Hoffmann-la Roche Inc.

F. Hoffmann-la Roche Ag

Genentech, Inc.

Klaus Schwendner

Roberto Falkenstein

Michael Wiedmann

Bernhard Spensberger

Benjamin Tran

Wolfgang Koehnlein

Marc Wong

Maria Laura Magri

Michaela Mehr

Frank Zettl

Annika Kleinjans

Carina Kopp

Richard St John

Paul Mcdonald

Ryan Erickson

Herein is reported a method for the final filtration of concentrated polypeptide solutions comprising the combination of two immediately consecutive filtration steps with a first filter of 3.0 μm and 0.8 μm pore size and a second filter of 0.45 μm and 0.22 μm pore size.

Multistep final filtration

Herein is reported a method for purifying a polypeptide comprising the steps of i) applying a solution comprising the polypeptide to an ion exchange chromatography material, and ii) recovering the polypeptide with a solution comprising a denaturant and thereby purifying the polypeptide, whereby the ion exchange chromatography material comprises a matrix of cross-linked poly (styrene-divinylbenzene) to which ionic ligands have been attached, and wherein the solution comprising the polypeptide applied to the ion exchange chromatography material is free of the denaturant and the polypeptide adsorbed to the ion exchange chromatography material is recovered with a solution comprising a denaturant at a constant conductivity.

Cation and anion exchange chromatography method

Herein is reported a method for producing an antibody preparation comprising the steps of a) applying a buffered solution comprising different isoforms of an antibody to a cation exchange chromatography material, b) applying a first solution with a first conductivity to the cation exchange chromatography material, whereby the antibody isoforms remain bound to the cation exchange chromatography material, and c) applying a second solution with a second conductivity to the cation exchange chromatography material and thereby obtaining the antibody preparation, whereby the conductivity of the second solution exceeds the conductivity of the first solution by not more than 10%.

Isoform enriched antibody preparation and method for obtaining it

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Weilheim, Germany

Klaus Schwendner