Do you happen to already use LC-MS for HCP characterization in QC and how is the GMP aspect of the processing and software managed ?
Yes, Alphalyse has many LC-MS projects in QC. See our webinar with BioQC for further in-depth information and discussions: ‘Moving HCP LC-MS analysis into a GMP environment’ https://bio-qc.com/moving-hcp-lc-ms-analysis-into-a-gmp-environment/
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/
The company I work for is not running LC-MS-based HCP analysis in a GMP environment, so I don’t have experience with the GMP aspects of data processing and software, but I assume this is no different from the requirements for other acquisition and processing software used in GMP (traceability, data integrity, audit trails, etc.). https://www.biorxiv.org/content/10.64898/2026.03.06.710150v1.full.pdf
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/
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