Amgen Inc.

Junfen Ma

Chio Mui Chan

Elaheh Binabaji

Xiaoyang Zhao

Diana Woehle

Hai Hoang

Brian Williamson

Rafael Gonzalez

Hadley Krizner

The present disclosure relates to methods of re-oxidizing an antigen-binding protein.

Method of antigen-binding protein production

Methods of producing an aqueous formulation of an antigen-binding protein or enhancing re-oxidation of an antigen-binding protein are disclosed. The methods comprise (a) contacting an aqueous solution comprising antigen-binding protein molecules with a charged depth filter under conditions sufficient to enhance re-oxidation of the antigen-binding protein molecules and achieve a decrease in the percentage of reduced antigen-binding protein molecules, compared to the percentage of reduced antigen-binding protein molecules observed prior to step (a); and (b) optionally, measuring the amount or relative amount of reduced antigen-binding protein molecules. Formulations comprising a re-oxidized antigen-binding protein are also described.

Charged depth filtration of antigen-binding proteins

Disclosed are methods of purifying a protein sample. More specifically, provide are methods of removing or reducing the amount of high molecular weight species and/or high mannose species from a protein sample using a mixed mode chromatography step and a hydrophobic interaction chromatography step.

Protein purification methods to remove impurities

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Thousand Oaks, CA, United States of America

Junfen Ma