In some cases it is an advantage to do GMP LC-MS analysis. E.g. when no suitable ELISA is available and it takes 2 years, a lot of money, and assay development risk if the coverage is too low. In other cases where ELISA cannot give the provided specificity for a problematic HCP, or the product is too complex with impurities from multiple sources.

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/

It is not needed to perform LC-MS-based HCP analysis in a GMP environment: in most cases, ELISA-based analysis works fine (and is accepted). The fact that LC-MS-based characterization (non-GMP) of (residual) HCPs throughout development can provide valuable insights into process performance and product quality is a great benefit and this information can be used to assess whether the analysis of residual HCPs in the final product can best be done by ELISA, or by LC-MS.

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/