Host Cell Protein (HCP) detection and quantitation by mass spectrometry

Volker Kruft, Sciex, Darmstadt, Germany

The detection and quantitation of host cell protein (HCP) contamination in biopharmaceuticals is essential in biopharmaceutical drug development and manufacture. The presence of such impurities can compromise patient safety, reduce drug efficacy, and delay the release or even kill a drug candidate. Current detection methods like SDS-PAGE, HPLC, Western blot or immunoassay might lack in sensitivity, specificity, or coverage.

Ideally, a method to screen for all possible HCPs contaminating production or formulation must be generic to the host cell and cover the complete set of host cell proteins. This is practically impossible with the methods mentioned above. SWATH® acquisition by mass spectrometry (MS) is close to ideal; it acquires MS and MS/MS data that represent every precursor mass of interest at every time point, thus mapping the complete set of potentially contaminating HCPs. We will show data that demonstrate the detection and quantitation to about 1 ppm of host cell protein. In addition, as MS has emerged as a de-facto technology for the discovery and development of biotherapeutics, we will demonstrate the ability of MS to provide highly accurate and detailed data on biopharmaceutical products, including their integrity, modifications and modification sites, and many other aspects that are unparalleled by any other single technique.

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Abstract Reference & Short Personal Biography of Presenting Author

Volker Kruft received his PhD from the Max-Planck-Institute of Molecular Genetics under the guidance of Prof. H.-G. Wittmann, working on structure-function relationships of the prokaryotic ribosome. He joined Sciex in 1993 as a product specialist for protein analysis. Since then, he has held various positions at Sciex in support and technical marketing. Currently he holds the position of Senior Business Development Manager for the high growth regions in Africa, Middle East and Eastern Europe/Russia.