Optimized CE-SDS purity detection method

Optimized CE-SDS purity detection method

The invention discloses an optimized CE-SDS purity detection method and an application thereof. The detection method provided by the invention is used for determining the purity of the anti-RANKL monoclonal antibody drug, and the specificity, the linearity and range, the accuracy and the precision a...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: CAI YUAN, DAI HU, DING MANSHENG, SHEN HONG, ZHOU JIEFANG
Format: Patent
Sprache:chi ; eng
Schlagworte:
INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES
MEASURING
PHYSICS
TESTING
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Beschreibung
Zusammenfassung:The invention discloses an optimized CE-SDS purity detection method and an application thereof. The detection method provided by the invention is used for determining the purity of the anti-RANKL monoclonal antibody drug, and the specificity, the linearity and range, the accuracy and the precision are verified, so that the detection method has important significance on research and development and quality control of RANKL targeted therapy drugs. 本发明公开了一种优化的CE-SDS纯度检测方法及其应用。采用本发明的检测方法测定抗RANKL单克隆抗体药物的纯度，对专属性、线性与范围、准确度、精密度方面进行验证，这对于RANKL靶向治疗药物的研究开发、质量控制都具有重要的意义。