Do you want to quantify host cell proteins in pre-clinical and clinical batches?
We identify and quantify the host cell proteins in purified drug substance batches by SWATH LC-MS. The analysis provides a much more detailed and accurate HCP documentation than ELISA. The total HCP content is measured in nanogram HCP/mg drug substance (ppm), and each host cell protein is identified and quantified individually.
You can use this LC-MS analysis to:
- Compare the HCP profile between pre-clinical tox and clinical batches
- As an orthogonal method to ELISA to document HCP content in clinical batches
- For regulatory documentation for FDA and EMA
For pure drug substance batches with low HCP-levels (1-500 ppm), we deliver a highly sensitive and reproducible analysis for both identification and quantification of host cell proteins down to low ppm concentrations.
The analysis includes:
- An optimized sample preparation for pure drug substance samples.
- Spike-in of internal standard proteins (0-2000 ppm) for quantification linearity and LOD.
- LC-MS peptide analysis on a robust microflow HPLC and Sciex TrippleTOF 6600 mass spectrometer.
- SWATH LC-MS for reproducible HCP identification and quantification. What is SWATH? >>
- Analysis report with table of total HCP and individual HCPs amounts, as well as comparison between batches.
Send us a description of your project and we will be glad to discuss Host Cell Protein analysis with you.