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Increases efficiency of process development and scale up stages
GE Healthcare has launched DeCyder 2D 7.1 SPN software, specifically designed to support 2-D DIGE for the characterization and quantitation of Host Cell Proteins (HCPs). HCP profiling is a critical Quality Assurance parameter associated with product safety during biopharmaceutical processing.
The software package offers an antibody-independent procedure to enable direct comparisons of individual target protein/HCP profiles between samples taken from distinctly different steps of a process. This capability increases process understanding, and facilitates process optimization and Quality by Design.
HCP profiling using 2-D DIGE is used in early process development, where it is critical to be able to track HCP changes resulting from process parameter changes. It is also used at several steps of the scale up process, from process development through to manufacturing, and can validate the use of ELISA in downstream processing.
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About 2-D DIGE
2-D electrophoresis is an established method, commonly used in proteomic research for analyzing complex protein mixtures. 2-D DIGE was developed with the aim of simplifying the process and improving quantitation. 2-D DIGE is an electrophoretic method, which allows detection and accurate quantitation of small differences in protein abundance between different samples with high statistical confidence. The Ettan™ DIGE technology allows for simultaneous co-separation of two different samples, plus an internal standard, on an individual gel. The protein samples and internal standard are each fluorescently labeled with a different CyDye™ DIGE Fluor dye. Because two samples are multiplexed using the same internal standard on each gel, and each protein spot has its own corresponding internal standard spot used for normalization, all gels can be directly compared, reducing the number of gels required for each experiment.
Dr Lynne Trowbridge, Katie Odgaard, Karen Manser
+44 (0)20 7866 7861
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