LC-MS-based analysis of HCPs can be used in support of process development to provide insight into the population of HCPs in the product throughout purification and what HCPs consistently end up in the final product. Following scale-up and/or transfer of the process, LC-MS-based analysis can be used to assess how these changes affect the capabilities of the process to clear HCPs. Depending on the strategy, LC-MS-based HCP analysis can also be used to characterize the performance of a process-specific ELISA assay in late stage development (coverage, 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/