Quality criteria for i.v.-immunoglobulins: importance of tests and product properties

Quality criteria for i.v.-immunoglobulins (i.v.- Igs) are critically discussed laying emphasis on spontaneous anticomplementary activity (aca) and size-dependent composition. Considering the percentage of fractions obtained by gel filtration (Ultrogel AcA 34), however, the monomeric IgG containing f...

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Bibliographic Details
Published inBehring Institute Mitteilungen no. 80; p. 16
Main Authors Gronski, P, Kanzy, E J, Ronneberger, H J, Geursen, R, Seiler, F R
Format Journal Article
LanguageEnglish
Published Germany 01.06.1986
Subjects
Complement C3 - immunology
Complement System Proteins - immunology
Humans
Immunodiffusion - methods
Immunoglobulin A - standards
Immunoglobulin G - immunology
Immunoglobulin G - standards
Immunoglobulins - administration & dosage
Immunoglobulins - standards
Injections, Intravenous
Macromolecular Substances
Nephelometry and Turbidimetry - methods
Quality Control
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Summary:Quality criteria for i.v.-immunoglobulins (i.v.- Igs) are critically discussed laying emphasis on spontaneous anticomplementary activity (aca) and size-dependent composition. Considering the percentage of fractions obtained by gel filtration (Ultrogel AcA 34), however, the monomeric IgG containing fraction contributed the major part of aca under the experimental conditions chosen. Subclass IgG3 seems to contribute considerably to aca. No correlation was found between aca and the percentage of fractions containing components larger in size than IgG dimers in various commercially available Igs. Moreover, the subclass distribution in different batches of individual products showed considerable variations. The amount of IgG4 is correlated with that of IgA in chemically unmodified products relatively poor in IgA (approx. less than or or equal to 10 mg/5 g Ig), indicating that attempts to reduce IgA consequently result in removal of IgG4.
ISSN:0301-0457