Host Cell Protein Analysis

Secure your regulatory dossier and improve your biomanufacturing robustness and consistency with a full analytical characterization of HCP at each step of your Down Stream Process (DSP) to secure your clinical trials.

Get identification and quantification of each individual host cell protein thanks to our HCPprofiler solution.

  • Individual HCP identification

  • Individual quantification of all HCPs

  • Improved quality control

  • Detailed report and recommandations

  • HCP ELISAs do not provide any details about the individual HCPs in your samples. HCP analysis by LC-MS gives you a list of individual HCPs and their physico-chemical properties to improve your DSP (MW, Pi, biological function...).

  • Our solution provides an accurate quantity assessment of your HCPs thanks to our proprietary standard and the READYBEADS technology, better than a simple relative quantification

  • Thanks to reproducibility and accuracy, our QC allow to compare batches and monitor DSP through time. Our specific software developed allows high consistency in analysis and clear data visualisation.

  • Get a full report with all HCPs identified and quantified in your sample at each step of your bioprocess with their physicochemical properties and their impact on your biologic stability.


Analysis for bioprocess optimization

  • > Compare HCP profiles for batches transfer

  • > Monitor HCPs to improve DSP process

Clinical Batch

  • > Analysis of pre-clinical and clinical batches for consistency

Specific HCPs

  • > Monitor and quantitate specific HCPs of concern based on your risk assessment.

Biosimilars

  • > Compare batches to improve your bioprocess

Coverage Analysis

  • > Validate your ELISA assay

  • > Characterize your raw materials (Anti-HCPs)

  • > Identify your HCPs

Residual Proteins

  • > Analysis of process-related residuals proteins