Intravenous Immunoglobulins: Evolution of Commercial IVIG Preparations

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.

Intravenous immunoglobulin as clinical immune-modulating therapy

“…However, multiple steps of chemical and enzymatic purification followed by chemical or physical virus inactivation help improve the safety of the product. 48 …”

Immunoglobulins and Their Use in Children

“…The safety of IVIG is guaranteed by a continuous technological progress [10] -refining methods of inactivation of both encapsulated and non-encapsulated pathogens, elimination of pathological PrP Sc prions and new filtration methods [11]. These can also eliminate such 'emerging pathogens' as the West Nile virus, Ebola or avian flu, as well as of non-encapsulated viruses and prions [12][13][14][15].…”

Intravenous immunoglobulin in pediatrics: A review

“…Today, over 25 IVIG preparations are available worldwide which have been approved by various regulatory bodies. 5 The various IVIG products differ in a number of ways including immunoglobulin and IgG subclass distribution, antibody content, approved maximum infusion rate and sideeffects. 6 The characteristics of the various products may result in differences in efficacy and safety which may have a significant impact on the choice of product for some patients.…”

“…Differences in the manufacturing processes of different IVIG preparations affect opsonic activity, Fc-receptor function and complement fixation. 5,6 An ideal IVIG preparation would contain structurally and functionally intact immunoglobulin molecules with a normal biological half-life and a normal proportion of IgG subclasses. The preparation should contain high levels of antibody or antibodies relevant to its proposed use.…”