Decyder 2D 7.1 SPN software from GE Healthcare is designed to support 2D DIGE for the characterisation and quantitation of host cell proteins for product safety during biopharmaceutical processing.
Host cell protein (HCP) profiling is a critical quality assurance parameter associated with product safety.
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 optimisation and quality by design, according to GE Healthcare.
HCP profiling used 2D 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.
