Personally, I have no experience with AAV gene therapy products. Generally speaking, residual HCPs can be monitored using an ELISA-based assay. The latter can even be a commercially available kit assay for Phase 1, but should be replaced by a validated, process-specific ELISA towards Phase 3 and commercial. LC-MS-based HCP analysis is gaining momentum as well, of course, and also here, the requirements regarding the method used are similar. In early stage, it probably suffices to provide qualitative and quantitative information on residual HCPs present in the final product based on a scientifically sound method, with an acceptance criterion on the total load of residual HCPs, while for Phase 3 and beyond, the analytical method should be validated and acceptance criteria reflective of process performance and batch variation.

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/