Advances on Size Exclusion Chromatography and Applications on the Analysis of Protein Biopharmaceuticals and Protein Aggregates: A Mini Review
作者： Gloria Brusotti , Enrica Calleri , Raffaella Colombo , Gabriella Massolini , Francesca Rinaldi
DOI: 10.1007/S10337-017-3380-5
关键词:
摘要: 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 safety. A major concern in manufacturing biopharmaceuticals propensity form aggregates. separation proteins by size-exclusion chromatography (SEC) well-established method for macromolecules demand increased resolution faster analysis SEC has led development small, more rigid fully porous particles superficially with different pore sizes. coupling three or four detectors enhanced generating accurate molecular weights (absolute determination) giving insight into degradation pathways associated aggregation. intent this review report continuous developments stationary phases applications on intact proteins, variants aggregates complexes. Thus, most recent focus reported discussed.
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