Hoffmann-la Roche Inc.

Genentech, Inc.

F. Hoffmann-la Roche Ag

Bernhard Spensberger

Roberto Falkenstein

Michael Wiedmann

Benjamin Tran

Klaus Schwendner

Wolfgang Koehnlein

Marc Wong

Maria Laura Magri

Yinges Yigzaw

Jeevan Prabhakar

Jie Gu

Alexandra Thomas Morris

Christian Meyer

Michael Leiss

Franziska Edelmann

Tobias Graf

Michaela Mehr

Frank Zettl

Annika Kleinjans

Carina Kopp

Richard St John

Paul Mcdonald

Ryan Erickson

The present disclosure provides purification platforms comprising a depth filter step and/or a hydrophobic interaction chromatography (HIC) step. Also disclosed herein are methods of using the purification platforms described herein and compositions obtained therefrom, such as pharmaceutical compositions.

Methods of reducing the enzymatic hydrolysis activity rate in a composition obtained from a purification platform

Herein is reported a method for the purification of a protein comprising erythropoietin and a single poly (ethylene glycol) residue from reaction by-products or not reacted starting material by a cation exchange chromatography method. It has been found that by employing a cation exchange Toyopearl® SP-650 chromatography material and employing a second wash step with an increased pH value compared to the first wash step a fusion protein of erythropoietin and a single poly (ethylene glycol) residue can be obtained in a single step with high purity and yield and suitability for large scale applications.

Method for purifying PEGylated erythropoietin

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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Eberfing, Germany

Bernhard Spensberger