title: Development, manufacturing and characterization of a highly purified, liquid immunoglobulin g preparation from human plasma.
abstract: BACKGROUND
  The use of plasma-derived immunoglobulin G (IgG) is increasing, and the number of diseases, including immunodeficiencies, neurological diseases and autoimmune conditions, treated with intravenous IgG (IVIG) is expanding. Consequently, there is a great need for high-yield production processes for plasma-derived IgG. The aim of this work was to develop a high-yield process leading to a highly purified, liquid, ready-to-use IgG for intravenous use.
  
  
  METHODS
  Plasma from healthy, voluntary, non-remunerated donors was fractionated by ethanol precipitation. IgG was extracted from fraction II + III using a phosphate/acetate buffer, pH 4, and purified by chromatography.
  
  
  RESULTS
  Precipitation with 6% polyethylene glycol at pH 7 removed high molecular-weight contaminating proteins, aggregates and contaminating viruses. Ion exchange chromatography at pH 5.7 on serially connected anion and cation exchange columns allowed for elution of IgG from the cation exchange column in good yield and high purity. Further safety was achieved by solvent/detergent treatment and repeated ion exchange chromatography. The product consisted of essentially only IgG monomers and dimers, and had a high purity with very low levels of IgM and IgA.
  
  
  CONCLUSIONS
  A process providing highly purified IVIG in good yield was developed.
authors: Department of Clinical Biochemistry and Immunology, Statens Serum Institut, Copenhagen, Denmark.
authors: Inga A
authors: IA
authors: Laursen
authors: Department of Clinical Biochemistry and Immunology, Statens Serum Institut, Copenhagen, Denmark.
authors: Lene
authors: L
authors: Blou
authors: Central Clinical School, University of Sydney, Australia.
authors: John S
authors: JS
authors: Sullivan
authors: Department of Clinical Biochemistry and Immunology, Statens Serum Institut, Copenhagen, Denmark.
authors: Peter
authors: P
authors: Bang
authors: Department of Clinical Biochemistry and Immunology, Statens Serum Institut, Copenhagen, Denmark.
authors: Flemming
authors: F
authors: Balstrup
authors: Department of Clinical Biochemistry and Immunology, Statens Serum Institut, Copenhagen, Denmark.
authors: Gunnar
authors: G
authors: Houen
keywords: Chromatography; Immunoglobulin G; Intravenous; Polyethylene glycol precipitation