Genentech, Inc.

F. Hoffmann-la Roche Ag

Boyan Zhang

Thomas W Patapoff

Steven J Meier

Martin Gawlitzek

Natarajan Vijayasankaran

Yi Yang

Sharat Varma

Yajun Wang

Liangyi Zhang

George Tony Moreno

Dell Farnan

Veronica Carvalhal

Melissa S Mun

Silvana R Arevalo

The present invention provides methods for analyzing compositions of polypeptides such as antibodies by ionic strength-mediated pH gradient ion exchange chromatography. In some aspects, the methods use a combination of pH gradients and ionic strength gradients to separate the polypeptide from charge variants of the polypeptide. In some aspects, the methods use a stable ionic strength to optimize the pH gradient separation window to separate the polypeptide from charge variants. Such methods are useful for analyzing polypeptide, e.g. antibodies, with a pI greater than 9 or a pI less than 7. In some aspects, the invention provides a multiproduct method for the analysis of polypeptides of varying pI's.

Ionic strength-mediated pH gradient ion exchange chromatography

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South San Francisco, CA, United States of America

Boyan Zhang