Automated Workflow for Host Cell Protein Monitoring by Mass Spectrometry: From Raw Data to Final Report

October 2, 2017

Presented at CASSS: Mass Spec, Boston, MA, USA

Allowing unbiased identification and high throughput quantification of multiple low-abundant proteins, mass spectrometry (MS) is proving to be the ideal analytical platform to provide a thorough assessment of host cell proteins (HCPs) in biotherapeutics.
However, the use of MS for HCP analysis also poses some challenges:

  • HCP contaminations can span a wide range of on centrations, with low abundant species present at the ppm level;
  • a number of analytical approaches are currently being explored, however no standardized methods are available yet;
  • robustness and reproducibility issues with complex MS instrumentation and methods delay deployment in regulated environments such
  • as production and quality control (QC).

We present an instrument- and vendor- independent software platform that allows innovative analytical approaches to address the major
challenges related to the identification, quantification, and routine monitoring of HCPs by MS.

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