Biosimilar analysis

Detailed analysis of biosimilar products and comparison to the originator

Alphalyse may analyze any biosimilar and compare it to its originator product for direct comparison. We can also evaluate on the production steps by analyzing multiple lots of biopharmaceutical product. This is especially useful for manufacturers with interest in comparing their own product to competitors with similar products.

All analyses are conducted according to the ICH Q6B guidelines – Test Procedures and Acceptance Criteria for Biotechnological/Biological Products.

You can choose and combine your preferred analysis package from the following services:

Identification

We identify your protein(s) by MS peptide analysis followed by a database search.

Peptide mapping

We confirm the theoretical amino acid sequence of proteins by peptide mapping.

Sequencing

We determine the exact amino acid sequence of your protein by Edman or N- and C-terminal sequencing.

Molecular weight

We determine the exact molecular weight of your recombinant protein.

Quantification

We quantify the protein concentration by amino acid assay or multiple reaction monitoring.

Modification/Stability

We determine the number and also the position of disulfide bridges and glycosylations in your product.

HCP analysis

We identify and quantify host cell proteins in your product and provide physical properties of each HCP.

Biosimilar analysis

You can choose and combine your preferred analysis package from the following services:

Send us your project description so we can design a service package that meets your needs.