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HOST CELL PROTEIN ANALYSIS BY MASS SPECTROMETRY

SHARESHARESHARE
The analysis of Host Cell Proteins (HCPs) has historically been performed using ELISA-based tests. A number of off-the-shelf products (e.g. Cygnus kits) are available and the testing is relatively straightforward. However, it been recognized for some time that these kits generally allow detection of a maximum of ~70% of the HCPs present in biopharmaceutical products. This is due to the fact that in any anti-HCP antibody pool, there won’t be antibodies available to cover the entire spectrum of HCP species present.