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Host cell protein quantification workflow using optimized standards combined with data-independent acquisition mass spectrometry

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Journal of Pharmaceutical Analysis 2023年第5期13卷 494-502页

作者： steve hessmann Cyrille Chery Anne-Sophie Sikora Annick Gervais Christine Carapito BioOrganic Mass Spectrometry Laboratory(LSMBO) IPHC UMR 7178University of StrasbourgCNRSProFI-FR2048Strasbourg67000France Department of Analytical Development Sciences for Biologicals UCB Pharma S.A.Braine l'Alleud1420Belgium

Monitoring of host cell proteins(HCPs)during the manufacturing of monoclonal antibodies(mAb)has become a critical requirement to provide effective and safe drug ***-linked immunosorbent assays are still the gold standard methods for the quantification of protein ***,this technique has several limitations and does,among others,not enable the precise identification of *** this context,mass spectrometry(MS)became an alternative and orthogonal method that delivers qualitative and quantitative information on all identified ***,in order to be routinely implemented in biopharmaceutical companies,liquid chromatography-MS based methods still need to be standardized to provide highest sensitivity and robust and accurate ***,we present a promising MS-based analytical workflow coupling the use of an innovative quantification standard,the HCP Profiler solution,with a spectral library-based data-independent acquisition(DIA)method and strict data validation *** performances of the HCP Profiler solution were compared to more conventional standard protein spikes and the DIA approach was benchmarked against a classical datadependent acquisition on a series of samples produced at various stages of the manufacturing *** we also explored spectral library-free DIA interpretation,the spectral library-based approach still showed highest accuracy and reproducibility(coefficients of variation<10%)with a sensitivity down to the sub-ng/mg mAb ***,this workflow is today mature to be used as a robust and straightforward method to support mAb manufacturing process developments and drug products quality control.

关键词： Host cell proteins Absolute quantification standards Data-independent acquisition

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