Particle sizing methods for the detection of protein aggregates in biopharmaceuticals.
Protein aggregation is a common biological phenomenon which is responsible for degenerative diseases and is problematic in the pharmaceutical industry. According to the rules provided by regulatory agencies, industry is supposed to assess the product quality regarding the presence of subvisible particles. Also, they should evaluate the technologies that are used to measure these particles. Therefore, US FDA and industry have been looking for methods capable of accurately characterizing the protein products. Four sizing techniques reviewed here are good candidates to be used for characterization of protein and their aggregates: dynamic light scattering, size-exclusion chromatography, electron microscopy and Taylor dispersion analysis. The first three are more established techniques while the last one is a more recent and growing technique.
['Khodabandehloo|Akram|A|', 'Chen|David Da Yong|DD|']
D059451:Biosimilar Pharmaceuticals D002623:Chemistry Techniques, Analytical D002850:Chromatography, Gel D006801:Humans D010316:Particle Size D066329:Protein Aggregates D011506:Proteins
protein aggregation pharmaceuticals sizing techniques dynamic light scattering size-exclusion chromatography electron microscopy Taylor dispersion analysis protein-based therapeutics