Do you want to monitor specific HCPs in your drug substance?
Alphalyse can setup Multiple Reaction Monitoring (MRM) LC-MS methods for quantification of specific host cell proteins in your process samples.
Individual HCPs can influence the product safety by:
- Immunogenicity. May induce an immune response against the drug substance or a human protein.
- Enzymatic activity. May degrade the drug substance or constituents in the drug product.
- Biological activity or Homology to the drug substance.
Therefore, we determine the quantity of your HCPs of concern by a targeted and sensitive LC-MS/MS analysis. For this purpose we identify unique signature peptides for the specific protein. For quantitation, we use synthetic isotope-labeled signature peptides or the intact reference protein. The labeled peptides are spiked in known amounts into the samples to generate standard curves for linearity and calibration.
The Host Cell Protein Analysis service includes:
- Absolute quantification of HCPs of concern by MRM LC-MS/MS.
- Identification of 3 unique signature peptides for quantitation.
- Standard curves and thus linearity assessment for dilution series of drug substance and quantification standards.
- Finally, reporting with determined protein amounts and analysis details.
Send us a project request so we can adjust the HCP MRM analysis to meet your specific needs.