Protagen Protein Services is pleased to inform you about our latest publication: A Comparison of UPLC and CE-based Approaches for Glycan Profiling of Biotherapeutic Proteins- Challenges for the Fast Characterization of New Biological Entities (NBEs) and Biosimilar Candidates
presented by Dr. Thomas Schröter, Team Leader Biotherapeutical Analytics, on the occasion of the 20th CE Pharm 2018, 29. Sep. - 02. Oct. 2018 Bethesda, USA. (Publications)
A comparison of UPLC and CE-based approaches for glycan profiling of biotherapeutic proteins - Challenges for the fast characterization of new biological entities (NBEs) and biosimilar candidates.
The characterization of biopharmaceuticals such as new biological entities (NBEs) and their biosimilars is a challenging field due to their structural complexity. When implementing a manufacturing process, variations in the protein structure or post-translational modifications occur. Therefore, a characterization program is required according to the guidelines of national authorities. When characterizing proteins from scratch, glycosylation is a central modification that has to be taken into account, as it can affect the half-life and the stability of the protein.
In this study, we evaluated a CE -based fast glycan labeling and analysis kit as a fast screening method to identify samples for subse quent detailed HILIC analysis. To assess the comparability the UHPLC method and CE method have been performed using the same sample. We analyzed a IgG market product and compared the obtained results with respect to identified glycans and the obtained relative peak areas.
As for the glycans identified by both methods, the relative areas were in the same value range with a certain degree of variance. All in all, the fast glycan analysis seems to be a suitable tool for fast screening of glycan composition and a decision support for selecting a reduced sample set for subsequent in-depth HILIC analysis.
Through this approach we are able to help customers to streamline, speed up and save money in the development process.