Technical advancement and practical considerations of LC-MS/MS-based methods for host cell protein identification and quantitation to support process development

Technical advancement and practical considerations of LC-MS/MS-based methods for host cell protein identification and quantitation to support process development

Host cell proteins (HCPs) are process-related impurities derived from the manufacturing of recombinant biotherapeutics. Residual HCP in drug products, ranging from 1 to 100 ppm (ng HCP/mg product) or even below sub-ppm level, may affect product quality, stability, efficacy, or safety. Therefore, rem...

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Bibliographic Details
Main Authors: Jia Guo, Regina Kufer, Delia Li, Stefanie Wohlrab, Midori Greenwood-Goodwin, Feng Yang
Format: Article
Language:English
Published: Taylor & Francis Group 2023-12-01
Series:mAbs
Subjects:
Host cell protein (HCP)
identification
impurities
liquid chromatography tandem mass spectrometry (LC-MS/MS)
process development
quantitation
Online Access:https://www.tandfonline.com/doi/10.1080/19420862.2023.2213365
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https://www.tandfonline.com/doi/10.1080/19420862.2023.2213365

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