LC-MS based coverage analysis of the ELISA antibody as well as characterization of the HCP standard fit to actual HCPs in process, are typically included.

Ejvind Mørtz, PhD, Co-Founder & COO of Alphalyse in Denmark, discusses the regulatory expectations for HCP analysis, highlighting the importance of USP <1132.1> to improve MS-based data quality. Don’t miss his presentation and expert insights at the panel discussion.

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/

When LC-MS is used to assess the coverage of a (kit) ELISA, an evaluation is made of the HCPs that are recognized by the polyclonals and the ones that are not recognized. This coverage is then included in the dossier. The details, e.g. about the specifics of the LC-MS procedure and how well is the (kit) ELISA capable of detecting various HCPs across the molecular weight and pI range can be provided upon request.

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/