What different approaches can be used to develop a quantitative LC/MS assay for HCP impurities? Compare and contrast. Which one tends to be the most accurate and precise?
This co-publication between USP and Alphalyse has a very good comparison of LC-MS approaches and performance on ICH Q2 guidelines on e.g. accuracy and precision. “Host cell protein quantitation by LC-MS. Experimental demonstration, qualification, and comparison of methods in USP 1132.1” 10.1016/j.jpba.2025.117051
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/
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