Does the HCP community have a definitive database of common HCPs and evidence supporting either little / no impact or potential impact. Would benefit all for safety reasons
Although I am not aware of a ‘definitive database of common HCPs’, ample scientific reports have been published over the past decade about what (CHO) HCPs are typically identified in certain pharmaceutical products, mainly monoclonal antibody-based products. These publications also provide background about the function/risk of the most abundant ones observed.
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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