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.
This LC-MS analysis is particularly good when you need to:
- Compare the HCP profile between pre-clinical tox and clinical batches.
- 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) you receive a highly sensitive and reproducible analysis. It both delivers identification and quantification of host cell proteins down to low ppm concentrations.
The HCP 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 contact you to discuss how you can benefit from Host Cell Protein analysis.