Host cell protein analysis of clinical batches
- Compare the HCP profile between pre-clinical and clinical batches
- Orthogonal method to ELISA to document HCP content in clinical batches
- Regulatory documentation for FDA and EMA
Do you want to quantify host cell proteins in pre-clinical and clinical batches?
Before entering clinical trials and submitting NDA or BLA, it is highly critical to determine the level of process-related impurities, Host Cell Proteins (HCPs).
By applying mass spectrometry, you have the complete overview of the HCP content beforehand and avoid costly delays at later-stage trial approval. Also you can compare different clinical batches to check for manufacturing consistency.
We identify and quantify the host cell proteins in purified drug substance batches by SWATH LC-MS/MS. The analysis provides a 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.
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:
- 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 mass spectrometer, using SWATH LC-MS/MS for reproducible HCP identification and quantification
- 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.