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6. Biosimilar comparability studies

Biosimilars such as all biomolecules are complex to characterize and can be affected by minor modifications of the production processes. Therefore, certifying the similarity of biologics is challenging comparing to generic small molecules. A large panel of methods is generally required.

With our FTIR spectroscopy-based analyses, we are able to compare four critical quality attributes: (I) the higher-order structure, (II) the glycosylation, (III) the total protein concentration and (IV) the quantity of other excipients (Tween, lipids,…). Using multivariate and statistical tools, an accurate comparison of the fingerprint provided by the FTIR spectra can be performed.