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:

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

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