Csl Limited

Rotkreuzstiftung Zentrallaboratorium Blutspendedienst

Martin Stucki

Yvonne Vucica

Gary Lee Warren

Christoph Kempf

Peter Lerch

Gerhard Hodler

A method for purifying Apo A-I is provided including the steps of providing a solution comprising Apo A-I and guanidine hydrochloride and filtering the solution through a filter having a pore size in a range from 15 nm to 35 nm to thereby reduce viral contamination of the Apo A-I. An Apo A-I preparation is provided having at least a 12 log LRV (log reduction value) for a parvovirus; and/or at least 9 log LRV for a non-enveloped virus; and/or at least 8.5 log LRV for a lipid enveloped virus. Also provided are pharmaceutical compositions and reconstituted high density lipoprotein formulation comprising Apo A-I and methods of treating diseases disorders or conditions.

Contaminant removal method

A method for purifying Apo A-I is provided including the steps of providing a solution comprising Apo A-I and guanidine hydrochloride and filtering the solution through a filter having a pore size in a range from 15 nrn to 35 nm to thereby reduce viral contamination of the Apo A-I. An Apo A-f preparation is provided having at least a 12 log LRV (log reduction value) for a parvovirus; and/or at least 9 log LRV for a non-enveloped virus; and/or at least 8.5 log LRV for a lipid enveloped virus. Also provided are pharmaceutical compositions and reconstituted high density lipoprotein formulation comprising Apo A-I and methods of treating diseases disorders or conditions.

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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Laupen, Switzerland

Martin Stucki