单克隆抗体与重组蛋白质越来越多地被作为生物治疗性制剂。相应地，LC和LC/MS方法也作为有力的分离技术而占据了重要地位，用于支持蛋白鉴定和稳定性测试。沃特世蛋白分离技术(PrST：Protein Separation Technology)产品包括反相、离子交换和分子筛色谱柱，能够很好的应对这些分离挑战。此外，我们基于HPLC的BioSuite、SEC、IEX、HIC和反相HPLC柱为这些大分子分离提供了杰出的色谱性能。
ACQUITY UPLC SEC系统解决方案基于独特的亚乙基桥杂化(BEH)
二醇包膜颗粒柱技术,能将蛋白质或肽单体与其聚合物快速分离并进行准确定量，这是生物制药领域中各大知名客户购买ACQUITYUPLC SEC系统解决方案的关键原因所在。
■与使用软凝胶或>5_m硬颗粒的传统SEC方法相比，该技术可将聚合物分析的准确测定速度提高10倍之多，且所消耗的洗脱液更少。
■显著降低了对高盐浓度流动相的需求，减少了蛋白质/肽和SEC颗粒表面之间的离子交换次级作用。
■用相关蛋白质和肽对填料批次进行质控测试，有助于确保达到极佳的批间稳定性，从而提供了验证方法的可靠程度。
■拥有三种孔径选择：125Å、200Å和450Å，适用于不同分子量级别的生物药项目。
2010年，沃特世推出了1.7µm的ACQUITY UPLC Protein BEH SEC色谱柱，用于在沃特世低扩散的UPLC仪器上获得最佳性能。与传统的5-8 µm SEC色谱柱相比，ACQUITYUPLC Protein BEH SEC色谱柱首次在更短时间内表现出了卓越的组分分离度。2015年开始，沃特世相继推出化学性质完全一致的XBridge Protein BEH SEC125Å、200Å和450Å, 3.5, 2.5 µm色谱柱，可在常规HPLC平台上提供相当的组分分离度。
Analysis of Biomolecules by Size- Exclusion UltraPerformanc e Liquid Chromatography
In the production of biopharmaceuticals, there may be different analytical requirements for groups performing clone section, formulations and stability, and quality control (QC). Depending on the goal of the separation, methods may be optimized for fast analysis time, highest possible resolution, and/or reproducibility. Size-exclusion (SEC) chromatography is often used throughout the biopharmaceutical production process for the analysis of proteins and their aggregates. While SEC has traditionally been used in conjunction with low pressure HPLC instrumentation, the advent of UPLC® Technology and new sub-2 µm packing materials allows for substantial improvements in chromatographic resolution and throughput. This application note will demonstrate the use of the new ACQUITY UPLC® SEC solution for the improved detection and/ or faster analysis of protein aggregates in biopharmaceuticals.
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