Upon joining expertise at the University of Salzburg in protein production and characterization, bioanalytical chemistry, synthetic chemistry, structural biology, and bioinformatics, this project aims at developing innovative characterization tools for biosimilarity, using and combining highly informative technologies such as high-performance liquid chromatography (HPLC), capillary electrophoresis (CE), mass spectrometry (MS), bioinformatics, crystallography, chemical synthesis, and biological assays. Novartis is a worldwide leader and the preferred collaboration partner in the production and marketing of biosimilars. Thermo Fisher Scientific is one of the global leaders for providing most of the instrumental technologies that are utilized by the team for protein characterization.
Researchers are developing biosimilar characterization methods using well-defined pairs of biosimilar and originator proteins to derive quantifiable parameters for biosimilarity. The therapeutic proteins Rituximab, Humira, Erythropoietin, Pegfilgrastim, and Etanercept were selected as representatives for various classes of biopharmaceutical drugs. HPLC and CE hyphenated to MS, as well as nuclear magnetic resonance spectroscopy are implemented for providing highly informative data for identification, sequence confirmation, and detection of co- and post-translational modifications. Conformational variability is studied with conformation-sensitive methods such as HPCE, size-exclusion HPLC, or light scattering methods. Three-dimensional structures of the biosimilars, also interacting with target molecules/receptors, are characterized by analytical cascades of enzymes or structure-specific aptamers molecules.