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1260 Infinity II Bio-SEC 系統(tǒng)是一種體積排阻色譜 (SEC) 系統(tǒng),旨在應(yīng)對分析生物聚合物所面臨的挑戰(zhàn)。無金屬流路可確保在高鹽濃度和極端 pH 值的惡劣分析條件下進行穩(wěn)定可靠的操作。1260 Infinity II GPC/SEC 柱溫箱帶有可選的冷卻功能,可確保樣品完整性。先進的檢測方法(比如采用 SEC MALS 檢測的多角度光散射)可測量溶液中大分子的絕對分子量、大小和構(gòu)象。這種獨特的組合使該系統(tǒng)擁有先進的檢測功能,是蛋白質(zhì)摩爾質(zhì)量、純度和聚集體分析的理想解決方案。
特性
無金屬樣品流路可對生物聚合物進行可靠表征
高耐鹽性和寬 pH 耐受范圍結(jié)合主動密封墊清洗和四元流動相混合功能,提高了靈活性
專用的 SEC 柱溫箱具有高容量和冷卻功能
靈活添加多角度光散射 (MALS) 檢測,可以表征生物聚合物的聚集體、尺寸和形狀
WinGPC 軟件符合軟件法規(guī)要求,提供了專用的 SEC 軟件平臺
增加多檢測器或動態(tài)光散射檢測可提供更多見解
卓越性能和可持續(xù)性:1260 Infinity II 液相色譜系統(tǒng)經(jīng)過獨立審計,確認(rèn)其在整個產(chǎn)品生命周期對環(huán)境的影響后,獲得了 My Green Lab ACT(歸責(zé)性、一致性、透明度)標(biāo)簽。
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.