That depends on the situation, for example: what expression system are you using? How well is your process clearing residual host cell proteins, are there any specific high-risk host cell proteins to be expected in your product? By characterizing the qualitative and quantitative ensemble of HCPs in your product throughout the purification process, you could decide to continue using a (commercially available) ELISA, or proceed by developing an LC-MS-based assay.

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/