EMA reviewers are recommending a science-driven risk-based HCP control strategy using best practice methods, including USP chapters 1132, 1132.1, with both ELISA and LC-MS methods. Use of current information about individual problematic HCPs are expected. ELISA alone is a black box without knowledge about the most abundant HCPs, potential problematics HCPs. Best practice is to include LC-MS to characterize ELISA reagents for individual HCP coverage, and for HCP profiling of the DS as orthogonal method to ELISA.

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/