Biosimilar analysis
Detailed analysis of biosimilars and comparison to originator
How do you make sure that your biosimilar lives up to the same strict regulatory criteria as the originator product?
An effective, thorough way is to apply mass spectrometry-based methods and thus analyze aspects, such as protein sequence, intact mass, concentration, post translational modifications or process-related impurities as part of your biosimil...
How do you make sure that your biosimilar lives up to the same strict regulatory criteria as the originator product?
An effective, thorough way is to apply mass spectrometry-based methods and thus analyze aspects, such as protein sequence, intact mass, concentration, post translational modifications or process-related impurities as part of your biosimilar analysis.
For approval of originator products, a comprehensive documentation of Host Cell Proteins (HCPs) must be carried out. Even though biosimilars contain the same active product ingredient (API), analysis shows that the HCP content might not be the same. Thus, the API in biosimilars might have different activity or immunogenic ability, and should be subject to just as extensive an HCP analysis as their originators to verify that the biosimilar does not have a critical Host Cell Protein population.
What you get out of a collaboration with us
Alphalyse can analyze any protein-based biosimilar and compare it to its reference product. With detailed HCP results, you might even find that your biosimilar has a safer HCP profile. This would be a great selling point to pass on to the regulatory authorities for market approval.
With the Alphalyse HCP analysis you can intelligently optimize your process development, track the removal of residual proteins added during manufacturing, measure the HCP assay coverage and even compare HCP ELISA kits from different vendors. We can also evaluate on the production steps by analyzing multiple lots of biopharmaceutical product. This is especially useful for you if you have an interest in comparing your biosimilar product to competitors with similar products or to the original product manufacturer.
You receive a report with lists of HCPs and their physiochemical properties (MW, pI, AA sequence, database accession number) for both the biosimilar and the originator analysis.
Your guarantee for world-class results
All analyses are conducted according to the ICH Q6B guidelines – Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. Furthermore, we always guarantee you that PhD-level scientists are involved in your project to apply their extensive knowledge, and ensure both fast turnaround-time and in-depth Host Cell Protein characterization.
Note, this mass spectrometry-based (LC-MS) analysis does not require access to any HCP ELISA reagents. We simply need to know the host organism and any other proteins that you add during the biologic’s process development.
