Measurement of anticomplementary activity in therapeutic intravenous immunoglobulin preparations

Biologicals : Journal of the International Association of Biological Standardization
I RamasamyA Farrugia

Abstract

Anticomplementary activity (ACA) of aggregates in intravenous immunoglobulin preparations (IVIG) was investigated using the modified Kabat and Meyer classical complement consumption method recommended by the European Pharmacopoeia and a C1q-coated microtitre enzyme-linked immunosorbent assay (ELISA). The physical characteristics of aggregates were found to affect complement binding. Aggregates formed by heating IVIG preparations at acid pH bound complement poorly, while aggregates formed by heating IVIG at neutral pH showed high ACA. This suggests that analysis of complement binding capacity provides a level of aggregate characterization of aggregates which is additional to quantitation by High-performance liquid chromatography ((HPLC). The correlation (r = 0.98) between the two tests was good when aggregates formed at neutral pH were compared, but decreased (r = 0.57) when aggregates formed at acid pH were included. A comparison of the results showed that there were no significant differences in the classification of aggregates with acceptable/unacceptable (i.e. pass/fail outcome) values of ACA. Between assay variation (CV = 7.6%) was lower in the ELISA test compared with the complement consumption assay (where percentage bind...Continue Reading

Citations

Jan 25, 2011·Biologicals : Journal of the International Association of Biological Standardization·Thanae GeorgakopoulosJoseph Bertolini
Jul 18, 2015·Biochemical and Biophysical Research Communications·Janos Szebeni, Gert Storm
Apr 30, 2014·Nutrition Journal·Heike StierJoerg Gruenwald
May 23, 1998·Annual Review of Immunology·S GhoshE B Kopp
Aug 7, 2013·Biochemical and Biophysical Research Communications·Mi LiWeijing Zhang
Sep 20, 2006·Journal of Immunoassay & Immunochemistry·El-Rashdy M Redwan

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