Analyzing Host Cell Proteins (HCPs)

The analysis of HCPs has historically been performed using ELISA-based tests. The level of coverage achieved using off-the-shelf kits can be improved with the use of product-specific methods, but a significant number of HCPs are still likely to be missed, especially very weakly immunogenic or non-immunogenic species.

In contrast to HCP-ELISA, which relies on the presence of polyclonal antibodies for positive HCP detection, Mass Spectrometric (MS) approaches have the advantage of detecting a wider population of HCPs in a de novo manner, without prior knowledge, specialized polyclonal antibody reagents or product and process specific method development.

Due to these technical benefits, HCP-MS has emerged as an orthogonal technique that serves to expand the identification of HCPs, with regulatory groups advising that HCP assessments should include MS as part of the normal process and product development.

The BioPharmaSpec Approach

BioPharmaSpec provides a service for MS-based HCP detection and quantitation as an orthogonal support to HCP-ELISA.

Phase 1

Qualitative analysis to identify protein impurities present in each sample.

Phase 2

Quantitation against the response from a known protein spiked into the sample.

Phase 3

Quantitation of HCPs of particular interest against heavy labeled marker peptides.

Phase 4

Routine testing of samples.

Contact BioPharmaSpec for more information on MS-based HCP detection and quantitation.