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Merck
  • In vitro and in vivo properties differ among liquid intravenous immunoglobulin preparations.

In vitro and in vivo properties differ among liquid intravenous immunoglobulin preparations.

Vox sanguinis (2012-09-26)
F Dhainaut, P-O Guillaumat, H Dib, G Perret, A Sauger, C de Coupade, M Beaudet, M Elzaabi, L Mouthon
摘要

To compare in vitro and in vivo biological and biochemical properties of five liquid intravenous immunoglobulin (IVIg) preparations licensed for therapeutic use in Europe. ClairYg(®) was compared in a blinded manner to four other liquid IVIg preparations licensed in Europe (Octagam(®) , Kiovig(®) , Gamunex(®) , Privigen(®) ). Three batches of each preparation were tested, except for the IgG repertoires and the animal model. Levels of anti-A and anti-B antibodies were lower in ClairYg(®) (0·11/0·11) relative to a positive EDQM standard and Octagam(®) (0·11/0·08) than in other preparations (0·33-0·69/0·42-0·46). IgG in ClairYg(®) recognized 365 and 416 protein spots in HEp-2 cell and Escherichia coli protein extracts vs. 230-330 and 402-842 protein spots, respectively, for IgG in other preparations. IgA content (301 vs. 165-820 ng/mg of IgG), Factor XI and Factor XII antigen (0·46 vs. 0·85-2·40 mU/mg of IgG and 7·8 vs. 20·0-46·2 lU/mg of IgG) C1q binding (0·42 vs. 0·67-1·89 arbitrary units) and C5a uptake (0·41 vs. 0·45-0·66% of activation) were lower in ClairYg(®) than in other preparations. Finally, intravenous infusion of ClairYg(®) , Gamunex(®) and Privigen(®) had no major effect on arterial blood pressure in spontaneously hypertensive rats. Our results evidence some differences in the biological and biochemical properties among licensed liquid IVIg preparations.

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乙二胺四乙酸 二钠盐 二水合物, suitable for electrophoresis, for molecular biology, 99.0-101.0% (titration)