Aventis Behring Gmbh

Csl Behring Lengnau Ag

Thomas Nowak

Hubert Metzner

Gerhardt Kumpe

Dieter Bernhardt

Carsten Horn

Albrecht Gr&ouml;ner

Tobias Brandt

Eckhard Schueler

A process for purifying a recombinant protein comprising the steps of: i) providing a solution comprising the recombinant protein; ii) adding an alkyl glycoside to the solution; and iii) purifying the recombinant protein. The addition of the alkyl glycoside provides improved clearance of process-related impurities. The purified recombinant protein of the invention has low levels of host cell DNA, host cell protein and viral contamination.

Protein purification and virus inactivation with alkyl glycosides

A process for the inactivation and/or elimination of coated and/or noncoated viruses from a plasma protein solution by addition of an ammonium salt at alkaline pHs is described, in which a chromatographically prepurified plasma protein solution is subjected to an incubation at room temperature and at an ammonium salt concentration of 13 to 22% by weight, pasteurized at approximately 60&deg; C. for several hours after separation of the precipitates and removal of the ammonium salt down to a residual content of less than 0.5 mol/l and then processed to give a therapeutically employable plasma protein preparation.

Process for the inactivation of viruses

The invention relates to the removal of viruses from aqueous solutions, as a rule protein solutions, by ultrafiltration. This entails the viruses to be removed being increased in size by incubation with a high molecular weight receptor binding thereto, preferably a specific antibody, so that, on the one hand, the separation effect is improved and, on the other hand, a larger pore diameter which can now be chosen for the filters used also makes it possible for smaller viruses to be separated from larger protein molecules present in protein solutions, and, where appropriate, the filtration rate is increased.

Removal of viruses from protein solutions by ultrafiltration

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Staufenberg, Germany

Thomas Nowak