Part 1

Development of biopharmaceuticals comprises many integrated steps, beginning with research and discovery and optimally ending with a commercial therapeutic molecule. Early screening of large numbers of clones and cell culture expression conditions is essential to identifying proteins that carry to greatest likelihood of clinical and commercial success.

Part one of this report reviews how high-throughput glycan screening can significantly improve current analytical strategies relating to cell line development.

Part 2

Minor impurities and changes in attributes such as glycosylation or charge heterogeneity in biopharmaceuticals can also have a profound impact on the safety and efficacy of a final product.  Traditionally, multiple analytical techniques have been required to assess the full range of biopharmaceutical product attributes, but the inevitable consequence of using multiple analytical techniques is a greater expenditure of time and resources.

Part two of this report reviews how Multiple Attribute Methodology (MAM), an orthogonal approach based on peptide map separation coupled with high-resolution mass spectrometry, is rapidly emerging as a powerful tool for characterization and monitoring of an extensive range of biopharmaceutical attributes.

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