Need analysis of process-related impurities in biosimilar compared to reference product?
We provide side-by-side comparison of process-related impurities in proposed product compared to originator. For a sensitive and reproducible analysis of HCPs in originator and biosimilar we therefore perform the analysis by SWATH LC-MS.
You can use this analysis to:
- Identify and quantify both total and individual HCPs in ng/mg drug substance.
- Compare HCP levels in multiple lots of biosimilar to multiple lots of reference product.
- Regulatory documentation for FDA/EMA approval.
Note, this LC-MS analysis does not require access to ELISA reagents. Above all, don’t risk your biosimilar project – let us help you with an objective HCP comparison between batches.
This Host Cell Protein assay includes:
- A generic sample preparation for purified batches and also process samples in different matrices.
- LC-MS peptide analysis on a robust microflow HPLC and Sciex TrippleTOF 6600 mass spectrometer.
- SWATH LC-MS for reproducible HCP identification and quantification. What is SWATH? >>
- Finally, we send you a report with a list of HCPs and their physiochemical properties (MW, pI, AA sequence, database accession number) for each biosimilar and originator lot.
Send us a description of your project and we will be glad to discuss Host Cell Protein analysis with you.