Quantification of Host Cell Proteins

Do you want to monitor specific HCPs of concern in your drug substance?

Host cell protein quantification of individual HCPs is important. Why? Because some HCP can influence product safety even at very low level.

Such problematic HCPs may thus cause

• 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 quantification of specific host cell protein in your sample – by a targeted and sensitive LC-MS/MS analysis based on Multiple Reaction Monitoring (MRM) methods.

The analysis includes identification of unique signature peptides for the specific protein. For host cell protein quantification, we prefer using the intact reference protein if available. Or alternatively, the synthetic isotope-labeled signature peptides.

Next, the reference protein or the labeled peptides are spiked in known amounts into the samples. This then generates standard curves for linearity and calibration.

Our standard host cell protein quantification service includes

• Identification of up to 3 unique signature peptides for HCP quantitation.
• Standard curves and linearity assessment for a dilution series of the HCP of concern and quantification standards.
• Absolute quantification of host cell proteins of concern by MRM LC-MS/MS.
• Reporting of the determined protein amounts and analysis details.