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Illuminating the Dark Host Cell Proteome: A Host Cell Protein Coverage Method for LC-MS Impurity Assays
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DOI:10.1016/j.jpba.2026.117555.png)
Abstract
En 中文
• DARK-COV pipeline quantifies theoretical LC-MS host cell protein coverage • Only 1–5% of proteins are predicted undetectable across four host proteomes • Predictions benchmarked against >15,000 experimental LC-MS datasets • Supports risk-based regulatory evaluation of LC-MS HCP impurity assays
Keywords:
Host Cell Proteins (HCPs)
Process-related impurities
Liquid Chromatography-Mass Spectrometry (LC-MS)
Coverage assessment
Dark Host Cell Proteome, DARK-COV
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