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1260 Infinity II Bio-SEC 系统是一种体积排阻色谱 (SEC) 系统,旨在应对分析生物聚合物所面临的挑战。无金属流路可确保在高盐浓度和极端 pH 值的恶劣分析条件下进行稳定可靠的操作。1260 Infinity II GPC/SEC 柱温箱带有可选的冷却功能,可确保样品完整性。先进的检测方法(比如采用 SEC MALS 检测的多角度光散射)可测量溶液中大分子的绝对分子量、大小和构象。这种独特的组合使该系统拥有先进的检测功能,是蛋白质摩尔质量、纯度和聚集体分析的理想解决方案。
特性
无金属样品流路可对生物聚合物进行可靠表征
高耐盐性和宽 pH 耐受范围结合主动密封垫清洗和四元流动相混合功能,提高了灵活性
专用的 SEC 柱温箱具有高容量和冷却功能
灵活添加多角度光散射 (MALS) 检测,可以表征生物聚合物的聚集体、尺寸和形状
WinGPC 软件符合软件法规要求,提供了专用的 SEC 软件平台
增加多检测器或动态光散射检测可提供更多见解
卓越性能和可持续性:1260 Infinity II 液相色谱系统经过独立审计,确认其在整个产品生命周期对环境的影响后,获得了 My Green Lab ACT(归责性、一致性、透明度)标签。
工作原理
CQA Analysis: Charge Variant and Aggregation Analysis by Bio-IEX and Bio-SEC
Monoclonal antibodies represent an important class of biomolecules that must be characterized in development and production in detail for their critical quality attributes (CQAs). CQAs include aggregation and charge variant analyses that characterize the originator or biosimilar in detail for critical variations. See this study for a comparison of two rituximab biosimilars from different manufacturers to the innovator for their aggregation and charge variant profiles via two analytical workflows using an Agilent 1260 Infinity II Bio-Inert LC and Agilent AdvanceBio columns.
Aggregation Analyses in Protein Production and Research and Development
For many biopharma applications, the extent of aggregation of monoclonal antibodies (mAbs) and proteins must be characterized and quantified precisely under many conditions, especially in critical quality attribute analyses (CQA). Size exclusion chromatography (SEC) is a powerful technique for analyzing biological polymers, providing excellent chromatography under conditions that accommodate natural protein conformation. In this application, see how Agilent Buffer Advisor Software can be used with the Agilent 1260 Infinity II Bio-SEC System to optimize aggregation analyses.
Size Exclusion Chromatography (SEC): Analysis of Antibody Drug Conjugates
Efficacy of monoclonal antibodies (mAbs) is connected to the correct primary, secondary, tertiary, and quaternary structure. Production processes, storage, and transportation conditions can stimulate aggregation. The presence of aggregates can lead to activity loss, decreased solubility, and enhanced immunogenicity. Therefore, mAbs including the derived antibody drug conjugates are subject to critical quality attribute analyses. SEC is the most commonly used liquid chromatography technique for analyzing biological polymers to determine the number of mAb aggregates.