Genentech, Inc.

Yajun Wang

Thomas W Patapoff

Liangyi Zhang

Boyan Zhang

Daniel McDonald

George Tony Moreno

Dell Farnan

The present invention provides methods for determining chromatography separation conditions; for example, separation of a polypeptide and its charge variants. The invention also provides methods to determine a buffer condition for chromatography separation conditions. The invention also provides a robust method to analyze multiple polypeptide products.

Elucidation of ion exchange chromatography input optimization

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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Foster City, CA, United States of America

Yajun Wang