Unique mass spectrometry service for Host Cell Protein analysis (HCP)
Alphalyse offers a unique Host Cell Protein analysis by LC-MS. Most importantly, the analysis provides identification and quantification of each individual Host Cell Protein. However, we also give you a quantitation of the total HCP content (ng HCP/mg DS) in your sample.
Host cell proteins (HCP’s) are the most important process-related impurity in recombinant biopharmaceuticals. This is because HCP’s may effect drug safety and efficacy. In addition, some HCPs may cause adverse effects in patients. And not to forget, HCPs can impact the drug stability by proteolytic and lipase activity.
We are experts in Host Cell Protein analysis by mass spectrometry in the following areas:
- Identification of HCP in each process sample.
- Physical properties of each host cell protein (aa sequence, Mw, pI, hydrophobicity).
- Comparison of host cell proteins between process steps and host cell protein clearance.
- Identification of host cell proteins in GMP batches.
- Documentation of host cell protein clearance for PAT and process validation.
- Absolute quantification of specific host cell proteins.
- Identification of HCP of potential concern in drug substance.
- Feature analysis of identified host cell proteins.
- Monitoring and quantification of specific host cell protein of concern based on your risk assessment.
Comparison of process related impurities in multiple lots of biosimilar and originator.. (read more)
- Quantification of individual host cell proteins in biosimilar and originator.
- Identification of single host cell protein in biosimilar and originator.
- Comparison of host cell protein in biosimilar and originator.