pools of human plasma collected from healthy donors by a combination of cold ethanol fractionation, caprylate precipitation and filtration, caprylate incubation, anion exchange chromatography, nanofiltration and low pH incubation. HyperHEP B consists of a 15% to 18% protein solution at a pH of 4.1 to 4.8 in 0.16 M to 0.26 M glycine. The product contains anti-HBs antibody equivalent to or exceeding the potency of anti-HBs in a U.S. reference hepatitis B immune globulin (Center for Biologics Evaluation and Research, FDA). The U.S. reference has been tested against the World Health Organization standard Hepatitis B Immune Globulin and found to be equal to 220 international units (IU) per mL.

When medicinal biological products are administered, the risk of 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 pathogen.

In the manufacturing process of HyperHEP B, there are several steps with the capacity for viral inactivation or removal.(1) The main steps of the manufacturing process that contribute to the virus clearance capacity are as follows:

  • Caprylate precipitation/depth filtration
  • Caprylate incubation
  • Depth filtration
  • Column chromatography
  • Nanofiltration
  • Low pH final container incubation

To provide additional assurance of the pathogen safety of the final product, the capacity of the HyperHEP B 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.(1) 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.

How Supplied

HyperHEP B is supplied in a 0.5 mL neonatal single dose syringe with attached needle, a 1 mL single dose syringe with attached needle and a 1 mL and a 5 mL single dose vial.

HyperHEP B contains no preservative and is not made with natural rubber latex.

NDC NumberSize
13533-636-03 0.5 mL syringe
13533-636-02 1 mL syringe
13533-636-01 1 mL vial
13533-636-05 5 mL vial

Grifols Therapeutics LLC, Research Triangle Park, NC 27709 USA

Drugs

Drug Countries
HYPERHEP B Canada, Hong Kong, Israel, New Zealand, Singapore, Turkey, United States

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