YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

Clq-Coated Microtitre Enzyme-linked Immunosorbent Assay for Measuring the Anticomplementary Activity of Intravenous Immunoglobulin Preparations

Clq-coated ELISA법을 이용한 정맥용 면역글로불린제제의 항보체성 측정

  • 강혜나 (식품의약품안전청 생물학평가부) ;
  • 김순남 (식품의약품안전청 생물학평가부) ;
  • 신광훈 (국립보건원 세균질환부) ;
  • 허숙진 (경인지방청 식품의약품안전청 시험분석실)
  • Published : 2001.12.01
Download PDF
⟨ Previous Next ⟩

Abstract

The quality of an intravenous immunoglobulin preparation (IVIG) is reflected by the degree of nonspecific activation of complements, the so-called anticomplementary activity (ACA). ACA of aggregates in IVIG was investigated using method by the European Pharmacopoeia and Clq-coated microtiter enzyme-linked immunosorbent assay (ELISA). Both the EP method and the ELISA method showed a dose response curve with the amount of complements bound increasing with the percentage content of aggregates in immunoglobulin standard. The correlation between the two tests was good (r=0.96, r=0.99). However, the correlation was not found when the ACA (EP method) of IVIG product was compared with its aggregate percentage. These results emphasize that the method of aggregate formation affects ACA and that estimation of the percentage distribution of aggregates by HPLC may not reflect ACA. In analysing WIG product for Clq binding activity test with the ELISA, the result by using Protein A-HRP correlated with aggregate percentage (r=0.84). But the correlation decreased (r=0.48) when the result used Protein A-AP(having poorer sensitivity than HRP) was compared with aggregate percentage. As a result, some variation between the two methods, due to differences in assay principles, is to be expected. However, ELISA technique has the advantage in that it is easier to perform, more precise and less subject to reagent variability, and is the more suitable screening method than HPLC analysis.

Keywords

References

  1. J. of Immunological Method v.164 no.101 Microtitier plate assay for measuring the anticomplementary activity of immunoglobulins Torma, E.;Suomela, H.;Hamalaine, E.
  2. Vox Sang v.39 no.101 Preparation of a stable intravenous gamma-globulin : process design and scale-up Fernandes, P. M.;Lundblad, J. L.
  3. The Annual Report of Ministry of Health and Welfare v.19 no.61 A study on anticomplementary activity of immunoglobulin products Cho, M. K.;Lee, Y. W.;Park, M. Y.
  4. Vox Sang v.51 no.10 Intravenous immunoglobulins : Pharmacological aspects and therapeutic use Hassig, A.
  5. Vox Sang v.56 no.155 Inactivation and elimination of virus during the fractionation of an intravenous immunoglobulin preparation : Liquid heat treatment and polyethylene glycol fraction Uemura, Y.;Uriyu, K.;Hirao, Y.;Takechi, K.;Ishikawa, H.;Nakajima, T.;Kagitani, Y.;Yokoyama, K.;Hamamoto, Y.;Tochikura, T. S.;Yamamoto, N.
  6. Biologicals v.25 no.87 Measurement of anticomplementary activity in therapeutic intravenous immunoglobulin preparations Ramasamy, I.;Tran E.;Farrugia, A.
  7. European Pharmacopoeia Tests for anticomplementary activity of immunoglobulins
  8. Experimental immunochemistry(2nd Ed.) Kabat, E. A.;Meyer, M. M.
  9. 생물학적제제기준 및 시험방법
  10. Immunology v.35 no.873 Possible mechanisms of the first step of the classical complement activation pathway : binding and activations of C1 Fust, G.;Medgyesi, G. A.;Rajnavolgyk;Eva;Csecsi-Nagy;Maria;Czikora;Klara;Gergely, J.
  11. Vox Sang v.67 no.339 Antibody Fc functional activity of intravenous immunoglobulin preparations treated with solvent-detergent for virus inactivation Joy Yang, Y. H.;Ngo, C.;Ng Yeh, I.;Uemura, Y.
  12. Journal of Immunological Methods v.83 no.36 Quantitation of circulating immune complexes in human serum by the Raji cell and F(ab')2 anti-C3 micro enzyme immunoassays Jordan, S. C.;Gautier, E.;Sakai, R.;Bahn, L.
  13. The Journal of Biological Chemistry v.255 no.2822 Effects of pH treatments and deglycosylation of rabbit immunoglobulin G on the binding of C1q Winkelhake, J. L.;Kunicki, T. J.;Elcombe, B. M.;Aster, R. H.
  14. Molecular Immunology v.25 no.41 Immunolobulin G dimer : An idiotype-anti-idiotype complex Tankersley, D. L.;Sue Preston, M.;Finlayson, J. S.
  15. Immunology v.45 no.705 Influence of aggregate size on the binding and activation of the first component of human complement by soluble IgG aggregates Doekes, G.;Vanes, L. A.;Daha, M. R.
  16. FEBS Letters v.112 no.152 Antigen-independent activation of the first component of complement C1 by chemically crosslinked rabbit IgG-oligomers Tschopp, J.;Schulthess, T.;Engel, J.;Jaton, J-C.
  17. Immunological Investigations v.19 no.109 Development and evaluation of a rapid, semi-automatic micro-method for CH50 estimation using a computor program Blann, A. D.;Lewin, I.;Bacon, P. A.
  18. Immunochemistry v.8 no.1011 The reaction of monomeric and aggregated immunoglobulins with C1 Augener, W.;Grey, H. M.;Cooper, N. R.;Muller-Eberhard, H. J.
  19. Journal of Immunologic Methods v.31 no.11 Aggregated human immunoglobulin G stabilized by albumin : A standard for immune complex detection Kauffmann, R. H.;Van Es, L. A.;Daha, M. R.