Characterisation of Anti-HCP antibodies by 2D differential Gel Electrophoresis

Host-cell proteins are a major class of process-related impurities in biotherapeutics that can impact the safety and efficacy of the product.

Despite the advent of advanced analytical techniques, ELISA remains as the industry gold standard for the detection and quantification of HCPs during process development and for routine testing.

However, it is necessary to understand the limitations of this technique, most of which are related to the anti-HCP antibodies used in the test. This application note describes an alternative approach for the characterisation of the HCP coverage of these anti-HCP antibodies.