In principle, it’s not, assuming an ELISA is (commercially) available to provide insight into the total levels of residual HCPs in the final product. In case you’re using a non-standard expression system, there might be a need to perform LC-MS-based HCP analysis already in early stage, as that might be one of the few ways to obtain information on the presence and abundance of residual HCPs.

Don’t miss Eef Dirksen, Director of Analytical Development and Quality Control at Byondis (Netherlands), who discusses regulatory expectations for HCP analysis and highlights the importance of USP <1132.1> in improving MS-based data quality.

Watch the On-Demand presentation here: https://bio-qc.com/regulatory-expectations-for-your-hcp-analysis-meet-usp-1132-1-to-enhance-the-quality-of-ms-based-data/