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Optimizing a Glycoprofiling Analytical Method for Therapeutic Proteins using DSD

 

Philip J. Ramsey, Ph.D., University of New Hampshire, USA

Eliza Yeung, Ph.D., Cytovance Biologics, Inc.

Post-translational modification of proteins has a large impact on protein functional properties. One of the most important PTMs is the addition of oligosaccharide chains (glycosylation).  Protein glycosylation is a typical critical quality attribute of glycoproteins such as antibodies. A robust and cost effective glycoprofiling analytical technique is required to characterize the glycosylation structures and support process development and GMP manufacturing.  In this e-poster we demonstrate how to use Definitive Screening Designs (DSD) in combination with Generalized Regression in JMP Pro 13 to perform a measurement systems analysis and optimization of a high- performance anion-exchange chromatography method for antibody glycoprofiling. We also show how to perform an alternative analysis not requiring JMP Pro.  In addition, we will compare the results from the  DSD against a traditional Central Composite Design (CCD) run in tandem. We show that the much smaller DSD achieve the same results as the larger CCD.