Intravenous immunoglobulin G: Trends in production methods, quality control and quality assurance

M. Radosevich, T. Burnouf

Research output: Contribution to journalReview article

92 Citations (Scopus)

Abstract

Intravenous immunoglobulin G (IVIG) is now the leading product obtained by fractionation of human plasma. It is the standard replacement therapy in primary and acquired humoral deficiency, and is also used for immunomodulatory therapy in various autoimmune disorders and transplantation. Over the last 30 years, the production processes of IVIG have evolved dramatically, gradually resulting in the development of intact IgG preparations safe to administer intravenously, with normal half-life and effector functions, prepared at increased yield, and exhibiting higher pathogen safety. This article reviews the developments that have led to modern IVIG preparations, the current methods used for plasma collection and fractionation, the safety measures implemented to minimize the risks of pathogen transmission and the major quality control tests that are available for product development and as part of mandatory batch release procedures.

Original languageEnglish
Pages (from-to)12-28
Number of pages17
JournalVox Sanguinis
Volume98
Issue number1
DOIs
Publication statusPublished - Jan 2010
Externally publishedYes

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Keywords

  • Fractionation
  • Human plasma
  • Immunoglobulin G
  • IVIG
  • Quality control
  • Standards
  • Viral safety

ASJC Scopus subject areas

  • Hematology

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