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Illuminating the Dark Host Cell Proteome: A Host Cell Protein Coverage Method for LC-MS Impurity Assays

delete2026-05-09
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OA
AI
V
Victor G Chrone *
M
Mads Kofoed
A
Anette H. Draborg
V
Veit Schwämmle
T
Thomas Kofoed
P
Peter Højrup
E
Ejvind Mørtz
DOI:10.1016/j.jpba.2026.117555delete
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Abstract

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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Journal

Journal of Pharmaceutical and Biomedical Analysis cover
Journal of Pharmaceutical and Biomedical Analysis
IF:
3.1
Papers:
1.5W
Citations:
2.5W

Organization

A
alphalyse a/s
Scholars:
5
Papers: 1
Citations: 0
U
university of southern denmark
Scholars:
3.1K
Papers: 1.4K
Citations: 1
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