Abstract
Biopharmaceutical drugs are large, complex protein molecules derived from living cells. The characterization of the protein-based products is a complicated and challenging task necessary to guarantee their efficacy and safety. A major concern in manufacturing protein biopharmaceuticals is their propensity to form aggregates. The separation of proteins by size-exclusion chromatography (SEC) is a well-established method for the characterization of macromolecules and their aggregates. The demand for increased resolution and faster analysis in SEC has led to the development of small, more rigid fully porous particles and superficially porous particles with different pore sizes. The coupling of SEC with three or four detectors has enhanced protein characterization by generating accurate molecular weights (absolute determination) and by giving insight into the degradation pathways and products associated with aggregation. The intent of this review is to report the continuous developments of SEC stationary phases and their applications on the characterization of intact proteins, their variants or aggregates and protein complexes. Thus, the most recent applications of SEC with the focus on proteins and protein aggregates are reported and discussed.
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Published in the topical collection Peptide and Protein Analysis with Debby Mangelings and Gerhard K. E. Scriba as editors.
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Brusotti, G., Calleri, E., Colombo, R. et al. Advances on Size Exclusion Chromatography and Applications on the Analysis of Protein Biopharmaceuticals and Protein Aggregates: A Mini Review. Chromatographia 81, 3–23 (2018). https://doi.org/10.1007/s10337-017-3380-5
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DOI: https://doi.org/10.1007/s10337-017-3380-5