Unique Host Cell Protein analysis service by mass spectrometry
Alphalyse offers unique Host Cell Protein (HCP) analysis service by the unique SWATH LC-MS approach. Most importantly, the analysis provides identification and quantification of each individual HCP. Additionally, the analysis also gives you the total HCP content (ng HCP/mg DS) in each sample.
HCPs are the most important process-related impurity in recombinant biopharmaceuticals. In patients, the HCPs may affect drug safety and efficacy and some HCPs may cause adverse effects. Moreover, the drug product stability can be reduced by HCPs with enzymatic activity, such as protease and lipase activity.
Do you know the HCPs in your biopharmaceutical protein? Read how you can learn about your HCPs in this brochure >
We are experts in HCP analysis by mass spectrometry in the following areas:
- Identification of HCP in each process sample.
- Moreover, physical properties of each HCP (amino acid sequence, MW, pI, hydrophobicity).
- Finally, a comparison of HCPs between process steps and HCP clearance.
- Identification of HCPs in GMP batches.
- Documentation of HCP clearance for PAT and process validation.
- Absolute quantification of specific HCPs.
- Identification of HCP of potential concern in drug substance.
- Moreover, feature analysis of identified HCPs.
- Monitoring and quantification of specific HCP of concern based on your risk assessment.
- Quantification of individual HCPs in biosimilar and originator.
- Identification of single HCP in biosimilar and originator.
- Finally, a comparison of HCP in biosimilar and originator.