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.

There is an increasing awareness of the valuable contribution that mass spectrometry (MS) can play in defining the HCP profile of a product more fully. MS approaches have the distinct advantage of detecting a wider population of HCPs in a de novo manner without prior knowledge or specialized antibody reagents, resulting in a complimentary HCP profile to the ELISA based HCP detection. MS is a highly sensitive, non-biased method for structural analysis that can lead to a better understanding of the product HCP profile and therefore higher product quality.

This webinar will describe the use of MS based analytical techniques as an orthogonal approach to HCP-ELISA and how, through the availability of new technologies and more specialized software, MS can be applied in to examine HCP profiles as fully as possible.


 

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