Quality control in the production of an immunoglobulin for intravenous use

Abstract

This paper briefly surveys the control measures and tests which are carried out before, during and after manufacture of an i.v. immunoglobulin in order to assure the quality of the preparation. The quality requirements are determined by both the standards expected by physicians and patients and by the specifications of the registration authorities in the various countries. A great deal of know-how and considerable technical investment is required to match these requirements. Furthermore a comprehensive quality assurance programme is compulsory: It begins with the careful collection and analysis of each single blood donation, continues through all the manufacturing stages and ends with the rigorous testing of every batch of the end product - an examination comprising 23 different tests.

Prophylaxis and Therapy for Chikungunya Virus Infection

“…Normal human Ig for intravenous administration (Tégéline) is a highly purified preparation obtained from plasma donors registered in France since 1996 [29]. Although Tégéline is obtained from plasma donors in continental France, where CHIKV is absent, after the outbreak in La Ré-union, the Etablissement Français du Sang implemented measures to prevent CHIKV transmission by transfusion in continental France, and all symptomatic travelers returning from areas where CHIKV circulates are excluded from donation for 2 weeks.…”

Effects of the manufacturing process on the anti‐A isoagglutinin titers in intravenous immunoglobulin products

“…IVIG product lots and intermediate fractions were produced from cryo‐poor plasma according to the manufacturing processes of either Sandoglobulin (CSL Behring AG, Berne, Switzerland), a lyophilized sucrose‐stabilized IVIG product prepared by the Kistler and Nitschmann method (a Cohn‐like fractionation method optimized for IgG extraction), or Privigen (CSL Behring AG ), a 10% l ‐proline–stabilized IgG solution produced by a chromatography‐based process …”

“…3,[7][8][9] In spite of the improvements to the purity of IVIG products, the presence of anti-A/B isoagglutinins originating from donor plasma is considered a probable cause of the rare cases of hemolysis in patients treated with IVIG products. [10][11][12][13] In this study we compared the anti-A/B isoagglutinin titers in IVIG preparations derived from Cohnlike and chromatography-based manufacturing processes.…”

Affinity-Purified Human Immunoglobulin G That Binds a Lacto-N-Neotetraose-Dependent Lipooligosaccharide Structure Is Bactericidal for Serogroup BNeisseria meningitidis

“…Immune globulin intravenous (human) Carimune NF (IGIV) (ZLB Behring AG, Berne, Switzerland) was used as the source of antibody (96% IgG according to the manufacturer's package insert). This concentrated, purified IgG pharmaceutical product is produced from pooled blood donations and contains all of the IgG antibodies that regularly occur in the blood donor population (16). One gram diluted in 50 ml phosphate-buffered saline (PBS) was loaded onto a column and allowed to bind to LOS.…”