METHOD OF PRODUCING A CONCENTRATE OF ANTI-D IMMUNOGLOBULIN GAND PHARMACEUTICAL PREPARATION WHICH CONTAINS IT

摘要

An anti-D immunoglobulin G-preparation is produced from human plasma containing anti-D IgG or a plasma fraction containing an anti-D IgG in which A) the plasma or the plasma fraction, with a pH in the range of pH 3.5 to 6.5 and a conductivity value in the range of 2 to 4 mS/cm, is subjected to an ion exchange chromatography with an adsorbant which has carboxymethyl groups as functional groups, the anti-D IgG being bound to the adsorbant, B) the adsorbant with the bound anti-D IgG is first rinsed with a wash solution at a pH in the range of to 8 and a conductivity value in the range of 2 to 4 mS/cm, and the anti-D IgG is subsequently eluted, and further C) the eluted anti-D IgG at a pH in the range of 6 to 8 and a conductivity value in the range of 2 to 4 mS/cm is treated with an alkaline adsorbant with ion-exchange characteristics in order to bind unde- sired components, and finally the anti-D IgG is concentrated. The non-infectious anti-D concentrate obtained with a high yield possesses a high specific activity of more than 1% anti-D IgG per gram of total IgG.