Capillary gel electrophoresis detection kit containing reducing agent

Abstract

The invention relates to a capillary gel electrophoresis detection kit containing a reducing agent. The reducing agent is selected from a monothiol compound and a dithiol compound, the monothiol compound is selected from 11-mercapto-1-undecanol, and the dithiol compound is selected from 2, 2'-(1, 2-ethanedioxy) bis-ethanethiol and ethylene glycol dithioglycolate. The kit disclosed by the invention can be used for reducing environmental pollution and harm to a human body in the process of analyzing biopharmacy such as monoclonal antibodies through reduced capillary gel electrophoresis, and ensuring accuracy of purity under a reduction condition at the same time; the biological drugs comprise a recombinant anti-ricin humanized monoclonal antibody, a recombinant anti-HER2 humanized monoclonal antibody, T-DM1 and a recombinant human type II tumor necrosis factor receptor-antibody fusion protein for injection.

Description

technical field

[0001] The invention belongs to the field of biotechnology, and relates to the analysis of protein by reduced capillary gel electrophoresis, in particular to a capillary gel electrophoresis detection kit containing a reducing agent that can accurately detect the purity of biopharmaceuticals such as antibodies. Background technique

[0002] With the continuous development of the field of biopharmaceuticals, more and more techniques are applied to the heterogeneity characterization of therapeutic proteins. Among them, capillary gel electrophoresis (CGE), as a technology developed from traditional slab gel electrophoresis, has gradually become the standard for the purity of many biopharmaceuticals, especially antibodies, due to its advantages of automation, rapidity, high resolution and on-line quantification. One of the characterization tools. Taking monoclonal antibody as an example, in the reduction analysis, the protein molecule will be reduced by the reduc...

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