Anthrax immune globulin, tradename Anthrasil, is a human

immune globulin An antibody (Ab), also known as an immunoglobulin (Ig), is a large, Y-shaped protein used by the immune system to identify and neutralize foreign objects such as pathogenic bacteria and viruses. The antibody recognizes a unique molecule of the ...

that is used in combination with antibiotics to treat

anthrax Anthrax is an infection caused by the bacterium ''Bacillus anthracis''. It can occur in four forms: skin, lungs, intestinal, and injection. Symptom onset occurs between one day and more than two months after the infection is contracted. The sk ...

. 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 U.S. Department of Health and Human Services (HHS) office responsible for the procurement and development of medical countermeasures, principally against bioterrorism, in ...

(BARDA) under

Project Bioshield The Project Bioshield Act was an act passed by the United States Congress in 2004 in the United States, 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorism, bioterrorist attack. This was a ten-ye ...

. On 24 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 respon ...

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 bacterial infections, and antibiotic medications are widely used in the treatment and prevention o ...

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Preparation

Anthrax immune globulin is prepared from the

plasma Plasma or plasm may refer to: Science * Plasma (physics), one of the four fundamental states of matter * Plasma (mineral), a green translucent silica mineral * Quark–gluon plasma, a state of matter in quantum chromodynamics Biology * Blood pla ...

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 rep ...

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 Food and Drug Administration (United States), FDA animal efficacy rule (also known as animal rule) applies to Drug development, development and testing of drugs and biopharmaceutical, biologicals to reduce or prevent serious or life-threatening ...

. 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

{{Immune sera and immunoglobulins Antibodies Blood products Medical treatments Polyclonal antibodies