Anthrax immune globulin, sold under the brand name Anthrasil, is a human

immune globulin An antibody (Ab) or immunoglobulin (Ig) is a large, Y-shaped protein belonging to the immunoglobulin superfamily which is used by the immune system to identify and neutralize antigens such as bacteria and viruses, including those that cause di ...

that is used in combination with antibiotics to treat

anthrax Anthrax is an infection caused by the bacterium '' Bacillus anthracis'' or ''Bacillus cereus'' biovar ''anthracis''. Infection typically occurs by contact with the skin, inhalation, or intestinal absorption. Symptom onset occurs between one ...

. It was developed by

Cangene Cangene Corporation was a biopharmaceutical company based in Winnipeg, Manitoba, Canada. It was founded in 1984 and specialized in hyperimmunes, contract manufacturing, biopharmaceuticals and biodefense. Cangene was 61% owned by Canadian pharmace ...

and purchased in 2011 by the

Biomedical Advanced Research and Development Authority The Biomedical Advanced Research and Development Authority (BARDA) is a center within the Administration for Strategic Preparedness and Response (ASPR) located within the U.S. Department of Health and Human Services (HHS) responsible for the p ...

(BARDA) under

Project Bioshield Project Bioshield, formally known as the Project Bioshield Act was enacted by the United States Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack. This was a ten-year progr ...

. In March 2015, it was granted approval by the United States

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

for use in treating inhalation

in conjunction with

antibiotics An antibiotic is a type of antimicrobial substance active against bacteria. It is the most important type of antibacterial agent for fighting pathogenic bacteria, bacterial infections, and antibiotic medications are widely used in the therapy ...

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Preparation

Anthrax immune globulin is prepared from the plasma of

donor A donor in general is a person, organization or government which donates something voluntarily. The term is usually used to represent a form of pure altruism, but is sometimes used when the payment for a service is recognized by all parties as re ...

s who have been vaccinated against anthrax.

Safety and efficacy testing

Due to the ethical and feasibility concerns with testing the efficacy of anthrax immune globulin in humans, it was tested in rabbits and monkeys under the FDA's

animal efficacy rule The FDA animal efficacy rule (also known as animal rule) applies to development and testing of drugs and biologicals to reduce or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic agents (che ...

. Following efficacy testing, anthrax immune globulin was tested for safety in human volunteers, where the most common side effects were headache, back pain, nausea and infusion site pain and swelling.

References

{{Authority control Antibodies Blood products Medical treatments Polyclonal antibodies