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.
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.