Virus Safety Built into the Manufacturing
Biotest Pharmaceuticals Corporation's ("Biotest Pharmaceuticals") manufacturing process employs a multistep viral removal/inactivation system, which further increases the safety of all our plasma protein-based products. Biotest Pharmaceuticals' manufacturing processes have been validated for their capability to eliminate or inactivate viruses. Incorporation of these processes in the manufacturing process ensures that our products fully comply with the requirements of the FDA and are safe and efficacious.
To ensure maximum performance of our plasma protein products, safety and quality control tests are integrated into the production process at several states.
Plasma Production
All plasma protein products produced in the Boca Raton, Fla., facility are manufactured from US-sourced plasma collected in FDA-licensed and IQPP-certified collection centers.
Plasma Hold Program
All plasma is held for at least 60 days after collection prior to use in product manufacturing. This 60-day hold prevents the use of unsuitable plasma units and allows for the retrieval of such units as a result of information received after donation (post-donation information) that would have disqualified the donor. This could include anything from subsequent reactive test results, high-risk behavior or incorrect information received at the time of collection. Any questionable plasma units are excluded from the manufacturing of pharmaceutical products and the units are destroyed.
Virological Testing of Each individual plasma pool
After the individual plasma units are pooled for production, a sample of the manufacturing plasma pool is tested for the presence of viral nucleic acid. Positive test results lead to rejection of the manufacturing lot.
Virus Removal/Inactivation
The manufacturing process used in our facility employs three effective steps to remove/inactivate adventitious viruses and minimize the risk of virus transmission. The steps are: "precipitation" during cold ethanol fractionation, classical "solvent/detergent treatment" and "35 nm virus filtration." In compliance with current guidelines, all three steps have been individually validated in a series of in vitro experiments for their capacity to inactivate or remove both enveloped and nonenveloped viruses.
Precipitation removes both enveloped and nonenveloped viruses, solvent/detergent treatment represents a virus inactivation step for enveloped viruses and 35 nm virus filtration removes both enveloped and nonenveloped viruses by size exclusion. In addition to the steps above, maintaining a low pH level during several steps of the production process contributes to virus inactivation.
Final Filling/Quality Control
The products are dispensed into final containers using aseptic processes and undergo further rigorous quality control testing prior to release for shipment to customers.
Important Safety Information for Nabi-HB®
Individuals known to have had an anaphylactic or severe systemic reaction to human globulin should not receive Nabi-HB® [Hepatitis B Immune Globulin (Human)] or any other human immune globulin. Individuals who are deficient in IgA have the potential to develop antibodies against IgA and anaphylactic reactions.
In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Nabi-HB should be given only if the expected benefits outweigh the potential risks.
Nabi-HB is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents (e.g., viruses) and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Nabi-HB [Hepatitis B Immune Globulin (Human)], must be administered only intramuscularly for post-exposure prophylaxis.
Vaccination with live virus vaccines (e.g., MMR) should be deferred until approximately three months after administration of Nabi-HB.
The most common adverse reactions associated with Nabi-HB in clinical trials were erythema and ache at the injection site as well as systemic reactions such as headache, myalgia, malaise, nausea and vomiting. No anaphylactic reactions with Nabi-HB have been reported.
Please see the full Prescribing Information for Nabi-HB [Hepatitis B Immune Globulin (Human)].
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.