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.