• Open Access

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

Authors


Luc Mouthon, Institut Cochin, Pavillon Gustave Roussy, 4èmeétage, Hôpital Cochin, 8 rue Méchain, 75014 Paris, France
E-mail: luc.mouthon@cch.aphp.fr

Abstract

Objective  To compare in vitro and in vivo biological and biochemical properties of five liquid intravenous immunoglobulin (IVIg) preparations licensed for therapeutic use in Europe.

Methods  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.

Results  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.

Conclusions  Our results evidence some differences in the biological and biochemical properties among licensed liquid IVIg preparations.

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