Although no formal requirement exist to include mass spec data, it is becoming more frequent in regulatory filings. With the USP chapter 1132.1 it is also becoming expected.

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/

Generally speaking, no MS data are required in the IND in the context of residual HCP analysis, assuming that an ELISA is available to evaluate the levels of residual HCPs in the final product. Depending on the analytical control strategy an ELISA-based, or an LC-MS-based method will be developed and eventually validated. This means more MS data are expected: either to show the performance of the LC-MS-based method, or that of the (process-specific) ELISA-based method (coverage of the polyclonals, populations of HCPs that are, or are not, recognized by the polyclonals, etc.)

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/