Quantify Host Cell Proteins of concern
- Determine HCPs specific to your process
- Obtain the exact amount in all purification steps
- Results to be used for removal of immunogenic and proteolytic proteins
Do you want to monitor specific HCPs in your drug substance?
Individual HCPs can influence product safety even at very low level. The problematic HCPs include:
- Immunogenicity: Induce immune response against drug substance or human protein
- Enzymatic activity: Degrade the drug substance or constituents in the drug product
- Biological activity or homology to the drug substance
Therefore, we offer to determine the quantity of specific HCPs in your sample – by a targeted and sensitive LC-MS/MS analysis based on Multiple Reaction Monitoring (MRM) methods.
The analysis include identification of unique signature peptides for the specific protein. For quantitation, we preferable use the intact reference protein if available, or alternatively, the synthetic isotope-labeled signature peptides. The reference protein or the labeled peptides are spiked in known amounts into the samples to generate standard curves for linearity and calibration.
Our standard service includes
- Identification of up to 3 unique signature peptides for quantitation
- Standard curves and linearity assessment for dilution series of the HCP of concern and quantification standards
- Absolute quantification of HCPs of concern by MRM LC-MS/MS
- Finally, reporting with determined protein amounts and analysis details