A method for preparing an anti-D immunoglobulin G concentrate and a pharmaceutical composition containing the same

摘要

An anti-D immunoglobulin G product is prepared from plasma containing human anti-D IgG or a plasma fraction containing anti-D IgG by A) subjecting the plasma or plasma fraction at a pH in the range from 3.5 to 6.5 to an ion exchange chromatography using an adsorbent which has carboxymethyl groups as functional groups, with the anti-D IgG being bound to the adsorbent, B) washing the adsorbent with bound anti-D IgG using a washing solution, and subsequently eluting the anti-D IgG, and further C) treating the eluted anti-D IgG with a basic adsorbent with ion exchange properties in order to bind unwanted components, and finally concentrating the anti-D IgG. The non-infectious anti-D concentrate is obtained in good yield and has a specific activity of more than 0.5% anti-D IgG per gram of total IgG.