Method of producing an anti-D immunoglobulin concentrate and a p

Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,...

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530413, 5303871, 5303891, 5303896, A61K 39395, C07K 1646, C07K 114

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active

055936750

ABSTRACT:
An anti-D immunoglobulin G-preparation is produced in high-yield 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 ion exchange chromatography with an adsorbent which has carboxymethyl groups as functional groups, the anti-D IgG being bound to the adsorbent, (B) the adsorbent with the bound anti-D IgG is first rinsed with a wash solution at a pH in the range of 5 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 adsorbent with ion-exchange characteristics in order to bind undesired components, and finally, the anti-D IgG is concentrated. The non-infectious anti-D concentrate thus obtained possesses a high specific activity of more than 1% anti-D IgG per gram of total IgG.

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