What is BabyBIG®?
BabyBIG®, Botulism Immune Globulin Intravenous (Human) (BIG-IV), is an orphan drug that consists of human-derived anti-botulism toxin antibodies that is approved by the U.S. Food and Drug Administration for the treatment of infant botulism types A and B.

The product is a solvent-detergent-treated, sterile, lyophilized powder of immunoglobulin G (IgG), stabilized with 5% sucrose and 1% albumin (human). It contains no preservative. The purified immunoglobulin is derived from pooled adult plasma from persons immunized with pentavalent botulinum toxoid who were selected for their high titers of neutralizing antibody against botulinum neurotoxins type A and B. All donors were tested and found negative for antibodies against the human immunodeficiency virus and the hepatitis B and hepatitis C viruses. The pooled plasma was fractionated by cold ethanol precipitation of the proteins according to the Cohn/Oncley method and modified to yield a product suitable for intravenous administration.

To date, use of BabyBIG® to treat more than 1,500 US infant botulism patients has resulted in more than 90 years of avoided hospital stay and more than $130 million of avoided hospital costs.

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