Thermo Fisher Scientific has been working with the Christian Doppler Laboratory for Innovative Tools for Biosimilar Characterization (CDL) at the University of Salzburg, Austria and other corporate members since 2013 to co-develop a toolkit of new/novel and appropriate methods and workflows for the analysis of biosimilar drug molecules. The collaboration aims to:
Robust manufacturing processes resulting in consistent glycosylation are critical for the efficacy and safety of biopharmaceuticals. Information on glycosylation can be obtained by conventional bottom–up methods but is often limited to the glycan or glycopeptide level. In this seminal publication researchers from the CDL detail the application of high-resolution native mass spectrometry (MS) for the characterization of the therapeutic fusion protein Etanercept, unravelling glycoform heterogeneity in conditions of hitherto unmatched mass spectral complexity.
Higher spatial resolution at lower charge states, an inherent characteristic of native MS, represents a key component for the successful revelation of glycan heterogeneity. Combined with enzymatic dissection using a set of proteases and glycosidases, assignment of specific glycoforms was achieved by transferring information from the subunit to the whole protein level. The application of native mass spectrometric analysis of intact Etanercept as a fingerprinting tool for the assessment of batch-to-batch variability is exemplified and its usage in demonstrating comparability after changes in the biologic manufacturing process is suggested.
The biopharma industry demands consistent quality and batch-to-batch comparability, which means that the in-depth characterization of a protein therapeutic and any modifications, such as glycosylation, is essential. In this article, co-authored by the CDL and Thermo Fisher Scientific, learn about the collaboration between Thermo Fisher and the CDL, the research focuses of the CDL and the reason why the Thermo Scientific Vanquish UHPLC has been a welcome addition to their laboratory.