Khodabandehloo Akram, Chen David Da Yong
Department of Chemistry, University of British Columbia, Vancouver, BC, V6T 1Z1, Canada.
Bioanalysis. 2017 Feb;9(3):313-326. doi: 10.4155/bio-2016-0269. Epub 2017 Jan 18.
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.
蛋白质聚集是一种常见的生物学现象，它与退行性疾病有关，并且在制药行业中是个难题。根据监管机构提供的规则，制药行业应该评估产品质量中关于亚可见颗粒的存在情况。此外，他们还应评估用于测量这些颗粒的技术。因此，美国食品药品监督管理局（US FDA）和制药行业一直在寻找能够准确表征蛋白质产品的方法。这里所综述的四种粒度分析技术是用于表征蛋白质及其聚集体的良好候选方法：动态光散射、尺寸排阻色谱法、电子显微镜和泰勒分散分析。前三种是更成熟的技术，而最后一种是一种较新且不断发展的技术。
