학술논문
In Search of The Needle in The Mariana Trench: Host Cell Proteins and the Problem of Dynamic Range.
Document Type
Article
Source
Subject
*HIGH performance liquid chromatography
*BIOPHARMACEUTICS
*MASS spectrometry
*TRENCHES
*DRUG efficacy
MARIANA Trench
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Language
ISSN
1471-6577
Abstract
In the course of biopharmaceutical production, host cell proteins (HCPs) may end up in the final drug product despite extensive purification processes. Since these contaminants potentially affect the efficacy and safety of a drug, regulatory guidelines require their levels to be as low as technically feasible. Consequently, the low abundance of HCPs relative to the drug substance (typically, below 100 ppm) poses a key challenge for analytical methods, which must cover a wide dynamic range of up to six orders of magnitude. Here, we outline the root of the analytical problem and review recent advances in HCP characterization, with special emphasis on high performance liquid chromatography mass spectrometry (HPLC-MS)-based methods and HCP-enrichment techniques. [ABSTRACT FROM AUTHOR]