Abstract
Since its first use in 1952, human immunoglobulin has been used to treat people who have inherited antibody deficiencies. This article summarizes IVIG clinical development in primary immunodeficient patients and manufacturing improvements introduced over time. Manufacturing improvements include purification procedures that have reduced the incidence of adverse events and improved clinical efficacy, as well as virus inactivation and removal steps that have increased safety from blood-borne infections. Current manufacturing procedures, IVIG production trends, and recent clinical trial results are also reviewed.
MeSH terms
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Animals
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Bacterial Infections / therapy
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Child
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Clinical Trials as Topic
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Consumer Product Safety
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Drug Contamination
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Drug Industry
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Drug-Related Side Effects and Adverse Reactions
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Humans
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Immunoglobulins, Intravenous* / adverse effects
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Immunoglobulins, Intravenous* / chemistry
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Immunoglobulins, Intravenous* / isolation & purification
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Immunoglobulins, Intravenous* / therapeutic use
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Immunologic Deficiency Syndromes / chemically induced
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Immunologic Deficiency Syndromes / drug therapy
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Infant
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Infant, Low Birth Weight
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Infant, Newborn
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Infant, Premature
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Infant, Premature, Diseases / chemically induced
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Infant, Premature, Diseases / drug therapy
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Infusions, Intravenous
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Pharmaceutical Preparations / administration & dosage
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Pharmaceutical Preparations / chemistry
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Purpura, Thrombocytopenic, Idiopathic / chemically induced
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Purpura, Thrombocytopenic, Idiopathic / drug therapy
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Virus Diseases / immunology
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Virus Diseases / prevention & control
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Virus Diseases / transmission
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Virus Inactivation
Substances
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Immunoglobulins, Intravenous
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Pharmaceutical Preparations