How is intravenous immunoglobulin (IVIG) prepared?

Updated: Jul 05, 2018
  • Author: Jessica Katz, MD, PhD, FACP; Chief Editor: Emmanuel C Besa, MD  more...
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Answer

Answer

The IVIG that is available contains complete IgG molecules. The IgG subclasses match those in normal human serum. Most preparations contain trace amounts of IgA, which can sensitize IgA-deficient persons during long-term treatment. Immune globulin also contains trace amounts of cytokines, soluble CD4, CD8, and HLA molecules.

Immune globulin is prepared from pooled plasma from 3000-10,000 healthy blood donors. In some instances, blood from as many as 100,000 donors is used. The entire array of variable (antigen-binding) regions of antibodies in normal serum is contained in IVIG. The large number of donors in the pool increases the number of individual antibody activities in the preparation but risks diluting any useful rare activity. Cold alcohol fractionation is used to isolate the immunoglobulin-containing fraction. This is followed by further purification techniques, including additional precipitation procedures to remove the non-immunoglobulin G proteins and ion exchange chromatography to further separate out the desire IgG. Most immune globulin preparations also undergo several specific treatments to inactivate or remove bloodborne pathogens that may be present.

All preparations of IgG have traces of IgA. IgA-deficient patients with severe recurrent viral or bacterial respiratory tract infections or with isolated IgA deficiency (and additional IgG2 and IgG4 deficiency) who may develop severe anaphylactic reactions after an IVIG infusion should receive the first infusion in the hospital under medical supervision.

The World Health Organization has published minimum standards for manufacturing IVIG preparations [122]

  • IVIG should be extracted from a pool of at least 1000 individual donors
  • It should contain as little IgA as possible

  • It should be free from preservatives or stabilizers that might accumulate in vivo

  • The IgG molecules should have as little biochemical modification as possible an possess opsonizing and complement-fixing activities


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