Quantify HCPs of concern

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

Host cell protein quantification of individual HCPs is important, because some HCP can influence product safety even at very low level. Such 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 specific host cell protein quantification 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 host cell protein quantification, 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 then spiked in known amounts into the samples to generate standard curves for linearity and calibration.

Our standard host cell protein quantification 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 host cell proteins of concern by MRM LC-MS/MS
• Finally, reporting with determined protein amounts and analysis details